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 granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals). This marks the second major product for which Gyre has submitted an NDA to the NMPA, and is a significant milestone for the Company in the commercialization of a new medication for the treatment of CHB-induced liver fibrosis.