Gyre Therapeutics is gearing up for a year of significant milestones in 2025, with key data readouts and product launches anticipated. The company's lead investigational drug, F351, is currently in a Phase 3 trial for Chronic Hepatitis B (CHB)-associated liver fibrosis and is expected to yield topline results in the first quarter of 2025.
F351 Clinical Trials
The Phase 3 trial of F351 enrolled 248 patients across 39 clinical research hospitals in China. Participants were randomized 1:1 to receive either F351 or a placebo, in addition to entecavir antiviral basic therapy for CHB. F351 represents a novel anti-fibrotic therapy, and positive results from this trial could pave the way for a Phase 2 trial in metabolic dysfunction-associated steatohepatitis (MASH)-associated liver fibrosis in the U.S. in 2025.
Expanding Pipeline
Beyond F351, Gyre Therapeutics has several other assets in its pipeline. F573, a caspase inhibitor, is currently in a Phase 2 clinical trial in China for acute liver failure. Additionally, F230, a selective endothelin receptor agonist for pulmonary arterial hypertension (PAH), is expected to advance into a Phase 1 trial this year.
Commercial Launches
Gyre is also preparing for the commercial launch of Avatrombopag maleate tablets and Nintedanib in China in 2025. Avatrombopag maleate is intended for the treatment of thrombocytopenia associated with chronic liver disease (CLD) in adult patients undergoing elective diagnostic procedures or therapy. Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis. These launches will complement Gyre's existing product portfolio, which includes ETUARY (Pirfenidone), already approved for idiopathic pulmonary fibrosis (IPF) in China.
Financial Position
For the third quarter of 2024, Gyre reported revenues of $25.5 million, a decrease from $32 million in the same period in 2023, primarily due to reduced anti-fibrosis drug sales linked to economic conditions in China. As of September 30, 2024, the company reported cash and equivalents of $15.9 million, which is expected to support operations through at least 2025.
