Gyre: Last patient completes trial evaluating F351 for CHB-liver fibrosis

Gyre Therapeutics (GYRE) announced that the last patient in Gyre Pharmaceuticals’ pivotal Phase 3 trial in the People’s Republic of China or PRC evaluating F351 hydronidone for Chronic Hepatitis B CHB -associated liver fibrosis has completed the 52-week study. Gyre Pharmaceuticals expects to report topline data from this trial by the first quarter of 2025. “The final patient completing our pivotal F351 Phase 3 trial marks an important milestone for Gyre and our development pipeline. We are grateful to the patients, researchers, trial investigators, and various teams who supported this trial and look forward to sharing data in the first quarter of 2025,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “Furthermore, we are excited to potentially use these results to spur initiation of our Phase 2 clinical trial in the United States evaluating F351 for Metabolic Dysfunction-Associated Steatohepatitis MASH -associated fibrosis in 2025.”…China’s National Medical Products Administration NMPA designated F351 as a “Breakthrough Therapy” in 2021.