BeiGene Reports China NMPA's Approval Of Tislelizumab - Quick Facts

(RTTNews) - BeiGene, Ltd. (BGNE) announced the China National Medical Products Administration or NMPA has granted approval to the company's anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma who have disease progression or are intolerant to first-line standard chemotherapy. The approval was supported by results from a randomized, open-label, multi-center, global phase 3 clinical trial, RATIONALE 302.

Tislelizumab is also under regulatory review in the U.S. and the European Union, submitted by Novartis in their licensed territories.