Gyre Therapeutics, Inc. released an updated corporate presentation detailing its clinical pipeline, upcoming catalysts, and commercial operations. The company provided full-year 2026 revenue guidance for its commercial product ETUARY™ and highlighted a potential early 2027 launch for its liver fibrosis drug candidate, F351, in China.
Key Details
- FY26 Revenue Guidance: The company issued FY2026 total revenue guidance for ETUARY™ (pirfenidone) of $100.5 million to $111.0 million.
- F351 (Hydronidone) Update: The New Drug Application (NDA) for F351 in Chronic Hepatitis B (CHB)-induced liver fibrosis was accepted by China's NMPA in May 2026. A potential launch is anticipated in early 2027 following the regulatory decision.
- Upcoming Clinical Milestones: Gyre plans to submit IND applications for two targeted protein degrader candidates in Q1 2027: CG923308 for CDK4/6i-resistant cancers and CG620953 for autoimmune diseases (SLE & RA).