---
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"
generated_at: "2026-06-27T12:22:43.397539+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# China accepts BRUKINSA sNDA for CLL/SLL with breakthrough therapy; board adds two directors

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 5.02, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001651308-22-000013
- JSON: https://secwatch.observer/filing/0001651308-22-000013.json
- Plain text: https://secwatch.observer/filing/0001651308-22-000013.txt

## Key facts
- Executive change
  Jing-Shyh (Sam) Su resigned as Director at BeOne Medicines Ltd..
  - Action: resigned
  - Role: Director
  source text: On January 31, 2022, Jing-Shyh (Sam) Su resigned from the Board of Directors (the “Board”) of BeiGene, Ltd. (the “Company”).
  evidence_url: https://www.sec.gov/Archives/edgar/data/1651308/000165130822000013/0001651308-22-000013-index.htm
- Executive change
  Alessandro Riva was appointed as Director at BeOne Medicines Ltd..
  - Action: appointed
  - Role: Director
  source text: 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_url: https://www.sec.gov/Archives/edgar/data/1651308/000165130822000013/0001651308-22-000013-index.htm
- Executive change
  Margaret Dugan was appointed as Director at BeOne Medicines Ltd..
  - Action: appointed
  - Role: Director
  source text: 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_url: https://www.sec.gov/Archives/edgar/data/1651308/000165130822000013/0001651308-22-000013-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.