BeiGene announced that the China National Medical Products Administration (NMPA) has granted conditional approval to BeiGene’s anti-PD-1 antibody, tislelizumab, for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, including:

Patients with advanced colorectal cancer (CRC) who had been treated with fluoropyrimidine, oxaliplatin and irinotecan; and other advanced solid tumours who develop disease progression after prior treatment and have no satisfactory alternative treatment options.

“Results from the clinical trial of tislelizumab in patients with MSI-H and dMMR solid tumours demonstrated that tislelizumab’s treatment effect was consistent and durable across tumour types and endpoints. We are proud of this approval in China as it underscores our ongoing commitment to pursuing the full potential of tislelizumab and expanding its access where there is an unmet medical need,” commented Mark Lanasa, M.D., Ph.D., Senior Vice President, Chief Medical Officer, Solid Tumors, at BeiGene.

“With seven approved indications in China, our 3,100+ science-based commercial team is working to make tislelizumab more broadly available to those who may benefit from this important immunotherapy,” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China, at BeiGene. “Today’s approval is a great step for patients in China with MSI-H and dMMR solid tumours.”

“In the pivotal Phase 2 trial, we observed consistent responses across tumor types with tislelizumab and it was generally well-tolerated,” said Lin Shen, Ph.D., Vice President at the Beijing Cancer Hospital, and the principal investigator of the trial.