BeiGene seeks fifth China indication for tislelizumab

The Center for Drug Evaluation (CDE) website indicates that BeiGene Ltd (Nasdaq.BGNE; HKEX.06160) has filed yet another supplementary market approval (sNDA) for its programmed death-1 (PD-1) inhibitor tislelizumab. The new indication has not been officially confirmed at this stage, but could be one of hepatocellular carcinoma (HCC), extensive small-cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), gastric cancer, or nasopharyngeal carcinoma, based on clinical trials.

Tislelizumab earned a first market nod in China in December 2019 as a treatment for relapsed or refractory classic Hodgkin lymphoma (cHL), and was waved through to treat locally advanced or metastatic urothelial carcinoma (UC) in April this year. Supplementary market filings for the drug in first-line advanced non-small cell lung cancer (NSCLC) and first-line advanced non-squamous NSCLC were accepted for review in April and June this year respectively.

In China, BeiGene has initiated over 40 clinical trials for tislelizumab, including 27 Phase III and 11 Phase II studies, with targeted indications including lymphoma, breast cancer, and others.


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