{"schema_version":"secwatch.filing_event.v1","accession":"0001651308-24-000028","form_type":"8-K","ticker":"ONC","cik":"0001651308","company_name":"BeOne Medicines Ltd.","filed_at":"2024-03-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.982223+00:00","generated_at":"2026-06-04T17:21:36.708168+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA approves BeiGene's TEVIMBRA for ESCC after prior chemo; available H2 2024","bullets":["FDA approved TEVIMBRA (tislelizumab) for ESCC after prior chemo; first US indication; available H2 2024.","Approval based on RATIONALE 302: median OS 8.6 vs 6.3 months (HR=0.70, p=0.0001).","FDA also reviewing BLAs for first-line ESCC (target July 2024) and G/GEJ adenocarcinoma (target Dec 2024).","Over 900,000 patients prescribed TEVIMBRA globally; 17+ registration-enabling trials ongoing.","Safety profile favorable over chemo; common adverse reactions include increased glucose, decreased hemoglobin, fatigue."],"urls":{"canonical":"https://secwatch.observer/filing/0001651308-24-000028","json":"https://secwatch.observer/filing/0001651308-24-000028.json","markdown":"https://secwatch.observer/filing/0001651308-24-000028.md","text":"https://secwatch.observer/filing/0001651308-24-000028.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1651308/000165130824000028/0001651308-24-000028-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1651308/000165130824000028/bgne-20240314.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T17:21:36.708168+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"}