| 2019-01-28 07:35:55|
ZLAB, TSRO 07:35 01/28 01/28/19
Zai Lab receives priority review status for Zejula NDA from NMPA
Zai Lab (ZLAB) announced that the Center for Drug Evaluation of China's National Medical Products Administration, or NMPA, has granted priority review status to the new drug application, or NDA, for Zejula for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete or partial response to platinum-based chemotherapy. Zejula is a potent and highly selective PARP1/2 inhibitor that does not require BRCA mutation or other biomarker testing prior to administration. Zai Lab in-licensed rights to Zejula from Tesaro (TSARO) for China, Hong Kong and Macau as an important, new treatment option for more than 50,000 Chinese patients who suffer from ovarian cancer every year. Zejula is a potential best-in-class PARP inhibitor due to its differentiated efficacy, once-daily dosing and superior pharmacokinetic properties including its ability to cross the blood brain barrier. The NDA was accepted by the NMPA on December 12, 2018. Zai Lab obtained approval for marketing Zejula in Hong Kong in October 2018 and has been actively commercializing the product.