Progress of Chinese Pharmaceutical Companies in Obtaining U.S. FDA First Generic Drug Approvals in 2025
From focusing primarily on the export of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates in the early 2000s to achieving breakthroughs in high-end generics and innovative drugs today, Chinese pharmaceutical companies have steadily increased their influence in the global pharmaceutical market.
Since the launch of China’s pharmaceutical regulatory reform in 2015, the country’s pharmaceutical industry has significantly strengthened its R&D capabilities, manufacturing systems, and international regulatory registration capacity.
Within just a decade, an increasing number of Chinese pharmaceutical companies have entered regulated global markets, including the United States, and have made progress in complex generics and biosimilars.
As a pharmaceutical distributor that closely monitors developments in both Chinese and international pharmaceutical markets, Hong Kong DengYueMed continues to follow the regulatory approval and registration progress of Chinese pharmaceutical companies in global regulated markets.
In 2025, several Chinese pharmaceutical companies received approvals from the U.S. Food and Drug Administration (FDA) for First Generic Drugs or related generic products. These approvals mainly come from the FDA’s First Generic Drug Approvals announcements as well as the Competitive Generic Therapy (CGT) program.
In certain cases, the first applicant to successfully submit and obtain approval for a generic drug may also be eligible for a 180-day market exclusivity period, provided that the application meets the relevant patent challenge and regulatory requirements.
Nantong Lianya: Focusing on Complex Formulations and Low-Dose Generics
Nantong Lianya Pharmaceutical was established in 2005 and focuses on developing complex formulations through the U.S. ANDA regulatory pathway, including technically challenging products such as controlled-release formulations and low-dose preparations.
Mesna Tablets
- ANDA Number: 218871
- Approval Date: January 13, 2025
- Reference Drug: MESNEX (Baxter)
- Strength: 400 mg
Mesna is an adjunctive therapy used in chemotherapy. It is primarily administered to prevent or reduce hemorrhagic cystitis caused by chemotherapeutic agents such as cyclophosphamide.
Drospirenone and Estradiol Tablets
- ANDA Number: 218031
- Approval Date: October 28, 2025
- Reference Drug: ANGELIQ (Bayer)
- Strengths: 0.25 mg / 0.5 mg and 0.5 mg / 1 mg
This combination product is used for hormone replacement therapy (HRT) in postmenopausal women.
Conjugated Estrogens Tablets
- ANDA Number: 214025
- Approval Date: October 15, 2025
- Reference Drug: Premarin (Wyeth / Pfizer)
Conjugated estrogens are commonly used for menopausal symptom relief, treatment of vulvar and vaginal atrophy, and prevention of postmenopausal osteoporosis.
The development of generic versions of this drug is technically challenging because its active ingredients are derived from pregnant mare urine extracts, containing multiple steroidal compounds.
Hainan Puli: Expanding Its Presence in the International Generic Drug Market
Hainan Puli Pharmaceutical has been actively pursuing international regulatory registrations in recent years.
Gadoteridol Injection
- ANDA Number: 218749
- Approval Date: February 11, 2025
- Reference Drug: ProHance (Bracco)
- Strength: 279.3 mg/mL
Gadoteridol is a gadolinium-based magnetic resonance imaging (MRI) contrast agent.
Voriconazole Injection
- ANDA Number: 220043
- Approval Date: November 14, 2025
- Reference Drug: Vfend (Pfizer)
Voriconazole is a broad-spectrum antifungal agent used to treat severe fungal infections.
Chia Tai Tianqing: Expanding in the Oncology Generic Drug Sector
Degarelix Acetate for Injection
- ANDA Number: 215791
- Tentative Approval Date: August 18, 2025
- Reference Drug: Firmagon (Ferring)
Degarelix is a GnRH receptor antagonist used for the treatment of prostate cancer.
Henlius Biotech: Breakthrough in Biosimilars
Pertuzumab Injection (Poherdy)
- BLA Number: 761450
- Approval Date: November 13, 2025
- Reference Product: Perjeta (Genentech)
Pertuzumab is a monoclonal antibody targeting the HER2 receptor used in the treatment of HER2-positive breast cancer.
Conclusion: The Role of Chinese Pharmaceutical Companies in the Global Market Is Growing
These approval cases demonstrate that Chinese pharmaceutical companies are gradually forming two major development pathways in international markets:
- Development of high-end complex generics
- Parallel development of generic and innovative drugs
With continuous improvements in R&D capabilities, manufacturing quality systems, and international regulatory experience, Chinese pharmaceutical companies are steadily expanding their participation in the global pharmaceutical supply chain.
If you would like to learn more about the development trends of China’s generic drug industry, you can read our analysis:
👉 China Generic Drug Market Trends and Patent Expiration Opportunities
As a global pharmaceutical distributor, Hong Kong DengYue Pharmaceutical continues to monitor the development of China’s pharmaceutical industry and provide global healthcare partners with information on generic drugs, oncology medicines, and pharmaceutical supply channels.