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What changed in CHINA PHARMA HOLDINGS, INC.'s 10-K2024 vs 2025

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Paragraph-level year-over-year comparison of CHINA PHARMA HOLDINGS, INC.'s 2024 and 2025 10-K 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 2025 report.

+261 added237 removedSource: 10-K (2026-04-01) vs 10-K (2025-03-31)

Top changes in CHINA PHARMA HOLDINGS, INC.'s 2025 10-K

261 paragraphs added · 237 removed · 208 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

51 edited+25 added13 removed110 unchanged
Biggest changeRising medical demand and consumption levels highlight the value of innovative, high-quality drugs. The State Council’s 2023 TCM revitalization plan positions Traditional Chinese Medicine as a key health pillar. The TCM market neared RMB 720 billion (approximately $101 billion) in 2023, with a 1.75% five-year CAGR, and is estimated to exceed RMB 750 billion (approximately $105 billion) in 2024.
Biggest changeFor the first time, revenue growth (2.7%) outpaced expenditure growth (0.8%), leading to more stable operation of the fund. Rising medical demand and consumption levels have highlighted the value of innovative and high-quality drugs. The Traditional Chinese Medicine (TCM) revitalization plan issued by the State Council in 2023 positions TCM as a key pillar of health security.
However, the PRC regulatory authorities may in the future promulgate laws, regulations, or implementing rules that require us, or Helpson, to obtain additional permissions or approvals to operate our business. Upon that time, we cannot assure we are able to receive such additional permissions and approvals on time.
However, the PRC regulatory authorities may in the future promulgate laws, regulations, or implementing rules that require us, or Helpson, to obtain additional permissions or approvals to operate our business. Upon that time, we cannot assure that we are able to receive such additional permissions and approvals on time.
In this context, we believe that the uncertainties in the timetables for obtaining NMPA production approvals for products under research are increasing. If a manufacturer chooses to manufacture a pre-clinical medicine, it is also required to conduct pre-clinical trials, apply to the NMPA for permission to conduct clinical trials and go through the clinical trials.
In this context, we believe that the uncertainties in the timetables for obtaining NMPA production approvals for products under research are increasing. If a manufacturer chooses to manufacture pre-clinical medicine, it is also required to conduct pre-clinical trials, apply to the NMPA for permission to conduct clinical trials and go through the clinical trials.
Such lack of inspection or re-evaluation could cause trading in the Company’s securities to be prohibited under the HFCAA ultimately result in a determination by a securities exchange to delist the Company’s securities.
Such lack of inspection or re-evaluation could cause trading in the Company’s securities to be prohibited under the HFCAA to ultimately result in a determination by a securities exchange to delist the Company’s securities.
We will proactively adjust our business focus and allocate resources to meet market development preferences, provide a more convenient user experience, better standard treatment plans, and bring higher patient satisfaction. 7 Our objective is to leverage our expertise in the PRC for the development, manufacture and commercialization of pharmaceutical products.
We will proactively adjust our business focus and allocate resources to meet market development preferences, provide more convenient user experience, better standard treatment plans, and bring higher patient satisfaction. 7 Our objective is to leverage our expertise in the PRC for the development, manufacture and commercialization of pharmaceutical products.
The Year 2011 GMP Standards became effective on March 1, 2011, and pharmaceutical manufacturers (except for manufacturers of injectables, blood products or vaccines, which had a three-year grace period) had a five-year grace period to upgrade existing facilities to comply with the revisions. All of Helpson’s existing production lines have met the Year 2011 GMP Standards.
The Year 2011 GMP Standards became effective on March 1, 2011, and pharmaceutical manufacturers (except for manufacturers of injectables, blood products or vaccines, which had a three-year grace period) had a five-year grace period to upgrade existing facilities to comply with the revisions. 18 All of Helpson’s existing production lines have met the Year 2011 GMP Standards.
The NMPA has a variety of enforcement actions available to enforce its regulations and rules, including fines and injunctions, recall or seizure of products, imposition of operating restrictions, partial suspension or complete shutdown of production and criminal prosecution. 17 Pharmaceutical Product Manufacturing Permits and Licenses for Pharmaceutical Manufacturers.
The NMPA has a variety of enforcement actions available to enforce its regulations and rules, including fines and injunctions, recall or seizure of products, imposition of operating restrictions, partial suspension or complete shutdown of production and criminal prosecution. Pharmaceutical Product Manufacturing Permits and Licenses for Pharmaceutical Manufacturers.
Prior to the latter of (1) the expiration of a new medicine’s monitoring period or (2) the date when the NMPA grants a final standard for a new medicine after the expiration of the provisional standard, the NMPA will not accept applications for an identical medicine nor will it approve the production of an identical medicine by other pharmaceutical companies.
Prior to the latter of (1) the expiration of a new medicine’s monitoring period or (2) the date when the NMPA grants a final standard for a new medicine after the expiration of the provisional standard, the NMPA will not accept applications for identical medicine nor will it approve the production of identical medicine by other pharmaceutical companies.
Consistency evaluation of our current existing major products will be the focus of our strategy in the near future. The consistency evaluation of generic drugs will improve Chinese generic drugs quality and eliminate unqualified enterprises, so that high-quality generic drug companies are expected to benefit from it.
Consistent evaluation of our current existing major products will be the focus of our strategy in the near future. The consistency evaluation of generic drugs will improve Chinese generic drugs quality and eliminate unqualified enterprises, so that high-quality generic drug companies are expected to benefit from it.
As of December 31, 2024, we have been distributing products directly to hospital endpoints and OTC pharmacies through provincially and municipally licensed pharmaceutical companies (holding valid Drug Supply Licenses and GSP certifications), achieving comprehensive coverage of primary healthcare markets. Leveraging our professional team's academic-driven promotion model, we engage with medical institutions by providing evidence-based medical support.
As of December 31, 2025, we have been distributing products directly to hospital endpoints and OTC pharmacies through provincially and municipally licensed pharmaceutical companies (holding valid Drug Supply Licenses and GSP certifications), achieving comprehensive coverage of primary healthcare markets. Leveraging our professional team’s academic-driven promotion model, we engage with medical institutions by providing evidence-based medical support.
It is expected to launch those products as soon as the registration process is completed. In addition, Helpson has launched N95 Medical Protective masks in early 2023.
It is expected to launch those products as soon as the registration process is completed. In addition, Helpson launched N95 Medical Protective masks in early 2023.
Helpson has actively promoted the consistency evaluation process of several important products in 2024; and its flagship product, Candesartan, has passed the evaluation of consistency in August 2023. 4 The PRC Legal System Legal and Operational Risks Associated with Having the Majority of the Company’s Operations in China The PRC legal system is based on written statutes.
Helpson has actively promoted the consistency evaluation process of several important products since 2023; and its flagship product, Candesartan, passed the evaluation of consistency in August 2023. 4 The PRC Legal System Legal and Operational Risks Associated with Having the Majority of the Company’s Operations in China The PRC legal system is based on written statutes.
Instead, it requires that drug manufacturing enterprises and drug trading enterprises establish and improve the quality management systems of manufacture and trade of drugs, and ensure that the process of manufacturing and trading of drugs always meets all legal requirements. This means a stricter form of supervision is implemented comparing to the prior GMP certificates system.
Instead, it requires that drug manufacturing enterprises and drug trading enterprises establish and improve the quality management systems of manufacture and trade of drugs and ensure that the process of manufacturing and trading of drugs always meets all legal requirements. This means a stricter form of supervision is implemented compared to the prior GMP certificates system.
Environmental Matters Helpson complies with the Environmental Protection Law of China as well as applicable local regulations. In addition to statutory and regulatory compliance, Helpson actively ensures the environmental sustainability of the operations. Penalties may be levied upon it if we fail to adhere to and maintain certain standards.
Environmental Matters Helpson complies with the Environmental Protection Law of China as well as applicable local regulations. In addition to statutory and regulatory compliance, Helpson actively ensures the environmental sustainability of the operations. Penalties may be levied upon them if we fail to adhere to and maintain certain standards.
The Company currently has no intention to distribute earnings to the shareholders and investors. The tables below present cash flow transfer between China Pharma and Helpson, through China Pharma’s wholly owned subsidiary Onny Investment Limited (“Onny”) for the year ended December 31, 2024 and 2023.
The Company currently has no intention to distribute earnings to the shareholders and investors. The tables below present cash flow transfer between China Pharma and Helpson, through China Pharma’s wholly owned subsidiary Onny Investment Limited (“Onny”) for the year ended December 31, 2025 and 2024.
As of December 31, 2024, Helpson owns 15 registered trademarks, including marks for eight of the 19 pharmaceutical products Helpson manufactures, including the tradenames Fukexing, Beisha, Shiduotai, Xinuo, Pusenlitai, Pusenouke, Shuchang, Shenkaineng, XERONINE, and Aronino, as well as marks for the HPS logo, two HELPSON logos and two other logos.
As of December 31, 2025, Helpson owns 15 registered trademarks, including marks for eight of the 19 pharmaceutical products Helpson manufactures, including the tradenames Fukexing, Beisha, Shiduotai, Xinuo, Pusenlitai, Pusenouke, Shuchang, Shenkaineng, XERONINE, and Aronino, as well as marks for the HPS logo, two HELPSON logos and two other logos.
Currently, Helpson relies on numerous suppliers in the PRC and overseas to deliver the required raw materials and believe it has at least three principal suppliers for each of our most critical raw materials. Historically, Helpson has not had difficulty obtaining raw materials from suppliers.
Currently, Helpson relies on numerous suppliers in the PRC and overseas to deliver the required raw materials and believes it has at least three principal suppliers for each of our most critical raw materials. Historically, Helpson has not had difficulty obtaining raw materials from suppliers.
If a manufacturer chooses to manufacture a post-clinical medicine, it only needs to go through the clinical trials. In both cases, a manufacturer needs to file clinical data with the NMPA for approval to manufacture after clinical trials are completed. 16 New Medicine .
If a manufacturer chooses to manufacture a post-clinical medicine, it only needs to go through clinical trials. In both cases, a manufacturer needs to file clinical data with the NMPA for approval to manufacture after clinical trials are completed. 17 New Medicine .
In November 2008, Helpson purchased the patented medical formula and the manufacturing processes for a cerebral/cardio-vascular indication from a third-party laboratory. In connection with that acquisition, we obtained the title of the patent. This patent expires in 2025. 15 In 2012, Helpson acquired another patent related to a medical formula for the treatment of cerebral/cardio-vascular diseases.
In November 2008, Helpson purchased the patented medical formula and the manufacturing processes for a cerebral/cardio-vascular indication from a third-party laboratory. In connection with that acquisition, we obtained the title of the patent. This patent expired in 2025. In 2012, Helpson acquired another patent related to a medical formula for the treatment of cerebral/cardio-vascular diseases. This patent expires in 2029.
The Company’s management understands that there are no tax consequences for cash flow transfers between China Pharma and Helpson through Onny. For the year ended December 31, 2024 No.
The Company’s management understands that there are no tax consequences for cash flow transfers between China Pharma and Helpson through Onny. For the year ended December 31, 2025 No.
For sore throat caused by upper respiratory tract infection 2003 Clarithromycin Granules and Capsules Nasopharynx infection, lower respiratory tract infection, skin tissue infection, acute tympanitis and mycoplasma pneumonia caused by clarithromycin susceptible organisms; urethritis and cervical infection caused by chlamydia trachomatis; and the treatment of legionella infection, mycobacterium avium complex (MAC) infection and helicobacter pylori infection. 2004 Naproxen Sodium and Pseudophedrine Hydrochlorida Sustained Release Tablet Relieves cold, sinus and flu symptoms, blocked nose caused by anaphylaxis rhinitis, runny nose, fever, sore throat, symptoms of myalgia in the limbs and pain around the joints. 2005 10 Digestive Diseases Hepatocyte Growth-promoting Factor for Injection Serious viral hepatitis symptoms caused by various viral hepatitis types (acute, subnormal temperature, chronic serious disease early or middle period of hepatitis). 2005 Tiopronin Acute and chronic Hepatitis B, and for the relief of drug-induced liver injury. 2009 Compound Ammonium Glycyrrhetate S for Injection Liver dysfunction caused by acute and chronic hepatitis; supplemental treatment to toxic/trauma hepatitis, liver cancer; also for the indication of food/drug poisoning, and drug allergy. 2009 Omeparzole Gastroesophageal reflux disease, and other conditions caused by excess acidic formulations in the stomach, including gastric ulcers, recurrent duodenal ulcers and Zollinger-Ellison Syndrome. 2009 Others Vitamin B6 for Injection Vitamin supplement. 2005 Granisetron Hydrochloride Injection Nausea and vomiting caused by radiotherapy and chemotherapy during the treatment of malignant tumors. 2006 Comprehensive Healthcare and Protective Products Noni Enzyme natural, healthy and nutrition-rich a natural, healthy and nutrition-rich food supplement 2018 Sanitizer 75% alcohol wash-free sanitizer 2020 Masks KN95 Particulate Respirator, Disposable Medical Mask, Particle Filtering Mask, N95 Medical Protective Mask 2020 to 2023 11 Set forth below are our revenues by product category in millions (USD) for the years ended December 31, 2024 and 2023: Twelve Months Ended December 31, Net Product Category 2024 2023 Change % Change CNS Cerebral & Cardio Vascular 1.35 1.62 -0.27 -17 % Anti-Viral/ Infection & Respiratory 2.75 3.57 -0.82 -23 % Digestive Diseases 0.20 1.09 -0.89 -82 % Other 0.18 0.73 -0.55 -75 % Due to the nature of the pharmaceutical industry, Helpson continually strives to change our product portfolio to respond to changes in market demand.
For sore throat caused by upper respiratory tract infection 2003 Clarithromycin Granules and Capsules Nasopharynx infection, lower respiratory tract infection, skin tissue infection, acute tympanitis and mycoplasma pneumonia caused by clarithromycin susceptible organisms; urethritis and cervical infection caused by chlamydia trachomatis; and the treatment of legionella infection, mycobacterium avium complex (MAC) infection and helicobacter pylori infection. 2004 Naproxen Sodium and Pseudophedrine Hydrochlorida Sustained Release Tablet Relieves cold, sinus and flu symptoms, blocked nose caused by anaphylaxis rhinitis, runny nose, fever, sore throat, symptoms of myalgia in the limbs and pain around the joints. 2005 10 Digestive Diseases Hepatocyte Growth-promoting Factor for Injection Serious viral hepatitis symptoms caused by various viral hepatitis types (acute, subnormal temperature, chronic serious disease early or middle period of hepatitis). 2005 Tiopronin Acute and chronic Hepatitis B, and for the relief of drug-induced liver injury. 2009 Compound Ammonium Glycyrrhetate S for Injection Liver dysfunction caused by acute and chronic hepatitis; supplemental treatment to toxic/trauma hepatitis, liver cancer; also for the indication of food/drug poisoning, and drug allergy. 2009 Omeparzole Gastroesophageal reflux disease, and other conditions caused by excess acidic formulations in the stomach, including gastric ulcers, recurrent duodenal ulcers and Zollinger-Ellison Syndrome. 2009 Others Vitamin B6 for Injection Vitamin supplement. 2005 Granisetron Hydrochloride Injection Nausea and vomiting caused by radiotherapy and chemotherapy during the treatment of malignant tumors. 2006 Comprehensive Healthcare and Protective Products Noni Enzyme natural, healthy and nutrition-rich a natural, healthy and nutrition-rich food supplement 2018 Sanitizer 75% alcohol wash-free sanitizer 2020 Masks KN95 Particulate Respirator, Disposable Medical Mask, Particle Filtering Mask, N95 Medical Protective Mask 2020 to 2023 11 Set forth below are our revenues by product category in millions (USD) for the years ended December 31, 2025 and 2024: Twelve Months Ended December 31, Net Product Category 2025 2024 Change % Change CNS Cerebral & Cardio Vascular 1.32 1.35 -0.03 -2 % Anti-Viral/ Infection & Respiratory 2.48 2.75 -0.27 -10 % Digestive Diseases 0.23 0.2 0.03 15 % Other 0.07 0.18 -0.11 -61 % Due to the nature of the pharmaceutical industry, Helpson continually strives to change our product portfolio to respond to changes in market demand.
This patent expires in 2029. In 2022, Helpson, our wholly owned subsidiary, acquired a utility model patent and an invention patent application regarding the creation of an ophthalmic oxygen enriched atomization therapeutic apparatus from Chengdu Bonier Medical Technology Development Co., Ltd. (“Bonier”).
In 2022, Helpson, our wholly owned subsidiary, acquired a utility model patent and an invention patent application regarding the creation of an ophthalmic oxygen enriched atomization therapeutic apparatus from Chengdu Bonier Medical Technology Development Co., Ltd. (“Bonier”).
As of December 31, 2024, China Pharma, through Helpson, manufactured 19 pharmaceutical products for a wide variety of diseases and medical indications, each of which may be classified into one of three general categories: Basic generic drugs, which are common drugs in the PRC for which there is a very large market demand; First-to-market generic drugs, which are generic drugs that are new to the PRC marketplace; or Modern Traditional Chinese Medicines (“TCMs”), which are generally comprised of non-synthetic, plant-based medicinal compounds that have been widely used in the PRC for thousands of years.
As of December 31, 2025, China Pharma, through Helpson, is granted rights to manufacture for 19 pharmaceutical products for a wide variety of diseases and medical indications, each of which may be classified into one of three general categories: Basic generic drugs, which are common drugs in the PRC for which there is a very large market demand; First-to-market generic drugs, which are generic drugs that are new to the PRC marketplace; or Modern Traditional Chinese Medicines (“TCMs”), which are generally comprised of non-synthetic, plant-based medicinal compounds that have been widely used in the PRC for thousands of years.
According to the National Bureau of Statistics of China, in the first half of 2024, pharmaceutical enterprises above a designated size reported operating income of RMB 1.47 trillion (approximately $205 billion), a 1.4% year-on-year decline, and profits of RMB 211.2 billion (approximately $29.5 billion), down 1.2%.
According to the National Bureau of Statistics of China, in the first half of 2024, pharmaceutical enterprises above a designated size achieved operating income of RMB 1.47 trillion (approximately USD 205 billion), a year-on-year decrease of 1.4%, and profits of RMB 211.2 billion (approximately USD 29.5 billion), down 1.2% year on year.
Helpson directly supplies products to hospital and OTC pharmacies through provincial and municipal pharmaceutical logistic companies with legal qualifications (such as the "Drug Supply License" and GSP certification), covering the primary healthcare institution market.
Helpson directly supplies products to hospital and OTC pharmacies through provincial and municipal pharmaceutical logistic companies with legal qualifications (such as the “Drug Supply License” and GSP certification), covering the primary healthcare institution market.
During the monitoring period, the NMPA will monitor the safety of the new medicine, and will neither accept new medicine certificate applications for an identical medicine by another pharmaceutical company, nor approve the production or import of an identical medicine by other pharmaceutical companies.
During the monitoring period, the NMPA will monitor the safety of the new medicine and will not accept new medicine certificate applications for identical medicine by another pharmaceutical company, nor will it approve the production or import o identical medicine by other pharmaceutical companies.
For the year ended December 31, 2023 three top suppliers accounted for 17.7%, 13.8%, and 8.9%, respectively. 13 Competition We believe we have established a commercially competitive position in the highly-fragmented pharmaceutical industry in China through our core competitive advantages, as described below: Helpson has a highly-efficient commercialization process for new products, including significant experience with the NMPA registration process.
For the year ended December 31, 2024, three top suppliers accounted for 22.9%, 21.3%, and 14.6%, respectively. 13 Competition We believe we have established a commercially competitive position in the highly-fragmented pharmaceutical industry in China through our core competitive advantages, as described below: Helpson has a highly-efficient commercialization process for new products, including significant experience with the NMPA registration process.
On December 15, 2022, the PCAOB announced in the 2022 Determination its determination that the PCAOB was able to secure complete access to inspect and investigate accounting firms headquartered in mainland China and Hong Kong, and the PCAOB Board voted to vacate previous determinations to the contrary.
On December 15, 2022, the PCAOB announced in the 2022 Determination its determination that the PCAOB was able to secure complete access to inspect and investigate accounting firms headquartered in mainland China and Hong Kong,.
Transfer from Transfer to Approximate value ($) Note 1 Helpson (via Onny) China Pharma 30,000 For the payment of the agent service fees of China Pharma For the year ended December 31, 2023 No.
Transfer from Transfer to Approximate value ($) Note 1 Helpson (via Onny) China Pharma 470,000 For the payment of the agent service fees of China Pharma 2 Onny China Pharma 5,000 For the payment of the agent service fees of China Pharma For the year ended December 31, 2024 No.
Transfer from Transfer to Approximate value ($) Note 1 China Pharma (via Onny) Helpson 1,300,000 For Helpson’s operations Our cash management policy basically is to allocate the cash resources based on the needs and projection of each subsidiary within the Company.
Transfer from Transfer to Approximate value ($) Note 1 Helpson (via Onny) China Pharma 530,000 For the payment of the agent service fees of China Pharma Our cash management policy basically is to allocate the cash resources based on the needs and projection of each subsidiary within the Company.
Employees As of December 31, 2024, we had 231 employees, among which 224 employees were full-time employees and 7 employees were temporary employees. None of our employees is represented by a labor union and, in general, we consider our relationship with our employees to be good.
Employees As of December 31, 2025, we had 221 employees, among which 215 employees were full-time employees and 6 employees were temporary employees. None of our employees is represented by a labor union and, in general, we consider our relationship with our employees to be good.
For the year ended December 31, 2024, the purchases of raw material purchases from its three top suppliers accounted for 22.9%, 21.3%, and 14.6%, respectively.
For the year ended December 31, 2025, the purchases of raw material purchases from its three top suppliers accounted for 26.6%, 26.3%, and 9.6%, respectively.
A pharmaceutical manufacturer must obtain a pharmaceutical manufacturing permit from the NMPA’s relevant provincial branch. This permit is valid for five years and is renewable for an additional five-year period upon its expiration. Our current pharmaceutical manufacturing permit, issued by the NMPA, will expire on November 8, 2025. We are confident the permit could be renewed before its expiration.
A pharmaceutical manufacturer must obtain a pharmaceutical manufacturing permit from the NMPA’s relevant provincial branch. This permit is valid for five years and is renewable for an additional five-year period upon its expiration. Our current pharmaceutical manufacturing permit, issued by the NMPA, will expire on June 8, 2030.
Based on the technology transfer agreement, Helpson will receive the utility model patent right of the technical invention and the patent application right of the invention, and Bonier will provide relevant technical services.
Based on the technology transfer agreement, Helpson will receive patent right of the invention, and Xiaoyan Zhang will provide relevant technical services.
The NMPA enforces lifecycle oversight to ensure safety and efficacy, with consistency evaluations enhancing generic substitutability for originals, offering affordable, high-quality options. Generics account for approximately 77.8% of drug sales, vital for chronic and common disease treatment. In the first half of 2024, 875 product specifications passed consistency evaluations, with injectables comprising 47.9%, covering 387 unique drug varieties.
The NMPA enforces lifecycle oversight to ensure safety and efficacy, with consistency evaluations enhancing generic substitutability for originals, offering affordable, high-quality options. Generics account for approximately 77.8% of drug sales, vital for chronic and common disease treatment. In 2025, 16,652 product specifications passed consistency evaluations, with injectables comprising 39.69%, covering 6,610 drug varieties.
By 2050, with over 30% of China’s population elderly, demand for premium healthcare products and services will likely sustain stable industry growth. 3 Intercompany activities between the holding company and our subsidiaries As of the date of this report, none of our subsidiaries has distributed any dividends to China Pharma, nor has China Pharma distributed any dividends to the investors.
By 2050, when the elderly population will account for more than 30% of China’s total population, demand for premium healthcare products and services is expected to support steady growth of the pharmaceutical industry. 3 Intercompany activities between the holding company and our subsidiaries As of the date of this report, none of our subsidiaries has distributed any dividends to China Pharma, nor has China Pharma distributed any dividends to the investors.
Professor Chen Youhua of Nanjing University notes that pension coverage has driven the retiree proportion from 9.26% in 2010 to 15.8% in 2020, projected to exceed 23% by 2030.
Professor Chen Youhua of Nanjing University noted that the expanded coverage of pension insurance has raised the proportion of retirees from 9.26% in 2010 to 15.8% in 2020, and it is projected to exceed 23% by 2030.
Our corporate organizational chart is set forth below. 2 Industry Background and Market Opportunities China’s pharmaceutical industry is heavily policy-driven. Policies like the generic drug consistency evaluation and centralized volume-based procurement (CP) significantly shape the market.
Our corporate organizational chart is set forth below. 2 Industry Background and Market Opportunities China’s pharmaceutical industry is highly policy-driven, with policies such as generic drug consistency evaluation and centralized volume-based procurement (CP) exerting a significant impact on the market landscape.
Prior to December 1, 2019, if a manufacturer meets the GMP standards, the NMPA will issue to the manufacturer a Good Manufacturing Practice certificate, or a GMP certificate, with a five-year validity period. However, for a newly-established pharmaceutical manufacturer that meets the GMP standards, the NMPA will issue a GMP certificate with only a one-year validity period.
However, for a newly established pharmaceutical manufacturer that meets the GMP standards, the NMPA will issue a GMP certificate with only a one-year validity period.
On December 29, 2022, the Consolidated Appropriations Act, 2023 (the “CAA”), which the AHFCAA forms a part, was signed into law, and it officially reduced the number of consecutive non-inspection years required for triggering the prohibitions under the HFCAA from three years to two, thus, would reduce the time before an applicable issuer’s securities may be prohibited from trading or delisted.
Senate passed the Accelerating Holding Foreign Companies Accountable Act, or AHFCAA, and on December 29, 2022, the Consolidated Appropriations Act, 2023 (the “CAA”), which the AHFCAA forms a part, was signed into law, and it officially reduced the number of consecutive non-inspection years required for triggering the prohibitions under the HFCAA from three years to two.
With China’s per capita GDP exceeding US$12,700 in 2023, consumption structure upgrade, and the establishment of a high-quality health care system has become one of the most important tasks. We currently manufacture a number of off-patent branded generic drugs.
We believe we are well-positioned in a comparatively steadily growing industry in one of the fastest-growing economies in the world. With continuing growth of China’s per capita GDP, and consumption structure upgrade, the establishment of a high-quality health care system has become one of the most important tasks. We currently manufacture a number of off-patent branded generic drugs.
China has entered a post epidemic era with the end of the dynamic zero-COVID policy since December 2022, and the burden of being protected from the COVID and other epidemics has fallen on each individual, which we believe will boost the sales of Helpson’s products.
In addition, we continue to explore comprehensive healthcare market after the launch of Noni enzymes in 2018. China has entered a post epidemic era with the end of the dynamic zero-COVID policy since December 2022, and the burden of being protected from the COVID and other epidemics has fallen on each individual.
Should the PCAOB again encounter impediments to inspections and investigations in mainland China or Hong Kong as a result of positions taken by any authority in either jurisdiction, including by the CSRC or the MOF, the PCAOB will make determinations under the HFCAA as and when appropriate.
Although currently the PCAOB is able to secure complete access for the inspection and investigation of accounting firms headquartered in mainland China and Hong Kong, due to the previous history that the PAOCB was at one time not able to do so, should the PCAOB again encounter impediments to inspections and investigations in mainland China or Hong Kong as a result of positions taken by any authority in either jurisdiction, including by the CSRC or the MOF, the PCAOB will make determinations under the HFCAA as and when appropriate.
An inability to obtain, or the incurrence of substantial costs in obtaining, such permits, authorizations and approvals may have a material adverse effect on our business, financial condition and results of operations. 5 CSRC Filing Requirements and Cybersecurity Review As China Pharma is already publicly listed in the U.S., the Trial Measures (as defined below) do not impose additional regulatory burden on us beyond the obligation to report to the CSRC any future offerings of our securities, or material events such as a change of control or delisting.
As the Company is already publicly listed in the U.S., the Trial Measures (as defined below) do not impose additional regulatory burden on us beyond the obligation to report to the CSRC any future offerings of our securities, or material events such as a change of control or delisting.
We believe that GMP inspection only switches to another form, which includes flight inspection, drug production license inspection (for on-site management and quality system), as well as product inspection. 18 Product Liability and Consumers Protection Product liability claims may arise if any of our pharmaceutical products have a harmful effect on a consumer, who may make a claim for damages or compensation as an injured party.
Product Liability and Consumers Protection Product liability claims may arise if any of our pharmaceutical products have a harmful effect on any consumer who may make a claim for damages or compensation as an injured party.
With 1.334 billion people enrolled in basic medical insurance (95% coverage) by 2023, personal health expenditures remain low (27.7% of total health costs in 2020, expected to hold near 27% by 2025), shifting the burden to government and social funds. This pressures the medical insurance system, with fewer premium payers supporting more beneficiaries, exacerbating fund imbalances.
By the end of 2025, the number of people covered by basic medical insurance in China reached 1.33 billion, with a coverage rate stable at 95%. The share of personal health expenditure remains low (27.7% of total health costs in 2020, expected to remain around 27% by 2025), shifting more of the healthcare burden to government and social funds.
Good Manufacturing Practice. A pharmaceutical manufacturer must meet the Good Manufacturing Practice standards, or GMP standards, for each of its production facilities in China in respect of each form of pharmaceutical product it produces. GMP standards include staff qualifications, production premises and facilities, equipment, raw materials, environmental hygiene, production management, quality control and customer complaint administration.
GMP standards include staff qualifications, production premises and facilities, equipment, raw materials, environmental hygiene, production management, quality control and customer complaint administration. Prior to December 1, 2019, if a manufacturer meets the GMP standards, the NMPA will issue to the manufacturer a Good Manufacturing Practice certificate, or a GMP certificate, with a five-year validity period.
We are passionate about protecting human health, and we always adhere to the highest standards of ethics and integrity to fulfill our firm commitment to our customers and patients. 6 We believe we are well-positioned in a comparatively steadily growing industry in one of the fastest-growing economies in the world.
Our Strategy We believe that the pursuit of innovation is imperative for providing the basic medical solutions needed by the majority of patients. We are passionate about protecting human health, and we always adhere to the highest standards of ethics and integrity to fulfill our firm commitment to our customers and patients.
In 2024’s first 11 months, it recorded RMB 3.11 trillion (approximately $434 billion) in revenue and RMB 2.63 trillion (approximately $367 billion) in expenditure, with a RMB 3.86 trillion (approximately $539 billion) cumulative balance.
In the first 11 months of 2025, the medical insurance fund recorded revenue of approximately RMB 2.7 trillion (approximately $380 billion), expenditure of approximately RMB 2.2 trillion (approximately $310 billion), and a cumulative balance of approximately RMB 4.1 trillion (approximately $58 billion).
An aging population and rising healthcare demand fuel industry growth, tempered by medical insurance cost controls. In 2024, China’s population aged 60 and above reached 310.31 million (22.0% of the total), up from 296.97 million (21.1%) in 2023.
By the end of 2025, China’s population aged 60 and above reached 323.38 million, accounting for 23.0% of the total population, a further rise from 310.31 million (22.0%) in 2024.
This has favored specialized and oncology drugs over adjuvant therapies, pushing generic manufacturers to innovate. In 2024’s first 11 months, the basic medical insurance fund recorded RMB 3.11 trillion (approximately $434 billion) in revenue and RMB 2.63 trillion (approximately $367 billion) in expenditure, with a cumulative balance of RMB 3.86 trillion (approximately $539 billion).
The centralized procurement policy has favored specialized and oncology drugs while squeezing out adjuvant therapies, forcing generic drug manufacturers to transition toward innovation. In 2025, the total revenue of China’s basic medical insurance fund (including maternity insurance) reached RMB 3.59 trillion (approximately USD 499 billion), with total expenditure of RMB 3.00 trillion (approximately USD 417 billion).
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Unlike Western markets, China’s pharmaceutical sector features numerous small-scale manufacturers, low industry concentration, and intense competition over homogeneous products. As of August 2024, there were 9,679 pharmaceutical firms, up 267 from year-end 2023. Recent healthcare reforms promote consolidation, but the longstanding issue of fragmentation persists.
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Unlike Western markets, China’s pharmaceutical sector features a large number of small and medium-sized manufacturers, low industrial concentration, and fierce competition over homogeneous products. Although recent healthcare reform policies have promoted industrial consolidation, the long-standing problem of industry fragmentation remains prominent. Population aging and rising healthcare demand have driven industrial development, while growth is constrained by medical insurance cost-control policies.
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The National Healthcare Security Administration (NHSA) has expanded CP nationwide, slashing drug prices to secure bids. Since 2018, ten batches of national drug procurement have occurred, with the tenth batch in October 2024 covering 62 products and 263 specifications (e.g., cardiovascular, anti-infection drugs). The NHSA plans an eleventh batch in 2025, targeting 700 varieties.
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This has put pressure on the medical insurance system, as the number of premium payers shrinks relative to the growing beneficiary population, further exacerbating fund imbalances. The National Healthcare Security Administration (NHSA) has expanded the scope of centralized volume-based procurement nationwide, securing winning bids through sharp reductions in drug prices.
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See “Risk Factor - We are not required to submit an application to CSRC pursuant to the M&A Rules, nor are we subject to the cybersecurity review.
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Since 2018, eleven batches of national drug procurement have been conducted: the eleventh batch opened for bidding on October 27, 2025, with results announced on November 7, 2025, incorporating 55 drugs and 1,182 consistency-evaluated products. In total, 453 products were selected, with a selection rate of 57%, covering therapeutic areas including anti-infection, oncology, diabetes, and cardiovascular diseases.
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However, based on the recent promulgation of the Trial Measures, which became effective on March 31, 2023, we may be required to complete the filing requirements when we have re-financing or any additional offerings in future” for more details.
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Data from the Medical Logistics and Supply Chain Branch of China Federation of Logistics & Purchasing shows that the scale of China’s entire TCM industrial chain reached RMB 1.05 trillion (approximately USD 146 billion) in 2024, a year-on-year increase of 11.6%, and is expected to exceed RMB 1.13 trillion (approximately USD 157 billion) in 2025.
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The PRC’s Medical Insurance System Since its inception, the NHSA has adjusted the drug catalog annually, adding 835 drugs (530 via negotiation, 38 via bidding) and removing 438 outdated or replaceable ones. By October 2024, negotiated drug payments exceeded RMB 350 billion (approximately $49 billion), aiding 830 million patients.
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An inability to obtain, or the incurrence of substantial costs in obtaining, such permits, authorizations and approvals may have a material adverse effect on our business, financial condition and results of operations. 5 CSRC Filing Requirements and Cybersecurity Review On February 17, 2023, the China Securities Regulatory Commission (“CSRC”) promulgated the Provisional Measures on the Administration of Overseas Securities Offering and Listing by Domestic Companies (“Provisional Measures”), effective March 31, 2023.
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The 2024 catalog, effective January 1, 2025, added 91 drugs (89 negotiated/bid, 2 CP-selected) and removed 43, totaling 3,159 drugs, reducing patient costs by over RMB 50 billion (approximately $7 billion) in 2025. Cost control drives policy. The medical insurance fund, covering ~40% of healthcare costs, dictates industry cash flow.
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Under these Provisional Measures, Chinese entities must comply with state security regulations and not divulge state secrets. The overseas issuers shall appoint a responsible entity in China to make filings. The relevant Chinese entity shall file with CSRC within three business days of completing any issuance of new securities overseas.
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The tenth CP batch (December 2024) procured 62 drugs, with 385 products from 234 firms selected, covering 435 drugs across 10 batches, creating RMB 500 billion (approximately $70 billion) in fund space for new drugs and technologies. Our Strategy We believe that the pursuit of innovation is imperative for providing the basic medical solutions needed by the majority of patients.
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See “Risk Factor - The approval, filing or other requirements of the China Securities Regulatory Commission or other PRC regulatory authorities will be required under PRC law in connection with any future issuance of securities overseas, and, if required, we cannot predict whether or for how long we will be able to obtain such approval or complete such filing” for more details.
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In addition, we continue to explore comprehensive healthcare market after the launch of Noni enzymes in 2018.
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The PRC’s Medical Insurance System Since its establishment, the National Healthcare Security Administration (NHSA) has adjusted the drug catalog for 8 consecutive years, with a total of 949 new drugs added (including 635 via negotiation, 45 via bidding, and 269 via direct inclusion) and 467 drugs removed that were proven ineffective, prone to abuse, or obsolete.
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Helpson’s production lines are subject to pilot inspections under the New Law.
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As of October 2025, the cumulative payment for negotiated drugs within the agreement period by the medical insurance fund has exceeded RMB 460 billion (approximately $65 billion), benefiting over 1 billion patient visits.
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Senate passed the Accelerating Holding Foreign Companies Accountable Act, or AHFCAA, which proposes to reduce the period of time for foreign companies to comply with PCAOB audits from three to two consecutive years, thus reducing the time period before the securities of such foreign companies may be prohibited from trading or delisted.
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The 2025 catalog has taken effect on January 1, 2026, with 114 new drugs added (105 via negotiation, 7 via bidding, and 2 via centralized procurement) and 29 drugs removed that are clinically replaceable or have been out of supply for a long time.
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On December 16, 2021, the PCAOB issued a report to notify the SEC its determinations that it is unable to inspect or investigate completely registered public accounting firms headquartered in China and Hong Kong, respectively, and identifies the registered public accounting firms in China and Hong Kong that are subject to such determinations.
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After the adjustment, the total number of drugs in the catalog will increase to 3,253, and it is expected to reduce patient costs by more than RMB 60 billion (approximately $8.5 billion). 6 Cost control is the core driver of policy. The medical insurance fund, which covers approximately 40% of healthcare costs, has a profound impact on industry cash flow.
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Our auditor, B F Borgers CPA PC, is headquartered in Denver, Colorado and has been inspected by the PCAOB on a regular basis, with the last inspection year being 2023, and is therefore not subject to the determinations announced by the PCAOB on December 16, 2021.
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The 11th batch of national centralized procurement (October 2025) procured 55 drugs, involving 453 products from 272 enterprises, covering a total of 490 drugs across 11 batches, freeing up approximately RMB 550 billion (approximately $78 billion) in medical insurance fund space for new drugs and technologies.
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On August 26, 2022, the PCAOB announced and signed a Statement of Protocol (the “Protocol”) with the China Securities Regulatory Commission and the Ministry of Finance of the People’s Republic of China.
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Based on the technology transfer agreement, Helpson will receive the utility model patent right of the technical invention and the patent application right of the invention, and Bonier will provide relevant technical services. 15 In 2023, Helpson, our wholly owned subsidiary, acquired an invention patent of medicine composition for treating the chronic obstructive pulmonary disease from Tao Liu.
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Based on the technology transfer agreement, Helpson will receive the patent right of the invention, and Tao Liu will provide relevant technical services. In 2024, Helpson, our wholly owned subsidiary, acquired an invention patent of a pharmaceutical composition for treatment of psoriasis disease from Lihua Li.
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Based on the technology transfer agreement, Helpson will receive the patent right of the invention, and Lihua Li will provide relevant technical services. In 2024, Helpson, our wholly owned subsidiary, acquired an invention patent of an Apst solid dispersion and preparation method thereof (psoriatic arthritis and moderate to severe plaque psoriasis) from Li Yong.
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Based on the technology transfer agreement, Helpson will receive the patent right of the invention, and Li Yong will provide relevant technical services. In 2024, Helpson, our wholly owned subsidiary, acquired an invention patent of a riboflavin stomach floating tablet and a preparation method from Zhao Xijun.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

95 edited+23 added8 removed250 unchanged
Biggest changeHowever, in the event the 2021 Negative List is amended in the future to include any of the business Helpson is operating, our ownership structure could be subject to change to the extent our structure is not given any “grandfather” protection. 39 Because we receive substantially all of our revenue in Renminbi, which currently is not a freely convertible currency, and the PRC government controls the currency conversion and the fluctuation of the Renminbi, we are subject to changes in the PRC’s political and economic decisions.
Biggest changeBecause we receive substantially all of our revenue in Renminbi, which currently is not a freely convertible currency, and the PRC government controls the currency conversion and the fluctuation of the Renminbi, we are subject to changes in the PRC’s political and economic decisions. We receive substantially all of our revenues in Renminbi, which currently is not a freely-convertible currency.
Risks Related to our Business and our Industry Our products’ commercial success depends on market acceptance among the medical community; low acceptance would adversely affect operations and profitability Failure to meet Drug Administration Law standards could lead to production line suspensions, adversely affecting operations and profitability Product cessations or recalls initiated by us or the NMPA could impose significant costs and affect our revenue generation Failure to develop high-profit-margin products while existing high-margin products face competition could adversely affect our gross and net profit margins Our products face substantial competition; competitors may develop, acquire or commercialize products earlier or more successfully Most of our products are off-patent branded generics that can be manufactured and sold by other pharmaceutical manufacturers, increasing competition and reducing profitability Our business depends on our Helpson brand name; failure to maintain and enhance brand recognition could harm our reputation, business and operating results Lack of reimbursement for our products could diminish sales or affect our ability to sell profitably Our growth and success depend on successfully marketing our principal products to hospitals and their selection in tender processes Our future research and development projects may not be successful for various reasons including regulatory approvals We cooperate with research institutions and universities for R&D; any failure in these collaborations could adversely affect our business Regulatory approval for new products is uncertain; failure to obtain approvals could materially harm our business New product development is time-consuming, costly and has a low rate of successful commercialization We may not be able to successfully identify and acquire new products or businesses We rely on distributors for all revenues; failure to maintain these relationships would materially affect our business We rely on a limited number of distributors for the majority of sales Our operations may be affected if we cannot pass the Consistency Evaluation requirement for our existing products Our operations may be affected if we cannot obtain raw materials from current key suppliers on acceptable terms We may not be able to effectively manage our employees and distribution network, affecting our reputation, business, and brand We have limited insurance coverage and may incur losses from product liability claims, business interruptions, or claims covered by D&O Insurance Our future liquidity needs are uncertain and we may need to raise additional funds Failure to manage growth effectively could adversely affect our business, financial condition and results We depend on key employees and consultants in a competitive market; inability to attract and retain key personnel could affect our ability to develop and market products 21 Power shortages, natural disasters, terrorist acts or other calamities could disrupt production and have a material adverse effect We cannot guarantee protection of our intellectual property rights; infringement or counterfeiting of our IP could affect our reputation and business Risks Related to Doing Business in China Adverse changes in political and economic policies of the PRC government could affect economic growth and our competitive position The Chinese government may intervene with or influence our business at any time, negatively affecting our operations, listing status, and share value The PRC legal system has inherent uncertainties that could limit legal protections available to us You may experience difficulties in effecting service of legal process, enforcing foreign judgments or bringing original actions in the PRC As a Foreign Invested Company in China, Helpson’s ownership structure may be impacted by foreign investment regulations Receiving substantially all revenue in Renminbi, which is not freely convertible, subjects us to changes in the PRC’s political and economic decisions We are subject to PRC environmental protection laws that may be costly to comply with and may affect manufacturing operations Failure to comply with PRC regulations regarding employee equity incentive plans may subject our PRC employees or us to fines and sanctions U.S. regulatory bodies may be limited in conducting investigations or inspections of our operations in China PRC regulation of loans to and direct investment in PRC entities by offshore holding companies may delay use of offering proceeds Complying with evolving cybersecurity, information security, privacy and data protection laws may be expensive and force adverse business changes The Holding Foreign Companies Accountable Act and related regulations could pose regulatory risks and restrictions PRC regulations on offshore special purpose companies by PRC residents may subject our PRC resident owners or our PRC subsidiary to liability Our ability to distribute dividends largely depends on dividends from our PRC operating entity, which may be limited by PRC laws Dividends payable to foreign investors and gain on sale of our shares may become subject to PRC taxes We face uncertainty regarding indirect transfers of equity interests in PRC resident enterprises by non-PRC holding companies The market price for our common stock may be volatile, potentially resulting in complete investment loss We may issue additional shares of capital stock to raise cash, diluting existing stockholders’ percentage ownership We are likely to remain subject to “penny stock” regulations with additional sales practice requirements and SEC warnings We are responsible for indemnifying officers and directors under certain circumstances, potentially resulting in substantial unrecoverable expenditures We have identified material weaknesses in internal control over financial reporting, affecting reliable reporting and investor confidence There is substantial doubt about our ability to continue as a going concern We do not anticipate paying cash dividends on our common stock 22 Risks Related to our Business and our Industry The commercial success of our products depends upon the degree of their market acceptance among the medical community.
Risks Related to our Business and our Industry Our products’ commercial success depends on market acceptance among the medical community; low acceptance would adversely affect operations and profitability Failure to meet Drug Administration Law standards could lead to production line suspensions, adversely affecting operations and profitability Product cessations or recalls initiated by us or the NMPA could impose significant costs and affect our revenue generation Failure to develop high-profit-margin products while existing high-margin products face competition could adversely affect our gross and net profit margins Our products face substantial competition; competitors may develop, acquire or commercialize products earlier or more successfully Most of our products are off-patent branded generics that can be manufactured and sold by other pharmaceutical manufacturers, increasing competition and reducing profitability Our business depends on our Helpson brand name; failure to maintain and enhance brand recognition could harm our reputation, business and operating results Lack of reimbursement for our products could diminish sales or affect our ability to sell profitably Our growth and success depend on successfully marketing our principal products to hospitals and their selection in tender processes Our future research and development projects may not be successful for various reasons including regulatory approvals We cooperate with research institutions and universities for R&D; any failure in these collaborations could adversely affect our business Regulatory approval for new products is uncertain; failure to obtain approvals could materially harm our business New product development is time-consuming, costly and has a low rate of successful commercialization We may not be able to successfully identify and acquire new products or businesses We rely on distributors for all revenues; failure to maintain these relationships would materially affect our business We rely on a limited number of distributors for the majority of sales Our operations may be affected if we cannot pass the Consistency Evaluation requirement for our existing products Our operations may be affected if we cannot obtain raw materials from current key suppliers on acceptable terms We may not be able to effectively manage our employees and distribution network, affecting our reputation, business, and brand We have limited insurance coverage and may incur losses from product liability claims, business interruptions, or claims covered by D&O Insurance Our future liquidity needs are uncertain and we may need to raise additional funds Failure to manage growth effectively could adversely affect our business, financial condition and results 21 We depend on key employees and consultants in a competitive market; inability to attract and retain key personnel could affect our ability to develop and market products Power shortages, natural disasters, terrorist acts or other calamities could disrupt production and have a material adverse effect We cannot guarantee protection of our intellectual property rights; infringement or counterfeiting of our IP could affect our reputation and business Risks Related to Doing Business in China Adverse changes in political and economic policies of the PRC government could affect economic growth and our competitive position The Chinese government may intervene with or influence our business at any time, negatively affecting our operations, listing status, and share value The PRC legal system has inherent uncertainties that could limit legal protections available to us You may experience difficulties in effecting service of legal process, enforcing foreign judgments or bringing original actions in the PRC As a Foreign Invested Company in China, Helpson’s ownership structure may be impacted by foreign investment regulations Receiving substantially all revenue in Renminbi, which is not freely convertible, subjects us to changes in the PRC’s political and economic decisions We are subject to PRC environmental protection laws that may be costly to comply with and may affect manufacturing operations Failure to comply with PRC regulations regarding employee equity incentive plans may subject our PRC employees or us to fines and sanctions U.S. regulatory bodies may be limited in conducting investigations or inspections of our operations in China PRC regulation of loans to and direct investment in PRC entities by offshore holding companies may delay use of offering proceeds Complying with evolving cybersecurity, information security, privacy and data protection laws may be expensive and force adverse business changes The Holding Foreign Companies Accountable Act and related regulations could pose regulatory risks and restrictions PRC regulations on offshore special purpose companies by PRC residents may subject our PRC resident owners or our PRC subsidiary to liability Our ability to distribute dividends largely depends on dividends from our PRC operating entity, which may be limited by PRC laws Dividends payable to foreign investors and gain on sale of our shares may become subject to PRC taxes We face uncertainty regarding indirect transfers of equity interests in PRC resident enterprises by non-PRC holding companies The market price for our common stock may be volatile, potentially resulting in complete investment loss We may issue additional shares of capital stock to raise cash, diluting existing stockholders’ percentage ownership We are likely to remain subject to “penny stock” regulations with additional sales practice requirements and SEC warnings We are responsible for indemnifying officers and directors under certain circumstances, potentially resulting in substantial unrecoverable expenditures We have identified material weaknesses in internal control over financial reporting, affecting reliable reporting and investor confidence There is substantial doubt about our ability to continue as a going concern We do not anticipate paying cash dividends on our common stock 22 Risks Related to our Business and our Industry The commercial success of our products depends upon the degree of their market acceptance among the medical community.
In particular, our products are subject to, among other statutes and regulations, those issued by the NMPA. If the NMPA issues any notices to cease the production, sale and use of any of our products, or request Helpson to recall any of our products we sold, we must comply with such requirements.
In particular, our products are subject to, among other statutes and regulations, those issued by the NMPA. If the NMPA issues any notices to cease production, sale and use of any of our products, or request Helpson to recall any of our products we sold, we must comply with such requirements.
Our competitors may obtain approval for a competitive product before our product we are developing is approved. If this occurs, we may be precluded from getting approval until the competitor’s monitoring period expires and realize little to no benefit from our research and development investment.
Our competitors may obtain approval for a competitive product before the product we are developing is approved. If this occurs, we may be precluded from getting approval until the competitor’s monitoring period expires and realize little to no benefit from our research and development investment.
In the event certain distributors choose not to continue their relationship with us after completing their existing sales agreements, they can do so without breaching any contract or agreement, our financial results could be adversely affected if we cannot find the substantially similar distributors in time under such circumstances.
In the event certain distributors choose not to continue their relationship with us after completing their existing sales agreements, they can do so without breaching any contract or agreement, our financial results could be adversely affected if we cannot find substantially similar distributors in time under such circumstances.
Aside from the increased difficulties and increased costs in the management of human resources, we may also encounter working capital issues, as we need increased liquidity to finance the purchases of raw materials and supplies, drug formulas for new products, investment in research and development, acquisition of new businesses and technologies.
Aside from the increased difficulties and increased costs in the management of human resources, we may also encounter working capital issues, as we need increased liquidity to finance the purchases of raw materials and supplies, drug formulas for new products, investment in research and development, and acquisition of new businesses and technologies.
Onny acquired 100% of the ownership in Helpson on May 25, 2005, by entering into an Equity Transfer Agreement with Helpson’s three former shareholders. The transaction was approved by the Commercial Bureau of Hainan Province on June 12, 2005 and Helpson received the Certificate of Approval for Establishment of Enterprises with Foreign Investment in the PRC on the same day.
Onny acquired 100% of the ownership of Helpson on May 25, 2005, by entering into an Equity Transfer Agreement with Helpson’s three former shareholders. The transaction was approved by the Commercial Bureau of Hainan Province on June 12, 2005, and Helpson received the Certificate of Approval for Establishment of Enterprises with Foreign Investment in the PRC on the same day.
Moreover, the Anti-Monopoly Law requires that transactions which involve the national security, the examination on the national security shall also be conducted according to the relevant provisions of the State.
Moreover, the Anti-Monopoly Law requires that transactions which involve national security, the examination on national security shall also be conducted according to the relevant provisions of the State.
Any disclosure of documents or information located in China by foreign agencies may be subject to jurisdiction constraints and must comply with China’s state secrecy laws, which broadly define the scope of “state secrets” to include matters involving economic interests and technologies.
Any disclosure of documents or information located in China by foreign agencies may be subject to jurisdiction constraints and must comply with China’s state secrecy laws, which broadly define the scope of “state secrets” to include matters involving economic interests and technologies.
The market price for our common stock is highly volatile and subject to wide fluctuations in response to factors including the following: actual or anticipated fluctuations in our quarterly operating results; announcements of new products by us or our competitors; changes in financial estimates by securities analysts; conditions in the pharmaceutical market; changes in the economic performance or market valuations of other companies involved in pharmaceutical production; 50 announcements by our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; economic, regulatory and political developments; addition or departure of key personnel, or potential litigation.
The market price for our common stock is highly volatile and subject to wide fluctuations in response to factors including the following: actual or anticipated fluctuations in our quarterly operating results; announcements of new products by us or our competitors; changes in financial estimates by securities analysts; conditions in the pharmaceutical market; changes in the economic performance or market valuations of other companies involved in pharmaceutical production; announcements by our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; economic, regulatory and political developments; addition or departure of key personnel, or potential litigation.
Our bylaws provide for the indemnification of our directors, officers, employees, and agents, under certain circumstances, against attorney’s fees and other expenses incurred by them in any litigation to which they become a party arising from their association with or activities on behalf of us. This indemnification policy could result in substantial expenditures, which we may be unable to recoup.
Our bylaws provide for the indemnification of our directors, officers, employees, and agents, under certain circumstances, against attorney’s fees and other expenses incurred by them in any litigation to which they become a party arising from their association with our activities on behalf of us. This indemnification policy could result in substantial expenditures, which we may be unable to recoup.
If we fail to complete the consistency evaluations for our generic drugs per the government’s requirements, our business and operation will be negatively impacted. 30 Our operations may be affected if we could not obtain raw materials from our current key suppliers on acceptable terms. We need a supply of a wide variety of raw materials to manufacture our products.
If we fail to complete the consistency evaluations for our generic drugs per the government’s requirements, our business and operation will be negatively impacted. Our operations may be affected if we could not obtain raw materials from our current key suppliers on acceptable terms. We need a supply of a wide variety of raw materials to manufacture our products.
Alliances may develop among competitors, and these alliances may rapidly acquire significant market share. 24 Furthermore, in order to gain market share in China, competitors may significantly increase their advertising expenditures and promotional activities or even engage in irrational or predatory pricing behavior. In addition, our competitors may engage in inappropriate competition or illegal acts, such as bribery.
Alliances may develop among competitors, and these alliances may rapidly acquire significant market share. Furthermore, in order to gain market share in China, competitors may significantly increase their advertising expenditures and promotional activities or even engage in irrational or predatory pricing behavior. In addition, our competitors may engage in inappropriate competition or illegal acts, such as bribery.
Our inability to enter into such agreements or our failure to maintain such arrangements could limit the number of new products that we develop and ultimately decrease our sources of future revenue. 27 We may not be able to obtain regulatory approval for any of the new products and failure to obtain these approvals could materially harm our business.
Our inability to enter into such agreements or our failure to maintain such arrangements could limit the number of new products that we develop and ultimately decrease our sources of future revenue. We may not be able to obtain regulatory approval for any of the new products and failure to obtain these approvals could materially harm our business.
Any disruption of our distribution network, including our failure to renew our existing distribution agreements with our desired distributors, could negatively affect our ability to effectively sell our products and would materially and adversely affect our business, financial condition and results of operations. 29 We rely on a limited number of distributors for the majority of sales of our products .
Any disruption of our distribution network, including our failure to renew our existing distribution agreements with our desired distributors, could negatively affect our ability to effectively sell our products and would materially and adversely affect our business, financial condition and results of operations. We rely on a limited number of distributors for the majority of sales of our products .
If any of our large distributors reduces the quantity of the products they purchase from us or stops purchasing from us, our net revenue would be materially and adversely affected. Our operations may be affected if we could not pass the Consistency Evaluation requirement issued by the State Council for any of our current existing products.
If any of our large distributors reduces the quantity of the products they purchase from us or stops purchasing from us, our net revenue would be materially and adversely affected. 27 Our operations may be affected if we could not pass the Consistency Evaluation requirement issued by the State Council for any of our current existing products.
If the PCAOB is unable to inspect the Company’s auditors for three consecutive years, the issuer’s securities are prohibited to trade on a national securities exchange or in the over the counter trading market in the U.S. On December 18, 2020, the HFCAA was signed into law. 46 On June 22, 2021, the U.S.
If the PCAOB is unable to inspect the Company’s auditors for three consecutive years, the issuer’s securities are prohibited to trade on a national securities exchange or in the over-the-counter trading market in the U.S. On December 18, 2020, the HFCAA was signed into law. On June 22, 2021, the U.S.
Furthermore, an original action may be brought in the PRC against us, our directors, executive officers or managers only if the actions are not required to be arbitrated by PRC law under Helpson’s articles of association, and only if the facts alleged in the complaint give rise to a cause of action under PRC law.
Furthermore, an original action may be brought in the PRC against us, our directors, executive officers or managers only if the actions are not required to be arbitrated by PRC law under Helpson’s articles of association, and only if the facts alleged in the complaint give rise to the cause of action under PRC law.
The approval, filing or other requirements of the China Securities Regulatory Commission or other PRC regulatory authorities may be required under PRC law in connection with any future issuance of securities overseas, 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, filing or other requirements of the China Securities Regulatory Commission or other PRC regulatory authorities will be required under PRC law in connection with any future issuance of securities overseas, and, if required, we cannot predict whether or for how long we will be able to obtain such approval or complete such filing.
Such lawsuits may divert the attention of our management from our business strategies, may be costly to defend and may negatively impact our reputation and our Helpson brand’s reputation, and may harm the sales of our other branded products. In addition, product liability insurance for pharmaceutical products is not available in the PRC.
Such lawsuits may divert the attention of our management from our business strategies, may be costly to defend and may negatively impact on our reputation and our Helpson brand’s reputation, and may harm the sales of our other branded products. In addition, product liability insurance for pharmaceutical products is not available in the PRC.
Our failure to manage any of the above business administration may lead to operational and financial inefficiencies that will have a negative effect on our profitability. We depend upon key employees and consultants in a competitive market for skilled personnel.
Our failure to manage any of the above business administration may lead to operational and financial inefficiencies that will have a negative effect on our profitability. 30 We depend upon key employees and consultants in a competitive market for skilled personnel.
As a result, we may find it difficult to maintain the existing level of sales of our products, and our revenues and profitability may decline. 26 Our future research and development projects may not be successful. The successful development of pharmaceutical products can be influenced by many factors.
As a result, we may find it difficult to maintain the existing level of sales of our products, and our revenues and profitability may decline. Our future research and development projects may not be successful. The successful development of pharmaceutical products can be influenced by many factors.
In connection with any such original action, a PRC court may impose civil liability, including monetary damages. As a Foreign Invested Company in China, Helpson’s ownership structure may be impacted by the foreign investment regulation and its measures in China.
In connection with any such original action, a PRC court may impose civil liability, including monetary damages. 34 As a Foreign Invested Company in China, Helpson’s ownership structure may be impacted by the foreign investment regulation and its measures in China.
The PRC Data Security Law provides for data security and privacy obligations on entities and individuals carrying out data processing activities, introduces a data classification and hierarchical protection system based on the importance of data, and imposes export restrictions on certain data and information.
The PRC Data Security Law provides data security and privacy obligations on entities and individuals carrying out data processing activities, introduces a data classification and hierarchical protection system based on the importance of data, and imposes export restrictions on certain data and information.
The Enterprise Income Tax Law of the PRC imposes a uniform enterprise income tax rate of 25% on all domestic enterprises, including foreign-invested enterprises unless they qualify for certain exceptions, and terminates most of the tax exemptions, reductions and preferential treatments available under previous tax laws and regulations. 47 Moreover, under the Enterprise Income Tax Law of the PRC, enterprises organized under the laws of jurisdictions outside China with their “de facto management bodies” located within China may be considered PRC resident enterprises and therefore subject to PRC enterprise income tax at the rate of 25% on their worldwide income.
The Enterprise Income Tax Law of the PRC imposes a uniform enterprise income tax rate of 25% on all domestic enterprises, including foreign-invested enterprises unless they qualify for certain exceptions, and terminates most of the tax exemptions, reductions and preferential treatments available under previous tax laws and regulations. 43 Moreover, under the Enterprise Income Tax Law of the PRC, enterprises organized under the laws of jurisdictions outside China with their “de facto management bodies” located within China may be considered PRC resident enterprises and therefore subject to PRC enterprise income tax at the rate of 25% on their worldwide income.
Furthermore, our sales and results of operations could be adversely affected if the Helpson brand or our reputation is impaired by recalls or negative publicity for one of our branded products, or certain actions taken by our distributors, competitors, third-party marketing firms or relevant regulatory authorities. 25 Reimbursement may not be available for our products, which could diminish our sales or affect our ability to sell our products profitably.
Furthermore, our sales and results of operations could be adversely affected if the Helpson brand or our reputation is impaired by recalls or negative publicity for one of our branded products, or certain actions taken by our distributors, competitors, third-party marketing firms or relevant regulatory authorities. 24 Reimbursement may not be available for our products, which could diminish our sales or affect our ability to sell our products profitably.
Both the transferor and the transferee may be subject to penalties under PRC tax laws if the transferee fails to withhold the taxes and the transferor fails to pay the taxes. 49 We face uncertainties as to the reporting and other implications of certain past and future transactions where PRC taxable assets are involved, such as offshore restructuring, sale of the shares in our offshore subsidiaries and investments.
Both the transferor and the transferee may be subject to penalties under PRC tax laws if the transferee fails to withhold the taxes and the transferor fails to pay the taxes. 45 We face uncertainties as to the reporting and other implications of certain past and future transactions where PRC taxable assets are involved, such as offshore restructuring, sale of the shares in our offshore subsidiaries and investments.
The Chinese economy differs from the economies of most developed countries in many respects, including: the degree of government involvement; the level of development; the growth rate; the control of foreign exchange; access to financing; and the allocation of resources. 36 While the Chinese economy has experienced significant growth in the past 30 years, growth has been uneven, both geographically and among various sectors of the economy.
The Chinese economy differs from the economies of most developed countries in many respects, including: the degree of government involvement; the level of development; the growth rate; the control of foreign exchange; access to financing; and the allocation of resources. 32 While the Chinese economy has experienced significant growth in the past 30 years, growth has been uneven, both geographically and among various sectors of the economy.
As an issuer listed before the effective date, we are not required to complete filing for prior offshore offerings. As of this annual report, we and our PRC operating entities have not been required to obtain permission from or complete filing with CSRC. However, our future capital raising activities may be subject to the filing requirement.
As an issuer listed before the effective date, we are not required to complete filing for prior offshore offerings. As of this annual report, we and our PRC operating entities have not been required to obtain permission from or complete filing with CSRC. However, our future capital raising activities will be subject to the filing requirement.
If the controlling shareholder or actual controller organizes the breach, they will be fined between RMB1 million and RMB10 million. 45 Restrictions contained in Chinese law on the ability of overseas securities regulators to collect information in China may deny investors in our Company the benefits of U.S. securities regulation.
If the controlling shareholder or actual controller organizes the breach, they will be fined between RMB1 million and RMB10 million. 41 Restrictions contained in Chinese law on the ability of overseas securities regulators to collect information in China may deny investors in our Company the benefits of U.S. securities regulation.
If our PRC operating entities failed to comply with such measures, they may face legal liability under the PRC Personal Information Protection Law, including fines of up to RMB50 million or 5% of annual revenues and may be ordered to suspend related activities or have business licenses revoked.
If our PRC operating entities fail to comply with such measures, they may face legal liability under the PRC Personal Information Protection Law, including fines of up to RMB50 million or 5% of annual revenues and may be ordered to suspend related activities or have business licenses revoked.
Our products compete with other products or treatments for diseases that treat similar medical conditions. Many of our products may compete against products that have lower prices, superior performance, greater ease of administration or other advantages. We would face enhanced competition if competitive products are added to the National Medical Insurance Program.
Our products compete with other products or treatments for diseases that treat similar medical conditions. Many of our products may compete against products that have lower prices, superior performance, greater ease of administration or other advantages. We would face enhanced competition if competitive products were added to the National Medical Insurance Program.
The Chinese government may intervene with or influence our operations at any time with little advance notice, which could result in a material change in our operations and in the value of our shares. 37 The PRC legal system has inherent uncertainties that could limit the legal protections available to us.
The Chinese government may intervene with or influence our operations at any time with little advance notice, which could result in a material change in our operations and in the value of our shares. 33 The PRC legal system has inherent uncertainties that could limit the legal protections available to us.
Although there is currently no claim against us, we may be subject to claims that these employees or consultants have, inadvertently or otherwise, used or disclosed trade secrets or other proprietary information of their former employers. It may be necessary to for us to litigate and defend against these claims.
Although there is currently no claim against us, we may be subject to claims that these employees or consultants have, inadvertently or otherwise, used or disclosed trade secrets or other proprietary information from their former employers. It may be necessary for us to litigate and defend against these claims.
The freeze-dried bird's nest and Buddha's hand rose products in the company's nutrition and health series have obtained food production licenses. They are currently undergoing market operation, and are planned to be launched this year and are expected to generate sales revenue. This will support the company's continuous operation.
The freeze-dried bird’s nest and Buddha’s hand rose products in the company’s nutrition and health series have obtained food production licenses. They are currently undergoing market operation and are planning to be launched this year and are expected to generate sales revenue. This will support the company’s continuous operation.
Our inability to compete effectively could reduce sales or margins, which could have a material adverse effect on our results of our operations. Some of our competitors are actively engaging in research and development in areas in which we have products or in which we are developing new product or new indications for existing products.
Our inability to compete effectively could reduce sales or margins, which could have a material adverse effect on the results of our operations. Some of our competitors are actively engaging in research and development in areas in which we have products or in which we are developing new products or new indications for existing products.
There is substantial doubt about our ability to continue as a going concern. Our auditors have indicated in their report on our financial statements for the years ended December 31, 2024 and 2023 that conditions exist that raise substantial doubt about our ability to continue as a going concern as discussed in Note 1 to the financial statements.
There is substantial doubt about our ability to continue as a going concern. Our auditors have indicated in their report on our financial statements for the years ended December 31, 2025 and 2024 that conditions exist that raise substantial doubt about our ability to continue as a going concern as discussed in Note 1 to the financial statements.
Even if a product is approved for commercial use by an appropriate governmental agency, there can be no assurance that users will not claim effects other than those intended resulted from the use of our products.
Even if a product is approved for commercial use by an appropriate governmental agency, there can be no assurance that users will not claim effects other than those intended resulting from the use of our products.
Therefore, the Company does not intend to have any dividend distribution in the future. 48 Dividends payable by us to our foreign investors and gain on the sale of our shares may become subject to taxes under PRC tax laws.
Therefore, the Company does not intend to have any dividend distribution in the future. 44 Dividends payable by us to our foreign investors and gain on the sale of our shares may become subject to taxes under PRC tax laws.
In the event we or any of our directors or officers are sued under any proceedings or actions that could be covered by a standard D&O insurance, we may incur substantial costs and expenses to defend such case. 32 Our future liquidity needs are uncertain and we may need to raise additional funds in the future.
In the event we or any of our directors or officers are sued under any proceedings or actions that could be covered by standard D&O insurance, we may incur substantial costs and expenses to defend such case. 29 Our future liquidity needs are uncertain and we may need to raise additional funds in the future.
If the Company fail to complete such registrations, our ability to use the proceeds of this offering and to capitalize our PRC operations may be negatively affected, which could adversely affect our liquidity and our ability to fund and expand our business. 42 On March 30, 2015, the SAFE promulgated the Circular on Reforming the Management Approach Regarding the Foreign Exchange Capital Settlement of Foreign-Invested Enterprises, or SAFE Circular 19, which took effect as of June 1, 2015.
If the Company fails to complete such registrations, our ability to use the proceeds of this offering and to capitalize our PRC operations may be negatively affected, which could adversely affect our liquidity and our ability to fund and expand our business. 37 On March 30, 2015, the SAFE promulgated the Circular on Reforming the Management Approach Regarding the Foreign Exchange Capital Settlement of Foreign-Invested Enterprises, or SAFE Circular 19, which took effect as of June 1, 2015.
As set forth in such report, our management has concluded that our internal controls over financial reporting were not effective as of December 31, 2023, and there existed a material weakness in our internal control over financial reporting as of December 31, 2023. 52 We are taking appropriate actions to internally training related personnel, such as Chief Financial Officer, to remediate such material weakness; however, such measures may not be sufficient to address the material weaknesses identified or ensure that our controls and procedures are effective.
As set forth in such report, our management has concluded that our internal controls over financial reporting were not effective as of December 31, 2025, and there existed a material weakness in our internal control over financial reporting as of December 31, 2025. 47 We are taking appropriate actions to internally training related personnel, such as Chief Financial Officer, to remediate such material weakness; however, such measures may not be sufficient to address the material weaknesses identified or ensure that our controls and procedures are effective.
The Company incurred recurring losses from operations, has net current liabilities and an accumulated deficit that raise substantial doubt about its ability to continue as a going concern.
The Company incurred recurring losses from operations, has net current liabilities and an accumulated deficit that raises substantial doubt about its ability to continue as a going concern.
Accordingly, investors must rely on sales of our common stock after price appreciation, which may never occur, as the only way to realize any return on their investment. 53
Accordingly, investors must rely on sales of our common stock after price appreciation, which may never occur, as the only way to realize any return on their investment. 48
Using product candidates in clinical trials also exposes us to product liability claims. These risks are greater for our products that receive regulatory approval for commercial sale.
Using product candidates in clinical trials also exposes us to product liability claims. These risks are greater for our products that receive regulatory approval for commercial sales.
As of the date of this annual report, Helpson plans to retain all the revenues and re-invest them into Helpson’s daily operation.
As of the date of this annual report, Helpson plans to retain all the revenues and re-invest them in Helpson’s daily operation.
In addition, business interruption insurance available in the PRC offers limited coverage compared to that offered in many other countries. We do not have any business interruption insurance. Any business disruption or natural disaster could result in substantial costs and diversion of resources. Lastly, we currently do not have directors and officers insurance.
In addition, business interruption insurance available in the PRC offers limited coverage compared to that offered in many other countries. We do not have any business interruption insurance. Any business disruption or natural disaster could result in substantial costs and diversion of resources. Lastly, we currently do not have directors’ and officers’ insurance.
We rely on a limited number of distributors for most of our net revenue. Our top five distributors in aggregate accounted for 24% and 22% of our net revenues in 2024 and 2023, respectively. We expect that a relatively small number of distributors will continue to account for a major portion of our net revenue in the near future.
We rely on a limited number of distributors for most of our net revenue. Our top five distributors in aggregate accounted for 23% and 24% of our net revenues in 2025 and 2024, respectively. We expect that a relatively small number of distributors will continue to account for a major portion of our net revenue in the near future.
We reported negative gross margins of -43.8% for the year ended December 31, 2024, a substantial deterioration from negative gross margins of -4.0% for the year ended December 31, 2023, indicating significant challenges in our cost structure and pricing environment.
We reported negative gross margins of -3.2% for the year ended December 31, 2025, a substantial deterioration from negative gross margins of -43.8.0% for the year ended December 31, 2024, indicating significant challenges in our cost structure and pricing environment.
Significant revaluation of the Renminbi may have a material adverse effect on your investment. For example, to the extent that we need to convert U.S. dollars we receive from securities offering into Renminbi for our operations, appreciation of the Renminbi against the U.S. dollar would have an adverse effect on the Renminbi amount we would receive from the conversion.
For example, to the extent that we need to convert U.S. dollars we receive from securities offering into Renminbi for our operations, appreciation of the Renminbi against the U.S. dollar would have an adverse effect on the Renminbi amount we would receive from the conversion.
A product candidate that appears promising in the early phases of development may fail to reach the market for a number of reasons, such as: the failure to demonstrate safety and efficacy in preclinical and clinical trials; the failure to obtain approvals for intended use from relevant regulatory bodies, such as the NMPA; 28 our inability to manufacture and commercialize sufficient quantities of the product economically; and proprietary rights, such as patent rights, held by others to our product candidates and their refusal to sell or license such rights to us on reasonable terms, or at all.
A product candidate that appears promising in the early phases of development may fail to reach the market for a number of reasons, such as: the failure to demonstrate safety and efficacy in preclinical and clinical trials; the failure to obtain approvals for intended use from relevant regulatory bodies, such as the NMPA; our inability to manufacture and commercialize sufficient quantities of the product economically; and proprietary rights, such as patent rights, held by others to our product candidates and their refusal to sell or license such rights to us on reasonable terms, or at all. 26 Delays in any part of the development process or our inability to obtain regulatory approval of our products could adversely affect our operating results by restricting or delaying our introduction of new products.
For the year ended December 31, 2024, three suppliers accounted for 22.9%, 21.3% and 14.6% of raw material purchases and for the year ended December 31, 2023, three suppliers accounted for 17.7%, 13.8% and 9.1% of raw material purchases. Historically, we have not had difficulty obtaining raw materials from suppliers.
For the year ended December 31, 2025, three suppliers accounted for 26.6%, 26.3% and 9.6% of raw material purchases and for the year ended December 31, 2024, three suppliers accounted for 22.9%, 21.3% and 14.6% of raw material purchases. Historically, we have not had difficulty obtaining raw materials from suppliers.
We have business relationships with certified distributors in the PRC. For the year ended December 31, 2024, no customer accounted for more than 10.0% of sales, and three customers accounted for 63.7%, 13.7% and 6.3% of accounts receivable. In line with industry practices in the PRC, we enter into written sales agreements with our distributors.
We have business relationships with certified distributors in the PRC. For the year ended December 31, 2025, no customer accounted for more than 10.0% of sales, and three customers accounted for 39.2%, 14.4% and 9.2% of accounts receivable. In line with industry practices in the PRC, we enter into written sales agreements with our distributors.
Such violations could have a material adverse effect on our reputation, business, prospects and brand. 31 Failure to adequately manage our employees, distribution network or third-party marketing firms, or their non-compliance with employment, distribution or marketing agreements could harm our corporate image among hospitals and end users of our products and disrupt our sales, resulting in a failure to meet our sales goals.
Failure to adequately manage our employees, distribution network or third-party marketing firms, or their non-compliance with employment, distribution or marketing agreements could harm our corporate image among hospitals and end users of our products and disrupt our sales, resulting in a failure to meet our sales goals.
However, because the validity, enforceability and scope of protection of intellectual property rights in the PRC are uncertain and still evolving, we may not be successful in prosecuting these cases.
Litigation may be necessary in the future to enforce our intellectual property rights or to determine the validity and scope of the intellectual property rights of others. However, because the validity, enforceability and scope of protection of intellectual property rights in the PRC are uncertain and still evolving, we may not be successful in prosecuting these cases.
Our ability to raise additional funds in the future is subject to a variety of uncertainties, including: our future financial condition, results of operations and cash flows; general market conditions for capital-raising activities by pharmaceutical companies; and economic, political and other conditions in China and elsewhere. 33 We cannot assure you that our revenues will be sufficient to meet our operational needs and capital requirements.
Our ability to raise additional funds in the future is subject to a variety of uncertainties, including: our future financial condition, results of operations and cash flows; general market conditions for capital-raising activities by pharmaceutical companies; and economic, political and other conditions in China and elsewhere.
Our auditor, BF Borgers CPA PC, the independent registered public accounting firm that issues the audit report included elsewhere in this annual report, is headquartered in Colorado, and is subject to inspection by the PCAOB on a regular basis with the last inspection in 2023.
Our auditor, Enrome LLP, the independent registered public accounting firm that issues the audit report included elsewhere in this annual report, is headquartered in Singapore, and is subject to inspection by the PCAOB on a regular basis.
Our operating subsidiary, Helpson, is incorporated under the laws of the PRC and substantially all of our assets are located in the PRC. Additionally, substantially all of our directors, executive officers and managers reside within the PRC, and substantially all assets of these persons are located within the PRC.
Additionally, substantially all of our directors, executive officers and managers reside within the PRC, and substantially all assets of these persons are located within the PRC.
We may also incur significant expenses and substantial amounts of time and effort to protect our intellectual property rights in the future.
We may also incur significant expenses and substantial amounts of time and effort to protect our intellectual property rights in the future. Such diversion of our resources may adversely affect our existing business and future expansion plans.
The income statements of our operations are translated into U.S. dollars at the average exchange rates in each applicable period. To the extent the U.S. dollar strengthens against foreign currencies, the translation of these foreign currencies denominated transactions results in reduced revenue, operating expenses and net income for our international operations.
To the extent the U.S. dollar strengthens against foreign currencies, the translation of these foreign currencies denominated transactions results in reduced revenue, operating expenses and net income for our international operations.
All of our products are produced at our manufacturing facility in Hainan, China, which is exposed to certain natural disasters such as typhoons. A significant disruption at that facility, even on a short-term basis, could impair our ability to timely produce and ship products, which could have a material adverse effect on our business, financial position and results of operations.
A significant disruption at that facility, even on a short-term basis, could impair our ability to timely produce and ship products, which could have a material adverse effect on our business, financial position and results of operations.
Any future restrictions on currency exchanges may limit our ability to use revenue generated in Renminbi to fund any future business activities outside China or to make dividend or other payments in U.S. dollars.
The PRC government may, at its discretion, restrict access in the future to foreign currencies for current account transactions. Any future restrictions on currency exchanges may limit our ability to use revenue generated in Renminbi to fund any future business activities outside China or to make dividend or other payments in U.S. dollars.
Our business’s profitability may be adversely affected if additional or modified environmental control regulations are imposed upon us. 41 Failure to comply with PRC regulations regarding the registration requirements for employee equity incentive plans may subject our PRC citizen employees or us to fines and other legal or administrative sanctions.
Failure to comply with PRC regulations regarding the registration requirements for employee equity incentive plans may subject our PRC citizen employees or us to fines and other legal or administrative sanctions.
While the current plans will allow the Company to fund its operations in the next twelve months, there can be no assurance that the Company will be able to achieve its future strategic alternatives raising substantial doubt about its ability to continue as a going concern.
Management believes that, if successfully implemented, these measures may improve the Company’s cash position and allow the Company to fund its operations in the next twelve months, however, there can be no assurance that the Company will be able to achieve its future strategic alternatives, raising substantial doubt about its ability to continue as a going concern.
We have properly attained a waste disposal permit for our manufacturing facility, which details the types and concentration of effluents and gases allowed for disposal. We are responsible for periodically renewing this waste disposal permit. There is no assurance that we will obtain a renewal of the waste disposal permit when the current permit expires in February 2028.
We have properly attained a waste disposal permit for our manufacturing facility, which details the types and concentration of effluents and gases allowed for disposal. We are responsible for periodically renewing this waste disposal permit.
As a result, we cannot assure you that our employees will not violate the anticorruption laws of the PRC, the United States and other countries.
As a result, we cannot assure you that our employees will not violate the anticorruption laws of the PRC, the United States and other countries. Such violations could have a material adverse effect on our reputation, business, prospects and brand.
We cooperate with research institutions and universities in the PRC for the research and development of certain new products and any failure of such research institutions to meet our timing and quality standards may pose impairment loss on our financial results and our failure to continue such collaborative arrangement or enter into such new arrangements could adversely affect our ability to develop new pharmaceuticals and our overall business prospects .
Should we fail to respond to these frequent technological advances by failing to improve our existing products, develop new products in a timely manner, or have these products reach a desirable level of market acceptance, our business and profitability will be materially and adversely affected. 25 We cooperate with research institutions and universities in the PRC for the research and development of certain new products and any failure of such research institutions to meet our timing and quality standards may pose impairment loss on our financial results and our failure to continue such collaborative arrangement or enter into such new arrangements could adversely affect our ability to develop new pharmaceuticals and our overall business prospects .
It is difficult to predict how long the current situation may last and when and how it may change again. There is significant international pressure on the PRC government to adopt a substantial liberalization of its currency policy, which could result in a further and more significant appreciation in the value of the Renminbi against the U.S. dollar.
There is significant international pressure on the PRC government to adopt a substantial liberalization of its currency policy, which could result in a further and more significant appreciation in the value of the Renminbi against the U.S. dollar. Significant revaluation of the Renminbi may have a material adverse effect on your investment.
The failure to manage growth effectively could have an adverse effect on our business, financial condition and results of our operations. The rapid market growth of our pharmaceutical products may pose more requirements or more costs on the employment management for managerial, operational, financial and other purposes. As of December 31, 2023, we had 231 employees.
The rapid market growth of our pharmaceutical products may pose more requirements or more costs on employment management for managerial, operational, financial and other purposes. As of December 31, 2025, we had 221 employees.
To date, we have not experienced any infringements of our trademarks for sales of pharmaceutical products or our exclusive patent license, and we are not aware of any infringement of our intellectual property rights.
We also purchased six pharmaceutical compounds from certain third parties that we are seeking to develop into a further product. To date, we have not experienced any infringements of our trademarks for sales of pharmaceutical products or our exclusive patent license, and we are not aware of any infringement of our intellectual property rights.
If we fail to complete such registrations or obtain such approvals, our ability to use the proceeds we expect to receive from this offering and to capitalize or otherwise fund our PRC operations may be negatively affected, which could materially and adversely affect our liquidity and our ability to fund and expand our business. 43 Complying with evolving laws, regulations and other obligations regarding cybersecurity, information security, privacy and data protection, and other related laws, regulations and obligations may be expensive and may force us to make adverse changes to our business.
If we fail to complete such registrations or obtain such approvals, our ability to use the proceeds we expect to receive from this offering and to capitalize or otherwise fund our PRC operations may be negatively affected, which could materially and adversely affect our liquidity and our ability to fund and expand our business.
We and our partners may routinely receive, collect, generate, store, process, transmit and maintain medical data, trail records and other personal details of the subjects enrolled in our clinical trials, along with other personal or sensitive information.
We and our partners may routinely receive, collect, generate, store, process, transmit and maintain medical data, trail records and other personal details of the subjects enrolled in our clinical trials, along with other personal or sensitive information. 38 On June 10, 2021, the Standing Committee of the National People’s Congress of China promulgated the PRC Data Security Law, which became effective in September 2021.
Our distributors and third-party marketing firms could take one or more of the following actions, any of which could have a material adverse effect on our business, prospects and brand: sell our products outside their designated territory, possibly in violation of the exclusive distribution rights of other distributors; fail to adequately promote our products; promote competing products in lieu of our products; or violate the anti-corruption laws of China, the United States or other countries.
Our distributors and third-party marketing firms could take one or more of the following actions, any of which could have a material adverse effect on our business, prospects and brand: sell our products outside their designated territory, possibly in violation of the exclusive distribution rights of other distributors; fail to adequately promote our products; promote competing products in lieu of our products; or violate the anti-corruption laws of China, the United States or other countries. 28 Additionally, although our company policies prohibit our employees from making improper payments to hospitals or otherwise engaging in improper activities to influence the procurement decisions of hospitals, we may not be able to effectively manage our employees, as the compensation of our sales and marketing personnel is partially linked to their sales performance.
Failure to comply with the relevant laws and regulations in relation to cross-border transfer of personal information may subject us and our PRC operating entities to legal liabilities and may materially and adversely affect our business, financial condition and results of operations. 44 Certain PRC regulations may make it more difficult for us to pursue growth through acquisitions.
Failure to comply with applicable requirements may subject us and our PRC operating entities to regulatory enforcement actions and could materially and adversely affect our business, financial condition, and results of operations. 40 Certain PRC regulations may make it more difficult for us to pursue growth through acquisitions.
Even if we successfully defend against these claims, litigation could result in substantial costs and be a distraction to our management.
Even if we successfully defend ourselves against these claims, litigation could result in substantial costs and be a distraction to our management. If we fail to defend such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
In addition, conversion of Renminbi for capital account items, including direct investment and loans, is subject to governmental approval in China, and companies are required to open and maintain separate foreign exchange accounts for capital account items.
In addition, conversion of Renminbi for capital account items, including direct investment and loans, is subject to governmental approval in China, and companies are required to open and maintain separate foreign exchange accounts for capital account items. 35 We cannot be certain that the Chinese regulatory authorities will not impose more stringent restrictions on the convertibility of the Renminbi, especially with respect to foreign exchange transactions.
On December 16, 2021, PCAOB announced HFCAA determinations relating to its inability to inspect or investigate completely registered public accounting firms headquartered in mainland China or Hong Kong because of positions taken by authorities in the PRC or Hong Kong.
On December 29, 2022, the Consolidated Appropriations Act, 2023 was signed into law, which officially reduced the number of consecutive non-inspection years required for triggering the prohibitions under the HFCAA from three years to two. 42 On December 16, 2021, PCAOB announced HFCAA determinations relating to its inability to inspect or investigate completely registered public accounting firms headquartered in mainland China or Hong Kong because of positions taken by authorities in the PRC or Hong Kong.
If we need to obtain external financing, we cannot assure you that financing will be available in amounts or on terms acceptable to us, if at all. Our future liquidity needs and other business reasons could require us to sell additional equity or debt securities or obtain a credit facility.
We cannot assure you that our revenues will be sufficient to meet our operational needs and capital requirements. If we need to obtain external financing, we cannot assure you that financing will be available in amounts or on terms acceptable to us, if at all.
On July 21, 2005, the PRC government changed this policy and began allowing modest appreciation of the Renminbi versus the U.S. dollar. Under the new policy, the Renminbi was permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies.
Under the new policy, the Renminbi was permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies. This change in policy caused the Renminbi to appreciate approximately 21.5% against the U.S. dollar over the following three years.
The PRC legal infrastructure, however, is significantly different in operation from its United States counterpart, and may present a significant impediment to the operation of a foreign invested enterprise. 38 You may experience difficulties in effecting service of legal process, enforcing foreign judgments or bringing original actions in the PRC against our company or our management based on U.S. or other foreign laws.
The PRC legal infrastructure, however, is significantly different in operation from its United States counterpart and may present a significant impediment to the operation of a foreign invested enterprise.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

2 edited+0 added0 removed8 unchanged
Biggest changeIn addition, our management team, including those with experience in dealing with confidentiality-related cybersecurity issues, oversee and manage cybersecurity related matters and formulate policies as necessary. Our Board review on an annual basis regarding assessment, identification and management on material risks from cybersecurity threats happened in the ordinary course of our business operations.
Biggest changeIn addition, our management team, including those with experience in dealing with confidentiality-related cybersecurity issues, oversee and manage cybersecurity related matters and formulate policies as necessary. Our Board review on an annual basis regarding assessment, identification and management on material risks from cybersecurity threats that happened in the ordinary course of our business operations.
If such disclosure is determined to be necessary, such disclosure material will be prepared and reviewed by our Board before it is disseminated to the public. 54
If such disclosure is determined to be necessary, such disclosure material will be prepared and reviewed by our Board before it is disseminated to the public. 49

Item 2. Properties

Properties — owned and leased real estate

3 edited+1 added1 removed8 unchanged
Biggest changeThe interest rate is 3.25% for the second twelve months of the loan, which covers September 21, 2024 to September 20, 2025. The loan is collateralized by the Company’s new production facility and the included production line equipment and machinery. In addition, the Company’s Chief Executive Officer and Chair of the Board personally guaranteed the new line of credit.
Biggest changeThe loan is collateralized by the Company’s production facility and the included production line equipment and machinery. In addition, the Company’s Chief Executive Officer and Chair of the Board personally guaranteed the new line of credit. Total interest paid on this loan was $42,528 for the years ended December 31, 2025.
The loans referred to above are set forth in the table below: Total Amount of the Line of Credit Lending Institution Contract Period Interest Rate Properties under Mortgage RMB 10 million (Approximately $1.41 million) Bank of China September 21, 2024 to September 20, 2025 3.25% Helpson’s new factory: 20,282.42 square meters (Certificate #: HK477872) Production line equipment and machinery included in the facility
The loan referred to above is set forth in the table below: Total Amount of the Line of Credit Lending Institution Contract Period Interest Rate Properties under Mortgage RMB 10 million (Approximately $1.41 million) Bank of China September 21, 2025 to September 20, 2026 2.9 % Helpson’s new factory: 20,282.42 square meters (Certificate #: HK477872) Production line equipment and machinery included in the facility
For office spaces on the second floor and third floor at a monthly rent of RMB 17,600 (approximately $2,485) and RMB 30,000 (approximately $4,236), respectively, based on the current lease dated June 5, 2023 that is for a two-year term ending June 30, 2025.
For office spaces on the second floor and third floor at a monthly rent of RMB 17,000 (approximately $2,418) and RMB 27,600 (approximately $3,927), respectively, based on the current lease dated July 1, 2025 that is for a three-year term ending June 30, 2028.
Removed
Total interest paid on this loan was $47,418 for the years ended December 31, 2024.
Added
The interest rate is 3.25% for the second twelve months of the loan, which covers September 21, 2024 to September 20, 2025. The interest rate is 2.9% for the third twelve months of the loan, which covers September 21, 2025 to September 20, 2026.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

1 edited+0 added0 removed1 unchanged
Biggest changeHowever, we are currently not aware of any such legal proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results. ITEM 4. MINE SAFETY DISCLOSURES. Not applicable. 55 PART II
Biggest changeHowever, we are currently not aware of any such legal proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results. ITEM 4. MINE SAFETY DISCLOSURES. Not applicable. 50 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

7 edited+0 added0 removed9 unchanged
Biggest changeSecurities Authorized for Issuance under Equity Compensation Plans Equity Compensation Plan Information Number of securities to be issued upon exercise of outstanding options, warrants and rights Weighted-average exercise price of outstanding options, warrants and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))* Plan category (a) (b) (c) Equity compensation plans not approved by security holders - - - Equity compensation plans approved by security holders - - 482,000 Totals - - 482,000 * All shares have been retroactively restated to reflect the effect of the 1-for-5 reverse stock split effective March 6, 2024 and the 1-for-10 reverse stock split effective March 6, 2023.
Biggest changeSecurities Authorized for Issuance under Equity Compensation Plans Equity Compensation Plan Information Number of securities to be issued upon exercise of outstanding options, warrants and rights Weighted-average exercise price of outstanding options, warrants and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))* Plan category (a) (b) (c) Equity compensation plans not approved by security holders - - - Equity compensation plans approved by security holders - - 559,800 Totals - - 559,800 * All shares have been retroactively restated to reflect the effect of the 1-for-10 reverse stock split effective April 15, 2025.
Instead, any fractional shares that resulted from the split were rounded up to the next whole number. The reverse stock split affects all stockholders uniformly and does not alter any stockholder’s percentage interest in China Pharma’s outstanding common stock, except for adjustments that may result from the treatment of fractional shares.
Instead, any fractional shares that resulted from the split were rounded up to the next whole number. The reverse stock split affects all stockholders uniformly and does not alter any stockholder’s percentage interest in the Company’s outstanding common stock, except for adjustments that may result from the treatment of fractional shares.
Prior to September 30, 2009, our shares traded on the OTC Bulletin Board under the symbol “CPHI.OB.” Holders As of March 24, 2025, there were approximately 137 stockholders of record of our common stock and an indeterminate number of beneficial holders who held our common stock in street name. 56 Transfer Agent and Registrar The transfer agent and registrar for our common stock is Equinity Trust Company, with offices located at 3200 Cherry Creek South Drive, Suite 430, Denver, Colorado 80209.
Prior to September 30, 2009, our shares traded on the OTC Bulletin Board under the symbol “CPHI.OB.” Holders As of March 24, 2026, there were approximately 140 stockholders of record of our common stock and an indeterminate number of beneficial holders who held our common stock in street name. 51 Transfer Agent and Registrar The transfer agent and registrar for our common stock is Equinity Trust Company, with offices located at 3200 Cherry Creek South Drive, Suite 430, Denver, Colorado 80209.
The aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and ask price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter: $4,290,693 as of June 30, 2024, based on the closing price of $0.25 of the Company’s common stock on such date.
The aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and ask price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter: $4,290,693 as of June 30, 2025, based on the closing price of $1.79 of the Company’s common stock on such date.
The reverse stock split was approved by the Company’s Board of Directors through unanimous written consent and China Pharma’s stockholders at its Annual Meeting for the fiscal year ended on December 31, 2021, which was held on December 27, 2022.
The reverse stock split was approved by the Company’s Board of Directors through unanimous written consent and China Pharma’s stockholders at its Annual Meeting for the fiscal year ended on December 31, 2023, which was held on December 22, 2024.
All share and per share amounts have been retroactively restated for all periods presented in the accompanying consolidated financial statements. Effective March 6, 2023 China Pharma implemented a 1-for-10 reverse split of its common stock.
All share and per share amounts have been retroactively restated for all periods presented in the accompanying consolidated financial statements. Effective March 6, 2024, the Company implemented a 1-for-5 reverse split of its common stock.
The number of outstanding shares of the registrant’s common stock on March 24, 2025, was 14,816,865. The number of outstanding shares reflects the impact of two reverse stock splits implemented in 2023 and 2024, as described below: Effective March 6, 2024, the Company implemented a 1-for-5 reverse split of its common stock.
The number of outstanding shares of the registrant’s common stock on March 24, 2026, was 40,522,002. The number of outstanding shares reflects the impact of two reverse stock splits implemented in 2024 and 2025, as described below: Effective April 15, 2025, the Company implemented a 1-for-10 reverse split of its common stock.

Item 7. Management's Discussion & Analysis

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

49 edited+4 added7 removed31 unchanged
Biggest changeWe account for the following respective percentage as credit loss allowance based on age of the accounts receivables: 10% of accounts receivable that are between 180 days and 365 days old, 70% of accounts receivable that are between 365 days and 720 days old, and 100% of accounts receivable that are greater than 720 days old. 61 Our allowance for credit losses as a percentage of accounts receivable of trade accounts receivable was 98.3% and 96.5% as of December 31, 2024 and 2023, respectively.
Biggest changeOur allowance for credit losses as a percentage of accounts receivable of trade accounts receivable was 5.1% and 98.3% as of December 31, 2025 and 2024, respectively.
One of the flagship products, Candesartan tablets, a hypertension product, has passed generic-drug-consistency-evaluation in early August 2023. Helpson has taken a more cautious and flexible attitude towards initiating and progressing any project for existing products’ consistency evaluation to cope with the changing macro environment of drug sales in China.
One of the flagship products, Candesartan tablets, a hypertension product, passed generic-drug-consistency-evaluation in early August 2023. 53 Helpson has taken a more cautious and flexible attitude towards initiating and progressing any project for existing products’ consistency evaluation to cope with the changing macro environment of drug sales in China.
Due to the restriction on dividend distribution to overseas shareholders, the amount of Helpson’s net assets that was designated for general and statutory capital reserves, and thus could not be transferred to our parent company as cash dividends, was 50% of Helpson’s registered capital, which was both $8,145,000 as of December 31, 2024 and December 31, 2023, respectively.
Due to the restriction on dividend distribution to overseas shareholders, the amount of Helpson’s net assets that was designated for general and statutory capital reserves, and thus could not be transferred to our parent company as cash dividends, was 50% of Helpson’s registered capital, which was both $8,145,000 as of December 31, 2025 and December 31, 2024, respectively.
Although the Company obtained additional lines of credit for the year ended December 31, 2024, there can be no assurance that the Company will be able to achieve its future strategic goals, including the launch of new products. This raises substantial doubt about the Company’s ability to continue as a going concern.
Although the Company obtained additional lines of credit for the year ended December 31, 2025, there can be no assurance that the Company will be able to achieve its future strategic goals, including the launch of new products. This raises substantial doubt about the Company’s ability to continue as a going concern.
The currency exchange control procedures imposed by Chinese government authorities may restrict Helpson, our Chinese subsidiary, from transferring its net assets to our parent company through loans, advances or cash dividends. Off-Balance Sheet Arrangements As of December 31, 2024, we did not have any off-balance sheet arrangements.
The currency exchange control procedures imposed by Chinese government authorities may restrict Helpson, our Chinese subsidiary, from transferring its net assets to our parent company through loans, advances or cash dividends. Off-Balance Sheet Arrangements As of December 31, 2025, we did not have any off-balance sheet arrangements.
The discussion of our critical accounting policies contained in Note 1 to our consolidated financial statements, “Organization and Significant Accounting Policies”, included in the Company’s annual report on Form 10-K for fiscal year ended December 31, 2024, which is incorporated herein by reference.
The discussion of our critical accounting policies contained in Note 1 to our consolidated financial statements, “Organization and Significant Accounting Policies”, included in the Company’s annual report on Form 10-K for fiscal year ended December 31, 2025, which is incorporated herein by reference.
China’s consistency evaluation of generic drugs continues to proceed for the year ended December 31, 2024. Helpson has always taken the task of promoting the consistency evaluation as a top priority, and worked on them actively.
China’s consistency evaluation of generic drugs continues to proceed for the year ended December 31, 2025. Helpson has always taken the task of promoting consistency evaluation as a top priority and worked on them actively.
Although our Chairperson and Chief Executive Officer had advanced funds for working capital for the year ended December 31, 2024, there can be no assurances that this will continue in the future.
Although our Chairperson and Chief Executive Officer had advanced funds for working capital for the year ended December 31, 2025, there can be no assurances that this will continue in the future.
This decrease was mainly due to a decrease in sales of Helpson not passing the consistency evaluation of Roxithromycin and therefore not being able to participate in CP.
This decrease was mainly due to the decrease in sales of the Cefaclor Dispersible Tablets due to a decrease in sales of Helpson not passing the consistency evaluation of Roxithromycin and therefore not being able to participate in CP.
Research and development expenses accounted for 6.3% and 3.4% of our total revenues for the years ended December 31, 2024 and 2023, respectively. These expenditures were mainly spent on the consistency evaluation of the existing products.
Research and development expenses accounted for 6.8% and 6.3% of our total revenues for the years ended December 31, 2025 and 2024, respectively. These expenditures were mainly spent on the consistency evaluation of the existing products.
Reason for this increase was the amortization expenses related to the purchased patent technology in 2024. Research and Development Expenses Our research and development expenses for the year ended December 31, 2024 was $0.28 million, compared to $0.24 million for the year ended December 31, 2023.
Reason for this increase was the increase of amortization expenses related to the purchased patent technology in 2025. Research and Development Expenses Our research and development expenses for the year ended December 31, 2025 was $0.28 million, compared to $0.28 million for the year ended December 31, 2024.
Allocations to these reserves and funds can only be used for specific purposes and are not transferrable to the parent company in the form of loans, advances or cash dividends. As of December 31, 2024 and December 31, 2023, Helpson’s net assets totaled ($6,197,000) and ($5,273,000), respectively.
Allocations to these reserves and funds can only be used for specific purposes and are not transferrable to the parent company in the form of loans, advances or cash dividends. As of December 31, 2025 and December 31, 2024, Helpson’s net assets totaled ($8,251,000) and ($6,197,000), respectively.
In the event the length of collection term is deviated from any of the past pattern of any particular customer, the Company will adjust its credit term. 60 The amount of net accounts receivable that was past due (or the amount of accounts receivable that was more than 180 days old) was $0.06 million and $0.01 million as of December 31, 2024 and 2023, respectively.
In the event the length of collection term is deviated from any of the past patterns of any particular customer, the Company will adjust its credit term. 56 The amount of net accounts receivable that was past due (or the amount of accounts receivable that was more than 180 days old) was $0.06 million and $0.06 million as of December 31, 2025 and 2024, respectively.
“Others” product category generated $0.18 million in sales revenue for the year ended December 31, 2024, compared to $0.73 million for the same period last year, which represented a decrease of $0.55 million. This decrease was mainly due to the decrease in sales of Vitamin B6 for Injection due to market volatility.
“Others” product category generated $0.07 million in sales revenue for the year ended December 31, 2025, compared to $0.18 million for the same period last year, which represented a decrease of $0.11 million. This decrease was mainly due to the decrease in sales of Vitamin B6 for Injection due to market volatility.
Sales in the “Anti-Viral/Infection & Respiratory” product category represented 61% and 51% of total sales in the years ended December 31, 2024 and 2023, respectively. The “CNS Cerebral & Cardio Vascular” category represented 30% of total revenue for the year ended December 31, 2024, compared to 23% for the year ended December 31, 2023.
Sales in the “Anti-Viral/Infection & Respiratory” product category represented 60% and 61% of total sales in the years ended December 31, 2025 and 2024, respectively. The “CNS Cerebral & Cardio Vascular” category represented 32% of total revenue for the year ended December 31, 2025, compared to 30% for the year ended December 31, 2024.
For customers (i) whose business license has been cancelled or expired; (ii) whose key business certificates such as GSP (Good Supply Practice) license have been invalid or revoked; (iii) who have no ability to continue operations, or (iv) who are encountering other issues that lead to accounts receivable unrecoverable, the receivable will be written-off as per the resolution of our Board of Directors.
For customers (i) whose business license has been cancelled or expired; (ii) whose key business certificates such as GSP (Good Supply Practice) license have been invalid or revoked; (iii) who have no ability to continue operations, or (iv) who are encountering other issues that lead to accounts receivable unrecoverable, the receivable will be written-off as per the resolution of our Board of Directors. 57 We recognize credit losses per actual write-offs as well as changes of allowance for credit losses.
Net Loss Net loss for the year ended December 31, 2024 was $4.74 million, compared to net loss of $3.08 million for the year ended December 31, 2023. The increase in net loss was mainly a result of the decline in expenses more than the decline in revenue.
Net Loss Net loss for the year ended December 31, 2025 was $3.19 million, compared to net loss of $4.74 million for the year ended December 31, 2024. The decrease in net loss was mainly a result of the decline in expenses more than the decline in revenue.
Selling Expenses Our selling expenses for the year ended December 31, 2024 were $0.53 million, a decrease of $0.25 million compared to $0.78 million for the year ended December 31, 2023. Selling expenses accounted for 11.7% of the total revenue for the year ended December 31, 2024 compared to 11.1% for the year ended December 31, 2023.
Selling Expenses Our selling expenses for the year ended December 31, 2025 were $0.38 million, a decrease of $0.15 million compared to $0.53 million for the year ended December 31, 2024. Selling expenses accounted for 9.1% of the total revenue for the year ended December 31, 2025 compared to 11.7% for the year ended December 31, 2024.
Our cash and cash equivalents were $0.63 million, representing 4.2% of our total assets, as of December 31, 2024, as compared to $1.42 million, representing 8.6% of our total assets as of December 31, 2023.
Our cash and cash equivalents were $0.35 million, representing 1.1% of our total assets, as of December 31, 2025, as compared to $0.63 million, representing 4.2% of our total assets as of December 31, 2024.
According to relevant PRC laws, companies registered in the PRC, including our PRC subsidiary, Helpson, are required to allocate at least ten percent (10%) of their after-tax net income, as determined under the accounting standards and regulations in the PRC, to statutory surplus reserve accounts until the reserve account balances reach fifty percent (50%) of the companies’ registered capital prior to their remittance of funds out of the PRC.
The change was mainly attributable to the repayment of certain bank loans, partially offset by proceeds from the new bank loan According to relevant PRC laws, companies registered in the PRC, including our PRC subsidiary, Helpson, are required to allocate at least ten percent (10%) of their after-tax net income, as determined under the accounting standards and regulations in the PRC, to statutory surplus reserve accounts until the reserve account balances reach fifty percent (50%) of the companies’ registered capital prior to their remittance of funds out of the PRC.
The “Digestive Diseases” category represented 4% and 16% of total revenue for the years ended December 31, 2024 and 2023, respectively. The “Other” category represented 4% and 10% of revenues for the years ended December 31, 2024 and 2023, respectively.
The “Digestive Diseases” category represented 6% and 4% of total revenue for the years ended December 31, 2025 and 2024, respectively. The “Other” category represented 2% and 4% of revenues for the years ended December 31, 2025 and 2024, respectively.
General and Administrative Expenses Our general and administrative expenses for the year ended December 31, 2024 were $1.78 million, an increase of $0.32 million compared to $1.47 million for the year ended December 31, 2023. General and administrative expenses accounted for 39.4% and 20.9% of our total revenues for the years ended December 31, 2024 and 2023, respectively.
General and Administrative Expenses Our general and administrative expenses for the year ended December 31, 2025 were $2.45 million, an increase of $0.67 million compared to $1.78 million for the year ended December 31, 2024. General and administrative expenses accounted for 59.2% and 39.4% of our total revenues for the years ended December 31, 2025 and 2024, respectively.
Cost of Revenue For the year ended December 31, 2024, our cost of revenue was $6.5 million, or 143.8% of total revenue, which represented a decrease of $0.78 million from $7.3 million, or 104.0% of total revenue, in 2023.
Cost of Revenue For the year ended December 31, 2025, our cost of revenue was $4.3 million, or 103.2% of total revenue, which represented a decrease of $2.2 million from $6.5 million, or 143.8% of total revenue, in 2024.
Loss from Operations Our operating loss for the year ended December 31, 2024 was $4.59 million, compared to $2.75 million in 2023. 62 Net Interest Expense Net interest expense was $0.15 million for the year ended December 31, 2024 and $0.33 million for the year ended December 31, 2023.
Loss from Operations Our operating loss for the year ended December 31, 2025 was $3.24 million, compared to $4.59 million in 2024. Net Interest Expense Net interest expense was $0.10 million for the year ended December 31, 2025 and $0.15 million for the year ended December 31, 2024.
Bad Debt Expense (reversal of allowance for credit losses) Our allowance for credit losses for the year ended December 31, 2024 was $5,702, as compared to reversal of bad debt expense of $15,757 for the same period in 2023. In general, our normal customer credit or payment terms are 90 days. This has not changed in recent years.
Bad Debt Expense (reversal of allowance for credit losses) F or the year ended December 31, 2025, the Company recorded a reversal of bad debt expense of $1,018, compared to bad debt expense of $5,072 for the same period in 2024. In general, our normal customer credit or payment terms are 90 days. This has not changed in recent years.
Product Category Twelve Months Ended December 31, 2024 2023 CNS Cerebral & Cardio Vascular 30 % 23 % Anti-Viral/ Infection & Respiratory 61 % 51 % Digestive Diseases 4 % 16 % Other 4 % 10 % For the year ended December 31, 2024, revenue breakdown by product category experienced certain variances compared with that of the prior year.
Fiscal Year Ended December 31, Product Category 2025 2024 CNS Cerebral & Cardio Vascular 32 % 30 % Anti-Viral/ Infection & Respiratory 60 % 61 % Digestive Diseases 6 % 4 % Other 2 % 4 % For the year ended December 31, 2025, revenue breakdown by product category experienced certain variances compared with that of the prior year.
There can be no assurance that any additional financing will be available on acceptable terms, if at all. 63 Operating Activities Net cash used in operating activities was $0.47million in the year ended December 31, 2024, compared to $0.70 million in the same period in 2023.
There can be no assurance that any additional financing will be available on acceptable terms, if at all. Operating Activities Net cash provided by operating activities was $0.14 million for the year ended December 31, 2025, compared to net cash used in operating activities of $0.41 million in 2024.
This decline was mainly due to an increasing number of drugs from other medicine providers being included in national CP, while Helpson’s peer products have not passed consistency evaluation. As a result, they are not qualified to participate in CP, the resulting sales has decreased.
This decline was mainly due to an increasing number of drugs from other medicine providers being included in national CP, while Helpson’s peer products have not passed consistency evaluation.
The allowance for credit losses balances were $13.6 million and $13.8 million as of December 31, 2024 and December 31, 2023, respectively.
The allowance for credit losses balances was $0.01 million and $13.6 million as of December 31, 2025 and December 31, 2024, respectively.
Liquidity and Capital Resources Our principal source of liquidity is cash generated from operations and bank lines of credit. Currently the Company has not witnessed or expected to encounter any difficulties to refinance those lines of credit this year. As of December 31, 2024, the aggregated advance from our CEO was$1,144,985 for use in operations.
Currently the Company has not witnessed or expected to encounter any difficulties to refinance those lines of credit this year. As of December 31, 2025, the aggregated advance from our CEO was $1,435,136 for use in operations.
The change in weighted-average shares and per-share amounts reflects the impact of two reverse stock splits: a 1-for-10 split effective March 6, 2023, and a 1-for-5 split effective March 6, 2024. These splits reduced the number of outstanding shares, with all share and per-share amounts retroactively restated for all periods presented in the accompanying consolidated financial statements.
The change in weighted-average shares and per-share amounts reflects the impact of three reverse stock splits: a 1-for-10 split effective March 6, 2023, and a 1-for-5 split effective March 6, 2024, and a 1-for 10 split effective April 15, 2025.These splits reduced the number of outstanding shares, with all share and per-share amounts retroactively restated for all periods presented in the accompanying consolidated financial statements. 58 Liquidity and Capital Resources Our principal source of liquidity is cash generated from operations and bank lines of credit.
Our “CNS Cerebral & Cardio Vascular” product category generated $1.35 million in sales revenue for the year ended December 31, 2024, compared to $1.62 million for the same period last year, which represented a decrease of $0.27 million. This decrease was mainly due to the decrease in sales of Ozagrel Sodium for Injection due to market fluctuation.
The “CNS Cerebral & Cardio Vascular” product category generated $1.32 million for the year ended December 31, 2025, compared to $1.35 million for the year ended December 31, 2024, which represented a decrease of $0.03 million. This decrease was mainly due to a decrease in sales of Candesartan.
In April 2024, Helpson began serving as a Contract Manufacturing Organization (CMO) for a project, undertaking its R&D and post-market commercial production. This initiative generated approximately $50,000 in revenue within the year. Under the contract terms, once the product is launched, the company will continue providing production services, further boosting sales revenue and ensuring sustained cash inflows.
In April 2024, Helpson began serving as a Contract Manufacturing Organization (CMO) for a project, undertaking its R&D and post-market commercial production. This initiative generated approximately $50,000 in revenue within the year.
The following table illustrates our trade accounts receivable aging distribution in terms of the percentage of the total accounts receivable, respective gross accounts receivables as well as the allocated allowance for credit losses as of December 31, 2024 and 2023: December 31, December 31, 2024 2023 1 - 180 Days 1.24 % 3.45 % 180 - 365 Days 0.48 % 0.06 % 365 - 720 Days 0.01 % 0.09 % > 720 Days 98.27 % 96.40 % Total 100.00 % 100.00 % Gross Accounts Receivable Amount Allocated Allowance for Doubtful Accounts December 31, 2024 December 31, 2023 December 31, 2024 December 31, 2023 1-180 Days 171,988 492,852 - - 180-365 Days 66,602 8,299 6,660 830 365-720 Days 700 13,756 490 9,629 Over 720 Days 13,580,031 13,775,615 13,580,031 13,775,615 Total 13,819,322 14,290,522 13,587,182 13,786,074 Our allowance for credit losses estimate practice using the current expected credit loss method considers accounts receivable balances aged within 180 days current, except for any individual uncollectible account assessed by management.
The following table illustrates our trade accounts receivable aging distribution in terms of the percentage of the total accounts receivable, respective gross accounts receivables as well as the allocated allowance for credit losses as of December 31, 2025 and 2024: December 31, December 31, 2025 2024 1 - 180 Days 72.38 % 1.24 % 180 - 365 Days 24.61 % 0.48 % 365 - 720 Days 1.17 % 0.01 % > 720 Days 1.84 % 98.27 % Total 100.00 % 100.00 % Gross Accounts Receivable Amount Allocated Allowance for Doubtful Accounts December 31, 2025 December 31, 2024 December 31, 2025 December 31, 2024 1-180 Days 184,159 171,988 - - 180-365 Days 62,624 66,602 6,262 6660 365-720 Days 2,973 700 2,081 490 Over 720 Days 4,680 13,580,031 4,680 13,580,031 Total 254,435 13,819,322 13,023 13,587,182 Our allowance for credit losses estimate practice using the current expected credit loss method considers accounts receivable balances aged within 180 days current, except for any individual uncollectible account assessed by management.
It generated $0.20 million for the year ended December 31, 2024, compared to $1.09 million for the year ended December 31, 2023, which represented a decrease of $0.89 million.
It generated $2.48 million for the year ended December 31, 2025, compared to $2.75 million for the year ended December 31, 2024, which represented a decrease of $0.27 million.
Investing Activities During the year ended December 31, 2024, net cash used in investing activities was $0.29 million, compared to $0.01 million for the year ended December 31, 2023. This was mainly due to the investment in the development of a medicine formula.
This decease was mainly due to the lower investment in the development of a medicine formula. 59 Financing Activities Cash used in financing activities was $0.29 million for the year ended December 31, 2025, compared to $0.03 million provided by financing activities in the same period of 2024.
As of December 31, 2024, our net trade accounts receivable was $0.23 million, a decrease of $0.27 million from $0.50 million as of December 31, 2023. As of December 31, 2024, total inventory was $2.27 million, compared to $3.73 million as of December 31, 2023.
As of December 31, 2025, our net trade accounts receivable was $0.24 million, an increase of $0.01 million from $0.23 million as of December 31, 2024. As of December 31, 2025, total inventory was $1.62 million, compared to $2.27 million as of December 31, 2024.
The changes in the allowances for credit losses of trade accounts receivable during the years ended December 31, 2024 and 2023 were as follows: For the Fiscal Years Ended December 31, 2024 2023 Balance, Beginning of Year $ 13,786,074 $ 16,739,527 Bad debt expense 5,702 (15,757 ) Bad debt write-offs - (2,671,896 ) Foreign currency translation adjustment (204,594 ) (265,800 ) Balance, End of Year $ 13,587,182 $ 13,786,074 Our bad debt expense for the year ended December 31, 2024 was $5,702, as compared to reversal of allowance for credit losses of $15,757 in 2023.
The changes in the allowances for credit losses of trade accounts receivable during the years ended December 31, 2025 and 2024 were as follows: For the Fiscal Years Ended December 31, 2025 2024 Balance, Beginning of Year $ 13,587,182 $ 13,786,074 (Reversal) Credit losses expenses (4,029 ) 5,702 Amounts written off (13,664,945 ) Foreign currency translation adjustment 94,815 (204,594 ) Balance, End of Year $ 13,023 $ 13,587,182 Our bad debt expense was $(4,029) and $5,702 for the years ended December 31, 2025 and 2024, respectively.
Loss per basic and diluted common share was $0.27 for the year ended December 31, 2024 and $0.91 for the year ended December 31, 2023, respectively. The number of basic and diluted weighted-average outstanding shares used to calculate loss per share was 17,463,723 for 2024, as compared to 3,383,573 for 2023.
Loss per basic and diluted common share was $0.74 for the year ended December 31, 2025 and $2.71 for the year ended December 31, 2024, respectively. The number of basic and diluted weighted-average outstanding shares used to calculate loss per share was 4,291,427 for 2025, as compared to 1,746,372 for 2024.
There were no allocations to the statutory surplus reserve accounts during the twelve months ended December 31, 2024. 64 The Chinese government also imposes controls on the conversion of RMB into foreign currencies and the remittance of currencies out of China. Our businesses and assets are primarily denominated in RMB.
The Chinese government also imposes controls on the conversion of RMB into foreign currencies and the remittance of currencies out of China. Our businesses and assets are primarily denominated in RMB.
The amount that Helpson must set aside for the statutory surplus fund accounts exceeds its total net assets at December 31, 2024 and December 31, 2023.
The amount that Helpson must set aside for the statutory surplus fund accounts exceeds its total net assets as of December 31, 2025 and December 31, 2024. There were no allocations to the statutory surplus reserve accounts during the fiscal year ended December 31, 2025.
Set forth below are our revenues by product category in millions (USD) for the years ended December 31, 2024 and 2023: Twelve Months Ended December 31, Product Category 2024 2023 Net Change % Change CNS Cerebral & Cardio Vascular 1.35 1.62 -0.27 -17 % Anti-Viral/ Infection & Respiratory 2.75 3.57 -0.82 -23 % Digestive Diseases 0.20 1.09 -0.89 -82 % Other 0.18 0.73 -0.55 -75 % The most significant revenue decrease in terms of dollar amount was in the “Digestive Diseases” category.
As a result, they are not qualified to participate in CP, the resulting sales has decreased. 54 Set forth below are our revenues by product category in millions (USD) for the years ended December 31, 2025 and 2024: Fiscal Year Ended December 31, Product Category 2025 2024 Net Change % Change CNS Cerebral & Cardio Vascular 1.32 1.35 -0.03 -2 % Anti-Viral/ Infection & Respiratory 2.48 2.75 -0.27 -10 % Digestive Diseases 0.23 0.2 0.03 15 % Other 0.07 0.18 -0.11 -61 % The most significant revenue decrease in terms of dollar amount was in the “Anti-Viral/ Infection & Respiratory” category.
Moving forward, we will leverage our competitive advantages as a CMO, including our highly skilled technical team, state-of-the-art facilities, multiple production lines, ample capacity, extensive manufacturing expertise, and a robust quality management system. 58 Results of Operations for the Fiscal Year ended December 31, 2024 Revenue Revenue was $4.5 million for the year ended December 31, 2024, which represented a decrease of $2.5 million, as compared to $7.0 million for the year ended December 31, 2023.
Registration with the National Medical Products Administration (NMPA) has made in the third quarter of 2025. Moving forward, we will leverage our competitive advantages as a CMO, including our highly skilled technical team, state-of-the-art facilities, multiple production lines, ample capacity, extensive manufacturing expertise, and a robust quality management system.
Financing Activities Cash flow provided by financing activities was $0.03 million in the twelve months ended December 31, 2024; compared to $0.07 million for the same period for the year ended December 31, 2023.
Investing Activities During the year ended December 31, 2025, net cash used in investing activities was $0.14 million, compared to $0.29 million for the year ended December 31, 2024.
The Company obtained various lines of credit in details described under Note 8 to its audited consolidated financial statements contained in this report which is incorporated by reference herein.
All of the $0.35 million of cash and cash equivalents as of December 31, 2025 are considered to be reinvested indefinitely in the Company’s Chinese subsidiary, Helpson. The Company obtained various lines of credit in detail described under Note 8 to its audited consolidated financial statements, which is included elsewhere in this annual report.
The “Anti-Viral/ Infection & Respiratory” product category generated $2.75 million for the year ended December 31, 2024, compared to $3.57 million for the year ended December 31, 2023, which represented a decrease of $0.82 million.
Results of Operations for the Fiscal Year ended December 31, 2025 Revenue Revenue was $4.1 million for the year ended December 31, 2025, which represented a decrease of $0.4 million, as compared to $4.5 million for the year ended December 31, 2024.
Notably, during the year ended December 31, 2024, the company generated an OEM income of $53,338, accounting for 1% of our total revenue.
Notably, during the year ended December 31, 2025, the company generated an OEM income of $33,227, accounting for 1% of our total revenue, which was attributed from the service income from the service Helpson provided to Contract Manufacturing Organization (CMO) for a project, undertaking its R&D and post-market commercial production.
The decrease in the dollar value of cost of revenues in the twelve months ended December 31, 2024 was mainly because that the decrease in revenue; and the increase in ratio of costs to revenue was mainly due to the increase in idle equipment costs due to reduced production, as well as the increased inventory impairments. 59 Gross Loss and Loss Margin Gross loss for the year ended December 31, 2024 was $2.0 million, compared to $0.3 million for the year ended December 31, 2023.
The decrease in cost of revenues for the fiscal year ended December 31, 2025 was primarily driven by a $1.10 million decrease in depreciation expense as certain property and equipment (“PP&E”) became fully depreciated in fiscal year ended December 31, 2024, and a $0.10 million reduction in inventory obsolescence. 55 Gross Loss and Loss Margin Gross loss for the year ended December 31, 2025 was $0.1 million, compared to $2.0 million for the year ended December 31, 2024.
Our gross loss margin for the year ended December 31, 2024 was 43.8%, compared to 4.0% for the year ended December 31, 2023.
Our gross loss margin for the year ended December 31, 2025 was 3.2%, compared to 43.8% for the year ended December 31, 2024. The decrease in the gross loss rate was primarily driven by lower depreciation, as certain property and equipment (“PP&E”) became fully depreciated in the fiscal year ended December 31, 2024, and a reduction in inventory obsolescence.
Removed
This project successfully completed process verification in January 2025 and is currently undergoing stability testing. Registration with the National Medical Products Administration (NMPA) is expected in the third quarter of 2025.
Added
In 2025 this (CMO) project generated $33,227 in revenue .Under the contract terms, once the customer’s product is launched, the company will continue providing production services, further boosting sales revenue and ensuring sustained cash inflows. This project successfully completed process verification in January 2025 and is currently undergoing stability testing.
Removed
This decrease was mainly due to the decrease in sales of the Omeprazole due to market fluctuation, as the market demand returned to normal after the demand spiked in the same period of 2023.
Added
Our “Digestive Diseases” product category generated $0.23 million in sales revenue for the year ended December 31, 2025, compared to $0.2 million for the same period last year, representing an increase of $0.03 million. This increase was mainly due to higher sales of Omeprazole as a result of market fluctuations.
Removed
The main reasons for the increase in the gross loss rate were: the rise in idle equipment costs of approximately $0.66 million, the increase in inventory impairment provisions of approximately $0.86 million, and the significant decline in product sales.
Added
As a result of implementation of centralized volume-based procurement programs administered by the National Healthcare Security Administration, the Company has reduced traditional selling and promotional activities.
Removed
Because of the adjustments in the sales practices and Chinese national CP, we reduced selling expenses to efficiently support the sales and the collection of accounts receivable, especially in the context of the increasing impact of CP, like other players in the industry, we have reduced the promotion expenses.
Added
The decrease in the allowance rate was mainly due to the write-off of long-outstanding accounts receivable during 2025, which reduces both gross accounts receivable and the allowance for doubtful accounts by the same amount, and lowers the ratio of allowance for doubtful accounts to gross accounts receivable.
Removed
We recognize credit losses per actual write-offs as well as changes of allowance for credit losses.
Removed
All of the $0.63 million of cash and cash equivalents as of December 31, 2024 are considered to be reinvested indefinitely in the Company’s Chinese subsidiary, Helpson and are not expected to be available for payment of dividends or for other payments to its parent company or to its shareholders.
Removed
China Pharma issued a convertible note to an institutional accredited investor as disclosed in Note 9 to the audited consolidated financial statements contained in this report which is incorporated by reference herein.

Other CPHI 10-K year-over-year comparisons