Gyre Therapeutics: A Year of Milestones and Exciting Developments in 2025
Gyre Therapeutics, a self-sustaining, commercial-stage biotechnology company specializing in organ fibrosis, had an eventful year in 2025. In their Q4 and full-year financial results update, Gyre shared their expectations for several significant developments.
Clinical Trials and Regulatory Milestones
Firstly, in the field of Cholestatic Hepatitis B (CHB)-associated liver fibrosis, Gyre anticipates data from the pivotal Phase 3 trial in Q2 2025. This trial focuses on their investigational compound, F3101, which aims to treat liver fibrosis caused by this condition.
Additionally, the commercial launch of generic nintedanib for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and avatrombopag maleate tablets for the treatment of Chronic Liver Disease (CLD)-associated thrombocytopenia is expected in the People’s Republic of China (PRC) during 2025.
Regarding their clinical-stage portfolio, the initiation of a U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis is anticipated in 2025. This compound is designed to address liver fibrosis caused by Mitochondrial Associated Fatty Liver Disease (MASH).
Financial Projections and Guidance
On the financial side, Gyre shared full-year 2025 total revenue guidance of $118 to $128 million.
Impact on Patients and the World
For individuals living with CHB, IPF, CLD, and MASH, these developments represent potential new treatment options. The successful completion of the pivotal Phase 3 trial for F3101 could lead to a new therapy for CHB-associated liver fibrosis. Similarly, the commercial launch of generic nintedanib and avatrombopag maleate tablets in the PRC could provide more affordable treatment options for patients in that region.
The initiation of the U.S. Phase 2 trial for F351 could bring hope to those suffering from MASH-associated liver fibrosis. A successful trial could pave the way for a new treatment option in the future.
Conclusion
In summary, Gyre Therapeutics’ 2025 outlook is filled with potential milestones. The anticipated data from the pivotal Phase 3 trial for F3101, the commercial launches in the PRC, and the initiation of the U.S. Phase 2 trial for F351 represent significant progress for the company and could bring new treatment options to patients dealing with various forms of liver fibrosis.
- Pivotal Phase 3 trial data for F3101 in CHB-associated liver fibrosis expected in Q2 2025
- Commercial launch of generic nintedanib and avatrombopag maleate tablets in the PRC in 2025
- Initiation of U.S. Phase 2 trial for F351 in MASH-associated liver fibrosis in 2025
- Full-year 2025 total revenue guidance of $118 to $128 million
These developments could provide new hope for patients and contribute to the ongoing efforts to address liver fibrosis, a condition that affects millions of people worldwide.
