NVSEF - BeiGene adds 12% as anti-PD-1 Inhibitor undergoes regulatory review in China

The ADRs of BeiGene (NASDAQ:BGNE) gained 12% in the pre-market Tuesday after the biotech announced that regulators in China have accepted a marketing application for drug combination involving its anti-PD-1 inhibitor, tislelizumab. With the supplemental biologics license application (sBLA), BeiGene (BGNE) has sought approval for tislelizumab, in combination with chemotherapy as a first-line treatment for certain patients with gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. China’s National Medical Products Administration has already approved tislelizumab for nine indications. The humanized IgG4 anti-PD-1 monoclonal antibody is not approved outside China. However, the drug is currently under regulatory review in the U.S. and EU for advanced or metastatic ESCC after prior chemotherapy. In January 2021, Novartis (NVS) (OTCPK:NVSEF) partnered with BeiGene (BGNE)for development and commercialization of tislelizumab in North America, Europe, and Japan.

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BeiGene adds 12% as anti-PD-1 Inhibitor undergoes regulatory review in China