Gyre Therapeutics is a biotechnology company dedicated to addressing organ fibrosis and inflammatory diseases, with a particular focus on liver conditions. Their lead product, Hydronidone (F351), is a structural analog of the anti-fibrotic drug pirfenidone, which is already approved for idiopathic pulmonary fibrosis. Hydronidone has shown promising results in Phase 1 and Phase 2 clinical trials, particularly for Hepatitis B-induced liver fibrosis, where it has received Breakthrough Therapy designation from China's National Medical Products Administration. The drug works by targeting key pathways involved in liver fibrosis, specifically inhibiting the activation of hepatic stellate cells, which play a crucial role in fibrogenesis.

In addition to its work on Hydronidone, Gyre Therapeutics is also exploring other disease areas, including Metabolic Dysfunction Associated Steatotic Hepatitis (MASH) and chronic obstructive pulmonary disease (COPD). The company plans to initiate a Phase 2a clinical trial in the United States to further investigate Hydronidone's efficacy in treating advanced liver fibrosis associated with MASH. This trial aims to assess the drug's pharmacodynamic effects using non-invasive biomarkers over a 24-week period. Gyre's strategic focus on organ fibrosis and inflammatory diseases highlights its commitment to developing effective therapies for conditions with significant unmet medical needs.

United States

Gyre Therapeutics is a biotechnology company focused on organ fibrosis and inflammatory diseases. Gyre is planning a Phase 2 trial of Hydronidone for Nonalcoholic Steatohepatitis (NASH) in the United States based on encouraging safety and efficacy data from a Phase 2 trial in Hepatitis B-induced liver fibrosis in China. Gyre’s controlling interest in Beijing Continent provides additional pipeline assets across a variety of indications, including the approved drug pirfenidone.

Inflammatory disorders

Liver Diseases

Gyre Therapeutics

Chronic liver disease

Thrombocytopenia

Avatrombopag is an oral thrombopoietin receptor agonist (“TPO-RA”

Avatrombopag

Chronic hepatitis B

Liver fibrosis

F351 (Hydronidone): F351 is a structural derivative of the approved anti-fibrotic drug ETUARY (Pirfenidone) with a TGF-β1 mechanism of action and is currently being evaluated by Gyre for the treatment of nonalcoholic steatohepatitis (“NASH”)-associated liver fibrosis in the U.S. and by Gyre Pharmaceuticals for the treatment of chronic hepatitis B (“CHB”)-associated liver fibrosis in the PRC.

Gyre Therapeutics

Company Details