Gyre Therapeutics’ Hydronidone Met the Primary Endpoint and Demonstrated Statistically Significant Fibrosis Regression in Pivotal Phase 3 Trial for the Treatment of CHB-associated Liver Fibrosis in China

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 approva ...