Zai Lab’s NDA for PARP Inhibitor Accepted for China Review

Published on: Dec 12, 2018
Author: Amy Liu

Zai Lab of Shanghai announced that the China National Medical Products Administration (NMPA) accepted its NDA for Zejula (niraparib), a novel Category 1 PARP1/2 drug — the first Zai NDA submission accepted in China. The candidate is indicated for maintenance treatment of patients with recurrent ovarian and fallopian tube cancer who are in a complete or partial response to platinum-based chemotherapy. According to Zai, Zejula is a potent, highly selective PARP1/2 inhibitor that does not require prior testing for BRCA mutation.

Source: China Biotoday

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