---
schema_version: "secwatch.filing_event.v1"
accession: "0001651308-24-000028"
form_type: "8-K"
ticker: "ONC"
cik: "0001651308"
company_name: "BeOne Medicines Ltd."
filed_at: "2024-03-15T23:59:59+00:00"
generated_at: "2026-06-04T17:21:36.708168+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA approves BeiGene's TEVIMBRA for ESCC after prior chemo; available H2 2024

## Summary
- FDA approved TEVIMBRA (tislelizumab) for ESCC after prior chemo; first US indication; available H2 2024.
- Approval based on RATIONALE 302: median OS 8.6 vs 6.3 months (HR=0.70, p=0.0001).
- FDA also reviewing BLAs for first-line ESCC (target July 2024) and G/GEJ adenocarcinoma (target Dec 2024).
- Over 900,000 patients prescribed TEVIMBRA globally; 17+ registration-enabling trials ongoing.
- Safety profile favorable over chemo; common adverse reactions include increased glucose, decreased hemoglobin, fatigue.

## SEC filing metadata
- accession: 0001651308-24-000028
- form_type: 8-K
- ticker: ONC
- cik: 0001651308
- company_name: BeOne Medicines Ltd.
- filed_at: 2024-03-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1651308/000165130824000028/0001651308-24-000028-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1651308/000165130824000028/bgne-20240314.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001651308-24-000028
- JSON: https://secwatch.observer/filing/0001651308-24-000028.json
- Plain text: https://secwatch.observer/filing/0001651308-24-000028.txt

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