---
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"
generated_at: "2026-05-15T20:14:58.350432+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# BeOne Medicines gets FDA accelerated approval for BEQALZI (sonrotoclax) in R/R MCL

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001651308-26-000012
- JSON: https://secwatch.observer/filing/0001651308-26-000012.json
- Plain text: https://secwatch.observer/filing/0001651308-26-000012.txt

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