Gyre Therapeutics Reports Strong Progress in Liver Fibrosis Pipeline and Financial Performance
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 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. The biopharmaceutical company submitted an application for Hydronidone approval in China and initiated a U.S. Phase 2 trial for the drug. Phase 3 data for Hydronidone in chronic hepatitis B-associated fibrosis met its primary endpoint of fibrosis regression, supporting an 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. This regulatory progress represents a significant milestone for the treatment of liver fibrosis conditions. Gyre also appointed 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 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. More information about the company's developments can be found at https://www.gyretx.com/. The full research report detailing Gyre's progress is available at https://ibn.fm/9wCTAA. The company's advancements in liver fibrosis treatment represent important progress in addressing unmet medical needs in hepatology.
Curated from InvestorBrandNetwork (IBN)
