Zai Lab Announces China’s NMPA Grants Priority Review to the sNDA for ZEJULA (Niraparib) for First-Line Ovarian Cancer Maintenance Treatment

SHANGHAI, China, and SAN FRANCISCO, April 16, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, today announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted priority review status to the supplemental New Drug Application (sNDA) for ZEJULA (niraparib) as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

“China NMPA’s decision to grant priority review to our sNDA for ZEJULA underscores both the urgency of the medical need and the potential of ZEJULA as an innovative therapeutic option in the first-line setting for ovarian cancer patients,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “Ovarian cancer remains a devasting disease in China and we are excited that many more patients may soon have access to ZEJULA earlier in the course of their treatment. We thank the agency for their commitment and continued support to patients in need and look forward to working closely with them to move this important indication for ZEJULA toward approval.”

Priority review was established in China to facilitate drug registration and accelerate the development of new drugs with clinical value under the guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval issued by CFDA in December 2017. According to these guidelines, the regulatory authority will prioritize the review process and evaluation resources for applications under priority review, which should expect reduced review and approval timelines.

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China with more than 52,000 newly diagnosed cases and 23,000 deaths each year. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.