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.