{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-000253","form_type":"8-K","ticker":"GYRE","cik":"0001124105","company_name":"GYRE THERAPEUTICS, INC.","filed_at":"2026-01-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.566283+00:00","generated_at":"2026-05-16T11:37:55.935491+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Gyre Therapeutics aligns with China's CDE on Hydronidone conditional approval pathway after Pre-NDA meeting","bullets":["CDE agreed existing Phase 3 data for Hydronidone supports conditional approval NDA for CHB-associated liver fibrosis.","CDE indicated Hydronidone meets priority review criteria; NDA submission planned for H1 2026.","Company will conduct a confirmatory Phase 3c trial to support conversion from conditional to regular approval.","Previously reported Phase 3 met primary endpoint: 52.85% treated vs 29.84% placebo achieved ≥1-stage fibrosis regression (p=0.0002)."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-000253","json":"https://secwatch.observer/filing/0001140361-26-000253.json","markdown":"https://secwatch.observer/filing/0001140361-26-000253.md","text":"https://secwatch.observer/filing/0001140361-26-000253.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1124105/000114036126000253/0001140361-26-000253-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1124105/000114036126000253/ny20062326x1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:37:55.935491+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"}