Gyre Therapeutics: NMPA acepta la NDA para F351 (hidronidona) en fibrosis por CHB

La NMPA de China ha aceptado formalmente la NDA para F351 (hidronidona) para fibrosis hepática inducida por CHB, iniciando el reloj formal de revisión. La presentación ya cuenta con el estatus de revisión prioritaria otorgado en marzo, lo que posiciona al activo para un cronograma regulatorio acelerado en China.

Datos clave

Presentado: 12 may 2026, 21:03
Evento: Solicitud aceptada
Dirección: Positivo
Empresa: GYREGyre Therapeutics
Activo: hydronidone
Fuente: SEC 8-K
Confianza: Con fuente

Extracto de la fuente

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

SEC 8-K