{"schema_version":"secwatch.filing_event.v1","accession":"0001651308-23-000141","form_type":"8-K","ticker":"ONC","cik":"0001651308","company_name":"BeOne Medicines Ltd.","filed_at":"2023-09-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.719824+00:00","generated_at":"2026-06-10T10:46:33.469517+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":"BeiGene receives EC approval for TEVIMBRA in ESCC; FDA accepts BLA for first-line ESCC","bullets":["EC approved TEVIMBRA (tislelizumab) as monotherapy for adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.","FDA accepted BLA for tislelizumab as first-line treatment for unresectable, recurrent, locally advanced, or metastatic ESCC; target action date H2 2024.","Approval based on RATIONALE 302 trial: median OS 8.6 vs 6.3 months (HR 0.70; p=0.0001) for TEVIMBRA vs chemotherapy.","FDA also granted Orphan Drug Designation for tislelizumab in previously untreated advanced or metastatic ESCC.","BeiGene recently regained full global rights to TEVIMBRA; more than 750,000 patients prescribed to date."],"urls":{"canonical":"https://secwatch.observer/filing/0001651308-23-000141","json":"https://secwatch.observer/filing/0001651308-23-000141.json","markdown":"https://secwatch.observer/filing/0001651308-23-000141.md","text":"https://secwatch.observer/filing/0001651308-23-000141.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1651308/000165130823000141/0001651308-23-000141-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1651308/000165130823000141/bgne-20230919.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T10:46:33.469517+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"}