原始来源记录
重大申请已受理
Gyre Therapeutics：NMPA 受理 F351（氢尼酮）治疗慢性乙型肝炎肝纤维化的 NDA
中国 NMPA 已正式受理 F351（氢尼酮）治疗慢性乙型肝炎（CHB）所致肝纤维化的 NDA，正式审查时钟已启动。该申请此前已于三月获得优先审评资格，预计将在中国获得加速审评通道。
关键事实
- 申报时间
- 2026年5月12日 21:03
- 事件
- 申请已受理
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 ef20073066-ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment San Diego, CA May 12, 2026 – 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 g