SHANGHAI, China, May 21, 2018 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, today announced that it has completed enrollment ahead of schedule of the pharmacokinetics (PK) study for ZL-2306 for Chinese patients with platinum-sensitive ovarian cancer. ZL-2306 is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) polymerase 1/2, or PARP 1/2, inhibitor with the potential to be a first-in-class category 1 drug for treatment across multiple solid tumor types in China.
“We are pleased that our pharmacokinetics study, initiated in late 2017 with the purpose of establishing the PK profile of ZL-2306 in Chinese patients, has successfully completed enrollment three months ahead of schedule,” said Samantha Du, Zai Lab’s Chief Executive Officer. “We expect to finalize the data from this study by mid-2018, also earlier than planned, and look forward to continuing our active dialogue with the regulatory authorities to bring ZL-2306 to Chinese patients with ovarian cancer as quickly as possible.” In China the current standard of care to treat ovarian cancer consists of radical surgery and chemotherapy.
ZL-2306 (niraparib) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) polymerase 1/2, or PARP 1/2, inhibitor. Niraparib was approved in March 2017 by the FDA in the US and in November 2017 by EMA in EU 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 approval status in the US and EU, Zai Lab recently submitted market registration application for ZL-2306 in Hong Kong and plans to launch and commercialize ZL-2306 in Hong Kong in the second half 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.
About Zai Lab
Zai Lab (NASDAQ:ZLAB) is a Shanghai-based innovative biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. The company’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 global 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.
Zai Lab Forward-Looking Statements
This press release includes certain disclosures which contain "forward-looking statements," including, without limitation, statements regarding the timing of commercialization of ZL-2306. You can identify forward-looking statements because they contain words such as "anticipate" and "expected." Forward-looking statements are based on Zai Lab's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2017, and its other filings with the Securities and Exchange Commission. Zai Lab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
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