Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China

BEIJING, China and CAMBRIDGE, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) of pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

“Pamiparib is our third internally developed drug candidate that has been granted priority review in China, following tislelizumab and BRUKINSA. It received priority review within a week of the acceptance of the application, reflecting the unmet need for patients with this advanced disease,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “We look forward to presenting the clinical data that support this NDA at an upcoming medical conference and the next milestones in the pamiparib program.” 

The NDA of pamiparib as a potential treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer was accepted in July 2020. It is supported by clinical results from the pivotal Phase 2 portion of the Phase 1/2 trial (NCT03333915), which enrolled 113 patients in China with high-grade epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer) or high-grade endometrioid epithelial cancer, harboring germline BRCA1/2 mutation, following at least two prior lines of standard chemotherapy. BeiGene is developing pamiparib as a monotherapy and in combination with other therapies for the treatment of a broad array of solid tumors.

Priority review and approval was established in China to facilitate drug registration management and accelerate the development of innovative drugs with significant clinical advantages and for which there is an urgent clinical need. According to the Drug Registration Regulation (Bureau Order 27) implemented on July 1, 2020, the regulatory authority will prioritize the review process and evaluation resources for applications under priority review. These applications are expected to have reduced review and approval timelines.