Gyre's Hydronidone meets Phase 3 primary endpoint with 52.85% fibrosis regression vs 29.84% placebo (p=0.0002)

GYRE THERAPEUTICS, INC.

Phase 3 trial met primary endpoint: ≥1-stage Ishak fibrosis regression at Week 52 (52.85% vs 29.84%, p=0.0002).
NDA submission to China's NMPA expected in Q3 2025; Breakthrough Therapy designation granted in 2021.
U.S. Phase 2 trial in MASH-associated fibrosis to begin in 2H2025; IND planned for Q3 2025.
Safety comparable to placebo: 4.88% serious AEs vs 6.45%; no discontinuations due to AEs.
248 patients enrolled across 39 hospitals in China; key secondary endpoint also statistically significant (p=0.0246).

item 7.01item 8.01item 9.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.