{"schema_version":"secwatch.filing_event.v1","accession":"0001651308-24-000039","form_type":"8-K","ticker":"ONC","cik":"0001651308","company_name":"BeOne Medicines Ltd.","filed_at":"2024-04-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.432409+00:00","generated_at":"2026-06-03T11:58:58.411909+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"EC approves BeiGene's tislelizumab for three NSCLC indications in EU","bullets":["EC approved tislelizumab on April 23, 2024 for first-line squamous NSCLC, first-line non-squamous PD-L1≥50%, and second-line after prior platinum therapy.","Approval based on three Phase 3 RATIONALE trials (307, 304, 303) enrolling 1,499 patients, showing PFS and OS benefits.","This is tislelizumab's second EU approval; previously approved for ESCC; brand will unify under TEVIMBRA later in 2024.","BeiGene plans to launch in first EU countries in 2024; over 900,000 patients prescribed tislelizumab globally."],"urls":{"canonical":"https://secwatch.observer/filing/0001651308-24-000039","json":"https://secwatch.observer/filing/0001651308-24-000039.json","markdown":"https://secwatch.observer/filing/0001651308-24-000039.md","text":"https://secwatch.observer/filing/0001651308-24-000039.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1651308/000165130824000039/0001651308-24-000039-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1651308/000165130824000039/bgne-20240423.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-03T11:58:58.411909+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"}