---
schema_version: "secwatch.filing_event.v1"
accession: "0001651308-22-000089"
form_type: "8-K"
ticker: "ONC"
cik: "0001651308"
company_name: "BeOne Medicines Ltd."
filed_at: "2022-06-22T23:59:59+00:00"
generated_at: "2026-06-25T00:00:50.413343+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# BeiGene's NMPA accepts sBLA for tislelizumab in first-line PD-L1+ gastric cancer

## Summary
- CDE of NMPA accepted sBLA for tislelizumab + chemo as first-line treatment for advanced G/GEJ adenocarcinoma with PD-L1 expression.
- Submission supported by interim analysis of global Phase 3 RATIONALE 305 trial showing survival benefit.
- This is the 10th regulatory submission for tislelizumab in China; it is already approved for 9 indications there.
- Tislelizumab is also under FDA and EMA review for ESCC and NSCLC; partnered with Novartis in North America, Europe, Japan.
- Gastric cancer is the 2nd leading cause of cancer death in China; few options exist for metastatic disease.

## SEC filing metadata
- accession: 0001651308-22-000089
- form_type: 8-K
- ticker: ONC
- cik: 0001651308
- company_name: BeOne Medicines Ltd.
- filed_at: 2022-06-22T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 5.02, 5.07, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1651308/000165130822000089/0001651308-22-000089-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1651308/000165130822000089/bgne-20220621.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001651308-22-000089
- JSON: https://secwatch.observer/filing/0001651308-22-000089.json
- Plain text: https://secwatch.observer/filing/0001651308-22-000089.txt

## Key facts
- Executive change
  Timothy Chen resigned as Director at BeOne Medicines Ltd..
  - Action: resigned
  - Role: Director
  source text: On June 22, 2022, Timothy Chen resigned from the Board of Directors (the “Board”) of BeiGene, Ltd. (the “Company”).
  evidence_url: https://www.sec.gov/Archives/edgar/data/1651308/000165130822000089/0001651308-22-000089-index.htm

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