Gyre Therapeutics announced on May 22, 2025, that its lead compound, Hydronidone (F351), met the primary endpoint in a pivotal Phase 3 trial for liver fibrosis in patients with chronic hepatitis B (CHB) in China. The trial demonstrated a statistically significant proportion of patients receiving Hydronidone achieved a ≥1-stage regression in liver fibrosis compared to placebo (P=0.0002).
The 52-week, multicenter, double-blind, placebo-controlled trial enrolled 248 patients across 39 hospitals in China. Hydronidone was well tolerated, with a comparable incidence of serious adverse events (4.88% vs. 6.45% in the placebo group) and no discontinuations due to adverse events.
These positive results are consistent with prior Phase 2 trial outcomes and position Hydronidone as a potential first therapy specifically indicated for reversing liver fibrosis in CHB patients in China, an addressable market of approximately 2.6 million patients. Gyre plans to file a New Drug Application (NDA) with China’s NMPA in the third quarter of 2025.
Building on this success, the company is preparing to file an Investigational New Drug (IND) application in the U.S. in the third quarter of 2025. Subject to IND clearance, Gyre plans to initiate a Phase 2 trial in the U.S. evaluating Hydronidone for the treatment of MASH-associated fibrosis in the second half of 2025.
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