The China National Medical Products Administration has approved Zai Lab’s (NASDAQ:ZLAB) New Drug Application (NDA) for ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase inhibitor as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
Zai Lab anticipates filing a supplemental NDA for ZEJULA (niraparib) with the NMPA as a first-line monotherapy maintenance treatment of platinum-responsive ovarian cancer patients soon after GlaxoSmithKline files with the relevant global health authorities.
Zai Lab in-licensed rights to ZEJULA from GSK for Mainland China, Hong Kong and Macau.
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