Gyre: la CDE de China acepta la NDA de F351 (hydronidone) para fibrosis por CHB

China’s CDE accepted the NDA for F351 (hydronidone) in May 2026 for CHB-induced liver fibrosis. The filing follows the March 2026 priority-review designation and was submitted by Gyre’s majority-owned subsidiary Gyre Pharmaceuticals. Acceptance moves the asset into active regulatory review in China.

Datos clave

Presentado: 7 ago 2026, 12:00
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 gyre-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Gyre Therapeutics Reports Second Quarter 2026 and Year-to-Date Financial Results and Provides Business Update Q2 2026 revenue of $29.1 million; GAAP basic EPS: $(0.12) Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed NDA for F351 (hydronidone) for CHB-induced liver fibrosis accepted by China’s CDE in May 2026 SAN DIEGO, August 7, 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 financial results for the second quarter ended June 30, 2026, and provided a business update. Dr. Ying Luo, President and Chief Executive Officer of Gyre Therapeutics, commented,

SEC 8-K