BioMedNewsBreaks — Gyre Therapeutics (NASDAQ: GYRE) Advances Toward China Approval and Expands Clinical Pipeline With Hydronidone

Gyre Therapeutics (NASDAQ: GYRE) has made 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 posted continued sales growth from two recently launched products, submitted an application for Hydronidone approval in China, and initiated a U.S. Phase 2 trial for the drug. Gyre also named Dr. Han Ying, a board member since January 2025, as CEO. Phase 3 data for Hydronidone in chronic hepatitis B-associated fibrosis met its primary endpoint of fibrosis regression, supporting an NMPA filing in 3Q25. With Breakthrough Therapy Designation, approval is anticipated in 2H26, followed by commercial launch in FY2027.

To view the full report, visit https://ibn.fm/9wCTA

About Gyre Therapeutics

Gyre Therapeutics is 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 Gyre’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.

For more information on Gyre Therapeutics please visit https://www.gyretx.com/

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