Why Did Gyre Therapeutics Plunge 10.79% Despite Positive Trial Results?

On May 23, 2025, Gyre Therapeutics experienced a significant drop of 10.79% in pre-market trading, marking a notable shift in investor sentiment towards the biopharmaceutical company.

Gyre Therapeutics recently announced that its lead drug, Hydronidone, met the primary endpoint in a pivotal Phase 3 trial for the treatment of liver fibrosis in patients with chronic hepatitis B (CHB). The trial demonstrated a statistically significant regression in liver fibrosis, with 52.85% of patients receiving Hydronidone achieving at least a one-stage regression compared to 29.84% in the placebo group. This result underscores the drug's efficacy and potential as a breakthrough therapy.

The trial also achieved key secondary endpoints, including a significant improvement in liver inflammation without fibrosis progression. The safety profile of Hydronidone was favorable, with no discontinuations due to adverse events and a low incidence of serious adverse events. These findings support Gyre Therapeutics' plan to seek accelerated approval for Hydronidone in CHB-associated liver fibrosis, with a New Drug Application (NDA) submission to the NMPA expected in the third quarter of 2025.

Gyre Therapeutics is also advancing its clinical trials, with plans to initiate a Phase 2 trial in the United States for the treatment of metabolic-associated steatohepatitis (MASH) fibrosis. The company's strategic focus on liver diseases and its promising pipeline position it well for future growth and potential market leadership in this therapeutic area.