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

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

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  • 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

Click here to read full press release/ article | Ref: GlobeNewsWire | Image: Signbox


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