Gyre Therapeutics' F351 NDA Accepted by China's NMPA for Liver Fibrosis Treatment
GYRE is trading near its 52-week low of $6.57 (11% above the low).
Summary
Gyre Therapeutics announced that China's NMPA has accepted the New Drug Application for its lead drug candidate, F351, for chronic hepatitis B-induced liver fibrosis, marking a significant step towards commercialization in a large market.
Key Events · Product Development and Regulatory · GYRE
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NDA Accepted in China
China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for F351 (hydronidone), Gyre's lead product candidate.
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Targeting Liver Fibrosis
F351 is intended for the treatment of chronic hepatitis B-induced liver fibrosis, a condition affecting tens of millions of patients in China.
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Regulatory Progress
This acceptance follows the NMPA's prior grant of priority review status for F351 in March and the initial NDA submission on March 23, 2026.
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Future U.S. Development
The company plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026 for MASH-associated liver fibrosis.
Analysis · GYRE · Life Sciences
This 8-K announces a critical regulatory milestone for Gyre Therapeutics, as its New Drug Application (NDA) for F351 (hydronidone) has been accepted for review by China's National Medical Products Administration (NMPA). F351 is the company's lead product candidate for chronic hepatitis B-induced liver fibrosis, a condition affecting a large patient population in China. This acceptance, following a prior priority review designation, de-risks the development pathway and moves the drug closer to potential commercialization, which is vital for the company's future revenue given its recent net losses.
At the time of this filing, GYRE was trading at $7.30 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $708.1M. The 52-week trading range was $6.57 to $11.78. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.