Gyre Therapeutics Inc., a biotechnology company focused on organ fibrosis, announced the successful completion of a pivotal Phase 3 trial for its lead compound, Hydronidone (F351), targeting liver fibrosis in patients with chronic hepatitis B $(CHB)$ in China. The 52-week, multicenter, double-blind, placebo-controlled trial enrolled 248 patients and demonstrated a statistically significant regression in fibrosis, with a ≥1-stage improvement at Week 52 for 52.85% of patients compared to 29.84% in the placebo group (P=0.0002). The trial also showed a favorable safety profile, with serious adverse events occurring in 4.88% of the treatment group compared to 6.45% in the placebo group, and no discontinuations due to adverse events. Based on these results, Gyre plans to file a New Drug Application (NDA) with China's National Medical Products Administration (NMPA) in the third quarter of 2025 and intends to seek accelerated approval for Hydronidone in CHB fibrosis. Additionally, a U.S. Phase 2 trial for MASH-associated liver fibrosis is expected to begin in the second half of 2025, pending investigational new drug $(IND.AU)$ application clearance.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.