{"schema_version":"secwatch.filing_event.v1","accession":"0001651308-26-000012","form_type":"8-K","ticker":"ONC","cik":"0001651308","company_name":"BeOne Medicines Ltd.","filed_at":"2026-05-15T20:08:07+00:00","discovered_at":"2026-05-15T20:14:00.220925+00:00","generated_at":"2026-05-15T20:14:58.350432+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"BeOne Medicines gets FDA accelerated approval for BEQALZI (sonrotoclax) in R/R MCL","bullets":["FDA approved BEQALZI for R/R mantle cell lymphoma after ≥2 prior therapies including a BTK inhibitor.","Phase 1/2 trial showed ORR 52%, CR 16%, median DOR 15.8 months; safety generally well tolerated.","Continued approval contingent on confirmatory CELESTIAL-RRMCL trial (NCT06742996) now underway.","BEQALZI is the first new BCL2 inhibitor approved in the U.S. in a decade and the only one for MCL.","Also approved in China for R/R MCL and CLL/SLL; EMA review ongoing; Fast Track for Waldenström."],"urls":{"canonical":"https://secwatch.observer/filing/0001651308-26-000012","json":"https://secwatch.observer/filing/0001651308-26-000012.json","markdown":"https://secwatch.observer/filing/0001651308-26-000012.md","text":"https://secwatch.observer/filing/0001651308-26-000012.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1651308/000165130826000012/0001651308-26-000012-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1651308/000165130826000012/bgne-20260513.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T20:14:58.350432+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"}