Gyre Therapeutics released an updated corporate presentation outlining its commercial and clinical strategy, including full-year 2026 revenue guidance for its commercial product ETUARY™ and key upcoming milestones for its pipeline, notably the recent NDA acceptance for F351 in China.
Key Details
- FY2026 Revenue Guidance: The company projects total revenue for ETUARY™ to be between $100.5 million and $111 million for the full year 2026.
- F351 (Hydronidone) Update: The New Drug Application (NDA) for F351 for Chronic Hepatitis B-induced liver fibrosis was accepted for priority review by China's NMPA in May 2026. A potential commercial launch is anticipated in early 2027.
- Pipeline Catalysts: The company expects to submit Investigational New Drug (IND) applications in Q1 2027 for two key degrader candidates: CG923308 (CDK2/Cyclin E for cancer) and CG620953 (TYK2/JAK1 for autoimmune diseases).