---
schema_version: "secwatch.filing_event.v1"
accession: "0001651308-24-000039"
form_type: "8-K"
ticker: "ONC"
cik: "0001651308"
company_name: "BeOne Medicines Ltd."
filed_at: "2024-04-23T23:59:59+00:00"
generated_at: "2026-06-03T11:58:58.411909+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# EC approves BeiGene's tislelizumab for three NSCLC indications in EU

## Summary
- EC approved tislelizumab on April 23, 2024 for first-line squamous NSCLC, first-line non-squamous PD-L1≥50%, and second-line after prior platinum therapy.
- Approval based on three Phase 3 RATIONALE trials (307, 304, 303) enrolling 1,499 patients, showing PFS and OS benefits.
- This is tislelizumab's second EU approval; previously approved for ESCC; brand will unify under TEVIMBRA later in 2024.
- BeiGene plans to launch in first EU countries in 2024; over 900,000 patients prescribed tislelizumab globally.

## SEC filing metadata
- accession: 0001651308-24-000039
- form_type: 8-K
- ticker: ONC
- cik: 0001651308
- company_name: BeOne Medicines Ltd.
- filed_at: 2024-04-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1651308/000165130824000039/0001651308-24-000039-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1651308/000165130824000039/bgne-20240423.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001651308-24-000039
- JSON: https://secwatch.observer/filing/0001651308-24-000039.json
- Plain text: https://secwatch.observer/filing/0001651308-24-000039.txt

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