{"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","discovered_at":"2026-05-14T18:02:34.566773+00:00","generated_at":"2026-05-15T09:19:38.283183+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Gyre Therapeutics subsidiary submits NDA in China for F351 for CHB-induced liver fibrosis","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-010654","json":"https://secwatch.observer/filing/0001140361-26-010654.json","markdown":"https://secwatch.observer/filing/0001140361-26-010654.md","text":"https://secwatch.observer/filing/0001140361-26-010654.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T09:19:38.283183+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}