---
schema_version: "secwatch.filing_event.v1"
accession: "0001651308-23-000141"
form_type: "8-K"
ticker: "ONC"
cik: "0001651308"
company_name: "BeOne Medicines Ltd."
filed_at: "2023-09-21T23:59:59+00:00"
generated_at: "2026-06-10T10:46:33.469517+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# BeiGene receives EC approval for TEVIMBRA in ESCC; FDA accepts BLA for first-line ESCC

## Summary
- EC approved TEVIMBRA (tislelizumab) as monotherapy for adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.
- FDA accepted BLA for tislelizumab as first-line treatment for unresectable, recurrent, locally advanced, or metastatic ESCC; target action date H2 2024.
- Approval based on RATIONALE 302 trial: median OS 8.6 vs 6.3 months (HR 0.70; p=0.0001) for TEVIMBRA vs chemotherapy.
- FDA also granted Orphan Drug Designation for tislelizumab in previously untreated advanced or metastatic ESCC.
- BeiGene recently regained full global rights to TEVIMBRA; more than 750,000 patients prescribed to date.

## SEC filing metadata
- accession: 0001651308-23-000141
- form_type: 8-K
- ticker: ONC
- cik: 0001651308
- company_name: BeOne Medicines Ltd.
- filed_at: 2023-09-21T23:59:59+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/1651308/000165130823000141/0001651308-23-000141-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1651308/000165130823000141/bgne-20230919.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001651308-23-000141
- JSON: https://secwatch.observer/filing/0001651308-23-000141.json
- Plain text: https://secwatch.observer/filing/0001651308-23-000141.txt

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