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ARTICLE | Company News

China's NMPA grants Priority Review to Zai's PARP inhibitor

Jennie Walters
January 28, 2019 10:40 PM UTC

Zai Lab Ltd. (NASDAQ:ZLAB) said it expects to launch Zejula niraparib in China next half now that China's National Medical Products Administration has granted Priority Review to an NDA for the PARP inhibitor as maintenance therapy of ovarian cancer, Zai Senior Director of Corporate Development Derek Yuan told BioCentury.

The NDA, which NMPA accepted on Dec. 12, is seeking approval of Zejula to treat adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal ovarian cancer who are in complete or partial response to platinum-based chemotherapy. Zai previously targeted a 2020 launch for the drug...

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