{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-020157","form_type":"8-K","ticker":"GYRE","cik":"0001124105","company_name":"GYRE THERAPEUTICS, INC.","filed_at":"2025-05-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.584884+00:00","generated_at":"2026-05-20T17:31:38.701717+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Gyre's Hydronidone meets Phase 3 primary endpoint with 52.85% fibrosis regression vs 29.84% placebo (p=0.0002)","bullets":["Phase 3 trial met primary endpoint: ≥1-stage Ishak fibrosis regression at Week 52 (52.85% vs 29.84%, p=0.0002).","NDA submission to China's NMPA expected in Q3 2025; Breakthrough Therapy designation granted in 2021.","U.S. Phase 2 trial in MASH-associated fibrosis to begin in 2H2025; IND planned for Q3 2025.","Safety comparable to placebo: 4.88% serious AEs vs 6.45%; no discontinuations due to AEs.","248 patients enrolled across 39 hospitals in China; key secondary endpoint also statistically significant (p=0.0246)."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-020157","json":"https://secwatch.observer/filing/0001140361-25-020157.json","markdown":"https://secwatch.observer/filing/0001140361-25-020157.md","text":"https://secwatch.observer/filing/0001140361-25-020157.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1124105/000114036125020157/0001140361-25-020157-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1124105/000114036125020157/ef20048898_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T17:31:38.701717+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"}