#Gyre Therapeutics Pioneers New Hope Hydronidones Breakthrough in Liver Fibrosis Treatment

Release - 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 - Channelchek

Research News and Market Data on GYRE May 22, 2025 PDF Version 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 supp…

#Gyre Therapeutics Pioneers New Hope Hydronidones Breakthrough in Liver Fibrosis Treatment

In a landmark achievement recently reported by Gyre Therapeutics Inc. (NASDAQ: GYRE), the company's lead candidate, Hydronidone, has successfully met its primary endpoint in a pivotal Phase 3 trial aimed at treating chronic hepatitis B (CHB)-associated liver fibrosis in China. This remarkable finding signals a turning point in the field of liver disease treatment, opening new avenues for patients suffering from this debilitating condition. Hydro…

Hydronidone Meets Primary Endpoint in Phase 3 Hepatitis B Trial

Gyre Therapeutics plans to file an NDA in China based on the phase 3 CHB data and, pending IND clearance, is looking to initiate a phase 2 MASH fibrosis trial in the US.