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중대신청 접수
Gyre Therapeutics: NMPA, F351(hydronidone)의 CHB 섬유증 NDA 수리
중국 NMPA가 CHB 유발 간섬유증 치료를 위한 F351(hydronidone)의 NDA를 공식 수리하여 정식 심사 절차가 개시되었습니다. 해당 신청서는 3월에 부여받은 우선심사 지위를 이미 보유하고 있어 중국 내 신속한 규제 일정을 기대할 수 있습니다.
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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