On October 22, 2018 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative biopharmaceutical company, reported that the Hong Kong Department of Health has approved ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor in Hong Kong for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in a complete response or partial response (CR or PR) to platinum-based chemotherapy (Press release, Zai Laboratory, OCT 22, 2018, View Source [SID1234530128]). Unlike other PARP inhibitors approved in Hong Kong, ZEJULA does not require BRCA mutation or other biomarker testing prior to administration.

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"We are now in final preparations to launch ZEJULA in Hong Kong this quarter to offer an important treatment option to ovarian cancer patients," said William Liang, Chief Commercial Officer of Zai Lab. "With the compelling clinical data, ZEJULA has the potential to save lives and have a major impact on public health. We have developed commercial and medical infrastructure in Hong Kong to educate physicians about the differentiated benefits of ZEJULA to drive its adoption. In addition, our upcoming launch is an excellent opportunity for Zai Lab to optimize best practices, as we prepare for the future launch of ZEJULA in Mainland China."

The approval of ZEJULA in Hong Kong was based upon the international Phase 3 ENGOT-OV16/NOVA trial sponsored by TESARO, Inc., a double-blind, placebo-controlled study that enrolled 553 patients with relapsed predominantly high grade serous ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by a CR or PR for more than six months to their penultimate (next to last) platinum-based therapy. The primary endpoint of the trial was progression free survival (PFS). Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by a robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients both with and without germline BRCA mutations as compared to the control arm. Treatment with ZEJULA reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (hazard ratio (HR) 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a CR or PR.

"Today’s approval of ZEJULA in Hong Kong represents a significant milestone for Zai Lab as it signifies our transition into a commercial stage company," said Dr. Samantha Du, Chief Executive Officer of Zai Lab. "We are grateful to the patients who participated in the clinical trials in the U.S. and Europe, the clinical investigators, our partner TESARO and our dedicated employees who collectively made this approval possible. While we are focused on making ZEJULA a commercial success in Hong Kong, we continue to drive development of ZEJULA in China, along with the rest of our broad and late-stage pipeline."

About ZL-2306

ZL-2306 (niraparib) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2inhibitor. Niraparib was approved in March 2017 by the FDA in the U.S. and by the EMA in the EU under the trade name ZEJULA in November 2017 as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the U.S. and EU, Zai Lab submitted a market registration application for niraparib in Hong Kong and expects to launch and commercialize niraparib in Hong Kong in the fourth quarter of 2018. Zai Lab believes ZL-2306 has the potential to be a first-in-class Category 1 drug for treatment across multiple solid tumor types in China.