{"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","discovered_at":"2026-05-12T21:04:00.412098+00:00","generated_at":"2026-05-12T21:04:10.759285+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Gyre Therapeutics' NDA for F351 accepted by China's NMPA for CHB-induced liver fibrosis","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-020845","json":"https://secwatch.observer/filing/0001140361-26-020845.json","markdown":"https://secwatch.observer/filing/0001140361-26-020845.md","text":"https://secwatch.observer/filing/0001140361-26-020845.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-12T21:04:10.759285+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"}