China's NMPA accepts sBLA for tislelizumab in nasopharyngeal cancer

Sino-America biotech firm BeiGene (Nasdaq: BGNE) today said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for its anti-PD-1 antibody tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC).

BeiGene’s shares gained 7.5% to $18.73 by mid-morning US trading today following the announcement.

“Treatment options for NPC, one of the most common head and neck cancers in China and many parts of Asia, are limited, with chemotherapy continuing to dominate front-line care. Supported by the positive RATIONALE 309 trial, the NMPA acceptance of this sBLA, which is the ninth for tislelizumab in China, represents an incredible milestone in its development history and serves as a validation of this potentially differentiated checkpoint inhibitor,” commented Dr Yong (Ben) Ben, chief medical officer, Immuno-Oncology at BeiGene, adding: “We look forward to bringing this important immunotherapy to the underserved NPC patient community in China.”