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China's NMPA accepts Gyre Therapeutics' new drug application for F351 to treat liver fibrosis from chronic hepatitis B.

Market News
12 May 2026
GlobeNewsWire
View Source
Bullish
pluang ai news

Gyre Therapeutics announced that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone), aimed at treating liver fibrosis caused by chronic hepatitis B (CHB). This acceptance follows the priority review status granted in March, highlighting the potential of F351 to address a significant medical need in China, where millions suffer from HBV infection leading to liver fibrosis and cirrhosis. Gyre plans further development in the U.S., including filing an Investigational New Drug application by the end of 2026 and initiating Phase 2 trials if approved. This milestone advances Gyre's efforts to commercialize innovative treatments for liver fibrosis globally.

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