10q10k10q10k.net

What changed in NovaBridge Biosciences's 20-F — 2022 vs 2023

vs

Paragraph-level year-over-year comparison of NovaBridge Biosciences's 2022 and 2023 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+1091 added−1705 removedSource: 20-F (2024-04-30) vs 20-F (2022-12-31)

Top changes in NovaBridge Biosciences's 2023 20-F

1091 paragraphs added · 1705 removed · 852 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

318 edited+96 added−271 removed383 unchanged
Biggest changeOperating and Financial Review and Prospects.” (2) Share-based compensation expenses were allocated as follows: 7 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2018 ​ 2019 ​ 2020 ​ 2021 ​ 2022 ​ RMB RMB RMB RMB RMB USS ​ (in thousands) Research and development expenses 1,056 470 284,431 201,926 117,876 17,090 Administrative expenses 2,464 514,733 209,033 406,683 239,272 34,691 Equity in loss of affiliates — — 32,707 13,267 13,852 2,008 Total 3,520 515,203 526,171 621,876 371,000 53,789 ​ The following table presents our selected consolidated statements of balance sheet data as of the dates indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, ​ ​ 2018 ​ 2019 ​ 2020 ​ 2021 ​ 2022 ​ RMB RMB RMB RMB RMB US$ ​ ​ (in thousands) Selected Consolidated Statements of Balance Sheet Data: Current assets: Cash and cash equivalents 1,588,278 1,137,473 4,758,778 3,523,632 3,214,005 465,987 Restricted cash 92,653 55,810 — — 96,764 14,029 Accounts receivable — — 130,498 33,081 — — Contract assets 11,000 — 227,391 253,780 — — Short-term investments — 32,000 31,530 753,164 235,429 34,134 Inventories — — — 27,237 — — Prepayments and other receivables 88,972 136,036 195,467 190,824 80,278 11,639 Other financial assets 255,958 — — — — — Total current assets 2,036,861 1,361,319 5,343,664 4,781,718 3,626,476 525,789 Property, equipment and software 27,659 30,069 25,272 45,716 60,841 8,821 Operating lease right-of-use assets — 16,435 14,997 112,781 63,125 9,152 Intangible assets 148,844 148,844 120,444 119,666 118,888 17,237 Goodwill 162,574 162,574 162,574 162,574 162,574 23,571 Investment accounted for using the equity method — — 664,832 352,106 30,850 4,473 Other non-current assets — 18,331 2,010 26,634 10,911 1,582 Total assets 2,375,938 1,737,572 6,333,793 5,601,195 4,073,665 590,625 Total liabilities 415,684 668,090 706,648 1,041,635 1,163,763 168,729 Total mezzanine equity 2,915,358 3,104,177 — — — — Shareholders’ deficit ​ ​ Ordinary shares (US$0.0001 par value, 800,000,000 shares authorized as of December 31, 2021 and 2022; 183,826,753 and 190,879,919 shares issued and outstanding as of December 31, 2021 and 2022, respectively) 6 6 114 126 132 19 Treasury stock (1) — — — (21,249) (3,081) Additional paid-in capital — 389,379 7,701,116 9,100,777 9,579,375 1,388,879 Accumulated other comprehensive income (loss) 59,380 70,127 (50,793) (186,510) 213,794 30,997 Accumulated deficit (1,014,489) (2,494,207) (2,023,292) (4,354,833) (6,862,150) (994,918) Total shareholders’ equity/(deficit) (955,104) (2,034,695) 5,627,145 4,559,560 2,909,902 421,896 Total liabilities, mezzanine equity and shareholders’ equity/(deficit) 2,375,938 1,737,572 6,333,793 5,601,195 4,073,665 590,625 ​ 8 Table of Contents The following table presents our selected consolidated statements of cash flow data for the years indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2018 ​ 2019 ​ 2020 ​ 2021 ​ 2022 ​ RMB RMB RMB RMB RMB USS ​ ​ (in thousands) Selected Consolidated Statements of Cash Flow Data: Net cash (used in) generated from operating activities (280,705) (867,982) 433,558 (973,093) (1,102,805) (159,892) Net cash generated from (used in) investing activities 9,500 212,462 (201,901) (727,206) 458,382 66,459 Net cash generated from financing activities 1,479,669 152,709 3,440,481 593,924 42,357 6,141 Effect of exchange rate changes on cash and cash equivalents and restricted cash 59,754 15,163 (106,643) (128,771) 389,203 56,429 Net increase (decrease) in cash, cash equivalents and restricted cash 1,268,218 (487,648) 3,565,495 (1,235,146) (212,863) (30,863) Cash, cash equivalents and restricted cash, beginning of the year 412,713 1,680,931 1,193,283 4,758,778 3,523,632 510,879 Cash, cash equivalents and restricted cash, end of the year 1,680,931 1,193,283 4,758,778 3,523,632 3,310,769 480,016 ​ A.
Biggest changeWe also reclassified impairment of goodwill amounted to RMB162.6 million (US$22.9 million) for the year ended December 31, 2023 to loss from operations, as compared to that reported in the same earnings release. ​ 8 Table of Contents The following table presents our selected consolidated statements of balance sheet data as of the dates indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, ​ ​ 2019 ​ 2020 ​ 2021 ​ 2022 ​ 2023 ​ RMB RMB RMB RMB RMB US$ ​ ​ (in thousands) Selected Consolidated Statements of Balance Sheet Data: ​ ​ Current assets: ​ ​ Cash and cash equivalents 1,137,473 4,758,778 3,523,632 3,214,005 2,141,445 301,616 Short-term restricted cash ​ 55,810 ​ — ​ — ​ 96,764 ​ — ​ — Accounts receivable — 130,498 33,081 — — — Contract assets — 227,391 253,780 — — — Short-term investments 32,000 31,530 753,164 235,429 143,221 20,172 Inventories — — 27,237 — — — Prepayments and other receivables 136,036 195,467 190,824 80,278 52,003 7,325 Total current assets 1,361,319 5,343,664 4,781,718 3,626,476 2,336,669 329,113 Long-term restricted cash ​ — ​ — ​ — ​ — ​ 58,913 ​ 8,298 Property, equipment and software 30,069 25,272 45,716 60,841 36,511 5,142 Operating lease right-of-use assets 16,435 14,997 112,781 63,125 46,400 6,535 Intangible assets 148,844 120,444 119,666 118,888 118,110 16,635 Goodwill 162,574 162,574 162,574 162,574 — — Investment accounted for using the equity method — 664,832 352,106 30,850 12,082 1,702 Other non-current assets 18,331 2,010 26,634 10,911 4,282 603 Total assets 1,737,572 6,333,793 5,601,195 4,073,665 2,612,967 368,028 Total liabilities 668,090 706,648 1,041,635 1,163,763 894,811 126,031 Total mezzanine equity 3,104,177 — — — — — Shareholders’ (deficit)/equity ​ ​ ​ ​ ​ ​ Ordinary shares (1) 6 114 126 132 133 19 Treasury stock (1) — — — (21,249) (56,803) (8,001) Additional paid-in capital (1) 389,379 7,701,116 9,100,777 9,579,375 9,804,379 1,380,918 Accumulated other comprehensive income (loss) 70,127 (50,793) (186,510) 213,794 298,291 42,013 Accumulated deficit (2,494,207) (2,023,292) (4,354,833) (6,862,150) (8,327,844) (1,172,952) Total shareholders’ (deficit)/equity (2,034,695) 5,627,145 4,559,560 2,909,902 1,718,156 241,997 Total liabilities, mezzanine equity and shareholders’ equity/(deficit) 1,737,572 6,333,793 5,601,195 4,073,665 2,612,967 368,028 Note: (1) In the course of preparing our audited consolidated financial statements for the year ended December 31, 2023, we corrected the shareholders’ (deficit)/equity balances of ordinary shares, treasury stock and additional paid-in capital contained in the earnings release reporting our unaudited financial results for the full year ended December 31, 2023, which was publicly announced and furnished with the SEC through our current report on Form 6-K in March 2024.
Global economies could suffer dramatic downturns as the result of a deterioration in the credit markets and related financial crisis as well as a variety of other factors including, extreme volatility in security prices, severely diminished liquidity and credit availability, ratings downgrades of certain investments and declining valuations of others.
Global economies could suffer dramatic downturns as a result of a deterioration in the credit markets and related financial crisis as well as a variety of other factors including, extreme volatility in security prices, severely diminished liquidity and credit availability, ratings downgrades of certain investments and declining valuations of others.
On December 15, 2022, the PCAOB issued a report that vacated its December 16, 2021 determination and removed mainland China and Hong Kong from the list of jurisdictions where it is unable to inspect or investigate completely registered public accounting firms.
On December 15, 2022, the PCAOB issued a report that vacated its December 16, 2021 determination and removed mainland China and Hong Kong from the list of jurisdictions where it is unable to inspect or investigate completely registered public accounting firms.
While we have not started commercialization of drug candidates, any rising trade and political tensions or unfavorable government policies on international trade, such as capital controls or tariffs, may affect the demand for our drug products, the competitive position of our drug products, the hiring of scientists and other research and development personnel, and import or export of raw materials in relation to drug development, or prevent us from selling our drug products in certain countries.
While we have not started the commercialization of our drug candidates, any rising trade and political tensions or unfavorable government policies on international trade, such as capital controls or tariffs, may affect the demand for our drug products, the competitive position of our drug products, the hiring of scientists and other research and development personnel, and import or export of raw materials in relation to drug development, or prevent us from selling our drug products in certain countries.
Taxation—United States Federal Income Tax Considerations”) will generally be subject to reporting requirements and may incur significantly increased United States income tax on gain recognized on the sale or other disposition of the ADSs or ordinary shares and on the receipt of distributions on the ADSs or ordinary shares to the extent such gain or distribution is treated as an “excess distribution” under the United States federal income tax rules and such U.S.
Taxation—United States Federal Income Tax Considerations”) will generally be subject to reporting requirements and may incur significantly increased U.S. federal income tax on gain recognized on the sale or other disposition of the ADSs or ordinary shares and on the receipt of distributions on the ADSs or ordinary shares to the extent such gain or distribution is treated as an “excess distribution” under the U.S. federal income tax rules and such U.S.
We do not have control over third-party manufacturers’ compliance with these regulations and requirements; ● we may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our drugs; ● our contract manufacturers could breach or terminate their agreements with us; 28 Table of Contents ● our contract manufacturers may be unable to sustain their business and become bankrupt as a result; ● raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier, may not be available or may not be suitable or acceptable for use due to material or component defects; ● products and components from our third-party manufacturers may be subject to additional customs and import charges, which may cause us to incur delays or additional costs as a result; ● our contract manufacturers and critical reagent suppliers may be subject to inclement weather, as well as natural or man-made disasters; and ● our contract manufacturers may have unacceptable or inconsistent product quality success rates and yields.
We do not have control over third-party manufacturers’ compliance with these regulations and requirements; 29 Table of Contents ● we may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our drugs; ● our contract manufacturers could breach or terminate their agreements with us; ● our contract manufacturers may be unable to sustain their business and become bankrupt as a result; ● raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier, may not be available or may not be suitable or acceptable for use due to material or component defects; ● products and components from our third-party manufacturers may be subject to additional customs and import charges, which may cause us to incur delays or additional costs as a result; ● our contract manufacturers and critical reagent suppliers may be subject to inclement weather, as well as natural or man-made disasters; and ● our contract manufacturers may have unacceptable or inconsistent product quality success rates and yields.
The following examples are illustrative: ● others may be able to make compounds that are similar to our drug candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; ● we might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own or may in the future exclusively license, which could result in the patents applied for not being issued or being invalidated after issuing; ● we might not have been the first to file patent applications covering certain of our inventions, which could result in the patents applied for not being issued or being invalidated after issuing; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors or other third parties; ● we may obtain patents for certain compounds many years before we receive regulatory approval for drugs containing such compounds, and because patents have a limited life, which may begin to run prior to the commercial sale of the related drugs, the commercial value of our patents may be limited; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive drugs for commercialization in our major markets; ● we may fail to develop additional proprietary technologies that are patentable; ● we may fail to apply for or obtain adequate intellectual property protection in all the jurisdictions in which we operate; ● third parties may gain unauthorized access to our intellectual property due to potential lapses in our information systems; and ● the patents of others may have an adverse effect on our business, for example by preventing us from commercializing one or more of our drug candidates for one or more indications.
The following examples are illustrative: ● others may be able to make compounds that are similar to our drug candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; ● we might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own or may in the future exclusively license, which could result in the patents applied for not being issued or being invalidated after issuing; ● we might not have been the first to file patent applications covering certain of our inventions, which could result in the patents applied for not being issued or being invalidated after issuing; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors or other third parties; ● we may obtain patents for certain compounds many years before we receive regulatory approval for drugs containing such compounds, and because patents have a limited life, which may begin to run prior to the commercial sale of the related drugs, the commercial value of our patents may be limited; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive drugs for commercialization in our major markets; ● we may fail to develop additional proprietary technologies that are patentable; 41 Table of Contents ● we may fail to apply for or obtain adequate intellectual property protection in all the jurisdictions in which we operate; ● third parties may gain unauthorized access to our intellectual property due to potential lapses in our information systems; and ● the patents of others may have an adverse effect on our business, for example by preventing us from commercializing one or more of our drug candidates for one or more indications.
If we or our licensors are unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms or at all, or to modify or cease the development, manufacture and commercialization of one or more of the drug candidates we may develop, which could have a material adverse impact on our business.
If we or our future licensors are unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms or at all, or to modify or cease the development, manufacture and commercialization of one or more of the drug candidates we may develop, which could have a material adverse impact on our business.
Our anticipated reliance on third-party manufacturers exposes us to certain risks, including, but not limited to, the following: ● we may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the NMPA, the FDA or other comparable regulatory authorities must approve any manufacturers as part of their regulatory oversight of our drug candidates.
Our reliance on third-party manufacturers exposes us to certain risks, including, but not limited to, the following: ● we may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the NMPA, the FDA or other comparable regulatory authorities must approve any manufacturers as part of their regulatory oversight of our drug candidates.
Since these laws and regulations are relatively new and may be amended from time to time, and the PRC legal system continues to rapidly evolve, and because of the limited number of published decisions and the nonbinding nature of such decisions, and because the laws and regulations often give the relevant regulator significant discretion in how to enforce them, the interpretations of many laws, regulations and rules may not be uniform and enforcement of these laws, regulations and rules involves uncertainties.
Since these laws and regulations are relatively new and may be amended from time to time, and the PRC legal system continues to rapidly evolve, and because of the limited number of published decisions and the nonbinding nature of such decisions, and because the laws and regulations often give the regulator significant discretion in how to enforce them, the interpretations of many laws, regulations and rules may not be uniform and enforcement of these laws, regulations and rules involves uncertainties.
Under each of our license and intellectual property-related agreements, in exchange for licensing or sublicensing us the right to develop and commercialize the applicable drug candidates, our licensors will be eligible to receive from us milestone payments, tiered royalties from commercial sales of such drug candidates, assuming relevant approvals from government authorities are obtained, or other payments.
Under each of our license and intellectual property-related agreements, in exchange for licensing or sublicensing us the right to develop and commercialize the applicable drug candidates, our licensors will be eligible to receive from us milestone payments, tiered royalties from commercial sales of such drug candidates, assuming applicable approvals from government authorities are obtained, or other payments.
We may not be able to initiate or continue clinical trials for our drug candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the NMPA, the FDA, or similar regulatory authorities, or if there are delays in the enrollment of eligible patients as a result of the competitive clinical enrollment environment.
We may not be able to initiate or continue clinical trials for our drug candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, or similar regulatory authorities, or if there are delays in the enrollment of eligible patients as a result of the competitive clinical enrollment environment.
Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. As a result, these companies may obtain regulatory approval from the NMPA, the FDA or other comparable regulatory authorities more rapidly than we are able to and may be more effective in selling and marketing their products as well.
Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. As a result, these companies may obtain regulatory approval from the FDA or other comparable regulatory authorities more rapidly than we are able to and may be more effective in selling and marketing their products as well.
Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities. We also rely on third parties to assist in conducting our pre-clinical studies in accordance with Good Laboratory Practices (“GLP”).
Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities. We also rely on third parties to assist in conducting our pre-clinical studies in accordance with good laboratory practices.
If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our drug candidates or bring them to market and generate product sales revenue, which would harm our business, financial condition, results of operations and prospects. 31 Table of Contents Risks Related to Our Intellectual Property If we are unable to obtain and maintain patent and other intellectual property protection for our drug candidates, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties could develop and commercialize products and technologies similar or identical to ours and compete directly against us, and our ability to successfully commercialize any product or technology may be adversely affected.
If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our drug candidates or bring them to market and generate product sales revenue, which would harm our business, financial condition, results of operations and prospects. 32 Table of Contents Risks Related to Our Intellectual Property If we are unable to obtain and maintain patent and other intellectual property protection for our drug candidates, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties could develop and commercialize products and technologies similar or identical to ours and compete directly against us, and our ability to successfully commercialize any product or technology may be adversely affected.
If we or our licensors are unsuccessful in any interference proceedings or other priority or validity disputes (including any patent oppositions) to which we or they are subject, we may lose valuable intellectual property rights through the loss of one or more patents owned or licensed or our owned or licensed patent claims may be narrowed, invalidated, or held unenforceable.
If we or our future licensors are unsuccessful in any interference proceedings or other priority or validity disputes (including any patent oppositions) to which we or they are subject, we may lose valuable intellectual property rights through the loss of one or more patents owned or licensed or our owned or licensed patent claims may be narrowed, invalidated, or held unenforceable.
Undesirable adverse events caused by our drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and may result in a more restrictive label, a delay or denial of regulatory approval by the NMPA, the FDA or other comparable regulatory authorities, or a significant change in our clinical protocol or even our development plan.
Undesirable adverse events caused by our drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and may result in a more restrictive label, a delay or denial of regulatory approval by the FDA or other comparable regulatory authorities, or a significant change in our clinical protocol or even our development plan.
We own registered trademarks. We may not be able to obtain trademark protection in territories that we consider of significant importance to us. In addition, any of our trademarks or trade names, whether registered or unregistered, may be challenged, opposed, infringed, cancelled, circumvented or declared generic, or determined to be infringing on other marks, as applicable.
We may not be able to obtain trademark protection in territories that we consider of significant importance to us. In addition, any of our trademarks or trade names, whether registered or unregistered, may be challenged, opposed, infringed, cancelled, circumvented or declared generic, or determined to be infringing on other marks, as applicable.
We may experience numerous unexpected events during, or as a result of, clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize our drug candidates, including, without limitation: ● regulators, institutional review boards, or IRBs, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● our inability to reach agreements on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● manufacturing issues, including problems with manufacturing, supply quality, compliance with good manufacturing practice, or GMP, or obtaining sufficient quantities of a drug candidate from third parties for use in a clinical trial; ● our partners identify safety concerns in the clinical assets that we licensed, which lead to the termination of the collaboration and development of the underlying clinical assets with our partners; ● clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide to conduct additional clinical trials or abandon drug development programs, or regulators may require us to do so; ● the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment may be insufficient or slower than we anticipate or patients may drop out at a higher rate than we anticipate; ● our third-party contractors, including clinical investigators, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; ● we might have to suspend or terminate clinical trials of our drug candidates for various reasons, including a finding of a lack of clinical response or other unexpected characteristics or a finding that participants are being exposed to unacceptable health risks; ● regulators, IRBs or ethics committees may require that we or our investigators suspend or terminate clinical research or not rely on the results of clinical research for various reasons, including non-compliance with regulatory requirements; 16 Table of Contents ● the cost of clinical trials of our drug candidates may be greater than we anticipate; and ● the supply or quality of our drug candidates, companion diagnostics or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate.
We may experience numerous unexpected events during, or as a result of, clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize our drug candidates, including, without limitation: ● regulators, institutional review boards, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● our inability to reach agreements on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● manufacturing issues, including problems with manufacturing, supply quality, compliance with good manufacturing practice or obtaining sufficient quantities of a drug candidate from third parties for use in a clinical trial; 18 Table of Contents ● our partners identify safety concerns in the clinical assets that we licensed, which lead to the termination of the collaboration and development of the underlying clinical assets with our partners; ● clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide to conduct additional clinical trials or abandon drug development programs, or regulators may require us to do so; ● the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment may be insufficient or slower than we anticipate or patients may drop out at a higher rate than we anticipate; ● our third-party contractors, including clinical investigators, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; ● we might have to suspend or terminate clinical trials of our drug candidates for various reasons, including a finding of a lack of clinical response or other unexpected characteristics or a finding that participants are being exposed to unacceptable health risks; ● regulators, institutional review boards or ethics committees may require that we or our investigators suspend or terminate clinical research or not rely on the results of clinical research for various reasons, including non-compliance with regulatory requirements; ● the cost of clinical trials of our drug candidates may be greater than we anticipate; and ● the supply or quality of our drug candidates, companion diagnostics or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate.
In addition, once a drug is approved by the NMPA, the FDA or a comparable regulatory authority for marketing, it is possible that there could be a subsequent discovery of previously unknown problems with the drug, including problems with third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements.
In addition, once a drug is approved by the FDA or a comparable regulatory authority for marketing, it is possible that there could be a subsequent discovery of previously unknown problems with the drug, including problems with third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements.
These types of adverse events could be caused by our drug candidates and could cause us or regulatory authorities to interrupt, delay or halt clinical trials and may result in a more restrictive indication or the delay or denial of regulatory approval by the NMPA, the FDA or other comparable regulatory authority.
These types of adverse events could be caused by our drug candidates and could cause us or regulatory authorities to interrupt, delay or halt clinical trials and may result in a more restrictive indication or the delay or denial of regulatory approval by the FDA or other comparable regulatory authority.
Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our products or their use. 34 Table of Contents If a third party were to assert claims of patent infringement against us, even if we believe such third-party claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, and the holders of any such patents may be able to block our ability to commercialize the applicable product unless we obtained a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable.
Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our products or their use. 35 Table of Contents If a third party were to assert claims of patent infringement against us, even if we believe such third-party claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, and the holders of any such patents may be able to block our ability to commercialize the applicable product unless we obtained a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable.
If the NMPA, the FDA or a comparable regulatory authority approves any of our drug candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the drug will be subject to extensive and ongoing regulatory requirements on pharmacovigilance.
If the FDA or a comparable regulatory authority approves any of our drug candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the drug will be subject to extensive and ongoing regulatory requirements on pharmacovigilance.
If these tests are not appropriately done and test data is not reliable, patients could be put at risk of serious harm and the NMPA, the FDA or other comparable regulatory authorities could place significant restrictions on our company until deficiencies are remedied.
If these tests are not appropriately done and test data is not reliable, patients could be put at risk of serious harm and the FDA or other comparable regulatory authorities could place significant restrictions on our company until deficiencies are remedied.
We seek to protect the drug candidates and technology that we consider commercially important by filing patent applications in China, the United States and other countries or regions, relying on trade secrets or pharmaceutical regulatory protection or employing a combination of these methods.
We seek to protect the drug candidates and technology that we consider commercially important by filing patent applications in the United States and other countries or regions, relying on trade secrets or pharmaceutical regulatory protection or employing a combination of these methods.
Under the America Invents Act (“AIA”) enacted in 2011, the United States moved to this first-to-file system in early 2013 from the previous system under which the first to make the claimed invention was entitled to the patent. Assuming the other requirements for patentability are met, the first to file a patent application is entitled to the patent.
Under the America Invents Act enacted in 2011, the United States moved to this first-to-file system in early 2013 from the previous system under which the first to make the claimed invention was entitled to the patent. Assuming the other requirements for patentability are met, the first to file a patent application is entitled to the patent.
These problems include logistics and shipping, difficulties with production costs and yields, quality control, including stability of the product, product testing, operator error and availability of qualified personnel, as well as compliance with strictly enforced regulations in the PRC, the United States and other applicable jurisdictions.
These problems include logistics and shipping, difficulties with production costs and yields, quality control, including stability of the product, product testing, operator error and availability of qualified personnel, as well as compliance with strictly enforced regulations in the United States and other applicable jurisdictions.
Our operations may be under the threat of floods, earthquakes, sandstorms, snowstorms, fire or drought, power, water or fuel shortages, failures, malfunction and breakdown of information management systems, unexpected maintenance or technical problems, or may be susceptible to potential wars or terrorist attacks.
Our operations may also be under the threat of floods, earthquakes, sandstorms, snowstorms, fire or drought, power, water or fuel shortages, failures, malfunction and breakdown of information management systems, unexpected maintenance or technical problems, or may be susceptible to potential wars or terrorist attacks.
In addition, we also face risks arising from the prospective uncertainties associated with the ability of the Public Company Accounting Oversight Board (United States), or the PCAOB, to completely inspect registered public accounting firms headquartered in mainland China (including our independent auditor).
In addition, we also face risks arising from the prospective uncertainties associated with the ability of the Public Company Accounting Oversight Board (United States), or the PCAOB, to completely inspect registered public accounting firms headquartered in China (including our independent auditor).
In such an event, our trials could be suspended or terminated and the NMPA, the FDA or other comparable regulatory authorities could order us to cease further development of, or deny approval of, our drug candidates for any or all targeted indications.
In such an event, our trials could be suspended or terminated and the FDA or other comparable regulatory authorities could order us to cease further development of, or deny approval of, our drug candidates for any or all targeted indications.
The approval of and filing with relevant PRC government authorities may be required in connection with our offshore offerings under PRC law, and, if required, we cannot predict whether or for how long we will be able to obtain such approval or complete such filing.
The approval of and filing with PRC government authorities may be required in connection with our offshore offerings under PRC law, and, if required, we cannot predict whether or for how long we will be able to obtain such approval or complete such filing.
In addition, if we or our licensors are unsuccessful in any inventorship disputes to which we or they are subject, we may lose valuable intellectual property rights, such as exclusive ownership of, or the exclusive right to use, our owned or in-licensed patents.
In addition, if we or our future licensors are unsuccessful in any inventorship disputes to which we or they are subject, we may lose valuable intellectual property rights, such as exclusive ownership of, or the exclusive right to use, our owned or future in-licensed patents.
Disputes may arise regarding intellectual property subject to a license agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● the extent to which our technology and processes infringe, misappropriate or violate intellectual property of the licensor that is not subject to the license agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and 39 Table of Contents ● the priority of invention of patented technology.
Disputes may arise regarding intellectual property subject to a license agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; 40 Table of Contents ● the extent to which our technology and processes infringe, misappropriate or violate intellectual property of the licensor that is not subject to the license agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology.
Further, any researcher conducting research funded, at least in part, by the PRC government is required to submit relevant scientific data for management by the entity to which such researcher is affiliated before such data may be published in any foreign academic journal.
Further, any researcher conducting research funded, at least in part, by the PRC government is required to submit scientific data for management by the entity to which such researcher is affiliated before the data may be published in any foreign academic journal.
Although we have policies and procedures designed to ensure that we, our employees and our agents comply with anti-bribery laws, there is no assurance that such policies or procedures will prevent our agents, employees and intermediaries from engaging in bribery activities.
Although we have policies and procedures designed to ensure that we, our employees and our agents comply with applicable anti-bribery laws, there is no assurance that such policies or procedures will prevent our agents, employees and intermediaries from engaging in bribery activities.
A number of governmental agencies or industry regulatory bodies in the PRC, the United States and other applicable jurisdictions impose strict rules, regulations and industry standards governing biopharmaceutical research and development activities, which apply to us.
A number of governmental agencies or industry regulatory bodies in the United States and other applicable jurisdictions impose strict rules, regulations and industry standards governing biopharmaceutical research and development activities, which apply to us.
We currently intend to retain most, if not all, of our available funds and any future earnings to fund the development and growth of our business. As a result, we do not expect to pay any cash dividends in the foreseeable future.
We currently intend to retain most, if not all, of our available funds and any future earnings to fund the development and development of our business. As a result, we do not expect to pay any cash dividends in the foreseeable future.
If we are unable to successfully identify new drug candidates, complete clinical development, obtain regulatory approval and commercialize our drug candidates, or experience significant delays in doing so, our business will be materially banned. ● We may not be able to identify, discover or in-license new drug candidates, and may allocate our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may later prove to be more profitable, or for which there is a greater likelihood of success.
If we are unable to successfully identify new drug candidates, complete clinical development, obtain regulatory approval and commercialize our drug candidates, or experience significant delays in doing so, our business will be materially harmed. ● We may not be able to identify, discover or in-license new drug candidates, and may allocate our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may later prove to be more profitable, or for which there is a greater likelihood of success.
Each of these risks could delay or prevent the completion of our clinical trials or the approval of any of our drug candidates by the NMPA, the FDA or other comparable regulatory authorities, result in higher costs or adversely impact the commercialization of our drug candidates.
Each of these risks could delay or prevent the completion of our clinical trials or the approval of any of our drug candidates by the FDA or other comparable regulatory authorities, result in higher costs or adversely impact the commercialization of our drug candidates.
There may be significant delays in obtaining reimbursement for approved drug candidates, and coverage may be more limited than the purposes for which the drug candidates are approved by the NMPA, the FDA or other comparable regulatory authorities.
There may be significant delays in obtaining reimbursement for approved drug candidates, and coverage may be more limited than the purposes for which the drug candidates are approved by the FDA or other comparable regulatory authorities.
The Overseas Listing Trial Measures comprehensively improve and reform the existing regulatory regime for overseas offering and listing of PRC domestic companies’ securities and regulate both direct and indirect overseas offering and listing of PRC domestic companies’ securities by adopting a filing-based regulatory regime.
The trial administrative measures comprehensively improve and reform the existing regulatory regime for overseas offering and listing of PRC domestic companies’ securities and regulate both direct and indirect overseas offering and listing of PRC domestic companies’ securities by adopting a filing-based regulatory regime.
Any delay or interruption in the supply of clinical trial supplies could delay the completion of our clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to begin new clinical trials at additional expense or terminate clinical trials completely. 29 Table of Contents We have entered into collaborations and may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
Any delay or interruption in the supply of clinical trial supplies could delay the completion of our clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to begin new clinical trials at additional expense or terminate clinical trials completely. 30 Table of Contents We have entered into collaborations and may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our drugs; ● our contract manufacturers may have little or no experience with manufacturing our drug candidates, and therefore may require a significant amount of support from us in order to implement and maintain the infrastructure and processes required to manufacture our drug candidates; ● our contract manufacturers may have limited capacity or limited manufacturing slots, which may affect the timeline for the production of our drugs; ● our contract manufacturers might be unable to timely manufacture our drug candidates or produce the quantity and quality required to meet our clinical and commercial needs, if any; ● contract manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately; ● our future contract manufacturers may not perform as agreed, may not devote sufficient resources to our drugs, or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our drugs; ● our contract manufacturers are subject to ongoing periodic unannounced inspections by the NMPA and the FDA to ensure strict compliance with cGMP and other government regulations in the PRC and the United States, respectively, and by other comparable regulatory authorities for corresponding regulatory requirements.
In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our drugs; ● our contract manufacturers may have little or no experience with manufacturing our drug candidates, and therefore may require a significant amount of support from us in order to implement and maintain the infrastructure and processes required to manufacture our drug candidates; ● our contract manufacturers may have limited capacity or limited manufacturing slots, which may affect the timeline for the production of our drugs; ● our contract manufacturers might be unable to timely manufacture our drug candidates or produce the quantity and quality required to meet our clinical and commercial needs, if any; ● contract manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately; ● our future contract manufacturers may not perform as agreed, may not devote sufficient resources to our drugs, or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our drugs; ● our contract manufacturers are subject to ongoing periodic unannounced inspections by the NMPA and the FDA to ensure strict compliance with current good manufacturing practice and other government regulations in the PRC and the United States, respectively, and by other comparable regulatory authorities for corresponding regulatory requirements.
If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for our ADSs to decline. 66 Table of Contents Because we do not expect to pay dividends in the foreseeable future, you must rely on price appreciation of our ADSs for return on your investment.
If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for our ADSs to decline. 58 Table of Contents Because we do not expect to pay dividends in the foreseeable future, you must rely on price appreciation of our ADSs for return on your investment.
The NMPA, the FDA or a comparable regulatory authority may require more information, including additional pre-clinical or clinical data, to support approval, which may delay or prevent approval and our commercialization plans.
The FDA or a comparable regulatory authority may require more information, including additional pre-clinical or clinical data, to support approval, which may delay or prevent approval and our commercialization plans.
Pursuant to the terms of the license agreements with some of our licensors, the licensors may have the right to control enforcement of our licensed patents or defense of any claims asserting the invalidity or unenforceability of these patents.
Pursuant to the terms of the license agreements with some of our licensors, the licensors may have the first right to control enforcement of our licensed patents or defense of any claims asserting the invalidity or unenforceability of these patents.
The occurrence of any of the foregoing events is beyond our control but may result in regional or global economic distress, which may materially and adversely affect our business, financial condition and results of operations. 50 Table of Contents If we fail to implement and maintain an effective system of internal controls over financial reporting, we may be unable to accurately report our results of operations, meet our reporting obligations or prevent fraud.
The occurrence of any of the foregoing events is beyond our control but may result in regional or global economic distress, which may materially and adversely affect our business, financial condition and results of operations. 49 Table of Contents If we fail to implement and maintain an effective system of internal controls over financial reporting, we may be unable to accurately report our results of operations, meet our reporting obligations or prevent fraud.
Periodic maintenance and annuity fees on any issued patent are due to be paid to the United States Patent and Trademark Office (“USPTO”) and foreign patent agencies over the lifetime of a patent.
Periodic maintenance and annuity fees on any issued patent are due to be paid to the United States Patent and Trademark Office and foreign patent agencies over the lifetime of a patent.
The trading performances of these PRC companies’ securities may affect the overall investor sentiment towards other PRC companies listed in the United States and consequently may impact the trading performance of our ADSs.
The trading performances of these companies’ securities may affect the overall investor sentiment towards other companies listed in the United States and consequently may impact the trading performance of our ADSs.
The following sets forth the major provisions of the ACA that may affect our drug candidates: ● an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic products; ● an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; ● expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; ● a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices; ● extension of manufacturers’ Medicaid rebate liability; ● expansion of eligibility criteria for Medicaid programs; ● expansion of the entities eligible for discounts under the Public Health Service Act’s pharmaceutical pricing program; ● new requirements to report to CMS financial arrangements with physicians and teaching hospitals; ● a new requirement to annually report to the FDA drug samples that manufacturers and distributors provide to physicians; and ● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
The following sets forth the major provisions of this act that may affect our drug candidates: ● an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic products; ● an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; ● expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; ● a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices; ● extension of manufacturers’ Medicaid rebate liability; ● expansion of eligibility criteria for Medicaid programs; ● expansion of the entities eligible for discounts under the Public Health Service Act’s pharmaceutical pricing program; ● new requirements to report financial arrangements with physicians and teaching hospitals with Centers for Medicare and Medicaid Services; ● a new requirement to annually report to the FDA drug samples that manufacturers and distributors provide to physicians; and ● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Moreover, even if our management concludes that our internal control over financial reporting is effective, our independent registered public accounting firm, after conducting its own independent testing, may issue an adverse report if it is not satisfied with our internal controls or the level at which our controls are documented, designed, operated or reviewed, or if it interprets the relevant requirements differently from us.
Moreover, even if our management concludes that our internal control over financial reporting is effective, our independent registered public accounting firm, after conducting its own independent testing, may issue an adverse report if it is not satisfied with our internal controls or the level at which our controls are documented, designed, operated or reviewed, or if it interprets the applicable requirements differently from us.
Sales of these registered shares in the form of ADSs in the public market, or sales of securities held by our significant shareholders or any other shareholder or the availability of these securities for future sale could cause the price of our ADSs to decline. 67 Table of Contents The voting rights of holders of ADSs are limited by the terms of the deposit agreement, and you may not be able to exercise the same rights as our shareholders.
Sales of these registered shares in the form of ADSs in the public market, or sales of securities held by our significant shareholders or any other shareholder or the availability of these securities for future sale could cause the price of our ADSs to decline. 59 Table of Contents The voting rights of holders of ADSs are limited by the terms of the deposit agreement, and you may not be able to exercise the same rights as our shareholders.
Additionally, if we or others identify undesirable side effects caused by those of our existing drug candidates that have received regulatory approval, or our other drug candidates after having received regulatory approval, this may lead to potentially significant negative consequences which include, but are not limited to, the following: ● we may suspend marketing of the drug candidate; ● regulatory authorities may withdraw their approvals of or revoke the licenses for the drug candidate; ● regulatory authorities may require additional warnings on the label; ● the FDA may require the establishment of a Risk Evaluation and Mitigation Strategy, or REMS, or the NMPA or a comparable regulatory authority may require the establishment of a similar strategy that may, for instance, restrict distribution of our drugs and impose burdensome implementation requirements on us; ● we may be required to conduct specific post-marketing studies; ● we could be subjected to litigation proceedings and held liable for harm caused to subjects or patients; and 19 Table of Contents ● our reputation may suffer.
Additionally, if we or others identify undesirable side effects caused by those of our existing drug candidates that have received regulatory approval, or our other drug candidates after having received regulatory approval, this may lead to potentially significant negative consequences which include, but are not limited to, the following: ● we may suspend marketing of the drug candidate; ● regulatory authorities may withdraw their approvals of or revoke the licenses for the drug candidate; ● regulatory authorities may require additional warnings on the label; ● the FDA may require the establishment of a risk evaluation and mitigation strategy or a comparable regulatory authority may require the establishment of a similar strategy that may, for instance, restrict distribution of our drugs and impose burdensome implementation requirements on us; 21 Table of Contents ● we may be required to conduct specific post-marketing studies; ● we could be subjected to litigation proceedings and held liable for harm caused to subjects or patients; and ● our reputation may suffer.
I-Mab has not declared or paid any cash dividends, nor does it have any present plan to pay any cash dividends on our ordinary shares in the foreseeable future. We currently intend to retain most, if not all, of our available funds and any future earnings to operate and expand our business. See “Item 8. Financial Information—A.
I-Mab has not declared or paid any cash dividends, nor does it have any present plan to pay any cash dividends on our ordinary shares in the foreseeable future. We currently intend to retain most, if not all, of our available funds and any future earnings to operate and develop our business. See “Item 8. Financial Information—A.
Risks Related to Clinical Development of Our Drug Candidates ● Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. 9 Table of Contents ● We depend substantially on the success of our drug candidates, all of which are in pre-clinical or clinical development, and our ability to identify additional drug candidates.
Risks Related to Clinical Development of Our Drug Candidates ● Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. 10 Table of Contents ● We depend substantially on the success of our drug candidates, all of which are in pre-clinical or clinical development, and our ability to identify additional drug candidates.
The time required to obtain the approval of the NMPA, the FDA and other comparable regulatory authorities is inherently uncertain and depends on numerous factors, including the substantial discretion of the regulatory authorities.
The time required to obtain the approval of the FDA and other comparable regulatory authorities is inherently uncertain and depends on numerous factors, including the substantial discretion of the regulatory authorities.
We are or will be subject to rules and regulations by various governing bodies, including, for example, the SEC, which is charged with the protection of investors and the oversight of companies whose securities are publicly traded, and the various regulatory authorities in China and the Cayman Islands, and to new and evolving regulatory measures under applicable law.
We are or will be subject to rules and regulations by various governing bodies, including, for example, the SEC, which is charged with the protection of investors and the oversight of companies whose securities are publicly traded, and the various regulatory authorities in the U.S., the Cayman Islands and China, and to new and evolving regulatory measures under applicable law.
On April 25, 2023, the arbitration award determined that the TJD5 Agreement has been terminated for a pre-agreed termination fee of US$9.0 million plus interest payable pursuant to the original agreement, and therefore Tracon has no rights to share any future economics with I-Mab.
On April 25, 2023, the arbitration award determined that the agreement in relation to TJD5 has been terminated for a pre-agreed termination fee of US$9.0 million plus interest payable pursuant to the original agreement, and therefore Tracon has no rights to share any future economics with I-Mab.
It is possible that we may be unable to obtain any additional licenses at a reasonable cost or on reasonable terms, if at all. Certain of our license agreements also require us to meet development thresholds to maintain the license, including establishing a set timeline for developing and commercializing products.
It is possible that we may be unable to obtain any additional licenses at a reasonable cost or on reasonable terms, if at all. Certain license agreements may also require us to meet development thresholds to maintain the license, including establishing a set timeline for developing and commercializing products.
In addition, none of our drug candidates has been approved for marketing in China or any other jurisdiction. Each of our drug candidates will require additional pre-clinical and/ or clinical development, regulatory approvals in multiple jurisdictions, development of manufacturing supply and capacity, substantial investment and significant marketing efforts before we generate any revenue from product sales.
In addition, none of our drug candidates has been approved for marketing in any jurisdiction. Each of our drug candidates will require additional pre-clinical and/or clinical development, regulatory approvals in multiple jurisdictions, development of manufacturing supply and capacity, substantial investment and significant marketing efforts before we generate any revenue from product sales.
If the PCAOB determines in the future that it no longer has full access to inspect and investigate completely accounting firms in mainland China and Hong Kong and we continue to use an accounting firm headquartered in one of these jurisdictions to issue an audit report on our financial statements filed with the Securities and Exchange Commission, we would be identified as a Commission-Identified Issuer following the filing of the annual report on Form 20-F for the relevant fiscal year.
If the PCAOB determines in the future that it no longer has full access to inspect and investigate completely accounting firms in mainland China and Hong Kong and we continue to use an accounting firm headquartered in one of these jurisdictions to issue an audit report on our financial statements filed with the SEC, we would be identified as a Commission-Identified Issuer following the filing of the annual report on Form 20-F for the relevant fiscal year.
Competitors may use our and our licensors’ technologies in jurisdictions where we have not obtained patent protection to develop their own drug candidates and, further, may export otherwise infringing drug candidates to territories, including the PRC, where we and our licensors have patent protection, but enforcement rights are not as strong as that in the United States or Europe.
Competitors may use our and our licensors’ technologies in jurisdictions where we have not obtained patent protection to develop their own drug candidates and, further, may export otherwise infringing drug candidates to territories, where we and our licensors have patent protection, but enforcement rights are not as strong as that in the United States or Europe.
If the PCAOB determines in the future that it no longer has full access to inspect and investigate completely accounting firms in mainland China and Hong Kong and we use an accounting firm headquartered in one of these jurisdictions to issue an audit report on our financial statements filed with the Securities and Exchange Commission, we would be identified as a Commission-Identified Issuer following the filing of the annual report on Form 20-F for the relevant fiscal year.
If the PCAOB determines in the future that it no longer has full access to inspect and investigate completely accounting firms in mainland China and Hong Kong and we use an accounting firm headquartered in one of these jurisdictions to issue an audit report on our financial statements filed with the SEC, we would be identified as a Commission-Identified Issuer following the filing of the annual report on Form 20-F for the relevant fiscal year.
In line with industry practice in the PRC, we have elected not to maintain certain types of insurances, such as business interruption insurance or key-man insurance. Our insurance coverage may be insufficient to cover any claim for product liability, damage to our fixed assets or employee injuries.
In line with industry practice, we have elected not to maintain certain types of insurances, such as business interruption insurance or key-man insurance. Our insurance coverage may be insufficient to cover any claim for product liability, damage to our fixed assets or employee injuries.
Regardless of the merits or eventual outcome, liability claims may result in significant negative consequences to our business and prospects, including, but not limited to: ● decreased demand for our drug candidates or any resulting products; ● injury to our reputation; ● withdrawal of other clinical trial participants; ● costs to defend the related litigation; ● a diversion of our management’s time and resources; ● substantial monetary awards to trial participants or patients; ● inability to commercialize our drug candidates; and ● a decline in the market price of our ADSs.
Regardless of the merits or eventual outcome, liability claims may result in significant negative consequences to our business and prospects, including, but not limited to: ● decreased demand for our drug candidates or any resulting products; ● injury to our reputation; ● withdrawal of other clinical trial participants; ● costs to defend the related litigation; ● a diversion of our management’s time and resources; 44 Table of Contents ● substantial monetary awards to trial participants or patients; ● inability to commercialize our drug candidates; and ● a decline in the market price of our ADSs.
In connection with the nature and scale of data processed or handled by us in our business operations and our historical issuance of securities to foreign investors, under the current PRC laws, regulations and regulatory rules, as of the date of this annual report, we and our PRC subsidiaries, (i) are not required to go through the filing procedures with regard to the listing and historical issuance of securities by our company to foreign investors with the China Securities Regulatory Commission, or the CSRC, under the Trial Administrative Measures of the Overseas Securities Offering and Listing by Domestic Companies (the “Overseas Listing Trial Measures”), (ii) are not required by the Cyberspace Administration of China, or the CAC, or any of its local counterparts, to go through the cybersecurity review under the Cybersecurity Review Measures, and (iii) have not received or were denied such permissions by the CSRC or the CAC.
In connection with the nature and scale of data processed or handled by us in our business operations and our historical issuance of securities to foreign investors, under the current PRC laws, regulations and regulatory rules, as of the date of this annual report, we and our PRC subsidiary, (i) are not required to go through the filing procedures with regard to the listing and historical issuance of securities by our company to foreign investors with the China Securities Regulatory Commission, or the CSRC, under the Trial Administrative Measures of the Overseas Securities Offering and Listing by Domestic Companies, (ii) are not required by the Cyberspace Administration of China, or the CAC, or any of its local counterparts, to go through the cybersecurity review under the Cybersecurity Review Measures, and (iii) have not received or were denied such permissions by the CSRC or the CAC.
The following selected consolidated statements of comprehensive income (loss) data for the years ended December 31, 2020, 2021 and 2022, selected consolidated balance sheet data as of December 31, 2021 and 2022 and selected consolidated statements of cash flow data for the years ended December 31, 2020, 2021 and 2022 have been derived from our audited consolidated financial statements included elsewhere in this annual report.
The following selected consolidated statements of comprehensive income (loss) data for the years ended December 31, 2021, 2022 and 2023, selected consolidated balance sheet data as of December 31, 2022 and 2023 and selected consolidated statements of cash flow data for the years ended December 31, 2021, 2022 and 2023 have been derived from our audited consolidated financial statements included elsewhere in this annual report.
The selected consolidated statements of comprehensive loss data for the years ended December 31, 2018 and 2019, selected consolidated balance sheet data as of December 31, 2018, 2019 and 2020, and selected consolidated statements of cash flow data for the years ended December 31, 2018 and 2019 have been derived from our audited consolidated financial statements that are not included in this annual report.
The selected consolidated statements of comprehensive loss data for the years ended December 31, 2019 and 2020, selected consolidated balance sheet data as of December 31, 2019, 2020 and 2021, and selected consolidated statements of cash flow data for the years ended December 31, 2019 and 2020 have been derived from our audited consolidated financial statements that are not included in this annual report.
In addition, we will rely on third parties to perform certain specification tests on our drug candidates prior to delivery to patients.
In addition, we rely on third parties to perform certain specification tests on our drug candidates prior to delivery to patients.
As a result, if we, our directors or executive officers commit any securities law violation, fraud or other financial misconduct, the U.S. authorities may not be able to conduct effective investigations or bring and enforce actions against us, our directors, executive officers or other gatekeepers.
As a result, if we or our directors commit any securities law violation, fraud or other financial misconduct, the U.S. authorities may not be able to conduct effective investigations or bring and enforce actions against us, our directors or other gatekeepers.
For example, in July 2022, due to an unexpected high incidence of fatal bleeding, MacroGenics terminated a phase 2 study of enoblituzumab as a combination therapy with PD-1 antibody or PD-1/LAG3 bispecific antibody in patients with head and neck cancers.
For example, in July 2022, due to an unexpectedly high incidence of fatal bleeding, MacroGenics terminated a phase 2 study of enoblituzumab as a combination therapy with PD-1 antibody or PD-1/LAG3 bispecific antibody in patients with head and neck cancers.
Risks Related to Our Intellectual Property ● If we are unable to obtain and maintain patent and other intellectual property protection for our drug candidates, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties could develop and commercialize products and technologies similar or identical to ours and compete directly against us, and our ability to successfully commercialize any product or technology may be adversely affected. ● We enjoy only limited geographical protection with respect to certain patents and may not be able to protect our intellectual property rights throughout the world, including in the PRC. 10 Table of Contents ● Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Risks Related to Our Intellectual Property ● If we are unable to obtain and maintain patent and other intellectual property protection for our drug candidates, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties could develop and commercialize products and technologies similar or identical to ours and compete directly against us, and our ability to successfully commercialize any product or technology may be adversely affected. ● We enjoy only limited geographical protection with respect to certain patents and may not be able to protect our intellectual property rights throughout the world. 11 Table of Contents ● Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Accordingly, you may be unable to participate in our rights offerings and may experience dilution in your holdings. 68 Table of Contents You may not receive cash dividends if the depositary decides it is impractical to make them available to you.
Accordingly, you may be unable to participate in our rights offerings and may experience dilution in your holdings. 60 Table of Contents You may not receive cash dividends if the depositary decides it is impractical to make them available to you.
Based upon the nature and composition of our assets (in particular, the retention of substantial amounts of cash and investments), and the market price of our ADSs, we believe that we were a PFIC for the taxable year ended December 31, 2022 and we will likely be a PFIC for our current taxable year unless the market price of our ADSs increases and/or we invest a substantial amount of the cash and other passive assets we hold in assets that produce or are held for the production of active income.
Based upon the nature and composition of our assets (in particular, the retention of substantial amounts of cash and investments), and the market price of our ADSs, we believe that we were a PFIC for the taxable year ended December 31, 2023 and we will likely be a PFIC for our current taxable year unless the market price of our ADSs significantly increases and/or we invest a substantial amount of the cash and other passive assets we hold in assets that produce or are held for the production of active income.
Any such class action suit, whether or not successful, could harm our reputation and restrict our ability to raise capital in the future. In addition, if a claim is successfully made against us, we may be required to pay significant damages, which could have a material adverse effect on our financial condition and results of operations. 72 Table of Contents
Any such class action suit, whether or not successful, could harm our reputation and restrict our ability to raise capital in the future. In addition, if a claim is successfully made against us, we may be required to pay significant damages, which could have a material adverse effect on our financial condition and results of operations.
The laws of some jurisdictions, including the PRC, do not protect intellectual property rights to the same extent as the laws or rules and regulations in the United States and Europe, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions.
The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or rules and regulations in the United States and Europe, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions.
Patient enrollment for our clinical trials may be affected by other factors, including, but not limited to, the following: ● severity of the disease under investigation; ● total size and nature of the relevant patient population; 15 Table of Contents ● design and eligibility criteria for the clinical trial in question; ● perceived risks and benefits of the drug candidate under study; ● our resources to facilitate timely enrollment in clinical trials; ● patient referral practices of physicians; ● availability of competing therapies also undergoing clinical trials; ● our investigators’ or clinical trial sites’ efforts to screen and recruit eligible patients; and ● proximity and availability of clinical trial sites for prospective patients.
Patient enrollment for our clinical trials may be affected by other factors, including, but not limited to, the following: ● severity of the disease under investigation; ● total size and nature of the patient population; ● design and eligibility criteria for the clinical trial in question; ● perceived risks and benefits of the drug candidate under study; ● our resources to facilitate timely enrollment in clinical trials; ● patient referral practices of physicians; ● availability of competing therapies also undergoing clinical trials; ● our investigators’ or clinical trial sites’ efforts to screen and recruit eligible patients; and ● proximity and availability of clinical trial sites for prospective patients.
A claim brought against us that is uninsured or under-insured could harm our business, financial condition and results of operations. 42 Table of Contents In addition, we rely on CROs, our partners and other third parties to monitor and manage data for some of our ongoing pre-clinical and clinical programs and control only certain aspects of their activities.
A claim brought against us that is uninsured or under-insured could harm our business, financial condition and results of operations. In addition, we rely on CROs, our partners and other third parties to monitor and manage data for some of our ongoing pre-clinical and clinical programs and control only certain aspects of their activities.
Liquidity and Capital Resources—Holding Company Structure.” Under PRC laws and regulations, our PRC subsidiaries are subject to certain restrictions with respect to paying dividends or otherwise transferring any of their net assets to us. Remittance of dividends by a wholly foreign-owned enterprise out of China is also subject to examination by the banks designated by SAFE.
Liquidity and Capital Resources—Holding Company Structure.” Under PRC laws and regulations, our PRC subsidiary is subject to certain restrictions with respect to paying dividends or otherwise transferring any of their net assets to us. Remittance of dividends by a wholly foreign-owned enterprise out of China is also subject to examination by the banks designated by SAFE.
Business Overview—Our Drug Pipeline.” Potential competitors further include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. 22 Table of Contents Many of our competitors have substantially greater financial, technical, and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations.
Business Overview—Our Drug Pipeline.” Potential competitors further include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. Many of our competitors have substantially greater financial, technical, and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations.

… 605 more changes not shown on this page.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

299 edited+86 added−450 removed193 unchanged
Biggest changeFurthermore, PRC-based investments by foreign investors have historically been regulated by the Catalogue for the Guidance of Foreign Investment Industries (2017 Revision) issued on June 28, 2017 and effective from July 28, 2017, the Special Management Measures (Negative List) for the Access of Foreign Investment (2018) issued on June 28, 2018 and effective from July 28, 2018, the Special Management Measures (Negative List) for the Access of Foreign Investment (2019) issued on June 30, 2019 and effective from July 30, 2019, and the Catalogue of Industries for Encouraging Foreign Investment (2019 Version) issued on June 30, 2019 and effective from July 30, 2019, the Special Management Measures (Negative List) for the Access of Foreign Investment (2020) issued on June 23, 2020 and effective from July 23, 2020, and the Catalogue of Industries for Encouraging Foreign Investment (2020 Version) issued on December 27, 2020 and effective from January 27, 2021.
Biggest changeFurthermore, PRC-based investments by foreign investors are currently regulated by the Special Management Measures (Negative List) for the Access of Foreign Investment (2021) issued on December 1, 2021 and effective from January 1, 2022, and the Catalogue of Industries for Encouraging Foreign Investment (2022 Version) issued on October 26, 2022 and effective from January 27, 2023.
Upon the occurrence of certain triggering events as specified in the shareholders agreement among I-Mab Hangzhou, we, through our wholly-owned subsidiary, and other domestic investors, including, but not limited to, I-Mab Hangzhou’s failure to accomplish certain public offering condition, we may be obligated to repurchase the equity held by other domestic investors in cash or in our securities in the period beyond 12 months.
Upon the occurrence of certain triggering events as specified in the shareholders agreement among I-Mab Hangzhou, we, through our wholly-owned subsidiary, and other domestic investors, including but not limited to, I-Mab Hangzhou’s failure to accomplish certain public offering condition, may be obligated to repurchase the equity held by other domestic investors in cash or in our securities in the period beyond 12 months.
We also have an option to receive an exclusive, sublicensable license under certain Ferring intellectual property to research, develop, make, have made, import, use, sell and offer to sell FE301 (and the licensed products containing FE301) in the countries in North America, the European Union and Japan that are mutually agreed upon by the parties.
We also have an option to receive an exclusive, sublicensable license under certain Ferring intellectual property to research, develop, make, have made, import, use, sell and offer to sell FE301 (and the licensed products containing FE301) in countries in North America, the European Union and Japan that are mutually agreed upon by the parties.
In particular, in order to compensate the time taken for the review and approval of new drugs, if the new drug-related invention patents are approved for marketing in China, the Patent Administration Department of the State Council should provide the Term Compensation to the patentee, for the duration of patent rights at the request of the patentee.
In particular, in order to compensate the time taken for the review and approval of new drugs, if the new drug-related invention patents are approved for marketing in China, the Patent Administration Department of the State Council should provide the compensation for patent term to the patentee, for the duration of patent rights at the request of the patentee.
These actions could include the suspension or termination of clinical trials by the FDA, the FDA’s refusal to approve pending applications or supplemental applications, withdrawal of an approval, “Warning Letters” (official messages from the FDA to a manufacturer or other organization that it has violated some rule in a federally regulated activity) or “Untitled Letters” (initial correspondences from the FDA with a regulated industry that cite violations that do not meet the threshold of regulatory significance for a Warning Letter and request correction of the violation), product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by the FDA, the Department of Justice (the “DOJ”), or other governmental entities.
These actions could include the suspension or termination of clinical trials by the FDA, the FDA’s refusal to approve pending applications or supplemental applications, withdrawal of an approval, “Warning Letters” (official messages from the FDA to a manufacturer or other organization that it has violated some rule in a federally regulated activity) or “Untitled Letters” (initial correspondences from the FDA with a regulated industry that cite violations that do not meet the threshold of regulatory significance for a Warning Letter and request correction of the violation), product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by the FDA, the Department of Justice, or other governmental entities.
The data are summarized as below: (1) Potent anti-tumor activity was observed with the proliferation of immune cells within the tumor microenvironment (TME) as well as an increase in memory T cells in the peripheral blood, suggesting long-term immunity against the tumor; (2) Givastomig was well tolerated in non-human primates and did not induce a systemic immune response or liver toxicity up to levels of 100 mg/kg; and (3) Activation of immune pathways by givastomig was demonstrated by a pro-inflammatory profile and increased gamma interferon-regulated gene expression in primary human CD8+ T cells co-cultured with CLDN18.2 expressing cells.
The data are summarized as below: (1) Potent anti-tumor activity was observed with the proliferation of immune cells within the tumor microenvironment as well as an increase in memory T cells in the peripheral blood, suggesting long-term immunity against the tumor; (2) Givastomig was well tolerated in non-human primates and did not induce a systemic immune response or liver toxicity up to levels of 100 mg/kg; and (3) Activation of immune pathways by givastomig was demonstrated by a pro-inflammatory profile and increased gamma interferon-regulated gene expression in primary human CD8+ T cells co-cultured with CLDN18.2 expressing cells.
Analysis of the data found: (1) Potent anti-tumor activity was observed with the proliferation of immune cells in the tumor microenvironment (TME) as well as an increase in memory T cells in the peripheral blood, suggesting long-term immunity against the tumor; (2) Givastomig was well tolerated in non-human primates and did not induce a systemic immune response or liver toxicity up to levels of 100mg/kg; and (3) Activation of immune pathways by givastomig/ABL111 was demonstrated by a pro-inflammatory profile and increased gamma interferon-regulated gene expression in primary human CD8+ T cells co-cultured with CLDN18.2 expressing cells.
Analysis of the data found: (1) Potent anti-tumor activity was observed with the proliferation of immune cells in the tumor microenvironment as well as an increase in memory T cells in the peripheral blood, suggesting long-term immunity against the tumor; (2) Givastomig was well tolerated in non-human primates and did not induce a systemic immune response or liver toxicity up to levels of 100mg/kg; and (3) Activation of immune pathways by givastomig/ABL111 was demonstrated by a pro-inflammatory profile and increased gamma interferon-regulated gene expression in primary human CD8+ T cells co-cultured with CLDN18.2 expressing cells.
Patent Term Restoration and Marketing Exclusivity After approval, owners of relevant drug or biological product patents may apply for up to a five-year patent extension to restore a portion of patent term lost during product development and FDA review of a BLA if approval of the application is the first permitted commercial marketing or use of a biologic containing the active ingredient under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act.
Patent Term Restoration and Marketing Exclusivity After approval, owners of drug or biological product patents may apply for up to a five-year patent extension to restore a portion of patent term lost during product development and FDA review of a BLA if approval of the application is the first permitted commercial marketing or use of a biologic containing the active ingredient under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act.
Unless terminated earlier in accordance with the terms thereof, this agreement will remain in effect until the later of (i) the expiry of the last to expire patent of the licensed intellectual property that includes a valid claim for China, Hong Kong, Macau or Taiwan and that covers the composition of GX-I7; and (ii) 15 years from the date of the first commercial sale of GX-I7.
Unless terminated earlier in accordance with the terms thereof, this agreement will remain in effect until the later of (i) the expiry of the last to expire patent of the licensed intellectual property that includes a valid claim for mainland China, Hong Kong, Macau or Taiwan and that covers the composition of GX-I7; and (ii) 15 years from the date of the first commercial sale of GX-I7.
Under this agreement, Ferring granted to us an exclusive, sublicensable license (excluding any non-exclusive license that Ferring granted to Conaris Research Institute AG under a licensing agreement entered into in November 2008) under certain Ferring intellectual property to research, develop, make, have made, import, use, sell and offer to sell FE301 (and the licensed products containing FE301) in China, Hong Kong, Macau, Taiwan and South Korea.
Under this agreement, Ferring granted to us an exclusive, sublicensable license (excluding any non-exclusive license that Ferring granted to Conaris Research Institute AG under a licensing agreement entered into in November 2008) under certain Ferring intellectual property to research, develop, make, have made, import, use, sell and offer to sell FE301 (and the licensed products containing FE301) in mainland China, Hong Kong, Macau, Taiwan and South Korea.
Under this agreement, Genexine granted to us an exclusive, sublicensable and transferable license to use and otherwise exploit certain intellectual property (including improvements subsequently developed or acquired by Genexine) in connection with the pre-clinical and clinical development, manufacturing, sale and distribution of GX-I7 to treat cancers in the field of oncology in China, Hong Kong, Macau and Taiwan.
Under this agreement, Genexine granted to us an exclusive, sublicensable and transferable license to use and otherwise exploit certain intellectual property (including improvements subsequently developed or acquired by Genexine) in connection with the pre-clinical and clinical development, manufacturing, sale and distribution of GX-I7 to treat cancers in the field of oncology in mainland China, Hong Kong, Macau and Taiwan.
The Implementation Rules of the Enterprise Income Tax Law provide that since January 1, 2008, an income tax rate of 10% should normally be applicable to dividends declared to non-PRC resident enterprise investors that do not have an establishment or place of business in the PRC, or have such establishment or place of business but the relevant income is not effectively connected with the establishment or place of business, to the extent such dividends are derived from sources within the PRC.
The Implementation Rules of the Enterprise Income Tax Law provide that since January 1, 2008, an income tax rate of 10% should normally be applicable to dividends declared to non-PRC resident enterprise investors that do not have an establishment or place of business in the PRC, or have an establishment or place of business but the income is not effectively connected with the establishment or place of business, to the extent such dividends are derived from sources within the PRC.
In addition, under the Pediatric Research Equity Act of 2003 (the “PREA”), as amended and reauthorized, certain applications or supplements must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
In addition, under the Pediatric Research Equity Act of 2003, as amended and reauthorized, certain applications or supplements must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
We have arranged compliance training courses for newly hired employee to help them understand the business code of conduct that falls in line with industry and our standards. In addition, we have adopted an employee handbook which describes the compliance management system implemented at I-Mab to ensure compliance with applicable legal and regulatory requirements.
We have arranged compliance training courses for newly hired employees to help them understand the business code of conduct that falls in line with industry and our standards. In addition, we have adopted an employee handbook which describes the compliance management system implemented at I-Mab to ensure compliance with applicable legal and regulatory requirements.
Unless prohibited by applicable laws and regulations, which include all international, national, federal, state, regional, provincial, municipal and local government laws, rules, and regulations that apply to either us or MacroGenics or to the conduct of the collaboration under this agreement (including Good Manufacturing Practice, Good Clinical Practices, General Biological Products Standards, and the laws, rules and regulations of the International Conference on Harmonisation, the United States, China, Hong Kong, Macau, and Taiwan, each as may be then in effect, as applicable and amended from time to time), we will co-own all clinical data generated pursuant to this agreement in any clinical trial conducted solely in Greater China, and, to the extent that such joint ownership is not legally permitted, MacroGenics will be the sole and exclusive owner of such clinical data.
Unless prohibited by applicable laws and regulations, which include all international, national, federal, state, regional, provincial, municipal and local government laws, rules, and regulations that apply to either us or MacroGenics or to the conduct of the collaboration under this agreement (including Good Manufacturing Practice, Good Clinical Practices, General Biological Products Standards, and the laws, rules and regulations of the International Conference on Harmonisation, the United States, mainland China, Hong Kong, Macau, and Taiwan, each as may be then in effect, as applicable and amended from time to time), we co-own all clinical data generated pursuant to this agreement in any clinical trial conducted solely in Greater China, and, to the extent that such joint ownership is not legally permitted, MacroGenics is the sole and exclusive owner of such clinical data.
Crystal structure of the complex of the Fab of lemzoparlimab (TJC4, Cyan) binding with the extracellular domain (ECD) of human CD47 (Green). The right. In a representative experiment, human RBCs were treated with PNGase for 1 hr, followed by the addition of lemzoparlimab (TJC4) ore comparator CD47 antibody that binds strongly to RBC at the indicated concentrations.
Crystal structure of the complex of the Fab of lemzoparlimab (TJC4, Cyan) binding with the extracellular domain of human CD47 (Green). The right. In a representative experiment, human RBCs were treated with PNGase for 1 hr, followed by the addition of lemzoparlimab (TJC4) ore comparator CD47 antibody that binds strongly to RBC at the indicated concentrations.
In addition, we agreed to pay Ferring tiered royalties ranging from the mid-single-digit to high-single-digit percentages of annual net sales for countries in China, Hong Kong, Macau, Taiwan, and South Korea, and from the high-single-digits to 10% of annual net sales for the mutually agreed upon countries in North America, the European Union and Japan.
In addition, we agreed to pay Ferring tiered royalties ranging from the mid-single-digit to high-single-digit percentages of annual net sales for countries in mainland China, Hong Kong, Macau, Taiwan, and South Korea, and from the high-single-digits to 10% of annual net sales for the mutually agreed upon countries in North America, the European Union and Japan.
The aforesaid milestones and royalties (other than the upfront payment) will be reduced by 50% following the entry of a generic version of GX-I7 in China, Hong Kong, Macau and Taiwan without the consent or authorization of us or any of our sublicensees.
The aforesaid milestones and royalties (other than the upfront payment) will be reduced by 50% following the entry of a generic version of GX-I7 in mainland China, Hong Kong, Macau and Taiwan without the consent or authorization of us or any of our sublicensees.
In the event of such termination, in addition to other obligations, we must grant to MorphoSys an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property relating to the licensed product to exploit MOR210/TJ210 in Greater China and South Korea. B.
In the event of such termination, in addition to other obligations, we must grant to MorphoSys an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property relating to the licensed product to exploit MOR210/TJ210 in Greater China and South Korea.
Unless terminated earlier in accordance with the terms thereof, the CSPC Agreement will remain in effect until the termination of the royalty term. This agreement may be terminated by either party for the other party’s uncured material breach, bankruptcy or insolvency or force majeure.
Unless terminated earlier in accordance with the terms thereof, this agreement will remain in effect until the termination of the royalty term. This agreement may be terminated by either party for the other party’s uncured material breach, bankruptcy or insolvency or force majeure.
Medical Patent Compulsory License According to the PRC Patent Law, for the purpose of public health, the CNIPA may grant a compulsory license for manufacturing patented drugs and exporting them to countries or regions covered under relevant international treaties to which the PRC has acceded.
Medical Patent Compulsory License According to the PRC Patent Law, for the purpose of public health, the CNIPA may grant a compulsory license for manufacturing patented drugs and exporting them to countries or regions covered under international treaties to which the PRC has acceded.
Additionally, we should grant to Genexine a fully paid up, royalty-free, exclusive license (with a right to sublicense) to use any such improvements, modifications or alterations anywhere outside of China, Hong Kong, Macau and Taiwan.
Additionally, we should grant to Genexine a fully paid up, royalty-free, exclusive license (with a right to sublicense) to use any such improvements, modifications or alterations anywhere outside of mainland China, Hong Kong, Macau and Taiwan.
However, if the dispute cannot be settled through mutual consultation, the patent owner, or an interested party who believes the patent is being infringed, may either file a civil legal suit or file an administrative complaint with the relevant patent administration authority.
However, if the dispute cannot be settled through mutual consultation, the patent owner, or an interested party who believes the patent is being infringed, may either file a civil legal suit or file an administrative complaint with the patent administration authority.
Only one patent claiming each approved product is eligible for restoration and the patent holder must apply for restoration within 60 days of approval. The United States Patent and Trademark Office (the “USPTO”), in consultation with the FDA, reviews and approves the application for patent term restoration.
Only one patent claiming each approved product is eligible for restoration and the patent holder must apply for restoration within 60 days of approval. The United States Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for patent term restoration.
In light of the PRC Company Law, companies established in the PRC are either in the form of a limited liability company or a joint stock company. The PRC Company Law applies to both PRC domestic companies and foreign-invested companies, unless otherwise provided in the relevant foreign investment laws and regulations.
In light of the PRC Company Law, companies established in the PRC are either in the form of a limited liability company or a joint stock company. The PRC Company Law applies to both PRC domestic companies and foreign-invested companies, unless otherwise provided in the foreign investment laws and regulations.
KG will pay us tiered royalties in the low to mid-teen percentages on net sales from the ASEAN and MENA regions, as well as Sri Lanka. C.
KG will pay us tiered royalties in the low to mid-teen percentages on net sales from the ASEAN and MENA regions, as well as Sri Lanka.
Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S.
Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several U.S.
The healthcare fraud and abuse laws and regulations that may affect our ability to operate include, but are not limited to: ● The federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under the Medicare and Medicaid programs, or other federal healthcare programs; ● The federal civil and criminal false claims laws and civil monetary penalty laws, including the civil False Claims Act, or FCA, which prohibits, among other things, knowingly presenting, or causing to be presented, claims for payment of government funds that are false or fraudulent, or knowingly making, or using or causing to be made or used, a false record or statement material to a false or fraudulent claim to avoid, decrease, or conceal an obligation to pay money to the federal government; ● The federal Health Insurance Portability and Accountability Act of 1996 (the “HIPAA”), which, among other things, prohibits executing a scheme to defraud any healthcare benefit program, including private third-party payors, and prohibits (i) knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation and (ii) making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services; 141 Table of Contents ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (the “HITECH”), and their respective implementing regulations, which impose requirements relating to the privacy, security and transmission of individually identifiable health information held by covered entities, including health plans, healthcare clearinghouses and certain healthcare providers, and their business associates, individuals or entities that perform certain services on behalf of a covered entity that involve the use or disclosure of individually identifiable health information.
The healthcare fraud and abuse laws and regulations that may affect our ability to operate include, but are not limited to: ● The federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under the Medicare and Medicaid programs, or other federal healthcare programs; ● The federal civil and criminal false claims laws and civil monetary penalty laws, including the civil False Claims Act, which prohibits, among other things, knowingly presenting, or causing to be presented, claims for payment of government funds that are false or fraudulent, or knowingly making, or using or causing to be made or used, a false record or statement material to a false or fraudulent claim to avoid, decrease, or conceal an obligation to pay money to the federal government; ● The federal Health Insurance Portability and Accountability Act of 1996, which, among other things, prohibits executing a scheme to defraud any healthcare benefit program, including private third-party payors, and prohibits (i) knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation and (ii) making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services; ● The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, which impose requirements relating to the privacy, security and transmission of individually identifiable health information held by covered entities, including health plans, healthcare clearinghouses and certain healthcare providers, and their business associates, individuals or entities that perform certain services on behalf of a covered entity that involve the use or disclosure of individually identifiable health information.
Under these circulars, employees working in the PRC who exercise share options, or whose restricted shares vest, will be subject to PRC individual income tax (the “IIT”).
Under these circulars, employees working in the PRC who exercise share options, or whose restricted shares vest, will be subject to PRC individual income tax.
Some trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board (the “DSMB”).
Some trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board.
Advantages of Givastomig Givastomig is a novel bi-specific antibody, with one arm targeting Claudin18.2 (CLDN18.2) and the other targeting 4-1BB through conditional or local activation. The key differentiation of givastomig is two-fold. Firstly, it binds to tumors with a wide range of CLDN18.2 expression levels, including lower expression, as demonstrated in pre-clinical animal models.
Potential Advantages of Givastomig Givastomig is a novel bi-specific antibody, with one arm targeting CLDN18.2 and the other targeting 4-1BB through conditional or local activation. The key differentiation of givastomig is two-fold. Firstly, it binds to tumors with a wide range of CLDN18.2 expression levels, including lower expression, as demonstrated in pre-clinical animal models.
Therefore, RBCs are only minimally accessible by lemzoparlimab. In contrast, the binding site on tumor cells does not have the same glycosylation pattern and is fully exposed to and accessible by lemzoparlimab. Therefore, lemzoparlimab can uniquely distinguish tumor cells from RBCs to avoid severe anemia that is commonly seen with other CD47 antibodies while retaining strong anti-tumor activity.
Therefore, RBCs are only minimally accessible by lemzoparlimab. In contrast, the binding site on tumor cells does not have the same glycosylation pattern and is fully exposed to and accessible by lemzoparlimab. Therefore, lemzoparlimab can uniquely distinguish tumor cells from RBCs to avoid severe anemia that is commonly observed with other CD47 antibodies while retaining strong anti-tumor activity.
The royalty term will terminate at the later of: (i) the expiry date of the underlying patents of the licensed products with application numbers 201410851771.1 and 201580071643.8 (final grant of rights requested relating to GLP-1) in China, whichever is later; and (ii) the ten-year anniversary of the initial commercialization of the product developed under the CSPC Agreement.
The royalty term will terminate at the later of: (i) the expiry date of the underlying patents of the licensed products with application numbers 201410851771.1 and 201580071643.8 (final grant of rights requested relating to GLP-1) in China, whichever is later; and (ii) the ten-year anniversary of the initial commercialization of the product developed under this agreement.
As of the date of this annual report, we have made an up-front payment of US$1.0 million to Wuxi Biologics and no milestone payments or royalties are due under this agreement. In April 2019, we extended our existing partnership with WuXi Biologics (Shanghai) Co., Ltd. (“WuXi Biologics Shanghai”).
As of the date of this annual report, we have made an up-front payment of US$1.0 million to Wuxi Biologics and no milestone payments or royalties are due under this agreement. In April 2019, we extended our existing partnership with WuXi Biologics (Shanghai) Co., Ltd..
On April 25, 2023, the arbitration award determined that the TJD5 Agreement has been terminated for a pre-agreed termination fee of $9.0 million plus interest payable pursuant to the original agreement, and, therefore Tracon has no rights to share any future economics with I-Mab.
On April 25, 2023, the arbitration award determined that the agreement in relation to TJD5 has been terminated for a pre-agreed termination fee of $9.0 million plus interest payable pursuant to the original agreement, and, therefore Tracon has no rights to share any future economics with I-Mab.
More importantly, all three responders were identified to exhibit higher co-expression of tumor CD73 and PD-L1 as compared to non-responders, indicating a correlation between higher CD73 expression and clinical activity of uliledlimab and a potential role of CD73 as a predictive biomarker to warrant further investigation. Figure: Treatment duration for the combination therapy of uliledlimab and atezolizumab.
All three responders were identified to exhibit higher co-expression of tumor CD73 and PD-L1 as compared to non-responders, indicating a correlation between higher CD73 expression and clinical activity of uliledlimab and a potential role of CD73 as a predictive biomarker to warrant further investigation. Figure: Treatment duration for the combination therapy of uliledlimab and atezolizumab.
We also agreed that, during the term of the CSPC Agreement, we should not develop, either for ourselves or for third parties, any other hyFc platform technology-based long-acting recombinant GLP-1 Fc fusion proteins that may be in a competitive position with TJ103.
We also agreed that, during the term of this agreement, we should not develop, either for ourselves or for third parties, any other hyFc platform technology-based long-acting recombinant GLP-1 Fc fusion proteins that may be in a competitive position with TJ103.
ITEM 4. INFORMATION ON THE COMPANY A. History and Development of the Company We commenced our operations in November 2014, when our predecessor Third Venture Biopharma (Nanjing) Co., Ltd (“Third Venture”) was established. I-Mab was established in June 2016 under the laws of the Cayman Islands as our offshore holding company.
ITEM 4. INFORMATION ON THE COMPANY A. History and Development of the Company We commenced our operations in November 2014, when our predecessor Third Venture Biopharma (Nanjing) Co., Ltd was established. I-Mab was established in June 2016 under the laws of the Cayman Islands as our offshore holding company.
Business Overview Executive Summary In 2022, we faced a series of risks, including macroeconomic and geopolitical headwinds, which prompted us to re-position our overall business in response to these challenges, while focusing on re-prioritizing the pipeline development to deliver on key clinical milestones.
Business Overview Executive Summary In 2023, we faced a series of risks, including macroeconomic and geopolitical headwinds, which prompted us to re-position our overall business in response to these challenges, while focusing on re-prioritizing the pipeline development to deliver on key clinical milestones.
With the agreement, KG will have a right of first negotiation for exclusive rights to commercialize these two product candidates in the ASEAN (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) and MENA (Algeria, Bahrain, Djibouti, Egypt, Israel, Jordan, Kuwait, Lebanon, Malta, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates, and Palestine) regions, as well as Sri Lanka.
With the agreement, KG has a right of first negotiation for exclusive rights to commercialize these two product candidates in the ASEAN (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) and MENA (Algeria, Bahrain, Djibouti, Egypt, Israel, Jordan, Kuwait, Lebanon, Malta, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates, and Palestine) regions, as well as Sri Lanka.
Serious offenses such as forgery of patents may be subject to criminal penalties. 128 Table of Contents When a dispute arises out of infringement of the patent owner’s patent right, Chinese law requires that the parties first attempt to settle the dispute through mutual consultation.
Serious offenses such as forgery of patents may be subject to criminal penalties. 95 Table of Contents When a dispute arises out of infringement of the patent owner’s patent right, Chinese law requires that the parties first attempt to settle the dispute through mutual consultation.
Under the HDYM License, I-Mab Shanghai agreed to grant to HDYM exclusive (even to I-Mab Shanghai itself), worldwide and sublicensable rights to develop, manufacture, have manufactured, use, sell, have sold, import, or otherwise exploit certain PD-L1 related patents, patent applications, know-hows, data and information of I-Mab Shanghai, relevant cell lines as well as any PD-L1 monoclonal antibody arising from such cell lines for the treatment of diseases.
Under this agreement, I-Mab Shanghai agreed to grant to HDYM exclusive (even to I-Mab Shanghai itself), worldwide and sublicensable rights to develop, manufacture, have manufactured, use, sell, have sold, import, or otherwise exploit certain PD-L1 related patents, patent applications, know-hows, data and information of I-Mab Shanghai, relevant cell lines as well as any PD-L1 monoclonal antibody arising from such cell lines for the treatment of diseases.
This localized T cell activation is conditional upon tumor engagement and is expected to exert strong anti-tumor activity while minimizing systemic side effects such as liver toxicity seen with 4-1BB agents in previous clinical studies.
This localized T cell activation is conditional upon CLDN18.2 engagement and is expected to exert strong anti-tumor activity while minimizing systemic side effects such as liver toxicity seen with 4-1BB agents in previous clinical studies.
In November 2021, we also entered into a strategic collaboration with Roche Diagnostics, a global leader in in vitro diagnostics industry, to co-develop companion diagnostics (CDx) solutions for our innovative pipeline, at the Fourth China International Import Expo (CIIE) in Shanghai.
In November 2021, we also entered into a strategic collaboration with Roche Diagnostics, a global leader in in vitro diagnostics industry, to co-develop companion diagnostics solutions for our innovative pipeline, at the Fourth China International Import Expo in Shanghai.
Although a number of these, and other proposed measures may require additional authorization to become effective, Congress and the Trump Administration have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs.
Although a number of these, and other proposed measures may require additional authorization to become effective, Congress and the Trump Administration have each indicated that they would continue to seek new legislative and/or administrative measures to control drug costs.
In addition, as detailed earlier, the anti-4-1BB moiety of TJ-L14B binds to a novel epitope that only triggers 4-1BB signaling upon tumor binding leading to a reduced cytokine release and hepatic and systemic immunotoxicity without compromising anti-tumor activity. TJ-L14B is also more specific than certain competitor molecules in terms of 4-1BB binding relative to other TNFR families of co-stimulatory molecules.
In addition, as detailed earlier, the anti-4-1BB moiety of ragistomig binds to a novel epitope that only triggers 4-1BB signaling upon tumor binding leading to a reduced cytokine release and hepatic and systemic immunotoxicity without compromising anti-tumor activity. Ragistomig is also more specific than certain competitor molecules in terms of 4-1BB binding relative to other TNFR families of co-stimulatory molecules.
Under the CSPC Agreement, we granted to CSPC entity exclusive, non-transferable, non-irrevocable and sublicensable rights under our patent rights in China to develop and commercialize TJ103 for treating type 2 diabetes mellitus and any other potential therapeutic applications.
Under this agreement, we granted to CSPC Entity exclusive, non-transferable, non-irrevocable and sublicensable rights under our patent rights in China to develop and commercialize TJ103 for treating type 2 diabetes mellitus and any other potential therapeutic applications.
In addition, we and Jumpcan will share profits generated from commercialization of the product in mainland China on a 50/50 basis, pursuant to which we will be entitled to receive tiered low double-digit royalties on net sales.
In addition, we and Jumpcan will share profits generated from commercialization of the product in mainland China on a 50/50 basis, pursuant to which we are entitled to receive tiered low double-digit royalties on net sales.
While we believe that our management’s research, development and commercialization experience provide us with competitive advantages, we face competition from global and China-based biopharmaceutical companies, including specialty pharmaceutical companies, generic drug companies, biologics drug companies, academic institutions, government agencies and research institutions.
While we believe that our management’s research, development and commercialization experience provide us with competitive advantages, we face competition from global biopharmaceutical companies, including specialty pharmaceutical companies, generic drug companies, biologics drug companies, academic institutions, government agencies and research institutions.
If proven in clinical trials, these potential advantages could differentiate TJ-L14B from other competing compounds. Summary of Preclinical Results PD-L1 level-dependent 4-1BB Agonism and T Cell Activity. The ability of TJ-L14B to ligate 4-1BB and activate downstream signaling was tested in a co-culture of PD-L1+ target cells with T cells as effectors.
If proven in clinical trials, these potential advantages could differentiate ragistomig from other competing compounds. Summary of Preclinical Results PD-L1 level-dependent 4-1BB Agonism and T cell Activity. The ability of ragistomig to ligate 4-1BB and activate downstream signaling was tested in a co-culture of PD-L1+ target cells with T cells as effectors.
The FDA must determine if the drug candidate qualifies for fast track designation within 60 days after receipt of the sponsor’s request. 140 Table of Contents In addition to other benefits, such as the ability to have more frequent interactions with the FDA, the agency may initiate review of sections of a fast track product’s BLA before the application is complete.
The FDA must determine if the drug candidate qualifies for fast track designation within 60 days after receipt of the sponsor’s request. In addition to other benefits, such as the ability to have more frequent interactions with the FDA, the agency may initiate review of sections of a fast track product’s BLA before the application is complete.
M&A Rules According to the Provisions on the Merger or Acquisition of Domestic Enterprises by Foreign Investors jointly issued by the MOFCOM, the State Assets Supervision and Administration Commission of the State Council, the State Administration of Taxation (the “SAT”), the State Administration for Industry and Commerce (now known as the State Administration for Market Regulation), the China Securities Regulatory Commission and the State Administration of Foreign Exchange (the “SAFE”), on August 8, 2006 and amended by the MOFCOM on June 22, 2009, among other things, (i) the purchase of an equity interest or subscription to the increase in the registered capital of non-foreign-invested enterprises, (ii) the establishment of foreign-invested enterprises to purchase and operate the assets of non-foreign-invested enterprises, or (iii) the purchase of the assets of non-foreign-invested enterprises and the use of such assets to establish foreign-invested enterprises to operate such assets, in each case, by foreign investors is subject to the Provisions on the Merger or Acquisition of Domestic Enterprises by Foreign Investors.
M&A Rules According to the Provisions on the Merger or Acquisition of Domestic Enterprises by Foreign Investors jointly issued by the Ministry of Commerce, the State Assets Supervision and Administration Commission of the State Council, the State Administration of Taxation, the State Administration for Industry and Commerce (now known as the State Administration for Market Regulation), the China Securities Regulatory Commission and the State Administration of Foreign Exchange, or the SAFE, on August 8, 2006 and amended by the Ministry of Commerce on June 22, 2009, among other things, (i) the purchase of an equity interest or subscription to the increase in the registered capital of non-foreign-invested enterprises, (ii) the establishment of foreign-invested enterprises to purchase and operate the assets of non-foreign-invested enterprises, or (iii) the purchase of the assets of non-foreign-invested enterprises and the use of such assets to establish foreign-invested enterprises to operate such assets, in each case, by foreign investors is subject to the Provisions on the Merger or Acquisition of Domestic Enterprises by Foreign Investors.
Remarkably, when these tumor-free mice were re-challenged with a second tumor implant a month after drug cessation, they remained totally protected, indicating that givastomig produced a durable anti-tumor response.
Remarkably, when these tumor-free mice were re-challenged with a second tumor implant a month after drug cessation, they remained totally protected from tumor implantation, indicating that givastomig produced a durable anti-tumor response.
Under the terms of the agreement, KG will receive a right of first negotiation for an exclusive license for the commercialization of two I-Mab-discovered product candidates: uliledlimab, a differentiated anti-CD73 antibody in Phase 1 development for advanced solid tumors, and an I-Mab product candidate to be agreed upon by both parties.
Under the terms of the agreement, KG has a right of first negotiation for an exclusive license for the commercialization of two I-Mab-discovered product candidates: uliledlimab, a differentiated anti-CD73 antibody in Phase 1 development for advanced solid tumors, and an I-Mab product candidate to be agreed upon by both parties.
Trade Secrets Pursuant to the PRC Anti-Unfair Competition Law promulgated by the Standing Committee of the NPC on September 2, 1993 and amended on November 4, 2017 and April 23, 2019, respectively, the term “trade secrets” refers to technical and business information that is unknown to the public, has utility, may create business interests or profits for its legal owners or holders, and is maintained as a secret by its legal owners or holders.
Trade Secrets Pursuant to the PRC Anti-Unfair Competition Law promulgated by the Standing Committee of the National People’s Congress on September 2, 1993 and amended on November 4, 2017 and April 23, 2019, respectively, the term “trade secrets” refers to technical and business information that is unknown to the public, has utility, may create business interests or profits for its legal owners or holders, and is maintained as a secret by its legal owners or holders.
Arcus Biosciences had also reported promising results in their Phase 1b/2 trial of quemliclustat, a small molecule CD73 inhibitor, in combination with zimberelimab plus chemotherapy in patients with pancreatic cancer.
Arcus Biosciences had also reported encouraging results in their Phase 1b/2 trial of quemliclustat, a small molecule CD73 inhibitor, in combination with zimberelimab plus chemotherapy in patients with pancreatic cancer.
MacroGenics will solely and exclusively own all other clinical data generated pursuant to this agreement. We are not aware of any applicable laws or regulations that would prohibit us from jointly owning such clinical data and, to our knowledge, we currently qualify for such joint ownership with MacroGenics under this agreement.
MacroGenics solely and exclusively owns all other clinical data generated pursuant to this agreement. We are not aware of any applicable laws or regulations that would prohibit us from jointly owning such clinical data and, to our knowledge, we currently qualify for such joint ownership with MacroGenics under this agreement.
If and when the deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the BLA, the FDA will issue an approval letter. In issuing the CRL, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional data, information or clarification.
If and when the deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the BLA, the FDA will issue an approval letter. In issuing the complete response letter, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional data, information or clarification.
As shown in the figure below, givastomig consistently exhibited stronger binding than the reference antibody zolbetuximab in cells with high, moderate, and even low levels of CLDN18.2. Figure: More potent binding by givastomig than zolbetuximab to cells expressing various levels of CLDN18.2. CLDN18.2-dependent 4-1BB Activation and T Cell Activity by givastomig.
As shown in the figure below, givastomig consistently exhibited stronger binding than the reference antibody zolbetuximab in cells with high, moderate, and even low levels of CLDN18.2. Figure: More potent binding by givastomig than zolbetuximab to cells expressing various levels of CLDN18.2. 73 Table of Contents CLDN18.2-dependent 4-1BB Activation and T Cell Activity by givastomig.
Pre-clinical studies include laboratory evaluations of product chemistry, toxicity and formulation, as well as in vitro and animal studies to assess the potential safety and activity of the biologic for initial testing in humans and to establish a rationale for therapeutic use. Pre-clinical studies are subject to federal regulations and requirements, including GLP regulations.
Pre-clinical studies include laboratory evaluations of product chemistry, toxicity and formulation, as well as in vitro and animal studies to assess the potential safety and activity of the biologic for initial testing in humans and to establish a rationale for therapeutic use. Pre-clinical studies are subject to federal regulations and requirements, including good laboratory practice regulations.
On July 16, 2022, I-Mab Hangzhou entered into a definitive financing agreement with a group of domestic investors in China to raise approximately US$46 million in RMB equivalent. Upon closing of the financing, we, through our wholly-owned subsidiary, will remain the largest shareholder.
On July 16, 2022, I-Mab Hangzhou entered into a definitive financing agreement with a group of domestic investors in China to raise approximately US$46 million (in RMB equivalent). Upon the closing of the financing, we, through our wholly-owned subsidiary, became the largest shareholder of I-Mab Hangzhou.
The anti-tumor efficacy of givastomig was dose-dependent, with a minimal efficacious dose of 0.4 mg/kg. 92 Table of Contents Figure: Potent in vivo anti-tumor activity of givastomig in a mouse tumor model. Mice transgenic for humanized 4-1BB were grafted with MC38 cells expressing human CLDN18.2.
The anti-tumor efficacy of givastomig was dose-dependent, with a minimal efficacious dose of 0.4 mg/kg. Figure: Potent in vivo anti-tumor activity of givastomig in a mouse tumor model. Mice transgenic for humanized 4-1BB were grafted with MC38 cells expressing human CLDN18.2.
We will also receive an exclusive license to use any improvements related to GX-G3 that Genexine develops or acquires free of charge in Taiwan and Hong Kong. Under this agreement, the scope of improvements is limited to GX-G3 and does not include the hyFc platform.
We also received an exclusive license to use any improvements related to GX-G3 that Genexine develops or acquires free of charge in Taiwan and Hong Kong. Under this agreement, the scope of improvements is limited to GX-G3 and does not include the hyFc platform.
Mice were treated with the indicated antibodies every three days for four times. Tumor-free animals were re-challenged with a second dose of the tumor on day 40 with treatment-naïve animals as a control. TJ-L14B is also known as ABL503. Preclinical Safety.
Mice were treated with the indicated antibodies every three days for four times. Tumor-free animals were re-challenged with a second dose of the tumor on day 40 with treatment-naïve animals as a control. Ragistomig is also known as ABL503. Preclinical Safety.
According to the terms of the collaboration agreement, Jumpcan will make an upfront payment of RMB224 million to I-Mab and, upon achievement of development, registration and sales milestones, certain milestone payments of up to RMB1.792 billion, making the non-royalty payments a total of up to RMB2.016 billion.
According to the collaboration agreement, Jumpcan agreed to make an upfront payment of RMB224 million to I-Mab and, upon achievement of development, registration and sales milestones, certain milestone payments of up to RMB1.792 billion, making the non-royalty payments a total of up to RMB2.016 billion.
BLA Submission and Review Assuming successful completion of all required clinical testing in accordance with all applicable regulatory requirements, an applicant may submit a BLA requesting licensing to market the biologic for one or more indications in the United States.
BLA Submission and Review Assuming successful completion of all required clinical testing in accordance with all applicable regulatory requirements, an applicant may submit a biologics license application, or BLA, requesting licensing to market the biologic for one or more indications in the United States.
We are required to use commercially reasonable efforts to obtain approval of FE301 and to promote, market, distribute and sell it in China, Hong Kong, Macau, Taiwan, and South Korea. Such activities are to be at our own cost and expense. Under this agreement, we paid to Ferring an upfront license fee of US$2.0 million.
We are required to use commercially reasonable efforts to obtain approval of FE301 and to promote, market, distribute and sell it in mainland China, Hong Kong, Macau, Taiwan, and South Korea. Such activities are to be at our own cost and expense. 82 Table of Contents Under this agreement, we paid to Ferring an upfront license fee of US$2.0 million.
Upon the occurrence of certain triggering events as specified in the shareholders agreement among I-Mab Hangzhou, we, through our wholly-owned subsidiary, and other domestic investors, including but not limited to I-Mab Hangzhou’s failure to accomplish certain public offering condition, we may be obligated to repurchase the equity held by other domestic investors in cash or in our stocks in the period beyond 12 months.
Upon the occurrence of certain triggering events as specified in the shareholders agreement among I-Mab Hangzhou, we, through our wholly-owned subsidiary, and other domestic investors, including but not limited to I-Mab Hangzhou’s failure to accomplish certain public offering condition, we may be obligated to repurchase the equity held by other domestic investors in cash or in our stocks.
Figure: Dose-dependent CLDN18.2-restricted T cell activity by givastomig but not urelumab in T cell and target cell co-culture system. Left, co-culture scheme; Middle, NF-kB reporter activity; Right, IL-2 production. Superior in vivo Anti-tumor Efficacy of Givastomig.
Figure: Dose-dependent CLDN18.2-restricted T cell activity by givastomig but not urelumab in T cell and target cell co-culture system. Left, co-culture scheme; Middle, NF-kB reporter activity; Right, IL-2 production. ​ 74 Table of Contents Superior in vivo Anti-tumor Efficacy of Givastomig.
An applicant seeking approval to market and distribute a biologic in the United States typically must undertake the following: ● completion of non-clinical laboratory tests and animal studies performed in accordance with the FDA’s good laboratory practice (the “GLP”), regulations; ● submission to the FDA of an application for an Investigational New Drug (“IND”), which must become effective before clinical trials may begin and must be updated annually or when significant changes are made; ● manufacture, labeling and distribution of an investigational drug in compliance with current good manufacturing practice (the “cGMP”); ● approval by an independent institutional review board (the “IRB”), or ethics committee at each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with the FDA’s current Good Clinical Practices requirements (the “cGCP”), to establish the safety, purity and potency of the proposed biological drug candidate for its intended purpose; 134 Table of Contents ● preparation of and submission to the FDA of a biologics license application (“BLA”), after completion of all pivotal clinical trials requesting marketing approval for one or more proposed indications; ● satisfactory completion of an FDA Advisory Committee review, where appropriate or if applicable, as may be requested by the FDA to assist with its review; ● satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the proposed product, or components thereof, are produced to assess compliance with cGMP and data integrity requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, safety, quality, purity and potency; ● satisfactory completion of FDA audits of selected clinical investigation sites to assure compliance with cGCP requirements and the integrity of the clinical data; ● payment of user fees under the Prescription Drug User Fee Act (the “PDLTFA”), for the relevant year; ● obtaining FDA review and approval of the BLA to permit commercial marketing of the licensed biologic for particular indications for use in the United States; and ● compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (the “REMS”), and the potential requirement to conduct post-approval studies.
An applicant seeking approval to market and distribute a biologic in the United States typically must undertake the following: ● completion of non-clinical laboratory tests and animal studies performed in accordance with the FDA’s good laboratory practice regulations; ● submission to the FDA of an application for an Investigational New Drug, or an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made; ● manufacture, labeling and distribution of an investigational drug in compliance with current good manufacturing practice; ● approval by an independent institutional review board or ethics committee at each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with the FDA’s current Good Clinical Practices requirements, to establish the safety, purity and potency of the proposed biological drug candidate for its intended purpose; ● preparation of and submission to the FDA of a biologics license application, after completion of all pivotal clinical trials requesting marketing approval for one or more proposed indications; ● satisfactory completion of an FDA Advisory Committee review, where appropriate or if applicable, as may be requested by the FDA to assist with its review; ● satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the proposed product, or components thereof, are produced to assess compliance with current good manufacturing practice and data integrity requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, safety, quality, purity and potency; ● satisfactory completion of FDA audits of selected clinical investigation sites to assure compliance with current Good Clinical Practices requirements and the integrity of the clinical data; ● payment of user fees under the Prescription Drug User Fee Act for the relevant year; ● obtaining FDA review and approval of the biologics license application to permit commercial marketing of the licensed biologic for particular indications for use in the United States; and 100 Table of Contents ● compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, and the potential requirement to conduct post-approval studies.
The key advantages of uliledlimab when compared with other CD73 antibodies or small molecule inhibitors can be summarized as follows: (1) uliledlimab exhibits a typical dose-response curve without the “hook effect” to achieve the complete inhibition of both soluble and surface-bound CD73; and (2) uliledlimab has a non-competitive inhibitory effect that is not blunted by high levels of CD73 enzyme substrates, which would be expected for small-molecule competitive blockers.
The key advantages of uliledlimab when compared with other CD73 antibodies or small molecule inhibitors can be summarized as follows: (1) uliledlimab exhibits a typical dose-response curve without the “hook effect” to achieve the complete inhibition of both soluble and surface-bound CD73; and (2) uliledlimab has a non-competitive inhibitory effect that is not blunted by high levels of CD73 enzyme substrates, which may occur with small-molecule competitive blockers.
Under the terms of the expanded collaboration, we will be mainly responsible for using commercially reasonable efforts to conduct the Phase 2 GBM clinical trial in Greater China, and Genexine will share the development strategies, data and costs for success of this clinical trial.
Under the expanded collaboration, we are mainly responsible for using commercially reasonable efforts to conduct the Phase 2 GBM clinical trial in Greater China, and Genexine will share the development strategies, data and costs for success of this clinical trial.
The Term Compensation should not exceed five (5) years, and the total effective patent right period after the new drug is approved for marketing should not exceed fourteen (14) years.
The compensation for patent term should not exceed five years, and the total effective patent right period after the new drug is approved for marketing should not exceed fourteen years.
Along with third-party contractors, we will be required to navigate the various pre-clinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of our drug candidates.
Along with third-party contractors, we are required to navigate the various pre-clinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of our drug candidates.
In accordance with the Stock Option Rules and relevant rules and regulations, PRC citizens or non-PRC citizens residing in China for a continuous period of not less than one year, who participate in any stock incentive plan of an overseas publicly listed company, subject to a few exceptions, are required to register with the SAFE through a domestic qualified agent, which could be a PRC subsidiary of such overseas listed company, and complete certain procedures.
In accordance with this regulation and applicable rules and regulations, PRC citizens or non-PRC citizens residing in China for a continuous period of not less than one year, who participate in any stock incentive plan of an overseas publicly listed company, subject to a few exceptions, are required to register with the SAFE through a domestic qualified agent, which could be a PRC subsidiary of such overseas listed company, and complete certain procedures.
We and our employees who are PRC citizens or who reside in China for a continuous period of not less than one year and who participate in our stock incentive plan will be subject to such regulation. In addition, the SAT has issued circulars concerning employee share options or restricted shares.
We and our employees who are PRC citizens or who reside in China for a continuous period of not less than one year and who participate in our stock incentive plan will be subject to such regulation. In addition, the State Administration of Taxation has issued circulars concerning employee share options or restricted shares.
In March 2021, we entered into two collaboration agreements with Complix, an EU-based biotech company (the “Complix Agreement”), and Affinity, a Shanghai-based biotech company (the “Affinity Agreement”), respectively, allowing us to access cutting-edge technology platforms to create next generation of novel and highly differentiated drug candidates, including Cell Penetrating Alphabodies (“CPAB”) for otherwise intractable intracellular drug targets and masked antibodies for targeted tumor-site activation.
In March 2021, we entered into two collaboration agreements with Complix, an EU-based biotech company, and Affinity, a Shanghai-based biotech company, respectively, allowing us to access cutting-edge technology platforms to create next generation of novel and highly differentiated drug candidates, including Cell Penetrating Alphabodies for otherwise intractable intracellular drug targets and masked antibodies for targeted tumor-site activation.
Our senior management is firmly committed to delivering our quality performance, actively involved in allocating sufficient resources to quality management system and setting quality governance mechanism.
Quality Control and Assurance Our senior management is firmly committed to delivering our quality performance, actively involved in allocating sufficient resources to quality management system and setting quality governance mechanism.
In February 2018, I-Mab Hong Kong established in Maryland, United States, a wholly-owned subsidiary I-Mab Biopharma US Limited (“I-Mab US”), as the hub for the discovery and development of the drug candidates in our Global Portfolio.
In February 2018, I-Mab Hong Kong established in Maryland, United States, a wholly-owned subsidiary I-Mab Biopharma US Limited, or I-Mab US, as the hub for the discovery and development of the drug candidates in our Global portfolio.
Concurrent with clinical trials, companies often complete additional animal studies, and develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
Concurrent with clinical trials, companies often complete additional animal studies, and develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with requirements of Good Manufacturing Practice.

… 755 more changes not shown on this page.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

98 edited+27 added−41 removed55 unchanged
Biggest changeResearch and Development Expenses The following table sets forth a breakdown of the major components of our research and development expenses in absolute amounts and as a percentage of our total research and development expenses for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2020 ​ 2021 ​ RMB % RMB % ​ ​ (in thousands, except percentages) CRO service fees 439,537 44.6 727,573 60.0 In-licensed patent right fees 28,266 2.9 66,344 5.5 Employee benefit expenses 460,149 46.7 347,571 28.7 Material costs for drug candidates 15,610 1.6 23,141 1.9 Other expenses 41,127 4.2 48,329 3.9 Total 984,689 100.0 1,212,958 100.0 ​ 157 Table of Contents Our research and development expenses increased by 23.2% from RMB984.7 million for the year ended December 31, 2020 to RMB1,213.0 million for the year ended December 31, 2021, primarily attributable to (i) an increase in CRO service fees from RMB439.5 million for the year ended December 31, 2020 to RMB727.6 million for the year ended December 31, 2021, to advance our clinical and preclinical pipelines, especially for lemzoparlimab (TJC4), uliledlimab (TJD5), and eftansomatropin alfa (TJ101); (ii) an increase in in-licensed patent right fees from RMB28.3 million for the year ended December 31, 2020 to RMB66.3 million for the year ended December 31, 2021, (iii) partially offset by a decrease in employee benefit expenses of employees involved in research and development from RMB460.1 million for the year ended December 31, 2020 to RMB347.6 million for the year ended December 31, 2021, mainly due to the decrease of share-based compensation expense by RMB82.5 million.
Biggest changeResearch and Development Expenses The following table sets forth a breakdown of the major components of our research and development expenses in absolute amounts and as a percentage of our total research and development expenses for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2022 ​ 2023 ​ RMB % RMB US$ % ​ ​ (in thousands, except for percentages) CRO service fees 523,559 57.9 519,345 73,148 64.1 In-licensed patent right fees 3,316 0.4 1,485 209 0.2 Employee benefit expenses 324,363 35.8 241,814 34,059 29.8 Material costs for drug candidates 20,857 2.3 13,926 1,961 1.7 Other expenses 32,806 3.6 34,076 4,800 4.2 Total 904,901 100.0 810,646 114,177 100.0 ​ Our research and development expenses decreased by 10.4% from RMB904.9 million for the year ended December 31, 2022 to RMB810.6 million (US$114.2 million) for the year ended December 31, 2023, primarily due to (i) a decrease in employee benefit expenses of employees involved in research and development from RMB324.4 million for the year ended December 31, 2022 to RMB241.8 million (US$34.1 million) for the year ended December 31, 2023, primarily due to reduced payroll expenses related to headcount optimization as a result of asset prioritization and reduced share-based compensation expenses; (ii) a slight decrease in service fees for CRO and contract manufacturing organizations from RMB523.6 million for the year ended December 31, 2022 to RMB519.3 million (US$73.1 million) for the year ended December 31, 2023; (iii) a decrease in material costs for drug candidates from RMB20.9 million for the year ended December 31, 2022 to RMB13.9 million (US$2.0 million) for the year ended December 31, 2023; and (iv) a slight increase in other expenses from RMB32.8 million for the year ended December 31, 2022 to RMB34.1 million (US$4.8 million) for the year ended December 31, 2023. 118 Table of Contents In 2023, 86.1% and 13.9% of our total research and development expenses were attributable to clinical programs and preclinical programs, respectively, as compared to 88.2% and 11.8% in 2022.
The decrease in 2022 net revenue was primarily due to a non-cash adjustment of US$-48.0 million (equivalent to RMB-314.2 million) recorded in the second half of 2022 following the amendment to the original license and collaboration agreement with AbbVie in August 2022.
The decrease in 2022 net revenue was primarily due to a non-cash adjustment of US$-48.0 million (equivalent to RMB-314.2 million) recorded in the second half of 2022 following the amendment to the original license and collaboration agreement with AbbVie in August 2022.
Interest Income We recorded interest income of RMB21.3 million and RMB26.9 million (US$3.9 million) for the years ended December 31, 2021 and 2022, respectively. The change was primarily attributable to the interest income derived from bank deposits and a decrease in bank balance.
Interest Income We recorded interest income of RMB21.3 million and RMB26.9 million for the years ended December 31, 2021 and 2022, respectively. The change was primarily attributable to the interest income derived from bank deposits and a decrease in bank balance.
This is due to the numerous risks and uncertainties associated with developing such drug candidates, including the uncertainty of: ● successful enrollment in and completion of clinical trials; ● establishing an appropriate safety profile; 149 Table of Contents ● establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; ● receipt of marketing approvals from applicable regulatory authorities; ● commercializing the drug candidates, if and when approved, whether alone or in collaboration with others; ● obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our drug candidates; ● continued acceptable safety profiles of the products following approval; and ● retention of key research and development personnel.
This is due to the numerous risks and uncertainties associated with developing such drug candidates, including the uncertainty of: ● successful enrollment in and completion of clinical trials; ● establishing an appropriate safety profile; ● establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; ● receipt of marketing approvals from applicable regulatory authorities; ● commercializing the drug candidates, if and when approved, whether alone or in collaboration with others; ● obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our drug candidates; ● continued acceptable safety profiles of the products following approval; and ● retention of key research and development personnel.
We do not have any variable interest in any unconsolidated entity that provides financing, liquidity, market risk or credit support to us or engages in leasing, hedging or product development services with us. Other than as discussed above, we did not have any significant capital and other commitments, long-term obligations or guarantees as of December 31, 2022.
We do not have any variable interest in any unconsolidated entity that provides financing, liquidity, market risk or credit support to us or engages in leasing, hedging or product development services with us. Other than as discussed above, we did not have any significant capital and other commitments, long-term obligations or guarantees as of December 31, 2023.
We recognize as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied. 159 Table of Contents Variable consideration in collaboration revenue arrangements If the consideration promised in a contract includes a variable amount, we will estimate the amount of consideration to which we will be entitled in exchange for transferring the promised goods or services to a customer.
We recognize as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied. 121 Table of Contents Variable consideration in collaboration revenue arrangements If the consideration promised in a contract includes a variable amount, we will estimate the amount of consideration to which we will be entitled in exchange for transferring the promised goods or services to a customer.
We believe that it is more likely than not that these net accumulated operating losses will not be utilized in the future based on the assessment as of December 31, 2022. Therefore, we have provided full valuation allowances for the deferred tax assets as of December 31, 2020, 2021 and 2022.
We believe that it is more likely than not that these net accumulated operating losses will not be utilized in the future based on the assessment as of December 31, 2023. Therefore, we have provided full valuation allowances for the deferred tax assets as of December 31, 2021, 2022 and 2023.
For the years ended December 31, 2020, 2021 and 2022, I-Mab Biopharma Hong Kong Limited did not make any provisions for Hong Kong profit tax as there were no assessable profits derived from or earnings in Hong Kong for any of the periods presented.
For the years ended December 31, 2021, 2022 and 2023, I-Mab Biopharma Hong Kong Limited did not make any provisions for Hong Kong profit tax as there were no assessable profits derived from or earnings in Hong Kong for any of the periods presented.
Our research and development expenses primarily include the following: ● costs related to development of our pipeline assets under all stages including discovery, pre-clinical testing or clinical trials; ● patent license fees and other fees under the licensing, collaboration and development agreements with respect to our in-licensed drug candidates; and ● employee salaries and related benefit costs, including share-based compensation expenses, for research and development personnel and key management.
Our research and development expenses primarily include the following: ● costs related to development of our pipeline assets under all stages including discovery, pre-clinical testing or clinical trials; ● patent license fees and other fees under the licensing, collaboration and development agreements with respect to our in-licensed drug candidates; and 112 Table of Contents ● employee salaries and related benefit costs, including share-based compensation expenses, for research and development personnel and key management.
Our cash, cash equivalents and restricted cash consist primarily of cash in bank and on hand. Historically, we have financed our operations principally through proceeds from the issuance and sale of preferred shares and convertible promissory notes in private placement transactions, and we also received total net proceeds of approximately US$105.3 million from our initial public offering.
Our cash, cash equivalents and restricted cash consist primarily of cash in multiple banks and on hand. Historically, we have financed our operations principally through proceeds from the issuance and sale of preferred shares and convertible promissory notes in private placement transactions, and we also received total net proceeds of approximately US$105.3 million from our initial public offering.
Other Income (Expenses), Net Other income (expenses), net consists primarily of income from the equity transfer of I-Mab Hangzhou, fair value change of short-term and other investments, fair value change of put right liabilities, net foreign exchang gains (losses) and subsidy income.
Other Income (Expenses), Net Other income (expenses), net consists primarily of income from the equity transfer of I-Mab Hangzhou, fair value change of short-term and other investments, fair value change of put right liabilities, net foreign exchange gains (losses) and subsidy income.
Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Item 3. Key Information—D. Risk Factors” or in other parts of this annual report on Form 20-F. 148 Table of Contents A.
Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Item 3. Key Information—D. Risk Factors” or in other parts of this annual report on Form 20-F. A.
For the years ended December 31, 2020, 2021 and 2022, the income tax expenses recorded in the consolidated statements of comprehensive income (loss) for I-Mab were nil, nil and RMB0.7 million, respectively.
For the years ended December 31, 2021, 2022 and 2023, the income tax expenses recorded in the consolidated statements of comprehensive income (loss) for I-Mab were nil, RMB0.7 million and nil, respectively.
Trend Information Other than as disclosed elsewhere in this annual report, we are not aware of any trends, uncertainties, demands, commitments or events since January 1, 2022 that are reasonably likely to have a material adverse effect on our net revenues, income, profitability, liquidity or capital resources, or that caused the disclosed financial information to be not necessarily indicative of future operating results or financial conditions.
Trend Information Other than as disclosed elsewhere in this annual report, we are not aware of any trends, uncertainties, demands, commitments or events for the period since January 1, 2024 that are reasonably likely to have a material adverse effect on our net revenues, income, profitability, liquidity or capital resources, or that caused the disclosed financial information to be not necessarily indicative of future operating results or financial conditions.
See Note 17 “Licensing and Collaboration Arrangements” of our consolidated financial statements included elsewhere in this annual report for a further discussion of our licensing and collaboration revenues. 160 Table of Contents Fair value measurement of put right liabilities Put right written by us to third party investors in our affiliate was recorded as a freestanding equity-linked instrument and classified as a put right liability.
See Note 14 “Licensing and Collaboration Arrangements” of our consolidated financial statements included elsewhere in this annual report for a further discussion of our licensing and collaboration revenues. 122 Table of Contents Fair value measurement of put right liabilities Put right written by us to third party investors in our affiliate was recorded as a freestanding equity-linked instrument and classified as a put right liability.
In 2022, 88.2% and 11.8% of our total research and development expenses were attributable to clinical programs and preclinical programs, respectively, as compared to 94.3% and 5.7% in 2021. In 2022, felzartamab and eftansomatropin alfa accounted for approximately 23.6% and 20.6% of our external research and development expenses, which primarily included payments to CROs and CMOs.
In 2022, 88.2% and 11.8% of our total research and development expenses were attributable to clinical programs and preclinical programs, respectively, as compared to 94.3% and 5.7% in 2021. In 2022, felzartamab and eftansomatropin alfa accounted for approximately 23.6% and 20.6% of our external research and development expenses, which primarily included payments to CROs and contract manufacturing organizations.
The difference between our net loss and our net cash used in operating activities was primarily attributable to certain non-cash expenses, including equity in loss of affiliates of RMB437.5 million (US$63.4 million) and share-based compensation of RMB357.1 million (US$51.8 million), and changes in certain working capital items, including a decrease of a contract assets of RMB253.8 million (US$36.8 million), an increase in accruals and other payables of RMB109.9 million (US$15.9 million), a decrease in prepayments and other receivables of RMB109.2 million (US$15.8 million) and an increase in contract liabilities of RMB52.6 million (US$7.6 million), partially offset by a decrease of lease liabilities of RMB35.7 million (US$5.2 million).
The difference between our net loss and our net cash used in operating activities was primarily attributable to certain non-cash expenses, including equity in loss of affiliates of RMB437.5 million and share-based compensation of RMB357.1 million, and changes in certain working capital items, including a decrease of a contract assets of RMB253.8 million, an increase in accruals and other payables of RMB109.9 million, a decrease in prepayments and other receivables of RMB109.2 million, and an increase in contract liabilities of RMB52.6 million, partially offset by a decrease of lease liabilities of RMB35.7 million.
Information on the Company—B. Business Overview—Licensing and Collaboration Arrangements” for more information on the existing out-licensing arrangements.” However, substantial uncertainties remain as to the availability and the recognition of revenue from out-licensing agreement.
See “Item 4. Information on the Company—B. Business Overview—Licensing and Collaboration Arrangements” for more information on the existing out-licensing arrangements.” However, substantial uncertainties remain as to the availability and the recognition of revenue from out-licensing agreement.
Research and development activities are central to our business model. We believe our ability to successfully develop drug candidates will be the primary factor affecting our long-term competitiveness, as well as our future growth and development.
Research and development activities are central to our business model. We believe our ability to successfully develop drug candidates is the primary factor affecting our long-term competitiveness, as well as our future growth and development.
In 2021, felzartamab and lemzoparlimab accounted for approximately 26.4% and 34.8% of our external research and development expenses, which primarily included licensing fees and payments to CROs and CMOs. No other programs accounted for a significant portion of our research and development expenses in 2022 and 2021.
In 2021, felzartamab and lemzoparlimab accounted for approximately 26.4% and 34.8% of our external research and development expenses, which primarily included licensing fees and payments to CROs and contract manufacturing organizations. No other programs accounted for a significant portion of our research and development expenses in 2022 and 2021.
As of December 31, 2020, 2021 and 2022, we did not have any significant unrecognized uncertain tax positions. 154 Table of Contents Results of Operations The following table sets forth a summary of our consolidated results of operations for the periods indicated.
As of December 31, 2021, 2022 and 2023, we did not have any significant unrecognized uncertain tax positions. 116 Table of Contents Results of Operations The following table sets forth a summary of our consolidated results of operations for the periods indicated.
The net cash increase was primarily attributable to RMB7,911.5 million (US$1,147.1 million) of the proceeds from disposal of short-term and other investments, partially offset by RMB7,407.3 million (US$1,074.0 million) of the cash used in the purchase of short-term and other investments. Net cash used in investing activities for the year ended December 31, 2021 was RMB727.2 million.
The net cash increase was primarily attributable to RMB7,911.5 million of the proceeds from disposal of short-term and other investments, partially offset by RMB7,407.3 million of the cash used in the purchase of short-term and other investments. Net cash used in investing activities for the year ended December 31, 2021 was RMB727.2 million.
Other Income (Expenses), Net We recorded other income of RMB83.2 million and other expenses of RMB126.6 million (US$18.4 million) for the years ended December 31, 2021 and 2022, respectively.
Other Income (Expenses), Net We recorded other income of RMB83.2 million and other expenses of RMB126.6 million for the years ended December 31, 2021 and 2022, respectively.
Collaborations, Licensing and Other Arrangements We entered into collaborative, licensing, and other arrangements with third parties that may require future milestone payments to third parties contingent upon the achievement of certain development, regulatory, or commercial milestones. Individually, these arrangements are insignificant in any one annual reporting period.
History and Development of the Company.” ​ 126 Table of Contents Collaborations, Licensing and Other Arrangements We entered into collaborative, licensing, and other arrangements with third parties that may require future milestone payments to third parties contingent upon the achievement of certain development, regulatory, or commercial milestones. Individually, these arrangements are insignificant in any one annual reporting period.
Any fluctuation in our ability to fund our operations will impact our cash flow plan and our results of operations. 150 Table of Contents Our Ability to Commercialize Our Drug Candidates Our business and results of operations depend on our ability to commercialize our drug candidates, once and if those candidates are approved for marketing by the respective health authority.
Any fluctuation in our ability to fund our operations will impact our cash flow plan and our results of operations. Our Ability to Commercialize Our Drug Candidates Our business and results of operations depend on our ability to commercialize our drug candidates, once and if those candidates are approved for marketing by the applicable health authority.
We have incurred net losses and negative cash flows from our operations for the years ended December 31, 2021 and 2022. Substantially all of our losses have resulted from funding our research and development programs and administrative costs associated with our operations.
Liquidity and Capital Resources ​ Cash Flows and Working Capital We have incurred net losses and negative cash flows from our operations for the years ended December 31, 2021, 2022 and 2023. Substantially all of our losses have resulted from funding our research and development programs and administrative costs associated with our operations.
Recent Accounting Pronouncements A list of recently issued accounting pronouncements that are relevant to us is included in Note 2 “Principal Accounting Policies—2.29 Recent Accounting Pronouncements” of our consolidated financial statements included elsewhere in this annual report. 161 Table of Contents B.
Recent Accounting Pronouncements A list of recently issued accounting pronouncements that are relevant to us is included in Note 2 “Principal Accounting Policies—2.27 Recent Accounting Pronouncements” of our consolidated financial statements included elsewhere in this annual report. B.
Other administrative expenses include professional fees for consulting and auditing as well as other direct and allocated expenses for rental expenses for our facilities, travel costs and other supplies used in administrative activities.
Other administrative expenses include professional fees for consulting and auditing as well as other direct and allocated expenses such as rent on our facilities, travel costs and other supplies used in administrative activities.
E. Critical Accounting Estimates For our critical accounting estimates, see “Item 5. Operating and Financial Review and Prospects—A. Operating Results—Critical Accounting Policies and Significant Judgments and Estimates.”
E. Critical Accounting Estimates For our critical accounting estimates, see “Item 5. Operating and Financial Review and Prospects—A. Operating Results—Critical Accounting Policies and Significant Judgments and Estimates.” 127 Table of Contents
Research and Development Expenses The following table sets forth a breakdown of the major components of our research and development expenses in absolute amounts and as a percentage of our total research and development expenses for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2021 ​ 2022 ​ RMB % RMB US$ % ​ ​ (in thousands, except percentages) CRO service fees 727,573 60.0 523,559 75,909 57.9 In-licensed patent right fees 66,344 5.5 3,316 481 0.4 Employee benefit expenses 347,571 28.7 324,363 47,028 35.8 Material costs for drug candidates 23,141 1.9 20,857 3,024 2.3 Other expenses 48,329 3.9 32,806 4,756 3.6 Total 1,212,958 100.0 904,901 131,198 100.0 ​ Our research and development expenses decreased by 25.4% from RMB1,213.0 million for the year ended December 31, 2021 to RMB904.9 million (US$131.2 million) for the year ended December 31, 2022, primarily attributable to (i) a decrease in CRO and CMO service fees from RMB727.6 million for the year ended December 31, 2021 to RMB523.6 million (US$75.9 million) for the year ended December 31, 2022, primarily due to the reduced demand for investigational products as we procured sufficient stock in 2021; (ii) a decrease in in-licensed patent right fees from RMB66.3 million for the year ended December 31, 2021 to RMB3.3 million (US$0.5 million) for the year ended December 31, 2022; and (iii) a slight decrease in employee benefit expenses of employees involved in research and development from RMB347.6 million for the year ended December 31, 2021 to RMB324.4 million (US$47.0 million) for the year ended December 31, 2022.
The decrease was partially offset by revenue of RMB92.6 million from license and collaboration arrangements and the supply of investigational products. 119 Table of Contents Research and Development Expenses The following table sets forth a breakdown of the major components of our research and development expenses in absolute amounts and as a percentage of our total research and development expenses for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2021 ​ 2022 ​ RMB % RMB % ​ ​ (in thousands, except for percentages) CRO service fees 727,573 60.0 523,559 57.9 In-licensed patent right fees 66,344 5.5 3,316 0.4 Employee benefit expenses 347,571 28.7 324,363 35.8 Material costs for drug candidates 23,141 1.9 20,857 2.3 Other expenses 48,329 3.9 32,806 3.6 Total 1,212,958 100.0 904,901 100.0 ​ Our research and development expenses decreased by 25.4% from RMB1,213.0 million for the year ended December 31, 2021 to RMB904.9 million for the year ended December 31, 2022, primarily attributable to (i) a decrease in service fees for CRO and contract manufacturing organizations from RMB727.6 million for the year ended December 31, 2021 to RMB523.6 million for the year ended December 31, 2022, primarily due to the reduced demand for investigational products as we procured sufficient stock in 2021; (ii) a decrease in in-licensed patent right fees from RMB66.3 million for the year ended December 31, 2021 to RMB3.3 million for the year ended December 31, 2022; and (iii) a slight decrease in employee benefit expenses of employees involved in research and development from RMB347.6 million for the year ended December 31, 2021 to RMB324.4 million for the year ended December 31, 2022.
See Note 17 “Licensing and Collaboration Arrangements” of our consolidated financial statements included elsewhere in this annual report for additional information on these collaboration arrangements. Holding Company Structure We are a holding company with no material operations of its own. We currently conduct our operations primarily through our PRC subsidiaries.
See Note 14 “Licensing and Collaboration Arrangements” of our consolidated financial statements included elsewhere in this annual report for additional information on these collaboration arrangements. Holding Company Structure We are a holding company with no material operations of its own.
Although we currently do not have any product approved for commercial sale and have not generated any revenue from product sales, we expect to generate revenue from sales of drug candidates after we complete the clinical development, obtain regulatory approval, and successfully commercialize such drug candidates.
Currently, our pipeline consists of three clinical stage drug candidates. Although we currently do not have any product approved for commercial sale and have not generated any revenue from product sales, we expect to generate revenue from sales of drug candidates after we complete the clinical development, obtain regulatory approval, and successfully commercialize such drug candidates. See “Item 4.
Goodwill is not amortized, but impairment of goodwill assessment is performed on at least an annual basis on December 31 or whenever events or changes in circumstances indicate that the carrying value of the reporting unit exceeds its fair value. No impairment was identified as of December 31, 2020, 2021 and 2022.
Goodwill is not amortized, but impairment of goodwill assessment is performed on at least an annual basis on December 31 or whenever events or changes in circumstances indicate that the carrying value of the reporting unit exceeds its fair value.
However, we witnessed an amendment to the overall collaboration arrangement with AbbVie, which resulted in a lowered probability of achieving such key milestone and a reversal of revenue of US$-48.0 million (equivalent to RMB-314.2 million) in 2022.
However, we witnessed an amendment to the overall collaboration arrangement with AbbVie, which resulted in a lowered probability of achieving such key milestone and a reversal of revenue of US$-48.0 million (equivalent to RMB-314.2 million) in 2022. In September 2023, we received a notice from AbbVie, terminating the collaboration agreement in its entirety.
Material Cash Requirements Contractual Obligation Our material cash requirements as of December 31, 2022 and any subsequent interim period primarily include our capital expenditures and operating lease obligations. Our capital expenditures were incurred for purposes of purchasing property, equipment and software.
Material Cash Requirements Contractual Obligation Our material cash requirements as of December 31, 2023 and any subsequent interim period primarily include our operating lease obligations, purchase obligations and other commitments. Our capital expenditures were incurred for purposes of purchasing property, equipment and software. Our capital expenditures were RMB29.9 million.
Companies registered in Hong Kong are subject to Hong Kong profits tax on the taxable income as reported in their respective statutory financial statements adjusted in accordance with the relevant Hong Kong tax laws.
I-Mab Biopharma Hong Kong Limited is incorporated in Hong Kong. Companies registered in Hong Kong are subject to Hong Kong profits tax on the taxable income as reported in their respective statutory financial statements adjusted in accordance with the Hong Kong tax laws.
Interest Income Interest income consists primarily of interest income derived from our term deposit and restricted cash pledged as collateral for a working capital loan.
Interest Expense Interest expense consists primarily of interest expenses on our short-term bank borrowings. Interest Income Interest income consists primarily of interest income derived from our term deposit and restricted cash pledged as collateral for a working capital loan.
No other programs accounted for a significant portion of our research and development expenses in 2021 and 2020. Though we manage our external research and development expenses by program, we do not allocate our internal research and development expenses by program because our employees and internal resources may be engaged in projects for multiple programs at any time.
Though we manage our external research and development expenses by program, we do not allocate our internal research and development expenses by program because our employees and internal resources may be engaged in projects for multiple programs at any time.
Equity in Loss of Affiliates We recorded equity in loss of affiliates of RMB108.6 million and RMB367.9 million for the years ended December 31, 2020 and 2021, respectively.
Equity in Loss of Affiliates We recorded equity in loss of affiliates of RMB367.9 million and RMB437.5 million for the years ended December 31, 2021 and 2022, respectively.
Equity In Loss Of Affiliates Equity in loss of affiliates consists primarily of the loss recognized based on our proportionat share in I-Mab Hangzhou. Taxation Cayman Islands I-Mab, our holding entity, is incorporated in the Cayman Islands.
Equity In Loss of Affiliates Equity in loss of affiliates consists primarily of the loss recognized based on our proportion ownership in I-Mab Hangzhou. 115 Table of Contents Taxation Cayman Islands I-Mab, our holding entity, is incorporated in the Cayman Islands.
Currently, the majority of our revenues come from the collaboration revenue arrangements. Once a contract is determined to be within the scope of ASC 606 at contract inception, we evaluate the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct.
Once a contract is determined to be within the scope of ASC 606 at contract inception, we evaluate the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct.
The probabilities of the success of the clinical trials based on the status of these trials and reference to the industry benchmark were also incorporated into the assumption of future revenues. No impairment was recognized for the year ended December 31, 2022.
The probabilities of the success of the clinical trials based on the status of these trials and reference to the industry benchmark were also incorporated into the assumption of future revenues. Impairment of goodwill of RMB162.6 million (US$22.9 million) was recognized for the year ended December 31, 2023.
We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our drug candidates and begin to commercialize any approved products. We also expect to incur additional costs associated with operating as a public company.
We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our drug candidates and begin to commercialize any approved products.
Revenue Recognition We adopted Accounting Standard Codification (“ASC”) 606, Revenue from Contracts with Customers (Topic 606) (“ASC 606”) for all periods presented.
Revenue Recognition We adopted Accounting Standard Codification 606, Revenue from Contracts with Customers (Topic 606), or the ASC 606, for all periods presented.
As we have not obtained marketing approval for or commercialized a drug candidate, our revenues at the current stage are primarily subject to the availability of the payments from granting licenses to use and otherwise exploit certain of our intellectual properties linked to our drug assets, which primarily contributed to our revenues in 2020 and 2021. See “Item 4.
As we have not obtained marketing approval for or commercialized a drug candidate, our revenues at the current stage are primarily subject to the availability of the payments from granting licenses to research, develop and otherwise exploit certain of our drug assets, and supply of the investigational products thereof, which primarily contributed to our revenues in 2020, 2021 and 2023.
The change in share-based compensation was attributable to the grant of stock options to certain directors and employees of our company under the 2017 Plan, 2018 Plan, 2019 Plan and 2020 Plan. Investing Activities Net cash generated from investing activities for the year ended December 31, 2022 was RMB458.4 million (US$66.5 million).
The change in share-based compensation was attributable to the grant of stock options to certain directors and employees of our company under our share incentive plans. Investing Activities Net cash generated from investing activities for the year ended December 31, 2023 was RMB102.5 million (US$14.4 million).
We incurred research and development expenses of RMB984.7 million, RMB1,213.0 million and RMB904.9 million (US$131.2 million) for the years ended December 31, 2020, 2021 and 2022, respectively, representing 71.0%, 57.4% and 55.7% of our total research and development and administrative expenses for the corresponding periods.
We incurred research and development expenses of RMB1,213.0 million, RMB904.9 million and RMB810.6 million (US$114.2 million) for the years ended December 31, 2021, 2022 and 2023, respectively, representing 57.4%, 52.6% and 64.2% of our total research and development and administrative expenses for the corresponding periods.
We generated net income of RMB470.9 million for the year ended December 31, 2020, and incurred net losses of RMB2,331.5 million and RMB2,507.3 million (US$363.5 million) for the year ended December 31, 2021 and 2022, respectively. Our primary use of cash is to fund our research and development activities.
We incurred net losses of RMB2,331.5 million, RMB2,507.3 million and RMB1,465.7 million (US$206.4 million) for the year ended December 31, 2021, 2022 and 2023, respectively. Our primary use of cash is to fund our research and development activities.
Risk Factors—Risks Related to Our Industry, Business and Operations—Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.” Key Components of Results of Operations Revenues For the years ended December 31, 2021 and 2022, we generated revenue from (i) licensing and collaboration, primarily through granting licenses to use and otherwise exploiting certain of our intellectual properties in connection with our drug assets, and (ii) supply of investigational products to AbbVie.
Key Components of Results of Operations Revenues For the years ended December 31, 2021 and 2022, we generated revenue from (i) licensing and collaboration, primarily through granting licenses to use and otherwise exploiting certain of our intellectual properties in connection with our drug assets, and (ii) supply of investigational products to AbbVie.
The change was primarily due to that I-Mab Hangzhou became an unconsolidated affiliate of our company since September 15, 2020. 158 Table of Contents Critical Accounting Policies and Significant Judgments and Estimates Our reported results are impacted by the application of certain accounting policies that require us to make subjective or complex judgments.
The change was primarily due to the increased expenditure of our investee, I-Mab Hangzhou. 120 Table of Contents Critical Accounting Policies and Significant Judgments and Estimates Our reported results are impacted by the application of certain accounting policies that require us to make subjective or complex judgments.
The issuance and sale of additional equity would result in further dilution to our shareholders and ADS holders, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as an ADS holder.
We may decide to enhance our liquidity position or increase our cash reserve for future operations and investments through additional financing. The issuance and sale of additional equity would result in further dilution to our shareholders and ADS holders, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as an ADS holder.
The change in share-based compensation was attributable to the grant of stock options to certain directors and employees of our company under the 2017 Plan, 2018 Plan, 2019 Plan, 2020 Plan, 2021 Plan and 2022 Plan. Net cash used in operating activities for the year ended December 31, 2021 was RMB973.1 million.
The change in share-based compensation was attributable to the grant of stock options to certain directors and employees of our company under our share incentive plans. Net cash used in operating activities for the year ended December 31, 2021 was RMB973.1 million. Our net loss was RMB2,331.5 million for the same period.
Since the commencement of our operation in 2014, we have devoted most of our efforts and financial resources to organize and staff our operations, formulate business planning, raise capital, establish our intellectual property portfolio and conduct pre-clinical and clinical trials of our drug candidates.
Since the commencement of our operation in 2014, we have devoted most of our efforts and financial resources to organizing and staffing our operations, formulating business planning, raising capital, establishing our intellectual property portfolio and conducting pre-clinical and clinical trials of our drug candidates.
The net cash decrease was primarily attributable to RMB10,173.3 million of purchase of short-term investments, partially offset by RMB9,482.0 million of proceeds from disposal of short-term investments. Net cash used in investing activities for the year ended December 31, 2020 was RMB201.9 million.
The net cash decrease was primarily attributable to RMB10,173.3 million of purchase of short-term investments, partially offset by RMB9,482.0 million of proceeds from disposal of short-term investments.
The Effect of Our Acquisition of I-Mab Tianjin We acquired a controlling interest in I-Mab Tianjin on July 15, 2017 and the remaining interest in I-Mab Tianjin in May 2018. Since our acquisition of the controlling interest in I-Mab Tianjin on July 15, 2017, I-Mab Tianjin has been consolidated into our results of operations.
The Effect of Our Acquisition of I-Mab Tianjin and Our Divestiture of the Greater China Assets and Business Operations We acquired a controlling interest in I-Mab Tianjin on July 15, 2017 and the remaining interest in I-Mab Tianjin in May 2018.
We expect research and development costs to continue to increase for the foreseeable future as we expand our operations and our development programs progress, including as we continue to support and advance the clinical trials of our drug candidates. Our administrative expenses consist primarily of employee salaries and related benefit costs.
Following the divestiture of our Greater China assets and business operations, we expect research and development costs to decrease in the foreseeable future, as we continue to support and advance the clinical trials of our drug candidates. Our administrative expenses consist primarily of employee salaries and related benefit costs.
Research and Development Expenses Research and development expenses primarily consist of: (i) payroll and other related expenses of research and development personnel, (ii) fees associated with the exclusive development rights of our in-licensed drug candidates, (iii) fees for services provided by contract research organizations, investigators and clinical trial sites that conduct our clinical studies, and (iv) expenses relating to the development of our drug candidates, including raw materials and supplies, product testing, depreciation, and facility related expenses.
For the year ended December 31, 2023, we generated revenue from the supply of investigational products to AbbVie and Human Immunology Biosciences, Inc. 114 Table of Contents Research and Development Expenses Research and development expenses primarily consist of: (i) payroll and other related expenses of research and development personnel, (ii) fees associated with the exclusive development rights of our in-licensed drug candidates, (iii) fees for services provided by CROs, investigators and clinical trial sites that conduct our clinical studies, and (iv) expenses relating to the development of our drug candidates, including raw materials and supplies, product testing, depreciation, and facility related expenses.
Net cash generated from financing activities for the year ended December 31, 2021 was RMB593.9 million, primarily attributable to the proceeds from exercise of warrants of RMB672.7 million, partially offset by payments of the issuance cost in relation to private placement of RMB128.8 million.
Net cash generated from financing activities for the year ended December 31, 2022 was RMB42.4 million, primarily attributable to the proceeds from exercise of stock options of RMB44.7 million and the proceeds from bank borrowings of RMB19.0 million, partially offset by RMB21.2 million of the cash used in the payment of stock repurchase. 125 Table of Contents Net cash generated from financing activities for the year ended December 31, 2021 was RMB593.9 million, primarily attributable to the proceeds from exercise of warrants of RMB672.7 million, partially offset by payments of the issuance cost in relation to private placement of RMB128.8 million.
Financing Activities Net cash generated from financing activities for the year ended December 31, 2022 was RMB42.4 million (US$6.1 million), primarily attributable to the proceeds from exercise of stock options of RMB44.7 million (US$6.5 million) and the proceeds from bank borrowings of RMB19.0 million (US$2.7 million), partially offset by RMB21.2 million (US$3.1 million) of the cash used in the payment of stock repurchase.
Financing Activities Net cash generated from financing activities for the year ended December 31, 2023 was RMB7.5 million (US$1.1 million), primarily attributable to the proceeds from bank borrowings of RMB118.9 million (US$16.7 million), partially offset by the repayment of bank borrowings of RMB48.9 million (US$6.9 million) and RMB61.3 million (US$8.6 million) of the cash used in the payment of stock repurchase.
We generated RMB433.6 million in cash from our operating activities for the year ended December 31, 2020, and used RMB973.1 million and RMB1,102.8 million (US$159.9 million) in cash for our operating activities for the year ended December 31, 2021 and 2022, respectively. As of December 31, 2022, we had cash, cash equivalents and restricted cash of RMB3,310.8 million (US$480.0 million).
We used RMB973.1 million, RMB1,102.8 million and RMB1,305.0 million (US$183.8 million) in cash for our operating activities for the year ended December 31, 2021, 2022 and 2023, respectively. As of December 31, 2023, we had cash and cash equivalents of RMB2,141.4 million (US$301.6 million).
Going forward, in the event of successful commercialization of one or more of our drug candidates, we expect to fund our operations in part with revenue generated from sales of our commercialized drug products.
Going forward, in the event of successful commercialization of one or more of our drug candidates, we expect to fund our operations in part with revenue generated from sales of our commercialized drug products. In addition, we may require further funding through public or private offerings, debt financing, collaboration, and licensing arrangements or other sources.
We have a contingent obligation to repurchase the equity held by certain investors in the period beyond 12 months. See Note 10 of the Consolidated Financial Statements for a further discussion of this contingent obligation.
We have a contingent obligation to repurchase the equity held by certain investors in the period beyond 12 months. For a detailed description of this contingent obligation, see “Item 4. Information on the Company—A.
Shortly after we acquired the controlling interest in I-Mab Tianjin, we integrated the operations of I-Mab Tianjin into our operations. I-Mab Tianjin did not generate any external revenue from July 15, 2017 to December 31, 2022. In connection with our acquisition of I-Mab Tianjin, we identified intangible assets of RMB148.8 million and goodwill of RMB162.6 million of I-Mab Tianjin.
Since our acquisition of the controlling interest in I-Mab Tianjin on July 15, 2017, I-Mab Tianjin has been consolidated into our results of operations. Shortly after we acquired the controlling interest in I-Mab Tianjin, we integrated the operations of I-Mab Tianjin into our operations. I-Mab Tianjin did not generate any external revenue from July 15, 2017 to December 31, 2023.
Though we manage our external research and development expenses by program, we do not allocate our internal research and development expenses by program because our employees and internal resources may be engaged in projects for multiple programs at any time. 156 Table of Contents Administrative Expenses Our administrative expenses decreased from RMB899.9 million for the year ended December 31, 2021 to RMB815.8 million (US$118.3 million) for the year ended December 31, 2022, primarily attributable to the decrease in share-based compensation expenses by RMB167.4 million (US$24.3 million) in relation to the management personnel and optimized control of operating and administrative expenses, and partially offset by the increase of the accrued expenses in relation to the disputes with Tracon of RMB95.5 million (US$13.8 million).
Though we manage our external research and development expenses by program, we do not allocate our internal research and development expenses by program because our employees and internal resources may be engaged in projects for multiple programs at any time. ​ Administrative Expenses Our administrative expenses decreased from RMB815.8 million for the year ended December 31, 2022 to RMB453.0 million (US$63.8 million) for the year ended December 31, 2023, primarily attributable to the decrease in payroll expenses by RMB36.2 million (US$5.1 million) related to decreased headcount as a result of resource optimization and share-based compensation expenses by RMB113.1 million (US$15.9 million) for management personnel, reduced expenses for professional services, and reduced legal expenses in relation to the disputes with Tracon Pharmaceuticals, Inc. of RMB95.5 million (US$13.5 million).
We expect our research and development expenses to continue to increase for the foreseeable future, as we continue to expand our operations and to advance our pipeline and our drug candidates toward later stages. 152 Table of Contents Administrative Expenses Administrative expenses primarily consist of salaries and related benefit costs, including share-based compensation, for employees engaged in managerial and administrative positions or involved in general corporate functions, professional fees for consulting and auditing as well as other direct and allocated expenses for rental expenses for our facilities, travel costs and other supplies used in administrative activities.
Administrative Expense Administrative expenses primarily consist of salaries and related benefit costs, including share-based compensation, for employees engaged in managerial and administrative positions or involved in general corporate functions, professional fees for consulting and auditing as well as other direct and allocated expenses such as rent on our facilities, travel costs and other supplies used in administrative activities.
This amendment led to a lowered probability of achieving a key milestone that was included in the total consideration of revenue recognition in prior years. The decrease was partially offset by revenue of RMB92.6 million from license and collaboration arrangements and the supply of investigational products.
This amendment led to a lowered probability of achieving a key milestone that was included in the total consideration of revenue recognition in prior years.
In that time, we expect that our expenses will increase substantially as we fund new and ongoing research and development activities and working capital needs. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect.
We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect.
Impairment charges could substantially affect our results of operations in the periods of such charges. In addition, impairment charges would negatively impact our financial ratios and could limit our ability to obtain financing in the future. See “Item 3. Key Information—D.
In addition, impairment charges would negatively impact our financial ratios and could limit our ability to obtain financing in the future.
Our company’s other PRC subsidiaries are subject to the statutory income tax rate of 25%. No provision for income taxes has been accrued because all of our PRC subsidiaries are in cumulative loss positions for all the periods presented.
No provision for income taxes has been accrued because our PRC subsidiary is in cumulative loss positions for all the periods presented.
In addition, after validating clinical safety and preliminary efficacy of a drug candidate in our Global Portfolio in clinical trials in the United States, we may elect to out-license the global rights (excluding Greater China) of such drug candidate, while retaining the Greater China rights for further development and commercialization.
In addition, after validating clinical safety and preliminary efficacy of a drug candidate in our Global portfolio in clinical trials in the United States, we may elect to out-license certain rights of such drug candidate, but we may choose to retain these rights for the United States or other countries or regions as we may deem fit.
Because of the numerous risks and uncertainties associated with the development and commercialization of our drug candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development and commercialization of our drug candidates. 162 Table of Contents We may decide to enhance our liquidity position or increase our cash reserve for future operations and investments through additional financing.
Because of the numerous risks and uncertainties associated with the development and commercialization of our drug candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development and commercialization of our drug candidates.
The operating results in any period are not necessarily indicative of the results that may be expected for any future period. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2020 ​ 2021 ​ 2022 ​ RMB RMB RMB USS ​ ​ (in thousands, except for per share data) Summary Consolidated Statements of Comprehensive Income (Loss) Data: Revenues Licensing and collaboration revenue 1,542,668 40,115 (249,665) (36,198) Supply of investigational products — 47,911 28,102 4,074 Total revenues 1,542,668 88,026 (221,563) (32,124) Cost of revenues — (46,432) (27,237) (3,949) Expenses ​ ​ Research and development expenses (1) (984,689) (1,212,958) (904,901) (131,198) Administrative expenses (1) (402,409) (899,943) (815,766) (118,275) Income (loss) from operations 155,570 (2,071,307) (1,969,467) (285,546) Interest income 24,228 21,333 26,908 3,901 Interest expense (957) — (9) (1) Other income (expenses), net 412,892 83,162 (126,587) (18,353) Equity in loss of affiliates (1) (108,587) (367,883) (437,465) (63,426) Income (loss) before income tax expense 483,146 (2,334,695) (2,506,620) (363,425) Income tax benefit (expense) (12,231) 3,154 (697) (101) Net income (loss) attributable to I-Mab 470,915 (2,331,541) (2,507,317) (363,526) Net income (loss) attributable to ordinary shareholders 470,915 (2,331,541) (2,507,317) (363,526) Other comprehensive income (loss) ​ ​ Foreign currency translation adjustments, net of nil tax (120,920) (135,717) 400,304 58,039 Total comprehensive income (loss) attributable to I-Mab 349,995 (2,467,258) (2,107,013) (305,487) Net income (loss) attributable to ordinary shareholders 470,915 (2,331,541) (2,507,317) (363,526) Weighted-average number of ordinary shares used in calculating net income (loss) per share ​ ​ Basic 134,158,824 174,707,055 189,787,292 189,787,292 Diluted 157,231,652 174,707,055 189,787,292 189,787,292 Net loss per share attributable to ordinary shareholders ​ ​ Basic 3.51 (13.35) (13.21) (1.92) Diluted 3.00 (13.35) (13.21) (1.92) Net income (loss) per ADS attributable to ordinary shareholders ​ ​ —Basic 8.07 (30.71) (30.38) (4.41) —Diluted 69.0 (30.71) (30.38) (4.41) Note: (1) Share-based compensation expenses were allocated as follows: 155 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2020 ​ 2021 ​ 2022 ​ RMB RMB RMB USS ​ ​ (in thousands) Research and development expenses 284,431 201,926 117,876 17,090 Administrative expenses 209,033 406,683 239,272 34,691 Equity in loss of affiliates 32,707 13,267 13,852 2,008 Total 526,171 621,876 371,000 53,789 ​ Year Ended December 31, 2022 Compared to Year Ended December 31, 2021 Revenues Total net revenues for the year ended December 31, 2022 were RMB-221.6 million (US$-32.1 million), compared with RMB88.0 million for the year ended December 31, 2021.
The operating results in any period are not necessarily indicative of the results that may be expected for any future period. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2021 ​ 2022 ​ 2023 ​ RMB RMB RMB US$ ​ ​ (in thousands, except for per share data) Summary Consolidated Statements of Comprehensive Income (Loss) Data: Revenues Licensing and collaboration revenue 40,115 (249,665) 16,814 2,368 Supply of investigational products 47,911 28,102 10,830 1,525 Total revenues 88,026 (221,563) 27,644 3,893 Cost of revenues (46,432) (27,237) — — Expenses ​ ​ ​ ​ Research and development expenses (1) (1,212,958) (904,901) (810,646) (114,177) Administrative expenses (1) (899,943) (815,766) (453,017) (63,806) Impairment of goodwill ​ — ​ — ​ (162,574) ​ (22,898) Loss from operations (2,071,307) (1,969,467) (1,398,593) (196,988) Interest income 21,333 26,908 51,749 7,289 Interest expense — (9) (722) (102) Other income (expenses), net 83,162 (126,587) (38,109) (5,368) Equity in loss of affiliates (1) (367,883) (437,465) (80,019) (11,270) Loss before income tax expense (2,334,695) (2,506,620) (1,465,694) (206,439) Income tax benefit (expense) 3,154 (697) — — Net loss attributable to I-Mab (2,331,541) (2,507,317) (1,465,694) (206,439) Net loss attributable to ordinary shareholders (2,331,541) (2,507,317) (1,465,694) (206,439) Other comprehensive (loss) income ​ ​ Foreign currency translation adjustments, net of nil tax (135,717) 400,304 84,497 11,901 Total comprehensive loss attributable to I-Mab (2,467,258) (2,107,013) (1,381,197) (194,538) Net loss attributable to ordinary shareholders (2,331,541) (2,507,317) (1,465,694) (206,439) Weighted-average number of ordinary shares used in calculating net loss per share ​ ​ ​ ​ Basic 174,707,055 189,787,292 191,423,850 191,423,850 Diluted 174,707,055 189,787,292 191,423,850 191,423,850 Net loss per share attributable to ordinary shareholders ​ ​ ​ ​ Basic (13.35) (13.21) (7.66) (1.08) Diluted (13.35) (13.21) (7.66) (1.08) Net (loss) income per ADS attributable to ordinary shareholders ​ ​ ​ ​ —Basic (30.71) (30.38) (17.62) (2.48) —Diluted (30.71) (30.38) (17.62) (2.48) Note: 117 Table of Contents (1) Share-based compensation expenses were allocated as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2021 ​ 2022 ​ 2023 ​ RMB RMB RMB US$ ​ ​ (in thousands) Research and development expenses 201,926 117,876 66,758 9,403 Administrative expenses 406,683 239,272 126,244 17,781 Equity in loss of affiliates 13,267 13,852 4,815 678 Total 621,876 371,000 197,817 27,862 ​ Year Ended December 31, 2023 Compared to Year Ended December 31, 2022 Revenues Total net revenues for the year ended December 31, 2023 were RMB27.6 million (US$3.9 million), compared with RMB-221.6 million for the year ended December 31, 2022.
I-Mab Biopharma US Ltd. has no taxable income for all periods presented and therefore no provision for income taxes is required. 153 Table of Contents China On March 16, 2007, the National People’s Congress of PRC enacted the Corporate Income Tax Law (the “CIT Law”) (as amended in 2017 and 2018, respectively), under which Foreign Investment Enterprises (“FIEs”) and domestic companies would be subject to corporate income tax at a uniform rate of 25%.
China On March 16, 2007, the National People’s Congress of the PRC enacted the Corporate Income Tax Law (as amended in 2017 and 2018, respectively), under which Foreign Investment Enterprises and domestic companies would be subject to corporate income tax at a uniform rate of 25%. The Corporate Income Tax Law became effective on January 1, 2008.
We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize a drug candidate, and we cannot assure you that we will ever generate significant revenue or profits.
In 2021, 2022 and 2023, our net losses were RMB2,331.5 million, RMB2,507.3 million and RMB1,465.7 million (US$206.4 million), respectively. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize a drug candidate, and we cannot assure you that we will ever generate significant revenue or profits.
Funding for Our Operations During the periods presented, we funded our operations primarily from financing through the issuance and sale of preferred shares and convertible promissory notes in private placement transactions.
Before the commercialization of one or more of our drug candidates, we expect that the majority of our revenue will continue to be generated from out-licensing our intellectual properties. 113 Table of Contents Funding for Our Operations During the periods presented, we funded our operations primarily from financing through the issuance and sale of preferred shares and convertible promissory notes in private placement transactions.
The change in share-based compensation was attributable to the grant of stock options to certain directors and employees of our company under the 2017 Plan, 2018 Plan, 2019 Plan, 2020 Plan and 2021 Plan. 163 Table of Contents Net cash generated from operating activities for the year ended December 31, 2020 was RMB433.6 million.
The change in share-based compensation was attributable to the grant of stock options to certain directors and employees of our company under our share incentive plans. Net cash used in operating activities for the year ended December 31, 2022 was RMB1,102.8 million. Our net loss was RMB2,507.3 million for the same period.
Under the CIT Law, preferential tax treatments will be granted to entities which conduct businesses in certain encouraged sectors and to entities otherwise classified as “High and New Technology Enterprises.” I-Mab Shanghai has been qualified as a “High and New Technology Enterprise” and enjoys a preferential income tax rate of 15% from 2021 to 2023.
Under the Corporate Income Tax Law, preferential tax treatments are granted to entities which conduct businesses in certain encouraged sectors and to entities otherwise classified as “High and New Technology Enterprises.” Our PRC subsidiary is subject to the statutory income tax rate of 25%.
In comparison, the revenues generated for the year ended December 31, 2020 solely consisted of the revenues recognized in connection with the strategic collaboration with AbbVie.
Total net revenues for the year ended December 31, 2023 consisted of revenues recognized in connection with the strategic collaboration with AbbVie and revenues generated from the supply of investigational products to AbbVie and Human Immunology Biosciences, Inc.
Revenue from Out-Licensing Agreements We continue to seek out-licensing opportunities for our drug assets through our strengthened and expanded network of global partnerships and alliances.
Following the divestiture of our Greater China assets and business operations, we expect our administrative expenses to decrease in the future to support our pipeline assets and research and development efforts. Revenue from Out-Licensing Agreements We continue to seek out-licensing opportunities for our drug assets through our network of global partnerships and alliances.
We have not generated any revenue from the sales of our commercial products, and as a result, we had incurred net losses since the commencement to the end of 2019 of our operations.
We have not generated any revenue from the sales of our products, and as a result, we had incurred net losses since the commencement of our operations to 2023, except that in 2020, we generated net income of RMB470.9 million, primarily attributable to the revenues recognized in connection with the strategic collaboration with AbbVie of RMB1,542.7 million.

… 86 more changes not shown on this page.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

120 edited+26 added−80 removed89 unchanged
Biggest changeOur board of directors has the authority to terminate, amend or modify the plan in accordance with our articles of association. 179 Table of Contents The following table summarizes, as of March 31, 2023, the number of ordinary shares underlying outstanding options and restricted share units that we granted under the 2021 Plan, excluding awards that were forfeited, cancelled, exercised or vested after the relevant grant date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Ordinary Shares ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Underlying Options ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ and Restricted Share ​ Exercise Price ​ ​ ​ ​ ​ ​ Name Units (US$/Share) Date of Grant Date of Expiration Jingwu Zhang Zang * (1) ​ N/A ​ July 27, 2021 ​ — ​ * ​ 26.39 ​ ​ July 27, 2021 ​ July 27, 2031 Weimin Tang * (1) ​ N/A ​ ​ July 27, 2021 to February 1, 2023 ​ ​ — ​ * ​ 26.39 ​ ​ July 27, 2021 ​ ​ July 27, 2031 Gigi Qi Feng * ​ N/A ​ ​ July 27, 2021 ​ ​ — ​ * ​ 26.39 ​ ​ July 27, 2021 ​ ​ July 27, 2031 Richard Cheng Li * (1) ​ N/A ​ ​ July 27, 2021 ​ ​ — ​ * ​ 26.39 ​ ​ July 27, 2021 ​ ​ July 27, 2031 ​ * ​ 9.20 ​ ​ March 4, 2022 ​ ​ March 4, 2032 Andrew Zhu * (1) ​ N/A ​ ​ March 4, 2022 ​ ​ — ​ * ​ 9.20 ​ ​ March 4, 2022 ​ ​ March 4, 2032 Richard Yeh ​ * (1) ​ N/A ​ ​ January 4, 2023 ​ ​ — ​ ​ * ​ 6.20 ​ ​ January 4, 2023 ​ ​ January 4, 2033 Ruyi He * (1) ​ N/A ​ ​ June 11, 2021 ​ ​ — ​ * ​ 31.23 ​ ​ June 11, 2021 ​ ​ June 11, 2031 Rong Shao * (1) ​ N/A ​ ​ June 11, 2021 ​ ​ — ​ * ​ 31.23 ​ ​ June 11, 2021 ​ ​ June 11, 2031 Other Grantees * (1) ​ N/A ​ ​ July 27, 2021 to February 1, 2023 ​ ​ — ​ * ​ 26.39 ​ ​ July 27, 2021 ​ ​ July 27, 2031 ​ ​ * ​ 9.20 ​ ​ March 4, 2022 ​ ​ March 4, 2032 ​ * ​ 2.43 ​ September 6, 2022 ​ September 6, 2032 Total 5,894,234 ​ ​ Notes: * Less than 1% of our total outstanding shares.
Biggest changeThe following table summarizes, as of April 15, 2024, the number of ordinary shares underlying outstanding options and restricted share units that we granted under the 2021 Plan, excluding awards that were forfeited, cancelled, exercised or vested after the grant date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Ordinary Shares ​ ​ ​ ​ ​ ​ ​ ​ Underlying Options ​ ​ ​ ​ ​ ​ ​ ​ and Restricted Share ​ Exercise Price ​ ​ ​ ​ Name Units (US$/Share) Date of Grant Date of Expiration Grantees * (1) ​ N/A ​ July 27, 2021 to May 23, 2023 ​ — ​ * ​ 26.39 ​ July 27, 2021 ​ July 27, 2031 ​ ​ * ​ 9.20 ​ March 4, 2022 ​ March 4, 2032 ​ * ​ 6.20 ​ January 4, 2023 ​ January 4, 2033 Total 2,565,981 ​ ​ ​ ​ ​ Notes: * Less than 1% of our total outstanding shares.
Awards granted under the plan are evidenced by an award agreement that sets forth the terms, conditions and restrictions for each award, which may include the term of the award, the provisions applicable in the event that the grantee’s employment or service terminates, and our authority to unilaterally or bilaterally amend, modify, suspend, cancel or rescind the award. Eligibility.
Awards granted under the plan are evidenced by an award agreement that sets forth the terms, conditions and restrictions for each award, which may include the term of the award, the provisions applicable in the event that the grantee’s employment or service terminates, and our authority to unilaterally or bilaterally amend, modify, suspend, cancel or rescind the award. Eligibility.
We may grant awards to our employees, directors and consultants of our company. However, we may grant options that are intended to qualify as incentive share options only to our employees and employees of our subsidiaries. Vesting Schedule.
We may grant awards to our employees, directors and consultants of our company. However, we may grant options that are intended to qualify as incentive share options only to our employees and employees of our subsidiaries. Vesting Schedule.
(2) Represents (i) 1,583,280 ADSs and 10 ordinary shares directly held by IBC Investment Seven Limited, a Hong Kong limited liability company, (ii) 2,423,720 ADSs and 4 ordinary shares directly held by CBC SPVII LIMITED, a Hong Kong limited liability company, (iii) 5,123,540 ADSs and 22 ordinary shares directly held by CBC Investment I-Mab Limited, a British Virgin Islands limited liability company, (iv) 1,030,230 ADSs and 17 ordinary shares directly held by C-Bridge II Investment Ten Limited, a British Virgin Islands limited liability company, and (v) 6,078,571 ordinary shares directly held by Everest.
(1) Represents (i) 1,583,280 ADSs and 10 ordinary shares directly held by IBC Investment Seven Limited, a Hong Kong limited liability company, (ii) 2,423,720 ADSs and 4 ordinary shares directly held by CBC SPVII LIMITED, a Hong Kong limited liability company, (iii) 5,123,540 ADSs and 22 ordinary shares directly held by CBC Investment I-Mab Limited, a British Virgin Islands limited liability company, (iv) 1,030,230 ADSs and 17 ordinary shares directly held by C-Bridge II Investment Ten Limited, a British Virgin Islands limited liability company, and (v) 6,078,571 ordinary shares directly held by Everest.
The plan administrator determines the exercise price for each award, which is stated in the relevant award agreement. Options that are vested and exercisable will terminate if they are not exercised prior to the time as the plan administrator determines at the time of grant. However, the maximum exercisable term is ten years from the date of grant. Transfer Restrictions.
The plan administrator determines the exercise price for each award, which is stated in the award agreement. Options that are vested and exercisable will terminate if they are not exercised prior to the time as the plan administrator determines at the time of grant. However, the maximum exercisable term is ten years from the date of grant. Transfer Restrictions.
The plan administrator determines the exercise price for each award, which is stated in the relevant award agreement. Options that are vested and exercisable will terminate if they are not exercised prior to the time as the plan administrator determines at the time of grant. However, the maximum exercisable term is ten years from the date of grant. Transfer Restrictions.
The plan administrator determines the exercise price for each award, which is stated in the award agreement. Options that are vested and exercisable will terminate if they are not exercised prior to the time as the plan administrator determines at the time of grant. However, the maximum exercisable term is ten years from the date of grant. Transfer Restrictions.
Options may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the 2017 Plan or the relevant offer letter or otherwise determined by the board of directors, such as transfers by will or the laws of descent and distribution. Termination and amendment of the 2017 Plan.
Options may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the 2017 Plan or the offer letter or otherwise determined by the board of directors, such as transfers by will or the laws of descent and distribution. Termination and amendment of the 2017 Plan.
Options may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the 2018 Plan or the relevant offer letter or otherwise determined by the board of directors, such as transfers by will or the laws of descent and distribution. Termination and amendment of the 2018 Plan.
Options may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the 2018 Plan or the offer letter or otherwise determined by the board of directors, such as transfers by will or the laws of descent and distribution. Termination and amendment of the 2018 Plan.
Awards may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the plan or the relevant award agreement or otherwise determined by the plan administrator, such as transfers by will or the laws of descent and distribution. Termination and Amendment of the Plan.
Awards may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the plan or the award agreement or otherwise determined by the plan administrator, such as transfers by will or the laws of descent and distribution. Termination and Amendment of the Plan.
Awards may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the plan or the relevant award agreement or otherwise determined by the plan administrator, such as transfers by will or the laws of descent and distribution. Termination and Amendment of the Plan.
Awards may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the plan or the award agreement or otherwise determined by the plan administrator, such as transfers by will or the laws of descent and distribution. Termination and Amendment of the Plan.
The plan administrator determines conditions and the time or times at which options and restricted share units may be exercised in whole or part. The vesting schedule of other share-based awards should be determined by the plan administrator, which is specified in the relevant award agreement. Exercise of Options.
The plan administrator determines conditions and the time or times at which options and restricted share units may be exercised in whole or part. The vesting schedule of other share-based awards should be determined by the plan administrator, which is specified in the award agreement. Exercise of Options.
We may grant awards to our independent directors, as determined by a committee of one or more members of the board of directors. Vesting Schedule. In general, the plan administrator determines the vesting schedule, which is specified in the relevant award agreement. Exercise of Options.
We may grant awards to our independent directors, as determined by a committee of one or more members of the board of directors. Vesting Schedule. In general, the plan administrator determines the vesting schedule, which is specified in the award agreement. Exercise of Options.
The nominating and corporate governance committee is responsible for, among other things: 183 Table of Contents ● selecting and recommending to the board nominees for election by the shareholders or appointment by the board; ● reviewing annually with the board the current composition of the board with regards to characteristics such as independence, knowledge, skills, experience and diversity; ● making recommendations on the frequency and structure of board meetings and monitoring the functioning of the committees of the board; and ● advising the board periodically with regards to significant developments in the law and practice of corporate governance as well as our compliance with applicable laws and regulations, and making recommendations to the board on all matters of corporate governance and on any corrective action to be taken.
The nominating and corporate governance committee is responsible for, among other things: ● selecting and recommending to the board nominees for election by the shareholders or appointment by the board; ● reviewing annually with the board the current composition of the board with regards to characteristics such as independence, knowledge, skills, experience and diversity; 140 Table of Contents ● making recommendations on the frequency and structure of board meetings and monitoring the functioning of the committees of the board; and ● advising the board periodically with regards to significant developments in the law and practice of corporate governance as well as our compliance with applicable laws and regulations, and making recommendations to the board on all matters of corporate governance and on any corrective action to be taken.
The options and restricted share units will vest according to the schedules specified in the plan, unless otherwise determined by the plan administrator. The vesting schedule of other share-based awards should be determined by the plan administrator, which is specified in the relevant award agreement. Exercise of Options.
The options and restricted share units will vest according to the schedules specified in the plan, unless otherwise determined by the plan administrator. The vesting schedule of other share-based awards should be determined by the plan administrator, which is specified in the award agreement. Exercise of Options.
The options and restricted share units will vest according to the schedules specified in the plan, unless otherwise determined by the plan administrator. The vesting schedule of other share-based awards should be determined by the plan administrator, which is specified in the relevant award agreement. Exercise of Options.
The options and restricted share units will vest according to the schedules specified in the plan, unless otherwise determined by the plan administrator. The vesting schedule of other share-based awards should be determined by the plan administrator, which is specified in the award agreement. Exercise of Options.
Subject to the Nasdaq Global Market rules and disqualification by the chairman of the relevant board meeting, a director may vote with respect to any contract, proposed contract or arrangement in which he is interested.
Subject to the Nasdaq Global Market rules and disqualification by the chairman of the board meeting, a director may vote with respect to any contract, proposed contract or arrangement in which he is interested.
He was previously the UK Chief Investigator for the CheckMate 331 Phase III trial in relapsed small cell lung cancer and the KEYNOTE-158 Phase II biomarker study in advanced solid tumors and multiple novel immunotherapy combination phase I trials. 171 Table of Contents Roy S. Herbst, M.D., Ph.D., has served on our scientific advisory board since July 2019. Dr.
He was previously the UK Chief Investigator for the CheckMate 331 Phase III trial in relapsed small cell lung cancer and the KEYNOTE-158 Phase II biomarker study in advanced solid tumors and multiple novel immunotherapy combination phase I trials. 131 Table of Contents Roy S. Herbst, M.D., Ph.D., has served on our scientific advisory board since July 2019. Dr.
He has led the Phase I development of several of the new generation of targeted agents for non-small cell lung cancer (NSCLC), including gefitinib, erlotinib, cetuximab, and bevacizumab.
He has led the Phase I development of several of the new generation of targeted agents for non-small cell lung cancer, including gefitinib, erlotinib, cetuximab, and bevacizumab.
Yap’s main research focuses on the first-in-human and combinatorial development of molecularly targeted agents and immunotherapies, and their acceleration through clinical studies using novel predictive and pharmacodynamic biomarkers. Dr. Yap leads immuno-oncology clinical and associated translational studies, including novel agents targeting PD-1/PD-L1, ICOS, IDO, LAG3, TIM3, STING, TGFbeta, adenosine A2A receptor and fucosylation.
Yap’s main research focuses on the first-in-human and combinatorial development of molecularly targeted agents and immunotherapies, and their acceleration through clinical studies using novel predictive and pharmacodynamic biomarkers. Dr. Yap leads immune-oncology clinical and associated translational studies, including novel agents targeting PD-1/PD-L1, ICOS, IDO, LAG3, TIM3, STING, TGFbeta, adenosine A2A receptor and fucosylation.
Weiner has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases. 170 Table of Contents Patricia LoRusso, D.O., M.A., Ph.D., has served on our scientific advisory board since July 2019. Dr.
Weiner has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases. 130 Table of Contents Patricia LoRusso, D.O., M.A., Ph.D., has served on our scientific advisory board since July 2019. Dr.
He received his bachelor’s degree and master’s degree in medical from China Medical University in 1983 and 1986, respectively, and his M.D. in Internal Medicine from Howard University in 1999.
He received his medical degree from China Medical University. Dr. He received his bachelor’s degree and master’s degree in medical from China Medical University in 1983 and 1986, respectively, and his M.D. in Internal Medicine from Howard University in 1999.
Herbst was the Barnhart Distinguished Professor and Chief of the Section of Thoracic Medical Oncology in the Department of Thoracic/Head and Neck Medical Oncology, at The University of Texas M.D. Anderson Cancer Center (UT-MDACC) in Houston, Texas. He also served as Professor in the Department of Cancer Biology and Co-Director of the Phase I Clinical Trials Program.
Herbst was the Barnhart Distinguished Professor and Chief of the Section of Thoracic Medical Oncology in the Department of Thoracic/Head and Neck Medical Oncology, at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. He also served as Professor in the Department of Cancer Biology and Co-Director of the Phase I Clinical Trials Program.
We have adopted a charter for each of the four committees. Each committee’s members and functions are described below. 182 Table of Contents Audit Committee. Our audit committee consists of Mr. Conor Chia-hung Yang, Mr. Chun Kwok Alan Au and Mr. Shuai Chen. Mr. Conor Chia-hung Yang is the chairperson of our audit committee.
We have adopted a charter for each of the four committees. Each committee’s members and functions are described below. 139 Table of Contents Audit Committee. Our audit committee consists of Mr. Conor Chia-hung Yang, Mr. Chun Kwok Alan Au and Mr. Shuai Chen. Mr. Conor Chia-hung Yang is the chairperson of our audit committee.
(1) Represents restricted share units. C. Board Practices. As of the date of this annual report, our board of directors consists of 11 directors. A director is not required to hold any shares in our company by way of qualification.
(1) Represents restricted share units. C. Board Practices. As of the date of this annual report, our board of directors consists of eight directors. A director is not required to hold any shares in our company by way of qualification.
LoRusso served as co-chair of the National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP) Investigational Drug Steering Committee, a prior parent member of the NCI’s Quick Trials Clinical Subcommittee, and has served as either an ad hoc or an appointed member on multiple study sections and has reviewed for Komen Promise grants, numerous SPORE and P01 study sections, and translational research grants.
LoRusso served as co-chair of the investigational drug steering committee of the National Cancer Institute Cancer Therapy Evaluation Program, a prior parent member of the quick trials clinical subcommittee of the National Cancer Institute, and has served as either an ad hoc or an appointed member on multiple study sections and has reviewed for Komen Promise grants, numerous SPORE and P01 study sections, and translational research grants.
Ruyi He satisfies the “independence” requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Rules. The compensation committee will assist the board in reviewing and approving the compensation structure, including all forms of compensation, relating to our directors and executive officers. Our chief executive officer may not be present at any committee meeting during which his compensation is deliberated.
Ruyi He satisfies the “independence” requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Rules. The compensation committee assists the board in reviewing and approving the compensation structure, including all forms of compensation, relating to our directors and executive officers. Our chief executive officer may not be present at any committee meeting during which his compensation is deliberated.
Awards granted under the plan are evidenced by an award agreement that sets forth the terms, conditions and restrictions for each award, which may include the term of the award, the provisions applicable in the event that the grantee’s employment or service terminates, and our authority to unilaterally or bilaterally amend, modify, suspend, cancel or rescind the award. Eligibility.
Awards granted under the plan are evidenced by an award agreement that sets forth the terms, conditions and restrictions for each award, which may include the term of the award, the provisions applicable in the event that the grantee’s employment or service terminates, and our authority to unilaterally or bilaterally amend, modify, suspend, cancel or rescind the award. 138 Table of Contents Eligibility.
We are carrying out a series of female leadership development programs committed to women’s career and personal development. We offer competitive salaries, benefits, and additional incentive to its employees. Employee compensation and benefits include position-specific salary, bonus and allowance, statutory insurance, and housing employee benefit funds (for those in China), statutory holidays, benefits and vacations, etc.
We are carrying out a series of female leadership development programs committed to women’s career and personal development. 142 Table of Contents We offer competitive salaries, benefits, and additional incentive to its employees. Employee compensation and benefits include position-specific salary, bonus and allowance, statutory insurance, and housing employee benefit funds (for those in China), statutory holidays, benefits and vacations, etc.
Environmental, Social and Governance Committee. Our environmental, social and governance committee consists of Dr. Andrew Zhu, Mr. Chun Kwok Alan Au and Dr. Rong Shao. Mr. Chun Kwok Alan Au is the chairman of our environmental, social and governance committee. We have determined that each of Mr. Chun Kwok Alan Au and Dr.
Environmental, Social and Governance Committee. Our environmental, social and governance committee consists of Mr. Chun Kwok Alan Au and Dr. Rong Shao. Mr. Chun Kwok Alan Au is the chairman of our environmental, social and governance committee. We have determined that each of Mr. Chun Kwok Alan Au and Dr.
Chen received a Master of Business Administration degree from China Europe International Business School in 2010 and a bachelor’s degree in economics from Beijing Forestry University in 1997. Chun Kwok Alan Au has served as our director since January 2020. Mr.
Chen received a Master of Business Administration degree from China Europe International Business School in 2010 and a bachelor’s degree in economics from Beijing Forestry University in 1997. 128 Table of Contents Chun Kwok Alan Au has served as our director since January 2020. Mr.
Except as otherwise approved by the board of directors, vested portion of option becomes exercisable upon the earlier of a listing or the occurrence of a change in control. Exercise of options. The board of directors determines the subscription price for each option, which is stated in the offer letter.
Except as otherwise approved by the board of directors, vested portion of option becomes exercisable upon the earlier of a listing or the occurrence of a change in control. 133 Table of Contents Exercise of options. The board of directors determines the subscription price for each option, which is stated in the offer letter.
Awards may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the plan or the relevant award agreement or otherwise determined by the plan administrator, such as transfers by will or the laws of descent and distribution. Termination and Amendment of the Plan.
Transfer Restrictions. Awards may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the plan or the award agreement or otherwise determined by the plan administrator, such as transfers by will or the laws of descent and distribution. Termination and Amendment of the Plan.
Rong Shao satisfies the “independence” requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Rules. In addition, we will also establish an ESG working group to address daily ESG workflows. The environmental, social and governance committee is responsible for, among other things: ● supervising the ESG strategies, policies, long-term sustainability objectives and risks.
Rong Shao satisfies the “independence” requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Rules. In addition, we have also established an ESG working group to address daily ESG workflows. The environmental, social and governance committee is responsible for, among other things: ● supervising the ESG strategies, policies, long-term sustainability objectives and risks.
Rong Shao satisfies the “independence” requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Rules. The nominating and corporate governance committee will assist the board of directors in selecting individuals qualified to become our directors and in determining the composition of the board and its committees.
Rong Shao satisfies the “independence” requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Rules. The nominating and corporate governance committee assists the board of directors in selecting individuals qualified to become our directors and in determining the composition of the board and its committees.
Our PRC subsidiaries are required by law to make contributions equal to certain percentages of each employee’s salary for his or her pension insurance, medical insurance, unemployment insurance and other statutory benefits and a housing provident fund. Employment Agreements and Indemnification Agreements We have entered into employment agreements with all of our executive officers.
Our PRC subsidiary is required by law to make contributions equal to certain percentages of each employee’s salary for his or her pension insurance, medical insurance, unemployment insurance and other statutory benefits and a housing provident fund. Employment Agreements and Indemnification Agreements We have entered into employment agreements with all of our executive officers.
Further, an option will lapse upon the earliest of, among other circumstances, two years after the date when the option becomes exercisable upon the listing or the occurrence of a change in control, and a violation in transfer restrictions. 174 Table of Contents Transfer restrictions.
Further, an option will lapse upon the earliest of, among other circumstances, two years after the date when the option becomes exercisable upon the listing or the occurrence of a change in control, and a violation in transfer restrictions. Transfer restrictions.
We may grant awards to employees or if approved by the board, designee of any employee. 175 Table of Contents Vesting schedule.
We may grant awards to employees or if approved by the board, designee of any employee. 134 Table of Contents Vesting schedule.
Awards may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the plan or the relevant award agreement or otherwise determined by the plan administrator, such as transfers by will or the laws of descent and distribution. Termination and Amendment of the Plan.
Awards may not be transferred in any manner by the participant other than in accordance with the exceptions provided in the plan or the award agreement or otherwise determined by the plan administrator, such as transfers by will or the laws of descent and distribution. 136 Table of Contents Termination and Amendment of the Plan.
(1) Represents restricted share units. 178 Table of Contents 2021 Share Incentive Plan In May 2021, we adopted 2021 Share Incentive Plan, which we refer to as the 2021 Plan, to promote the success and enhance the value of our company.
(1) Represents restricted share units. 2021 Share Incentive Plan In May 2021, we adopted 2021 Share Incentive Plan, which we refer to as the 2021 Plan, to promote the success and enhance the value of our company.
Compensation Committee. Our compensation committee consists of Dr. Jingwu Zhang Zang, Mr. Chun Kwok Alan Au, Dr. Pamela M. Klein, and Dr. Ruyi He. Dr. Jingwu Zhang Zang is the chairperson of our compensation committee. We have determined that each of Mr. Chun Kwok Alan Au, Dr. Pamela M. Klein and Dr.
Compensation Committee. Our compensation committee consists of Mr. Chun Kwok Alan Au, Dr. Pamela M. Klein, and Dr. Ruyi He. Dr. Pamela M. Klein is the chairperson of our compensation committee. We have determined that each of Mr. Chun Kwok Alan Au, Dr. Pamela M. Klein and Dr.
The plan permits the awards of options, restricted shares, restricted share units or other types of awards approved by the board of directors or a committee of one or more members of the board of directors. Plan Administration. Our board of directors or a committee of one or more members of the board of directors will administer the plan.
The plan permits the awards of options, restricted shares, restricted share units or other types of awards approved by the board of directors or a committee of one or more members of the board of directors. Plan Administration. Our board of directors or a committee of one or more members of the board of directors administers the plan.
Conor Chia-hung Yang qualifies as an “audit committee financial expert.” The audit committee will oversee our accounting and financial reporting processes and the audits of the financial statements of our company.
Conor Chia-hung Yang qualifies as an “audit committee financial expert.” The audit committee oversees our accounting and financial reporting processes and the audits of the financial statements of our company.
We may also terminate an executive officer’s employment without cause upon a 60-day prior written notice. In such case of termination by us, we will provide severance payments to the executive officer as may be agreed between the executive officer and us. The executive officer may resign at any time with a 60-day prior written notice.
We may also terminate an executive officer’s employment without cause upon a 60-day prior written notice. In such case of termination by us, we will provide severance payments to the executive officer as may be agreed between the executive officer and us.
We have undertaken multiple initiatives to encourage female leadership, including launching the I-Mab Women’s Leadership Council (WLC) in July 2020. Approximately 71% of our employees are female, of which 59% hold a master’s degree or above, while over 25% of our board of directors are female.
We have undertaken multiple initiatives to encourage female leadership, including launching the I-Mab Women’s Leadership Council in July 2020. Approximately 71% of our employees are female, of which 65% hold a master’s degree or above, while over 27% of our board of directors are female.
From August 2011 to December 2013, Mr. Fu served as the general manager of the investment department at Far East Horizon International, a financial services organization. Mr. Fu served as a partner and the head of the Beijing office of Themes Investment Management Ltd, a private equity firm specializing in healthcare and environmental businesses, from July 2010 to July 2011.
Fu served as the general manager of the investment department at Far East Horizon International, a financial services organization. Mr. Fu served as a partner and the head of the Beijing office of Themes Investment Management Ltd, a private equity firm specializing in healthcare and environmental businesses, from July 2010 to July 2011. From March 2008 to April 2010, Mr.
The plan administrator determines the price, conditions and time(s) for exercising each award, which is stated in the relevant award agreement. Options that are vested and exercisable will terminate if they are not exercised prior to the time as the plan administrator determines at the time of grant.
The plan administrator determines the exercise price for each award, which is stated in the award agreement. Options that are vested and exercisable will terminate if they are not exercised prior to the time as the plan administrator determines at the time of grant.
Approximately 28% of total employees were hired through internal referrals. We recruit our employees based on their qualification and potential. We promote culture diversity, and our employees come from the United States, Taiwan and South Korea, in addition to mainland China.
Approximately 25% of total employees were hired through internal referrals. We recruit our employees based on their qualification and potential. We promote culture diversity, and our employees come from the United States, Taiwan and Canada, in addition to mainland China.
The plan administrator determines the exercise price for each award, which is stated in the relevant award agreement. Options that are vested and exercisable will terminate if they are not exercised prior to the time as the plan administrator determines at the time of grant. However, the maximum exercisable term is ten years from the date of grant. Transfer Restrictions.
The plan administrator determines the price, conditions and time(s) for exercising each award, which is stated in the award agreement. Options that are vested and exercisable will terminate if they are not exercised prior to the time as the plan administrator determines at the time of grant. However, the maximum exercisable term is ten years from the date of grant.
In addition, a director will cease to be a director if he or she (i) becomes bankrupt or makes any arrangement or composition with his or her creditors; (ii) dies or is found to be or becomes of unsound mind; (iii) resigns his or her office by notice in writing; (iv) without special leave of absence from our board, is absent from meetings of our board for three consecutive meetings and our board resolves that his or her office be vacated; or (v) is removed from office pursuant to any other provision of our articles of association.
In addition, a director will cease to be a director if he or she (i) becomes bankrupt or makes any arrangement or composition with his or her creditors; (ii) dies or is found to be or becomes of unsound mind; (iii) resigns his or her office by notice in writing; (iv) without special leave of absence from our board, is absent from meetings of our board for three consecutive meetings and our board resolves that his or her office be vacated; or (v) is removed from office pursuant to any other provision of our articles of association. 141 Table of Contents Our officers are appointed by and serve at the discretion of the board of directors, and may be removed by our board of directors.
However, the maximum exercisable term is ten years from the date of grant. Transfer Restrictions.
However, the maximum exercisable term is ten years from the date of grant. 137 Table of Contents Transfer Restrictions.
Plan administration. Our board of directors will administer the 2017 Plan. The board of directors will determine, among other things, the participants to receive options, the number and subscription price of options to be granted to each participant, and the terms and conditions of each option granted. Offer letter.
Our board of directors administers the 2017 Plan. The board of directors determines, among other things, the participants to receive options, the number and subscription price of options to be granted to each participant, and the terms and conditions of each option granted. Offer letter.
Plan administration. Our board of directors will administer the 2018 Plan. The board of directors will determine, among other things, the participants to receive options, the number and subscription price of options to be granted to each participant, and the terms and conditions of each option granted. Offer letter.
Our board of directors administers the 2018 Plan. The board of directors determines, among other things, the participants to receive options, the number and subscription price of options to be granted to each participant, and the terms and conditions of each option granted. Offer letter.
The following table summarizes, as of March 31, 2023, the number of ordinary shares underlying our outstanding options that we granted under the 2018 Plan, excluding options that were forfeited, cancelled or exercised after the relevant grant date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Ordinary ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Shares ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Underlying ​ Exercise ​ ​ ​ ​ ​ ​ ​ ​ Outstanding ​ Price ​ ​ ​ ​ Date of Name Options (US$/ Share) Date of Grant Expiration Weimin Tang * 1.00 ​ ​ July 25, 2019 ​ ​ February 22, 2029 Other grantees * 1.00 ​ ​ July 25, 2019 ​ ​ February 22, 2029 Total 1,354,384 ​ ​ Note: * Less than 1% of our total outstanding shares. 2019 Share Incentive Plan In October 2019, we adopted an equity incentive plan, which we refer to as 2019 Plan, to promote the success and enhance the value of our company.
The following table summarizes, as of April 15, 2024, the number of ordinary shares underlying our outstanding options that we granted under the 2018 Plan, excluding options that were forfeited, cancelled or exercised after the grant date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Ordinary ​ ​ ​ ​ ​ ​ ​ ​ Shares ​ ​ ​ ​ ​ ​ ​ ​ Underlying ​ Exercise ​ ​ ​ ​ ​ ​ Outstanding ​ Price ​ ​ ​ Date of Name Options (US$/Share) Date of Grant Expiration Grantees ​ * ​ 1.00 ​ July 25, 2019 ​ February 22, 2029 Total 598,388 ​ ​ Note: * Less than 1% of our total outstanding shares. 2019 Share Incentive Plan In October 2019, we adopted an equity incentive plan, which we refer to as 2019 Plan, to promote the success and enhance the value of our company.
Under these agreements, each executive officer has agreed to hold, both during and after the termination or expiry of his or her employment agreement, in strict confidence and not to use, except as required in the performance of his or her duties in connection with the employment or pursuant to applicable law, any of our confidential information or trade secrets, any confidential information or trade secrets of our clients or prospective clients, or the confidential or proprietary information of any third party received by us and for which we have confidential obligations.
The executive officer may resign at any time with a 60-day prior written notice. 132 Table of Contents Under these agreements, each executive officer has agreed to hold, both during and after the termination or expiry of his or her employment agreement, in strict confidence and not to use, except as required in the performance of his or her duties in connection with the employment or pursuant to applicable law, any of our confidential information or trade secrets, any confidential information or trade secrets of our clients or prospective clients, or the confidential or proprietary information of any third party received by us and for which we have confidential obligations.
The committee or the board of directors, as applicable, will determine the participants to receive awards, the type and number of awards to be granted to each participant, and the terms and conditions of each grant Award Agreement.
The committee or the board of directors, as applicable, determines the participants to receive awards, the type and number of awards to be granted to each participant, and the terms and conditions of each grant 135 Table of Contents Award Agreement.
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 31, 2023 by: ● each of our directors and executive officers; and 186 Table of Contents ● each person known to us to own beneficially 5% or more of our total outstanding shares.
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of April 15, 2024 by: ● each of our directors and executive officers; and ● each person known to us to own beneficially 5% or more of our total outstanding shares.
The functions and powers of our board of directors include: ● convening shareholders’ annual general meetings and reporting its work to shareholders at such meetings; ● declaring dividends and other distributions; ● appointing officers and determining the term of office of the officers; ● exercising the borrowing powers of our company and mortgaging the property of our company; and ● approving the transfer of shares in our company, including the registration of such shares in our share register. 184 Table of Contents Terms of Directors and Officers Our directors may be elected by an ordinary resolution of our shareholders.
The functions and powers of our board of directors include: ● convening shareholders’ annual general meetings and reporting its work to shareholders at such meetings; ● declaring dividends and other distributions; ● appointing officers and determining the term of office of the officers; ● exercising the borrowing powers of our company and mortgaging the property of our company; and ● approving the transfer of shares in our company, including the registration of such shares in our share register.
Information regarding beneficial ownership is reported as of September 23, 2021, based on the information contained in the Schedule 13D/A jointly filed by HHLR and HIM on September 27, 2021. Please see the Schedule 13D/A jointly filed by HHLR and HIM with SEC on September 27, 2021 for information relating to the Hillhouse entities, HHLR and HIM.
Information regarding beneficial ownership is reported as of June 28, 2023, based on the information contained in the Schedule 13D/A jointly filed by HHLR and HIM on June 30, 2023. Please see the Schedule 13D/A jointly filed by HHLR and HIM with SEC on June 30, 2023 for information relating to the Hillhouse entities, HHLR and HIM.
The following table summarizes, as of March 31, 2023, the number of ordinary shares underlying outstanding options that we granted under the 2017 Plan, excluding options that were forfeited, cancelled or exercised after the relevant grant date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Ordinary ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Shares ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Underlying ​ Exercise ​ ​ ​ ​ ​ ​ ​ ​ Outstanding ​ Price ​ ​ ​ ​ Date of Name Options (US$/Share) Date of Grant Expiration Weimin Tang * 1.00 ​ ​ April 2, 2018 ​ ​ October 1, 2027 Other grantees * 1.00 ​ October 1, 2017 to December 28, 2018 ​ ​ October 1, 2027 Total 1,748,628 ​ ​ Note: * Less than 1% of our total outstanding shares.
The following table summarizes, as of April 15, 2024, the number of ordinary shares underlying outstanding options that we granted under the 2017 Plan, excluding options that were forfeited, cancelled or exercised after the grant date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Ordinary ​ ​ ​ ​ ​ ​ ​ ​ Shares ​ ​ ​ ​ ​ ​ ​ ​ Underlying ​ Exercise ​ ​ ​ ​ ​ ​ Outstanding ​ Price ​ ​ ​ Date of Name Options (US$/Share) Date of Grant Expiration Grantees ​ * ​ 1.00 ​ October 1, 2017 to December 28, 2018 ​ October 1, 2027 Total 1,108,636 ​ ​ Note: * Less than 1% of our total outstanding shares.
Chen also serves as a non-executive director of Century Ginwa Retail Holdings Limited (HKEX: 0162) and an executive director, chairman of the board and acting chief executive officer of Hospital Corporation of China Limited (HKEX: 3869). Mr.
Chen has extensive experience in investment management, supplier management and retail business. Currently, Mr. Chen also serves as a non-executive director of Century Ginwa Retail Holdings Limited (HKEX: 0162) and an executive director, chairman of the board and acting chief executive officer of Hospital Corporation of China Limited (HKEX: 3869). Mr.
As of March 31, 2023, options to purchase an aggregate of 1,748,628 ordinary shares under the 2017 Plan had been granted and remained outstanding, excluding options that were forfeited, cancelled or exercised after the relevant grant date. The following paragraphs describe the principal terms of the 2017 Plan. Types of awards. The 2017 Plan permits the awards of options.
As of April 15, 2024, options to purchase an aggregate of 1,108,636 ordinary shares under the 2017 Plan had been granted and remained outstanding, excluding options that were forfeited, cancelled or exercised after the grant date. The following paragraphs describe the principal terms of the 2017 Plan. Types of awards. The 2017 Plan permits the awards of options. Plan administration.
He completed his residency training in Internal Medicine at Howard University Hospital in Washington DC and received his clinical and research training at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH) in Bethesda, Maryland. Dr. He is a licensed, board-certified physician in Internal Medicine in the United States.
He completed his residency training in Internal Medicine at Howard University Hospital in Washington DC and received his clinical and research training at the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health in Bethesda, Maryland. Dr.
Klein has served as the president at PMK BioResearch since 2008, offering consultancy in Oncology Drug Development to Biotech, Pharma and the Investment Community. Dr. Klein has also served as the consulting chief medical officer at Olema Oncology since 2018. Previously, Dr. Klein served as Chief Medical Officer for successful biotech start-ups and prior to that, Vice President, Genentech, Development.
Klein has also served as the consulting chief medical officer at Olema Oncology since 2018. Previously, Dr. Klein served as chief medical officer for successful biotech start-ups and prior to that, Vice President, Genentech, Development. Dr.
One of the U.S. holders is Citibank, N.A., the depositary of our ADS program. The number of beneficial owners of our ADSs in the United States is likely to be much larger than the number of record holders of our ordinary shares in the United States. F. Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation Not applicable.
One of the U.S. holders is Citibank, N.A., the depositary of our ADS program. The number of beneficial owners of our ADSs in the United States is likely to be much larger than the number of record holders of our ordinary shares in the United States.
The table below sets forth our employees by function as of December 31, 2022: ​ ​ ​ ​ Number Management 11 Research and development 190 Chemistry, manufacturing and controls 31 General and administrative 62 Business and corporate development 9 Commercial 15 Total 318 ​ We recruit our employees primarily through recruitment websites, recruiters, internal referrals and job fairs.
The table below sets forth our employees by function as of December 31, 2023: ​ ​ ​ ​ Number Management 11 Research and development 130 Chemistry, manufacturing and controls 29 General and administrative 44 Business and corporate development 6 Total 220 ​ We recruit our employees primarily through recruitment websites, recruiters, internal referrals and job fairs.
Dr. Klein received her bachelor’s degree in cell and molecular biology from California State University in 1985 and an M.D. from Stritch School of Medicine, Loyola University Chicago in 1992 followed by an internal medicine residency at Cedars Sinai, Los Angeles. Dr. Klein spent seven years at the National Cancer Institute of the NIH in Bethesda, Maryland in medical oncology.
Klein received her bachelor’s degree in cell and molecular biology from California State University in 1985 and an M.D. from Stritch School of Medicine, Loyola University Chicago in 1992 followed by an internal medicine residency at Cedars Sinai, Los Angeles. Dr.
As of March 31, 2023, awards to purchase an aggregate of 1,354,384 ordinary shares under the 2018 Plan had been granted and remained outstanding, excluding options that were forfeited, cancelled or exercised after the relevant grant date. The following paragraphs describe the principal terms of the 2018 Plan. Types of awards. The 2018 Plan permits the awards of options.
As of April 15, 2024, awards to purchase an aggregate of 598,388 ordinary shares under the 2018 Plan had been granted and remained outstanding, excluding options that were forfeited, cancelled or exercised after the grant date. The following paragraphs describe the principal terms of the 2018 Plan. Types of awards. The 2018 Plan permits the awards of options. Plan administration.
Herbst is also a member of the medical advisory committee for the Lung Cancer Research Foundation and chair of the communications committee for ASCO and the International Association for the Study of Lung Cancer.
He is a fellow of the American College of Physicians and an elected member of the Association of American Physicians. Dr. Herbst is also a member of the medical advisory committee for the Lung Cancer Research Foundation and chair of the communications committee for ASCO and the International Association for the Study of Lung Cancer.
Rong Shao, Ph.D., has served as our director since June 2021. Dr. Shao is a professor of drug administration policies and regulations, the Executive Deputy Director of the Research Center of National Drug Policy & Ecosystem (NDPE) and the Director of the NMPA Key Laboratory of Drug Regulatory Innovation and Evaluation, at China Pharmaceutical University. Dr.
Shao is a professor of drug administration policies and regulations, the Executive Deputy Director of the Research Center of National Drug Policy & Ecosystem and the Director of the NMPA Key Laboratory of Drug Regulatory Innovation and Evaluation, at China Pharmaceutical University. Dr.
The following table summarizes, as of March 31, 2023, the number of ordinary shares underlying outstanding options and restricted share units that we granted under the 2020 Plan, excluding awards that were forfeited, cancelled, exercised or vested after the relevant grant date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Ordinary Shares ​ ​ ​ ​ ​ ​ ​ Underlying Options ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ and Restricted Share ​ Exercise Price ​ ​ ​ ​ ​ ​ Name ​ Units ​ (US$/Share) ​ Date of Grant ​ Date of Expiration Jingwu Zhang Zang * (1) ​ N/A ​ September 4, 2020 to March 4, 2022 ​ — ​ * 9.20 ​ ​ March 4, 2022 ​ ​ March 4, 2032 Weimin Tang * (1) ​ N/A ​ ​ September 4, 2020 to March 4, 2022 ​ ​ — ​ * 9.20 ​ ​ March 4, 2022 ​ ​ March 4, 2032 Gigi Qi Feng * (1) ​ N/A ​ ​ September 4, 2020 to March 4, 2022 ​ ​ — ​ * ​ 9.20 ​ ​ March 4, 2022 ​ ​ March 4, 2032 Richard Cheng Li * (1) ​ N/A ​ ​ March 4, 2022 ​ ​ — Other grantees * ​ 5.91 ​ ​ August 14, 2020 to January 11, 2021 ​ ​ January 11, 2031 ​ * ​ 19.67 ​ ​ April 1, 2021 ​ ​ April 1, 2031 ​ * ​ 9.20 ​ ​ March 4, 2022 ​ ​ March 4, 2032 ​ * (1) ​ N/A ​ August 14, 2020 to March 4, 2022 ​ — Total 3,395,094 ​ ​ Notes: * Less than 1% of our total outstanding shares.
The following table summarizes, as of April 15, 2024, the number of ordinary shares underlying outstanding options and restricted share units that we granted under the 2020 Plan, excluding awards that were forfeited, cancelled, exercised or vested after the grant date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Ordinary Shares ​ ​ ​ ​ ​ Underlying Options ​ ​ ​ ​ ​ ​ ​ ​ and Restricted Share ​ Exercise Price ​ ​ ​ ​ Name ​ Units ​ (US$/Share) ​ Date of Grant ​ Date of Expiration Grantees * ​ 5.91 ​ August 14, 2020 to January 11, 2021 ​ January 11, 2031 ​ * ​ 19.67 ​ April 1, 2021 ​ April 1, 2031 ​ * ​ 9.20 ​ March 4, 2022 ​ March 4, 2032 ​ * (1) ​ N/A ​ August 14, 2020 to March 4, 2022 ​ — Total 2,078,250 ​ ​ Notes: * Less than 1% of our total outstanding shares.
To our knowledge, as of March 31, 2023, three of our ordinary shares were held by three record holders in the United States (including 2,096,836 ordinary shares issued to our depositary bank for bulk issuance of ADSs reserved for future issuances upon the exercising or vesting of awards granted under our share incentive plans), representing approximately 85.8% of our total outstanding shares.
To our knowledge, as of April 15, 2024, 168,563,781 of our ordinary shares were held by three record holders in the United States (including 8,043,040 ordinary shares issued to our depositary bank for bulk issuance of ADSs reserved for future issuances upon the exercising or vesting of awards granted under our share incentive plans), representing approximately 90.6% of our total outstanding shares.
Timothy Yap, M.D., Ph.D., has served on our scientific advisory board since August 2019. Dr. Yap is a medical oncologist and physician-scientist based at the University of Texas MD Anderson Cancer Center. He is an Associate Professor in the Department for Investigational Cancer Therapeutics (Phase I Program), and the Department of Thoracic/Head and Neck Medical Oncology. Dr.
Yap is a medical oncologist and physician-scientist based at the University of Texas MD Anderson Cancer Center. He is an Associate Professor in the Department for Investigational Cancer Therapeutics (Phase I Program), and the Department of Thoracic/Head and Neck Medical Oncology. Dr.
For the fiscal year ended December 31, 2022, we paid an aggregate of approximately US$9.8 million for salaries and benefits in cash to our executive officers, including the ones who resigned in 2022, and an aggregate of approximately US$448 thousand for compensation in cash to our independent directors.
For the fiscal year ended December 31, 2023, we paid an aggregate of approximately US$7.4 million for salaries and benefits in cash to our current and former executive officers, and an aggregate of approximately US$448 thousand for compensation in cash to our independent directors.
Board Diversity ​ ​ ​ Board Diversity Matrix (As of March 31, 2023) Country of Principal Executive Offices: People’s Republic of China Foreign Private Issuer Yes Disclosure Prohibited Under Home Country Law No Total Number of Directors 11 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Did Not ​ Female Male Non-Binary Disclose Gender Part I: Gender Identity ​ ​ ​ ​ Directors 3 8 — — Part II: Demographic Background ​ Underrepresented Individual in Home Country Jurisdiction ​ ​ ​ ​ — ​ ​ LGBTQ+ ​ ​ ​ ​ — ​ ​ Did Not Disclose Demographic Background ​ ​ ​ ​ — ​ ​ ​ 185 Table of Contents D.
Board Diversity ​ ​ ​ Board Diversity Matrix (As of April 15, 2024) Country of Principal Executive Offices: United States Foreign Private Issuer Yes Disclosure Prohibited Under Home Country Law No Total Number of Directors 8 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Did Not ​ Female Male Non-Binary Disclose Gender Part I: Gender Identity ​ ​ ​ ​ Directors 2 6 — — Part II: Demographic Background ​ Underrepresented Individual in Home Country Jurisdiction — LGBTQ+ — Did Not Disclose Demographic Background — ​ D.
Employees. We had 228, 378 and 318 employees as of December 31, 2020, 2021 and 2022, respectively. As of December 31, 2022, 272 employees were located in China and 46 were located outside China.
Employees. We had 378, 318 and 220 employees as of December 31, 2021, 2022 and 2023, respectively. As of December 31, 2023, 184 employees were located in China and 36 were located outside China.
He is a member of the Hong Kong Institute of Financial Analysts and member of the American Institute of Certified Public Accountants. 168 Table of Contents Conor Chia-hung Yang has served as our director since January 2020. Mr. Yang has also served as the chief financial officer of Sunrate Holdings Limited since February 2023. Mr.
He is a member of the Hong Kong Institute of Financial Analysts and member of the American Institute of Certified Public Accountants. Conor Chia-hung Yang has served as our director since January 2020. Mr. Yang has been the chief financial officer of Ehang Holdings Limited (Nasdaq: EH) since September 2023. During the period spanning 2007 to 2023, Mr.
The following paragraphs describe the principal terms of the 2021 Plan: Type of Awards. The plan permits the awards of options, restricted shares, restricted share units or other share-based awards. Plan Administration. Our board of directors or one or more committees or subcommittees of the board of directors, or the Committee, will administer the plan.
The following paragraphs describe the principal terms of the 2021 Plan: Type of Awards. The plan permits the awards of options, restricted shares, restricted share units or other share-based awards. Plan Administration.
Shao holds a Ph.D. in Pharmacy Administration from Shenyang Pharmaceutical University, bachelor’s degree in Medicinal Chemistry from China Pharmaceutical University, and bachelor’s degree in Law from Nanjing University. Dr. Shao is also a Chinese practicing lawyer.
Shao holds a Ph.D. in Pharmacy Administration from Shenyang Pharmaceutical University, bachelor’s degree in Medicinal Chemistry from China Pharmaceutical University, and bachelor’s degree in Law from Nanjing University. Dr. Shao is also a Chinese practicing lawyer. Joseph Skelton has served as our chief financial officer since February 2024. Mr.
The Committee or the board of directors, as applicable, will determine the participants to receive awards, the type and number of awards to be granted to each participant, and the terms and conditions of each grant. Award Agreement.
Our board of directors or one or more committees or subcommittees of the board of directors administer the plan and determine the participants to receive awards, the type and number of awards to be granted to each participant, and the terms and conditions of each grant. Award Agreement.
The Committee or the board of directors, as applicable, will determine the participants to receive awards, the type and number of awards to be granted to each participant, and the terms and conditions of each grant. Award Agreement.
Our board of directors or one or more committees or subcommittees of the board of directors administer the plan and determine the participants to receive awards, the type and number of awards to be granted to each participant, and the terms and conditions of each grant. Award Agreement.

… 146 more changes not shown on this page.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

17 edited+4 added−11 removed18 unchanged
Biggest changeAt any time after the earlier of (i) December 31, 2020, or (ii) six months following the effectiveness of a registration statement for a firm underwritten public offering of our ordinary shares on The Stock Exchange of Hong Kong Limited, the New York Stock Exchange, the Nasdaq Stock Market or other internationally recognized securities exchange, with an offering price (exclusive of underwriting commissions and expenses) that reflects a market capitalization (immediately prior to the public offering) of not less than US$1.0 billion, the holders of a majority of the registrable securities then issued and outstanding may request in writing that we file a registration statement covering the registration of at least 20% of the registrable securities (or any lesser percentage if the anticipated gross receipts from the offering are to exceed US$5.0 million).
Biggest changeThe holders of a majority of the registrable securities then issued and outstanding may request in writing that we file a registration statement covering the registration of at least 20% of the registrable securities (or any lesser percentage if the anticipated gross receipts from the offering are to exceed US$5.0 million).
Deed of Undertaking In December 2019, a deed of undertaking was made by our company and a few shareholders of our company, each as a warrantor, to the other shareholders of our company (other than the shareholder warrantors), each as a warrantee, pursuant to which each warrantor represents and warrants to each warrantee that it has provided each warrantee with all information and documents in connection with the initial public offering of our company that has the effect of establishing rights or otherwise benefiting any shareholder in a manner more favorable than the corresponding terms applicable to the relevant warrantee in relation to the initial public offering of our company (collectively, the “More Favorable Arrangements”).
Deed of Undertaking In December 2019, a deed of undertaking was made by our company and a few shareholders of our company, each as a warrantor, to the other shareholders of our company (other than the shareholder warrantors), each as a warrantee, pursuant to which each warrantor represents and warrants to each warrantee that it has provided each warrantee with all information and documents in connection with the initial public offering of our company that has the effect of establishing rights or otherwise benefiting any shareholder in a manner more favorable than the corresponding terms applicable to the warrantee in relation to the initial public offering of our company (collectively, the “More Favorable Arrangements”).
Pursuant to the deed of undertaking, until the fifth anniversary of the completion of our initial public offering, we will not directly or indirectly enter into any agreements or arrangements or modify, amend or waive any existing agreements or arrangements of any kind that would have the effect of establishing the More Favorable Arrangements; provided that it will be allowed to adopt or modify any employee incentive plans and grant options to the management or any employee of our company after our initial public offering pursuant to such plans and in accordance with the then effective memorandum and articles of association and the applicable listing rules for the purpose of rewarding their bona fide services. 190 Table of Contents Subscription Agreement with Hillhouse Entities In September 2020, we entered into a Subscription Agreement with the Hillhouse Entities, as amended by an amendment to Subscription Agreement entered into between Hillhouse Entities and our company in December 2020.
Pursuant to the deed of undertaking, until the fifth anniversary of the completion of our initial public offering, we will not directly or indirectly enter into any agreements or arrangements or modify, amend or waive any existing agreements or arrangements of any kind that would have the effect of establishing the More Favorable Arrangements; provided that it will be allowed to adopt or modify any employee incentive plans and grant options to the management or any employee of our company after our initial public offering pursuant to such plans and in accordance with the then effective memorandum and articles of association and the applicable listing rules for the purpose of rewarding their bona fide services. 146 Table of Contents Subscription Agreement with Hillhouse Entities In September 2020, we entered into a Subscription Agreement with the Hillhouse Entities, as amended by an amendment to Subscription Agreement entered into between Hillhouse Entities and our company in December 2020.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A. Major Shareholders Please refer to “Item 6. Directors, Senior Management and Employees—E. Share Ownership.” B. Related Party Transactions Shareholders Agreement In July 2019, we entered into our fourth amended and restated shareholders agreement with our shareholders.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A. Major Shareholders Please refer to “Item 6. Directors, Senior Management and Employees—E. Share Ownership.” B. Related Party Transactions Shareholders Agreement In July 2019, we entered into our fourth amended and restated shareholders agreement with our then-shareholders.
Under the framework of this biologics master services agreement, we entered into series of work orders with respect to process development and manufacturing service for our drug assets in 2021 and 2022, respectively.
Under the framework of this biologics master services agreement, we entered into series of work orders with respect to process development and manufacturing service for our drug assets in 2021, 2022 and 2023, respectively.
In 2021 and 2022, I-Mab Hangzhou paid us RMB52.4 million and nil for the product development services we offered. In July 2021, we entered into a biologics master services agreement with I-Mab Hangzhou.
In 2021, 2022 and 2023, I-Mab Hangzhou paid us RMB52.4 million, nil and nil for the product development services we offered. In July 2021, we entered into a biologics master services agreement with I-Mab Hangzhou.
We will bear all registration expenses, except any (i) portions of fees and disbursements of counsel for the Hillhouse Entities exceeding US$30,000, (ii) underwriting discounts and selling commissions applicable to sale of registrable securities, and (iii) fees payable pursuant to the deposit agreement. 191 Table of Contents Ranking of Registration Rights.
We will bear all registration expenses, except any (i) portions of fees and disbursements of counsel for the Hillhouse Entities exceeding US$30,000, (ii) underwriting discounts and selling commissions applicable to sale of registrable securities, and (iii) fees payable pursuant to the deposit agreement. Ranking of Registration Rights.
We should cause an individual jointly designated by the Hillhouse Entities to be appointed as the investor director with immediate effect no later than the fifteenth (15th) business day after receiving written notice from Hillhouse Entities or such later date on which we receive necessary shareholder approval. Lock-up.
We should cause an individual jointly designated by the Hillhouse Entities to be appointed as the investor director with immediate effect no later than the fifteenth business day after receiving written notice from Hillhouse Entities or such later date on which we receive necessary shareholder approval.
On the same date, we, through our wholly-owned subsidiary, entered into a shareholders agreement with I-Mab Hangzhou and other domestic investors in I-Mab Hangzhou named therein (the “I-Mab Hangzhou Shareholders Agreement”).
On the same date, we, through our wholly owned subsidiary, entered into a shareholders agreement with I-Mab Hangzhou and other domestic investors in I-Mab Hangzhou named therein.
Pursuant to our shareholders agreement, we have granted certain registration rights to our shareholders. Set forth below is a description of the registration rights granted under the agreement. 189 Table of Contents Demand Registration Rights.
Pursuant to our shareholders agreement, we have granted certain registration rights to our shareholders. Set forth below is a description of the registration rights granted under the agreement. 145 Table of Contents Demand Registration Rights.
After receiving the milestone payment of RMB19.1 million (US$3.0 million) from I-Mab Hangzhou, we settled the payment of US$3.0 million with Ferring, as of December 31, 2022. 192 Table of Contents On July 16, 2022, I-Mab Hangzhou entered into a definitive financing agreement with a group of domestic investors in China to raise approximately US$46 million (in RMB equivalent).
After receiving the milestone payment of RMB19.1 million (equivalent to US$3.0 million) from I-Mab Hangzhou, we settled the payment of US$3.0 million with Ferring, as of December 31, 2023. On July 16, 2022, I-Mab Hangzhou entered into a definitive financing agreement with a group of domestic investors in China to raise the RMB equivalent of approximately US$46 million.
Our obligations to effect any demand, Form F-3 or piggyback registration will terminate upon the earlier of (i) the tenth anniversary of the initial public offering (ii) after the initial public offering, the date on which such shareholder is eligible to sell all of the registrable securities held by it under Rule 144 within any 90-day period without volume limitations.
Our obligations to effect any demand, Form F-3 or piggyback registration will terminate upon the earlier of (i) January 22, 2030, which is the tenth anniversary of our initial public offering, or (ii) with respect to any shareholder, the date on which such shareholder is eligible to sell all of the registrable securities held by it under Rule 144 within any 90-day period without volume limitations.
Upon the occurrence of certain triggering events as specified in the I-Mab Hangzhou Shareholders Agreement, including but not limited to I-Mab Hangzhou’s failure to accomplish certain public offering condition, we may be obligated to repurchase the equity held by other domestic investors in cash or in our stocks in the period beyond 12 months. C.
Upon the occurrence of certain triggering events as specified in this agreement, including but not limited to I-Mab Hangzhou’s failure to accomplish certain public offering conditions, we may be obligated to repurchase the equity held by other domestic investors in cash or in our stocks in the period beyond 12 months. C. Interests of Experts and Counsel Not applicable.
The Subscription Agreement, as amended, provides for (i) certain investors’ rights, such as registration rights, board representation rights and anti-dilution rights and (ii) lock-up and other transfer restrictions. Set forth below is a description of certain rights and restrictions thereof. Mandatory Registration after Initial Closing (September 11, 2020).
The Subscription Agreement, as amended, provides for (i) certain investors’ rights, such as registration rights, board representation rights and anti-dilution rights and (ii) lock-up and other transfer restrictions. Set forth below is a description of certain rights and restrictions thereof. Demand Registration Rights.
In August 2021, we entered into a project development service agreement with I-Mab Hangzhou, for the product development services we rendered for selected pipeline sub-licensed or assigned to I-Mab Hangzhou, including TJ301, TJM2 (excluding cytokine release syndrome indications) and a few pre-clinical programs that are unessential to our immune-oncology focus.
Compensation—Share Incentive Plans.” Other Transactions with Related Parties In August 2021, we entered into a project development service agreement with I-Mab Hangzhou, for the product development services we rendered for selected pipeline sub-licensed or assigned to I-Mab Hangzhou, including TJ301, TJM2 (excluding COVID-19 indication) and a few pre-clinical programs that are unessential to our immune-oncology focus.
Pursuant to the work orders signed with I-Mab Hangzhou in 2022, I-Mab Hangzhou will provide us with CMC development and manufacturing services for a total of RMB126.5 million (US$18.3 million). We paid I-Mab Hangzhou RMB10.7 million and RMB46.2 million (US$6.7 million) for the years ended December 31, 2021 and 2022, respectively.
Pursuant to the work orders signed with I-Mab Hangzhou in 2022 and 2023, I-Mab Hangzhou provided us with development of chemistry, manufacturing and controls and manufacturing services for a total of RMB226.7 million (US$31.9 million). We paid I-Mab Hangzhou RMB10.7 million, RMB46.2 million and RMB120.5 million (US$17.0 million) for the years ended December 31, 2021, 2022 and 2023, respectively.
Employment Agreements and Indemnification Agreements See “Item 6. Directors, Senior Management and Employees—A. Directors and Senior Management — Employment Agreements and Indemnification Agreements.” Share Option Grants See “Item 6. Directors, Senior Management and Employees—B.
The total amount of potential repurchase obligations owed to the non-participating shareholders upon the closing of the transaction is expected to range from US$30 million to US$35 million. 147 Table of Contents Employment Agreements and Indemnification Agreements See “Item 6. Directors, Senior Management and Employees—A. Directors and Senior Management—Employment Agreements and Indemnification Agreements.” Share Option Grants See “Item 6.
Removed
We agree to file with the SEC a registration statement to register the resale of Hillhouse Entities’ registrable securities, which include ordinary shares issued and issuable upon exercise of Investor Warrants under the Subscription Agreement, on Form F-3 or Form F-1, as applicable.
Added
Divestiture of Greater China Assets and Business Operations On February 6, 2024, we entered into definitive agreements to divest the Greater China assets and business operations to I-Mab Hangzhou.
Removed
We should have the relevant registration statement declared effective by the SEC no later than ninety (90) calendar days after September 11, 2020, which period could be extended to one hundred and twenty (120) calendar days if the SEC reviews and comments on the registration statement.
Added
Pursuant to the definitive agreements, we transferred 100% of the outstanding equity interest in I-Mab Shanghai, which operates our business in China, on a cash-free and debt-free basis, to I-Mab Hangzhou, including our rights to the Greater China portfolio, to I-Mab Hangzhou for an aggregate consideration of the RMB equivalent of up to US$80 million, contingent on the achievement of certain future regulatory and sales-based milestone events.
Removed
However, if the SEC prevents inclusion of the registrable securities in the registration statement pursuant to limitations under Rule 415 of the Securities Act, the number of registrable securities to be registered for each selling shareholder named in the registration statement should be reduced pro rata among all such selling shareholders.
Added
After the completion of the divestiture, we do not own any rights to the Greater China portfolio. The transaction also extinguishes existing repurchase obligations owed by a wholly owned subsidiary of ours in the amount of approximately US$183 million.
Removed
We should maintain the continuous effectiveness of the registration statement for a period of ninety (90) days after its effectiveness or such shorter period upon which the Hillhouse Entities have notified us that their registrable securities have actually been sold. Mandatory Registration after Subsequent Closing (December 17, 2020).
Added
However, the non-participating shareholders of I-Mab Hangzhou have initiated legal proceedings against I-Mab Hong Kong and our company in connection with the aforementioned transaction.
Removed
With respect to the registrable securities then held by the Hillhouse Entities which have not been previously registered and sold, we agree to file a prospectus supplement or a registration statement to register the resale of such registrable securities on a Form F-3 or Form F-3ASR registration statement (or, if Form F-3 or Form F-3ASR is not then available to us, on Form F-1 or such other form of registration statement as is then available to effect a registration for resale of such registrable securities), and have such registration statement declared effective by the SEC no later than (a) the ten (10) business days after the later of (i) the first date when we become eligible to use registration statement on F-3, or (ii) the expiration of the lock-up period with respect to the subsequent closing, or forty-five (45) calendar days after such lock-up period expiration date if the SEC reviews and comments on the registration statement.
Removed
We should maintain the effectiveness of such registration statement for a period ending on the date the registrable securities registered thereon have ceased to be registrable securities. Demand Registration Rights.
Removed
The Hillhouse Entities should not dispose of any of the ordinary shares purchased by Hillhouse Entities on the applicable initial or subsequent closing date within a 90-day period following September 11, 2020 or a subsequent closing date set forth in the subscription agreement to any person other than affiliates of the Hillhouse Entities, who should be bound by the Hillhouse Entities’ lock-up obligations for the balance of each applicable lock-up period.
Removed
Each of the Hillhouse Entities and their affiliates may directly or indirectly, place any charge, mortgage, lien, pledge, restrictions, security interest or other encumbrance in respect of the lock-up securities in connection with such Hillhouse Entity’s (or any of its affiliates’) margin loans, collars, derivative transactions or other such downside protection transactions to be entered into on or after the date of the subscription agreement.
Removed
We agree not to issue, offer, sell, or grant any option or right to purchase any new securities, without the prior written consent of the Hillhouse Entities, (i) during the 90-day period following each closing date; or (ii) at an effective purchase price per share lower than the purchase price under the Subscription Agreement with Hillhouse Entities during the 90-day period commencing from the expiration of each lock-up period.
Removed
Compensation—Share Incentive Plans.” Other Transactions with Related Parties In January 2018, we entered into a collaboration agreement with Everest, an affiliate of C-Bridge Capital Investment Management, Ltd., whereby both parties agreed to collaborate on programs to co-develop MorphoSys’ proprietary CD38 antibody for all indications in hematologic oncology and commercialize the CD38 product in mainland China, Hong Kong, Macau and Taiwan.
Removed
On November 4, 2019, we and Everest Medicines Limited terminated the collaboration agreement (including all the supplements and amendments thereto) with respect to the co-development and commercialization of felzartamab in Greater China.