secwatch.observer — SEC 8-K summary
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Issuer:     GYRE THERAPEUTICS, INC. (GYRE)
CIK:        0001124105
Form:       8-K
Filed at:   2026-03-23T23:59:59+00:00
Accession:  0001140361-26-010654
Event type: regulatory
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1124105/000114036126010654/0001140361-26-010654-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1124105/000114036126010654/ef20068482_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-010654

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