Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy for Patients with Recurrent Ovarian Cancer in China

Zai Lab and Novocure’s Optune Receive NMPA’s Innovative Medical Device Designation for its Tumor Treating Field Delivery System


  • Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
  • The NMPA approval of Zejula is novel product approved in Mainland China, has shown 73% reduction in risk of disease progression and death in patients with germline BRCA mutations and 55% in patients without germline BRCA mutations with expected for sNDA submission to the NMPA for 1L monothx maintenance treatment of platinum-responsive ovarian cancer patients
  • The candidate has also received priority review status on Jan 29, 2019 and is also evaluated in NORA study for Chinese patients with recurrent ovarian cancer plus expected completion in Q3’20. Zai Lab in-licensed exclusive rights to commercialize Zejula in Mainland China, Hong Kong, and Macau from GSK

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