Business
Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment
SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is l
About this update from Gyre Therapeutics, Inc.
[{"type":"image","alt":"Gyre Therapeutics Inc.","displaySize":"","headline":null,"caption":"Gyre Therapeutics Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":63,"url":"https://media.zenfs.com/en/globenewswire.com/c821ee8b66ffe1346b42dcf8cb4fcc33"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/dkF_tplYVubYNSEnkNWn4Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTg4O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/c821ee8b66ffe1346b42dcf8cb4fcc33","width":300,"height":63},"resize_sm":{"url":"https://s.yimg.com/ny/api/res/1.2/dkF_tplYVubYNSEnkNWn4Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTg4O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/c821ee8b66ffe1346b42dcf8cb4fcc33","width":300,"height":63}},"lazy":false},{"type":"text","content":"SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). The acceptance comes after the NMPA previously granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals). This marks the second major product for which Gyre has submitted an NDA to the NMPA, and is a significant milestone for the Company in the commercialization of a new medication for the treatment of CHB-induced liver fibrosis.","length":1016,"tagName":"p"},{"type":"text","content":"Dr. Ying Luo, President and Chief Executive Officer of Gyre, commented, “This is another significant achievement for Gyre. This NDA is our third submission accepted for review by the NMPA, and the first one for our F351 program. Our interactions with the CDE have been very positive to date, reinforcing the agency’s support for addressing the medical need to treat liver fibrosis and the potential of F351 as an innovative therapeutic option. If approved, F351 could address the tens of millions of patients in China with HBV infe...