Gyre Therapeutics announced that the Center for Drug Evaluation (?CDE?) of China?s National Medical Products Administration (?NMPA?) has approved Gyre Pharmaceuticals? (Gyre?s indirectly controlled subsidiary) Investigational New Drug (?IND?) application for F230 tablets, a selective endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension (?PAH?). F230 was originally licensed from Eisai through Gyre?s indirect majority stockholder, GNI Group Ltd. In preclinical animal studies, F230 resulted in significant decreases of, or exhibited a decrease trend based on different dose groups in, mean pulmonary arterial pressure, right ventricular systolic pressure, right ventricular/left ventricular plus septum and pulmonary artery wall thickness.

Even at the minimum effective dosage, the differences of those indexes between the treatment group and the PAH model group were statistically significant. In addition to PAH, Gyre is also exploring other disease indications for F230. Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of NASH-associated fibrosis in the U.S. Gyre?s development strategy for F351 in NASH is based on the company?s experience in NASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies.

Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.