By Fineline Cube 
The National Health Commission (NHC) today released its fourth catalogue of medicines earmarked for generic development. The list targets drugs whose domestic patents are nearing expiry, or whose clinical supply is constrained by limited competition.
Why the NHC Is Expanding the Generic Development Programme
- Patent Expiry Window – Drugs with domestic patents about to lapse but that have not yet attracted registration applications are flagged to fill forthcoming market gaps.
- Supply‑Chain Vulnerabilities – Medications that currently face shortages due to a paucity of competitors are also included, ensuring patient access and market stability.
- Policy Momentum – The initiative aligns with China’s broader strategy to increase affordable drug availability and reduce reliance on imported therapies.
List Highlights
- Fourth Batch Size – 21 drugs have been added, bringing the cumulative total to 89 across all four releases.
- Notable Inclusions
- Bexarotene – An oral retinoid used in cutaneous T‑cell lymphoma.
- Deflazacort – A glucocorticoid indicated for asthma, Duchenne muscular dystrophy, and inflammatory disorders.
- Prussian Blue – A chelating agent for heavy‑metal poisoning.
- Previous Batches
- 1st batch: 33 drugs
- 2nd batch: 17 drugs
- 3rd batch: 39 drugs
Next Steps for Manufacturers
- Registration Applications – Generic producers are encouraged to submit dossiers promptly to secure early market entry.
- Quality & Efficacy Assurance – All candidates must meet stringent Chinese regulatory standards for bioequivalence and safety.
- Market Readiness – Manufacturers should coordinate with distributors to ensure supply chains can meet anticipated demand once patents expire.
Forward‑Looking Statements
The information herein reflects the NHC’s current policy and may change. Actual outcomes may differ materially.-Fineline Info & Tech