---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-010654"
form_type: "8-K"
ticker: "GYRE"
cik: "0001124105"
company_name: "GYRE THERAPEUTICS, INC."
filed_at: "2026-03-23T23:59:59+00:00"
generated_at: "2026-05-15T09:19:38.283183+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Gyre Therapeutics subsidiary submits NDA in China for F351 for CHB-induced liver fibrosis

## Summary
- Gyre's majority-owned subsidiary Gyre Pharmaceuticals submitted NDA to China's CDE for lead candidate F351 (Hydronidone).
- F351 is for treatment of chronic hepatitis B (CHB)-induced liver fibrosis.
- NDA subject to formatting verification; CDE will issue acceptance number before technical review.
- Company will work with CDE on supplementary materials if requested.

## SEC filing metadata
- accession: 0001140361-26-010654
- form_type: 8-K
- ticker: GYRE
- cik: 0001124105
- company_name: GYRE THERAPEUTICS, INC.
- filed_at: 2026-03-23T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1124105/000114036126010654/0001140361-26-010654-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1124105/000114036126010654/ef20068482_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-010654
- JSON: https://secwatch.observer/filing/0001140361-26-010654.json
- Plain text: https://secwatch.observer/filing/0001140361-26-010654.txt

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