Zai Lab's First Product Zejula® Approved in Hong Kong, Expanding Access for Ovarian Cancer Patients

VCBeat (WeChat ID: vcbeat) has learned that on October 22, Zai Lab’s (NASDAQ: ZLAB) first innovative drug, ZEJULA® (niraparib), was approved in Hong Kong and is expected to be officially launched there in the fourth quarter of 2018.

Previously, Zejula® was approved in the United States and Europe in March and November 2017, respectively, for second-line treatment of ovarian cancer. Zejula® is the first and only PARP inhibitor approved in Hong Kong for maintenance therapy in all patients with platinum-sensitive recurrent ovarian cancer, regardless of BRCA mutation status, marking a global first.

It is understood that the approval of Zejula® in Hong Kong is based on the results of the international Phase III clinical trial ENGOT-OV16/NOVA. Initiated by Zai Lab’s partner TESARO, this double-blind, placebo-controlled study enrolled a total of 553 patients with platinum-sensitive recurrent high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Platinum sensitivity was defined as achieving complete or partial response for more than six months after the second-to-last platinum-based chemotherapy regimen.

The primary endpoint of the study was progression-free survival (PFS), with approximately two-thirds of enrolled patients lacking germline BRCA mutations. In the NOVA study, disease progression was determined by a robust, unbiased, blinded central review, preceding radiographic detection or clinical progression.

Compared with the control group, Zejula® significantly prolonged progression-free survival (PFS), regardless of whether patients had germline BRCA mutations. 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).

Du Ying, CEO of Zai Lab. Photo provided by the interviewee

Currently, the efficacy of PARP inhibitors available in the Hong Kong market is contingent upon patients having germline BRCA mutations. Du Ying, CEO of Zai Lab, told VCBeat that only about 25% of patients meet this criterion. Therefore, Zejula® can benefit a broader population of patients with recurrent ovarian cancer, including those who have achieved complete or partial response to platinum-based chemotherapy. Patients do not need to undergo BRCA or other biomarker testing prior to treatment.

Furthermore, Zejula® is the only PARP inhibitor on the market that requires only once-daily oral administration. It is indicated for the treatment of patients with platinum-sensitive recurrent high-grade serous epithelial ovarian cancer who have achieved a complete response (CR) or partial response (PR) to platinum-based chemotherapy. Additionally, based on results from international Phase III clinical trials, Zejula® has demonstrated favorable long-term tolerability following dose adjustments, with treatment duration exceeding three years.

To help clinicians better understand Zejula®ofProduct Advantages and Clinical Applications: Zai Lab has already established commercial and medical teams in Hong Kong. According to Du Ying, Zejula® is scheduled to be launched in mainland China in 2020. Currently, Zai Lab is also actively advancing the registration and listing process in China, with the aim of making the product available to Chinese patients as soon as possible.

ZL-2306 (niraparib) is a highly potent, selective, once-daily oral small-molecule inhibitor of poly(ADP-ribose) polymerase 1/2 (PARP 1/2). Niraparib was approved in the United States in March 2017 and in Europe in November of the same year for maintenance treatment of patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy. Leveraging its approvals in the United States and Europe, Zai Lab submitted a marketing authorization application for niraparib in Hong Kong, with the expectation of launching the drug in Hong Kong in the fourth quarter of 2018. Zai Lab believes that ZL-2306 has the potential to become the first-in-class therapy in China for the treatment of multiple types of solid tumors.

Zai Lab (NASDAQ: ZLAB) is an innovative biopharmaceutical company headquartered in Shanghai, dedicated to providing novel therapies for patients with oncology, autoimmune, and infectious diseases in China and around the world. Leveraging its experienced team, the company has established strategic collaborations with leading global biopharmaceutical companies to build a robust pipeline of innovative drug candidates, addressing the rapidly growing needs of the Chinese pharmaceutical market and unmet medical needs worldwide. Zai Lab’s vision is to become a fully integrated innovative biopharmaceutical company that researches, develops, manufactures, and commercializes both internally discovered and partnered products, striving to advance health and well-being for people everywhere.