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

BeOne Medicines Ltd.

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.

item 5.02 item 5.07 item 8.01 item 9.01

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Departed

Timothy Chen

Director

ONC · BeOne Medicines Ltd.

Effective: 2022-06-22
Filed: June 22, 2022, 7:59 PM ET

On June 22, 2022, Timothy Chen resigned from the Board of Directors (the “Board”) of BeiGene, Ltd. (the “Company”).

Key facts

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Executive change SEC 8-K Item 5.02 confidence 0.95

Timothy Chen resigned as Director at BeOne Medicines Ltd..

Action: resigned
Role: Director

Exact text from the filing

On June 22, 2022, Timothy Chen resigned from the Board of Directors (the “Board”) of BeiGene, Ltd. (the “Company”).

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Source: SEC EDGAR

accession 0001651308-22-000089

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