Press release
Gyre Pharmaceuticals Receives IND Approval from China’s NMPA to Evaluate F230 for the Treatment of Pulmonary Arterial Hypertension
SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today 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. “PAH is a rare disease and a progressive, life-threatening disorder that represents a significant unmet need with no known cure,” said Han Ying, Ph.D., Chief Executive Officer of Gyre. “Through Gyre Pharmaceuticals, we are committed to advancing F230 through clinical development with the ultimate goal of improving patient outcomes and enhancing the quality of life for those affected by this devastating condition.” 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. About Gyre Therapeutics 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. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisi...