Gyre Therapeutics Advances Hydronidone Toward China Approval and Expands Clinical Pipeline

Gyre Therapeutics (NASDAQ: GYRE) has demonstrated strong 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 significant developments for its lead drug candidate Hydronidone.

The company submitted an application for Hydronidone approval in China and initiated a U.S. Phase 2 trial for the drug, marking important milestones in its global development strategy. Phase 3 data for Hydronidone in chronic hepatitis B-associated fibrosis met its primary endpoint of fibrosis regression, supporting the company's NMPA filing in the third quarter of 2025. With Breakthrough Therapy Designation, approval is anticipated in the second half of 2026, followed by commercial launch in FY2027.

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

The progress reflects Gyre Therapeutics' position as a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the United States. For more information on the company's developments, visit https://www.gyretx.com/. The full research report detailing these advancements can be accessed at https://ibn.fm/9wCTAA.