Semaglutide Mania in China: Inside the Biosimilar Gold Rush

Update (Sep 3, 2025): Chengdu Brilliant’s NDA accepted — 8th domestic filer.

Semaglutide (Ozempic/Wegovy), Novo Nordisk's GLP‑1 receptor agonist, has revolutionized type 2 diabetes and weight‑management care—delivering ~USD 21.6 billion in diabetes and obesity sales during H1 2025. With Wegovy’s FDA approval for MASH on August 15, 2025, its therapeutic influence continues to expand.

In China, where 148 million patients live with diabetes and the number of overweight or obese individuals is projected to hit 610 million by 2030, demand is exploding. Analysts forecast the Chinese semaglutide market will climb from $3.5 billion in 2022 to $61 billion by 2032.

That opportunity has unleashed a frenzy: by September 2025, more than 25 Chinese pharmaceutical companies had filed 90+ applications for semaglutide, according to the CDE. eight have already reached the marketing application stage, with Hangzhou Jiuyuan expected to secure the first approval in H2 2025. But this crowded race risks “involution” — over-competition and price wars — echoing Humira’s 54.7% sales drop in 2025 H1 after biosimilar entry and centralized procurement. Novo’s recent U.S. move to cut Ozempic’s cash price to $499/month underlines that semaglutide’s competitive squeeze is already global.

A Crowded Field: Over 25 Companies Compete

Eight companies — Hangzhou Jiuyuan, Livzon, Qilu, Lianbang, Huadong Medicine, CSPC, Huisheng Biopharma and Chengdu Brilliant Pharma— have filed marketing applications, mostly for type 2 diabetes. Jiuyuan is expected to win the first approval. The CDE’s "under review" catalog lists over 90 pending applications for semaglutide injections, categorized as biologics (Class 3.3) or chemical drugs (Class 2.2), spanning July 2021 to August 2025 from at least 25 domestic companies. Eight companies have reached the marketing application stage, with over 10 others in Phase II/III trials. Below is a summary of filings, organized by earliest submission date per company.

Notes:

• Biologics (Class 3.3) use recombinant biotech processes, while chemical drugs (Class 2.2) rely on synthetic methods like solid-phase peptide synthesis.
• Multiple entries often reflect dosage variations (0.5mg, 1mg) or different indications (diabetes, obesity).
• As of Sep 3, 2025, no domestic approvals exist. Jiuyuan is closest to launch (expected H2 2025).

Patent Battles: The Biggest Wildcard

Patent disputes will determine how quickly biosimilars reach patients.

United States: Locked Until 2031

• Core compound patents: US8129343 (expires Dec 5, 2031, extended by FDA delays) and US8536122 (expires Mar 20, 2026).
• Mylan’s IPR challenge failed; settlements with generics push entry to ~2031–2032.
• Additional patents (e.g., US10335462, expires 2033) reinforce protection.
• Why it matters: U.S. exclusivity preserves billions in high-margin revenue — Goldman Sachs estimates up to $166B extra for Novo.

China: Pending Supreme People’s Court Ruling

• Core patent CN101133082B expires Mar 20, 2026.
• CNIPA invalidated it in 2022, but the Beijing IP Court reinstated it in 2024 based on post-filing data.
• Huadong’s appeal is now before the SPC (hearing held Sept 27, 2024; ruling pending).
• Novo’s PTE request was preliminarily rejected in Apr 2025; final decision pending.
• Why it matters: If upheld, biosimilar launches wait until 2026 or later. If invalidated, launches can start as soon as NDAs clear.

India & Canada: Expiry in 2026

• Patents IN200700466P and CA2607206C both expire Mar 20, 2026.
• Dr. Reddy’s and others plan launches in 87 countries post-2026.
• Why it matters: India and Canada will see generics years before the U.S., intensifying global competition.

Formulation & Process Patents

• Novo also holds patents such as CN102612522B (formulations, expires 2031).
• These may block specific biosimilar formats, though chemical filers like Qilu and Zhejiang Apeloa seek workarounds.

Takeaway: The U.S. is shielded until 2031, while China, India, and Canada face a 2026 patent cliff. China’s SPC ruling and PTE outcome will shape whether biosimilars flood the market immediately or face delays.

The “Involution” Trap

China’s biosimilar race risks collapsing into over-competition:

• Price Wars: With 25+ approvals possible by 2027, centralized procurement could slash prices, as happened with PD-1s and Humira.
• Lack of Differentiation: Most filings target diabetes, with some obesity add-ons — but few offer meaningful innovation.
• Financial Strain: Smaller companies face high R&D costs and uncertain returns, raising the likelihood of consolidation or exits.

Innovation Amid the Chaos

Some Chinese firms are pushing beyond copycat strategies. Key themes:

1. Indication Expansion
   • Huisheng Biopharma: advancing semaglutide for weight management alongside diabetes.
   • Innogen Pharma: launched Efsubaglutide Alfa (Diabegone®) in Jan 2025 — a long-acting GLP-1 with 204-hour half-life and 6.2% weight loss in 4 weeks. Its 285% IPO surge (Aug 15, 2025) raised HK$1.4B. Phase IIb/III obesity and MASH trials are ongoing.
2. Multi-Target Agonists
   • Ainuoglutide: 13.8kg weight loss in 48 weeks.
   • Mazdutide (Innovent/Eli Lilly): GLP-1/GCGR dual agonist, 15% weight loss in 36 weeks.
   • UBT251: GLP-1/GCGR/GIP triple agonist in development.
3. New Delivery Formats
   • Oral GLP-1s (e.g., ASC30) and biweekly injections aim to improve compliance and differentiation.

Impact on Global Players

Novo Nordisk: Immediate China Pressure

• Ozempic sales in China hit $698M in 2023, doubling YoY.
• First biosimilars (likely Jiuyuan in H2 2025) will erode revenue; GS projects 25% price cuts post-2026.
• Wegovy approval (2024) and $500M Tianjin investment may not offset losses.
• Strategic moves: patent litigation, expanding into new indications (MASH, kidney), oral GLP-1 pipeline.
• Stock fell 50% in 2025, reflecting investor concerns.
• U.S. Pricing Response: Facing pressure from competitors and compounders, Novo cut Ozempic’s U.S. cash price to $499/month (via NovoCare, GoodRx, Ro, LifeMD), underscoring that semaglutide price wars are global, not just China-specific.

Eli Lilly: Hedging with Partnerships

• Mounjaro approved in China (May 2024); Zepbound expected in 2025.
• Patents extend to 2040–41 in some markets, giving more exclusivity than Novo.
• Pressure comes from falling semaglutide prices, which could force Lilly to compete on cost.
• Partnership with Innovent (mazdutide) positions it for local advantage.

Western Generics: Waiting Until 2026–2031

• Limited impact from China biosimilars in near term.
• U.S. market closed until 2031; quality and regulatory concerns block Chinese exports.
• Generics like Apotex, Dr. Reddy’s target India, Canada, and emerging markets post-2026.

Bottom Line: Novo faces the sharpest near-term pain in China. Lilly is somewhat insulated via patents and partnerships. Western generics must bide their time.

Broader Implications

• Patients: Will benefit from cheaper, more diverse treatment options — injections, oral drugs, multi-target agonists.
• Market: Risks of over-crowding and collapsing margins, especially under centralized procurement.
• Global: Market fragmentation — U.S. monopolized until 2031, while China, India, and Canada open in 2026.

Outlook

China’s semaglutide biosimilar race is a high-stakes contest: 90+ applications, 25+ companies, and eight NDAs under review. With the SPC patent ruling pending and Jiuyuan likely to gain the first approval in H2 2025, the next year will define the market’s trajectory.

The outcome could be a price-crushing free-for-all or a more measured market shaped by court rulings and innovative challengers. Novo’s U.S. price cut shows how global dynamics may spill into China, reinforcing that survival will hinge on legal wins, strategic differentiation, and escaping the “involution” trap.

Sources

FDA Orange Book, DrugPatentWatch, Markman Advisors, ChemRobotics, CSRxP, Canadian Intellectual Property Office, China National Intellectual Property Administration, Beijing Intellectual Property Court, Supreme People’s Court Intellectual Property Tribunal, Novo Nordisk Investor Relations, Huadong Medicine HKEX Filings, CDE Database