ZL-2306 (Niraparib) receives the second funding support from National “Significant New Drugs Development Project”
Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, announced today that its innovative drug, poly (ADP-ribose) polymerase (PARP) inhibitor ZL-2306 (Niraparib), has been granted funding support from the National Major Scientific and Technological Special Project for Significant New Drugs Development in China. The grant will support the clinical research and new drug applications of ZL-2306.
The Significant New Drugs Development Project, which was launched in 2008, aims to encourage pharmaceutical companies and research institutions to develop medicines in 10 major disease areas that seriously endanger the health of Chinese people, in order to improve the nation’s drug innovation system. This is the third project of Zai Lab and the second project of ZL-2306 (Niraparib) supported by the Significant New Drugs Development Project following the study of “ZL-2306 (Niraparib) as maintenance therapy in women with first-line ovarian cancer,” acknowledging Zai Lab’s innovation capabilities and product values of Niraparib.
Ovarian cancer is one of the most common gynecologic cancers in China with more than 52,000 newly diagnosed cases and 23,000 deaths in China each year. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited, especially for patients without germline BRCA mutations.
“As the first PARP inhibitor with Category 1 designation and manufactured in Mainland China, we are very pleased that ZL-2306 can be supported again by the National Major Scientific and Technological Special Project for Significant New Drugs Development. The recent study showed ZL-2306 as the first PARP inhibitor to significantly improve PFS when given as monotherapy in women with first-line platinum responsive ovarian cancer, regardless of biomarker status.” said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab, “Zai Lab will continue to promote the development of ZL-2306 and other assets as soon as possible, and strive to achieve more breakthroughs in the closing year of 'Significant New Drugs Development', while realizing our commitment to patients in China and globally.”
About ZL-2306
Niraparib is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor. It was approved in March 2017 by the FDA in the United States and in November 2017 by the EMA in the European Union under the trade name Zejula 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 United States and European Union by our partner, GSK, Zai Lab obtained the approval for marketing Zejula in Hong Kong in October 2018 and Macau in June 2019. In December 2019, The NMPA approved the New Drug Application for Zejula (niraparib) as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
About Zai Lab
Zai Lab (NASDAQ: ZLAB) is a China and U.S.-based innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China's pharmaceutical market and addressing unmet medical needs. Zai Lab's vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its partners' and its own products in order to impact human health worldwide.