Date: 18-Oct-2019

NMPA grants priority review to BeiGene's sNDA for tislelizumab

BeiGene, a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA, formerly known as the CFDA) has granted priority review status to the supplemental new drug application (sNDA) for tislelizumab, an investigational Fc-engineered anti-PD-1 antibody, for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC). “This is our second priority review granted by the NMPA for tislelizumab, and our first for a solid tumor indication and first in China for a PD-1/PDL1 antibody for bladder cancer,” said Wendy Yan, Senior Vice President, Global Head of Regulatory Affairs, at BeiGene. “Along with the two priority reviews granted for zanubrutinib in China, our regulatory team is working closely with the NMPA as it reviews our applications to treat patients with solid tumors and hematologic cancers. With full global rights to tislelizumab, 13 ongoing pivotal or potentially registration-enabling trials, maturing international clinical and non-clinical data, and advanced manufacturing capabilities, we are excited by the prospects for tislelizumab to help patients in-need around the world.” The sNDA for tislelizumab as a potential treatment for patients with previously treated locally-advanced or metastatic UC was accepted by the NMPA in May 2019. It is supported by a clinical, non-clinical, and Chemistry, Manufacturing and Controls (CMC) data package, including the results from a pivotal Phase 2 study of tislelizumab in 113 Chinese and South Korean patients with previously treated PD-L1+ locally-advanced or metastatic UC ( registration number: CTR20170071). BeiGene is developing tislelizumab as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid and hematologic cancers. An NDA for tislelizumab as a potential treatment for patients with relapsed / refractory (R/R) classic Hodgkin’s lymphoma (cHL) was accepted by the NMPA in August 2018 and granted priority review status in November 2018.