Gyre Therapeutics, Inc. is a commercial-stage biopharmaceutical company that discovers, develops, and commercializes small-molecule therapies targeting organ fibrosis and inflammatory diseases. The company operates through a dual-market strategy, advancing clinical programs in the United States while commercializing products and conducting trials in the People's Republic of China through its majority-owned subsidiary, Gyre Pharmaceuticals (formerly Beijing Continent Pharmaceuticals).
Gyre generates its revenue primarily from the commercialization of ETUARY (pirfenidone) in China, which was the country's first approved treatment for idiopathic pulmonary fibrosis (IPF). The company is also preparing to commercialize nintedanib for IPF in the Chinese market. In its clinical pipeline, Gyre's lead investigational candidate is F351 (hydronidone), a structural derivative of pirfenidone. F351 is currently in Phase 2 clinical trials in the U.S. for the treatment of Metabolic Dysfunction Associated Steatohepatitis (MASH)-associated liver fibrosis, and in Phase 3 trials in China for Chronic Hepatitis B (CHB)-associated liver fibrosis. The company's broader pipeline includes F573 for acute/acute-on-chronic liver failure, F528 for chronic obstructive pulmonary disease, and F230 for pulmonary arterial hypertension.
In May 2026, Gyre expanded its research capabilities by acquiring Cullgen Inc., a clinical-stage company focused on targeted protein degraders and degrader-antibody conjugate (DAC) therapies for cancer and inflammatory diseases. This acquisition broadens Gyre's discovery platform beyond its core anti-fibrotic focus. By leveraging its commercial footprint in Asia and its clinical development operations in the U.S., Gyre aims to address significant unmet medical needs in chronic and progressive fibrotic conditions.