Core Insights - Gyre Therapeutics has published findings indicating that hydronidone, a novel derivative of pirfenidone, shows promise in treating liver fibrosis by inducing apoptosis in activated hepatic stellate cells (HSCs) through the endoplasmic reticulum stress-associated mitochondrial apoptotic pathway [2][3] Company Overview - Gyre Therapeutics is a clinical-stage biotechnology company focused on developing anti-fibrotic therapeutics for chronic organ diseases, with its lead candidate being F351 (Hydronidone) for treating NASH-associated fibrosis in the U.S. [4] - The company is advancing a diverse pipeline in the People's Republic of China (PRC) through its indirect controlling interest in Gyre Pharmaceuticals, which includes therapeutic expansions and other candidates [4] Research and Development - The recent study published in the Journal of Gastroenterology and Hepatology supports the potential of hydronidone as a therapy for liver fibrosis, demonstrating significant apoptosis in activated HSCs in both in vivo and in vitro models [2][3] - Gyre Pharmaceuticals is currently conducting a Phase 3 trial in the PRC for hydronidone's efficacy in treating Chronic Hepatitis B (CHB)-associated liver fibrosis, with topline data expected by early 2025 [7] - The trial involves 248 patients, aiming for a primary endpoint of reducing the liver fibrosis score by at least one grade after treatment with hydronidone in combination with entecavir [7]
Gyre Therapeutics Announces Publication in Journal of Gastroenterology and Hepatology