Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment
SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (Nasdaq: GYRE), a San Diego-based 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 granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) 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). This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process.
