Gyre Therapeutics' Hydronidone Meets Primary Endpoint In Pivotal Phase 3 Trial Evaluating Efficacy And Safety For Treatment Of Liver Fibrosis In Patients With Chronic Hepatitis B In China

Author: Benzinga Newsdesk | May 22, 2025 03:03pm

• Achieved statistically significant ≥1-stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002).
• Demonstrated favorable safety and tolerability profile: 4.88% serious adverse events vs. 6.45% for placebo; zero discontinuations due to adverse events.
• Breakthrough Therapy Designation granted by China's National Medical Products Administration ("NMPA") in 2021 supports potential first-in-class approval in CHB-associated liver fibrosis ("CHB fibrosis").
• Gyre intends to seek accelerated approval for Hydronidone in CHB fibrosis, with a New Drug Application ("NDA") submission to the NMPA expected in Q3 2025.
• U.S. Phase 2 trial in MASH-associated liver fibrosis expected to begin in 2H2025.

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that its lead compound, Hydronidone (F351), met the primary endpoint in a pivotal Phase 3 trial evaluating its efficacy and safety for the treatment of liver fibrosis in patients with chronic hepatitis B ("CHB") in China.

The 52-week, multicenter, double-blind, placebo-controlled trial enrolled 248 patients with CHB fibrosis across 39 hospitals in China. Patients were randomized 1:1 to receive either Hydronidone (270 mg/day, orally) or placebo, in addition to background entecavir antiviral therapy. The trial met its primary endpoint, with a statistically significant proportion of patients receiving Hydronidone achieving a ≥1-stage regression in liver fibrosis compared to placebo (P=0.0002). These results are consistent with the efficacy and safety outcomes observed in Gyre's prior Phase 2 trial.

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