{"schema_version":"secwatch.filing_event.v1","accession":"0001651308-22-000013","form_type":"8-K","ticker":"ONC","cik":"0001651308","company_name":"BeOne Medicines Ltd.","filed_at":"2022-02-02T23:59:59+00:00","discovered_at":"2026-05-14T18:04:07.578024+00:00","generated_at":"2026-06-27T12:22:43.397539+00:00","sec_items":["5.02","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"China accepts BRUKINSA sNDA for CLL/SLL with breakthrough therapy; board adds two directors","bullets":["China NMPA accepted sNDA for BRUKINSA (zanubrutinib) in CLL/SLL, supported by Phase 3 SEQUOIA trial (HR=0.42 for PFS vs B+R).","First breakthrough therapy designation for BRUKINSA in China; filing seeks expansion from relapsed/refractory to frontline use.","Director Jing-Shyh (Sam) Su resigned Jan 31, 2022; no disagreement disclosed.","Board expanded to 12; appointed Margaret Dugan, M.D. and Alessandro Riva, M.D. effective Feb 1, 2022.","New directors receive standard cash compensation ($60K/yr) and share options valued at $400K each, pro-rated first year."],"urls":{"canonical":"https://secwatch.observer/filing/0001651308-22-000013","json":"https://secwatch.observer/filing/0001651308-22-000013.json","markdown":"https://secwatch.observer/filing/0001651308-22-000013.md","text":"https://secwatch.observer/filing/0001651308-22-000013.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1651308/000165130822000013/0001651308-22-000013-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1651308/000165130822000013/bgne-20220128.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-27T12:22:43.397539+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":[{"claim_id":"28cc93c4c1","claim":"Jing-Shyh (Sam) Su resigned as Director at BeOne Medicines Ltd..","evidence_excerpt":"On January 31, 2022, Jing-Shyh (Sam) Su resigned from the Board of Directors (the “Board”) of BeiGene, Ltd. (the “Company”).","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1651308/000165130822000013/0001651308-22-000013-index.htm","confidence":0.95,"family_label":"Executive change","details":[{"label":"Action","value":"resigned"},{"label":"Role","value":"Director"}],"fact_type":"executive_change"},{"claim_id":"3d6b96ed26","claim":"Alessandro Riva was appointed as Director at BeOne Medicines Ltd..","evidence_excerpt":"On February 1, 2022, the Board enlarged the Board from 11 to 12 members and appointed Margaret Dugan, M.D. and Alessandro Riva, M.D. to fill the two vacancies.","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1651308/000165130822000013/0001651308-22-000013-index.htm","confidence":0.95,"family_label":"Executive change","details":[{"label":"Action","value":"appointed"},{"label":"Role","value":"Director"}],"fact_type":"executive_change"},{"claim_id":"e12091537c","claim":"Margaret Dugan was appointed as Director at BeOne Medicines Ltd..","evidence_excerpt":"On February 1, 2022, the Board enlarged the Board from 11 to 12 members and appointed Margaret Dugan, M.D. and Alessandro Riva, M.D. to fill the two vacancies.","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1651308/000165130822000013/0001651308-22-000013-index.htm","confidence":0.95,"family_label":"Executive change","details":[{"label":"Action","value":"appointed"},{"label":"Role","value":"Director"}],"fact_type":"executive_change"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}