Gyre Therapeutics Advances Hydronidone Toward China Approval and Expands Clinical Pipeline

Gyre Therapeutics has demonstrated significant progress through the first three quarters of FY2025, according to a report by Noble Capital Markets Senior Vice President and Equity Research Analyst Robert LeBoyer. The company achieved continued sales growth from two recently launched products while advancing its clinical pipeline with Hydronidone, a drug targeting liver fibrosis conditions.

The company submitted an application for Hydronidone approval in China and simultaneously initiated a U.S. Phase 2 trial for the drug. Phase 3 data for Hydronidone in chronic hepatitis B-associated fibrosis successfully met its primary endpoint of fibrosis regression, providing strong support for the NMPA filing scheduled for the third quarter of 2025. With Breakthrough Therapy Designation status, regulatory approval is anticipated in the second half of 2026, followed by commercial launch in FY2027.

Gyre Therapeutics also strengthened its leadership by appointing Dr. Han Ying, who has served as a board member since January 2025, as the new CEO. The company's strategy leverages extensive experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In China, Gyre is advancing a broad therapeutic pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUAR(R) and development programs for F573, F528, and F230 compounds.

The progress reported by Noble Capital Markets highlights Gyre's dual-track approach to drug development, targeting both U.S. and Chinese markets simultaneously. The Hydronidone development program represents a significant advancement in treating liver fibrosis conditions, particularly given the high prevalence of chronic hepatitis B in Asian populations. The successful Phase 3 results and subsequent regulatory filings position Gyre Therapeutics as a emerging player in the hepatology therapeutics space. For additional information about the company's developments, visit https://www.gyretx.com/.