BRIEF—BeiGene applies for Chinese approval for tislelizumab

BeiGene has applied for Chinese marketing approval for tislelizumab as a treatment for people with previously treated locally advanced or metastatic urothelial carcinoma (UC).

The application is supported by a clinical, non-clinical, and CMC data package, including the results from a pivotal Phase II study which show that, with a median follow-up time of 8 months at the data cutoff, the overall response rate (ORR) was 23.1%, including 7.7% confirmed complete responses.

President Xiaobin Wu said: “The development program for tislelizumab is achieving its milestones swiftly with our first solid-tumor filing for patients with previously treated urothelial carcinoma following our initial filing last year for patients with relapsed/refractory classical Hodgkin’s lymphoma.”