Gyre Therapeutics Advances Hydronidone Toward China Approval and Expands Clinical Pipeline

Gyre Therapeutics 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 reported continued sales growth from two recently launched products while making significant advancements in its clinical pipeline.

The company submitted an application for Hydronidone approval in China following successful Phase 3 data showing the drug met its primary endpoint of fibrosis regression in chronic hepatitis B-associated fibrosis. This achievement supports the company's NMPA filing planned for the third quarter of 2025. With Breakthrough Therapy Designation already secured, regulatory approval is anticipated in the second half of 2026, followed by commercial launch in FY2027.

Concurrently, Gyre Therapeutics has initiated a U.S. Phase 2 trial for Hydronidone, expanding the drug's development footprint beyond China. The company's strategy builds on extensive experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis, positioning Hydronidone as a potential treatment for liver fibrosis conditions including MASH.

In leadership developments, the company appointed Dr. Han Ying, who has served as a board member since January 2025, as Chief Executive Officer. This leadership transition comes during a period of significant corporate growth and pipeline expansion.

Through its indirect controlling interest in Gyre Pharmaceuticals, the company is advancing a broad pipeline in the People's Republic of China that includes therapeutic expansions of ETUAR(R) and development programs for F573, F528, and F230. This diversified approach demonstrates the company's commitment to addressing multiple therapeutic areas within liver disease and fibrosis treatment.

The progress reported by Noble Capital Markets highlights Gyre Therapeutics' position as a biopharmaceutical company primarily focused on the development and commercialization of innovative treatments for liver fibrosis. The company's headquarters in San Diego, California serves as the base for its U.S. operations and clinical development activities.

For additional information on the company's developments and pipeline, interested parties can visit https://www.gyretx.com/. The full research report providing detailed analysis of Gyre Therapeutics' progress is available at https://ibn.fm/9wCTAA.