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Gyre Therapeutics Advances Hydronidone with Strong Clinical Progress and Leadership

Gyre Therapeutics reports strong FY2025 progress with Hydronidone for liver fibrosis, including China approval submission and U.S. Phase 2 trial initiation. Breakthrough therapy status accelerates potential treatment.

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.