---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-000253"
form_type: "8-K"
ticker: "GYRE"
cik: "0001124105"
company_name: "GYRE THERAPEUTICS, INC."
filed_at: "2026-01-05T23:59:59+00:00"
generated_at: "2026-05-16T11:37:55.935491+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Gyre Therapeutics aligns with China's CDE on Hydronidone conditional approval pathway after Pre-NDA meeting

## Summary
- CDE agreed existing Phase 3 data for Hydronidone supports conditional approval NDA for CHB-associated liver fibrosis.
- CDE indicated Hydronidone meets priority review criteria; NDA submission planned for H1 2026.
- Company will conduct a confirmatory Phase 3c trial to support conversion from conditional to regular approval.
- Previously reported Phase 3 met primary endpoint: 52.85% treated vs 29.84% placebo achieved ≥1-stage fibrosis regression (p=0.0002).

## SEC filing metadata
- accession: 0001140361-26-000253
- form_type: 8-K
- ticker: GYRE
- cik: 0001124105
- company_name: GYRE THERAPEUTICS, INC.
- filed_at: 2026-01-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1124105/000114036126000253/0001140361-26-000253-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1124105/000114036126000253/ny20062326x1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-000253
- JSON: https://secwatch.observer/filing/0001140361-26-000253.json
- Plain text: https://secwatch.observer/filing/0001140361-26-000253.txt

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