---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-020157"
form_type: "8-K"
ticker: "GYRE"
cik: "0001124105"
company_name: "GYRE THERAPEUTICS, INC."
filed_at: "2025-05-22T23:59:59+00:00"
generated_at: "2026-05-20T17:31:38.701717+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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).

## SEC filing metadata
- accession: 0001140361-25-020157
- form_type: 8-K
- ticker: GYRE
- cik: 0001124105
- company_name: GYRE THERAPEUTICS, INC.
- filed_at: 2025-05-22T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1124105/000114036125020157/0001140361-25-020157-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1124105/000114036125020157/ef20048898_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-020157
- JSON: https://secwatch.observer/filing/0001140361-25-020157.json
- Plain text: https://secwatch.observer/filing/0001140361-25-020157.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.