Gyre Therapeutics Advances Hydronidone Toward China Approval and Expands Clinical Pipeline
TL;DR
Gyre Therapeutics gains competitive edge with Hydronidone's Breakthrough Therapy Designation and anticipated 2026 approval, positioning it for leadership in liver fibrosis treatment.
Gyre Therapeutics submitted Hydronidone for NMPA approval in China, initiated a U.S. Phase 2 trial, and reported positive Phase 3 data meeting fibrosis regression endpoints.
Hydronidone's approval could significantly improve outcomes for chronic hepatitis B patients with liver fibrosis, enhancing global healthcare and patient quality of life.
Gyre Therapeutics appointed Dr. Han Ying as CEO while advancing Hydronidone through clinical trials with Breakthrough Therapy Designation for liver fibrosis treatment.
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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 biopharmaceutical company posted continued sales growth from two recently launched products while advancing its lead candidate Hydronidone through key regulatory and clinical milestones.
The company submitted an application for Hydronidone approval in China and initiated a U.S. Phase 2 trial for the drug, marking significant steps 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 National Medical Products Administration (NMPA) filing expected in the third quarter of 2025.
With Breakthrough Therapy Designation already secured, approval for Hydronidone is anticipated in the second half of 2026, followed by commercial launch in FY2027. This timeline positions Gyre Therapeutics to potentially bring a new treatment option to patients suffering from liver fibrosis conditions, including metabolic dysfunction-associated steatohepatitis (MASH).
The company also strengthened its leadership by naming Dr. Han Ying, a board member since January 2025, as CEO. This leadership transition comes at a critical time as the company expands its clinical pipeline and prepares for potential market entry in China.
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 company's strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis.
For investors and industry observers seeking detailed analysis, the full research report is available at https://ibn.fm/9wCTA. Additional information about Gyre Therapeutics' development programs and corporate strategy can be found at https://www.gyretx.com/.
The progress reported by Gyre Therapeutics represents important developments in the liver disease treatment landscape, particularly given the growing global prevalence of liver fibrosis conditions. Successful approval and commercialization of Hydronidone could provide new therapeutic options for patients while establishing Gyre as a significant player in the hepatology space.
Curated from InvestorBrandNetwork (IBN)
