Curated News
By: NewsRamp Editorial Staff
September 09, 2025
Gyre Therapeutics Advances Hydronidone with Strong Clinical Progress and Leadership
TLDR
- 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.
Impact - Why it Matters
This development matters because liver fibrosis affects millions worldwide, particularly those with chronic hepatitis B, and effective treatments remain limited. Gyre Therapeutics' progress with Hydronidone represents a potential breakthrough in addressing this serious medical condition. If approved, this therapy could significantly improve patient outcomes by reversing fibrosis progression, reducing the need for liver transplants, and decreasing healthcare costs associated with advanced liver disease. The company's expansion into both Chinese and U.S. markets indicates global potential for this treatment, while the Breakthrough Therapy Designation accelerates regulatory review, potentially bringing this innovative solution to patients faster.
Summary
Gyre Therapeutics (NASDAQ: GYRE) has demonstrated strong performance through the first three quarters of FY2025, as highlighted in a report by Noble Capital Markets Senior Vice President and Equity Research Analyst Robert LeBoyer. The San Diego-based biopharmaceutical company achieved continued sales growth from two recently launched products while making significant regulatory progress with its flagship drug Hydronidone. The company submitted an application for Hydronidone approval in China and initiated a U.S. Phase 2 trial, positioning itself for potential market expansion in both regions.
The company's clinical advancements are particularly noteworthy, with Phase 3 data for Hydronidone in chronic hepatitis B-associated fibrosis meeting its primary endpoint of fibrosis regression. This success supports the NMPA filing expected in 3Q25, and with Breakthrough Therapy Designation already secured, approval is anticipated in 2H26 followed by commercial launch in FY2027. Leadership changes also marked this period, as Dr. Han Ying, a board member since January 2025, was named CEO. Gyre's strategy leverages its expertise in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis, while its Chinese subsidiary Gyre Pharmaceuticals advances additional therapeutic candidates including ETUAR(R), F573, F528, and F230.
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Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Gyre Therapeutics Advances Hydronidone with Strong Clinical Progress and Leadership
