---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-020845"
form_type: "8-K"
ticker: "GYRE"
cik: "0001124105"
company_name: "GYRE THERAPEUTICS, INC."
filed_at: "2026-05-12T21:03:02+00:00"
generated_at: "2026-05-12T21:04:10.759285+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Gyre Therapeutics' NDA for F351 accepted by China's NMPA for CHB-induced liver fibrosis

## Summary
- NDA for F351 (hydronidone) accepted by CDE of China's NMPA for chronic hepatitis B-induced liver fibrosis.
- NMPA granted priority review status in March 2026; this is Gyre's first NDA for the F351 program.
- If approved, F351 could address tens of millions of HBV patients in China at risk of fibrosis and cirrhosis.
- Dr. Ying Luo noted positive CDE interactions and the potential of F351 as an innovative therapeutic option.

## SEC filing metadata
- accession: 0001140361-26-020845
- form_type: 8-K
- ticker: GYRE
- cik: 0001124105
- company_name: GYRE THERAPEUTICS, INC.
- filed_at: 2026-05-12T21:03:02+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1124105/000114036126020845/0001140361-26-020845-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1124105/000114036126020845/ef20073066_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-020845
- JSON: https://secwatch.observer/filing/0001140361-26-020845.json
- Plain text: https://secwatch.observer/filing/0001140361-26-020845.txt

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