BRIEF—BeiGene gains 10th approval for tislelizumab in China

China’s National Medical Products Administration (NMPA) has granted approval for BeiGene’s tislelizumab, in combination with fluoropyrimidine and platinum chemotherapy, for the first-line treatment of patients with local- advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with high PD-L1 expression, marking the 10th indication authorized for the PD-1 inhibitor.

In China, gastric cancer (GC) has become the third most common cancer and adenocarcinoma represents the major histologic subtype, comprising over 90% of reported GC cases across the world.

More than 70% of patients in China are in advanced or late stage when diagnosed and the previous standard first-line treatment in China for advanced GC, chemotherapy, provided median overall survival (OS) around one year.

Newer treatments, including immunotherapy, have improved survival in this treatment setting.

Ex-China rights have been licensing to Swiss pharma giant Novartis, as part of a  2021 deal worth up to around $2 billion.