Gyre Therapeutics announces Hydronidone trial met primary endpoint

Gyre Therapeutics (GYRE) announced that its lead compound, Hydronidone, 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 in China. The efficacy analysis followed the intent-to-treat principle. The ITT population comprised all randomized subjects who received at least one dose of study drug. One randomized subject who did not receive any treatment was excluded. All biopsies were independently reviewed by three blinded central pathologists to ensure consistency and objectivity of fibrosis and inflammation assessments. In the ITT population, Hydronidone demonstrated statistically significant regression in liver fibrosis compared to placebo. Hydronidone was well tolerated, with a comparable incidence of serious adverse events and no discontinuations due to adverse events in either group. Most adverse events were mild or moderate and unrelated to Hydronidone, while a small number of severe adverse events occurred, none of which were considered related to the trial drug. Gyre plans to submit primary results for publication in a peer-reviewed journal and present full trial results at a future medical congress. Based on these positive results, Gyre plans to file an NDA with China’s NMPA in the third quarter of 2025. In parallel, the Company is actively preparing to file an investigational new drug application in the third quarter of 2025 and, subject to IND clearance, plans to initiate a Phase 2 trial in the U.S. evaluating Hydronidone for the treatment of MASH-associated fibrosis in the second half of 2025. A prior U.S. Phase 1 trial in healthy volunteers confirmed Hydronidone’s tolerability and demonstrated a pharmacokinetic profile consistent with the Chinese population.