RegulatoryMay 12, 2026, 05:07 PM
Gyre Therapeutics' F351 NDA Accepted by China NMPA
AI Summary
Gyre Therapeutics announced that its majority indirectly owned subsidiary, Gyre Pharmaceuticals Co., Ltd., received notification of acceptance of its New Drug Application (NDA) from China's National Medical Products Administration (NMPA) for F351 (Hydronidone). This lead product candidate is intended for the treatment of chronic hepatitis B-induced liver fibrosis. The acceptance follows a priority review status granted in March and represents a significant milestone towards commercialization for a large patient population in China.
Key Highlights
- China NMPA accepted New Drug Application for F351 (Hydronidone) for chronic hepatitis B-induced liver fibrosis.
- F351 is Gyre's lead product candidate for liver fibrosis treatment.
- NMPA previously granted priority review status for F351 in March.
- This marks the third NDA submission accepted for review by the NMPA for Gyre.
- F351 targets the TGF-β1 signaling pathway, a key mediator of fibrogenesis.
- Gyre plans to file a US IND for F351 by the end of 2026 to initiate a Phase 2 clinical trial.
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