BeiGene’s new drug application for tislelizumab accepted by China NMPA

Approval of this submission can bring a significant treatment option for patients with urothelial carcinoma in China BeiGene, a commercial-stage biopharmaceutical company has reportedly announced that the China National Medical Products Administration (NMPA) has recently accepted a supplemental new drug application for tislelizumab, an investigational anti-PD-1 antibody for treating locally advanced or metastatic urothelial carcinoma (UC) patients that were treated previously. BeiGene, for the record, is focused on commercializing and developing innovative immuno-oncology and molecularly targeted drugs for the treatment of cancer. According to General Manager of China and President of BeiGene, Dr. Xiaobin Wu, the tislelizumab development program is reaching its milestones rapidly with the first solid-tumor filing for patients with formerly treated urothelial carcinoma, following the company’s filing previous year for patients with refractory/relapsed classical Hodgkin’s lymphoma. The company believes that the approval of this submission can bring a significant treatment option for patients with urothelial carcinoma in China, Dr. Wu said. Dr. Wu added that the company hopes the comprehensive development program for the anti-PD1 inhibitor, together with production capabilities that are at completion phase, and non-clinical data showed earlier in 2019, support tislelizumab as a potentially distinguished immuno-oncology compound. Citing reliable sources, a recent independent review of data suggested that with an average follow-up time of 8 months at the data cut off, overall response rate in total 104 efficacy evaluable patients was 23.1% including 16% confirmed partial responses and 8% confirmed complete responses. Apparently, the sNDA is supported by a non-clinical, clinical, and CMC data package, including the results from an essential Phase 2 trial of tislelizumab in 113 South Korean and Chinese patients with formerly treated PD-L1 along with locally advanced or metastatic UC. Severity and frequency of adverse events were usually constant with the prior reported Phase 1/2 tolerability and safety data for tislelizumab or in case of specific immune-related adverse events which are in line with former reports of other PD-1 antibodies. Source Credit: http://ir.beigene.com/news-releases/news-release-details/beigene-announces-acceptance-supplemental-new-drug-application