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Zai Lab's ovarian cancer drug application accepted by Chinese regulator

Shanghai-based Zai Lab Ltd. said its application for ovarian cancer therapy Zejula was accepted by the China National Medical Products Administration.

Zejula is an oral, once-daily poly ADP ribose polymerase, or PARP, inhibitor that works by trapping PARP at the sites of DNA damage, preventing cancer cells from repairing their DNA, leading to their death.

The company applied to use the drug as a maintenance treatment for patients with recurrent ovarian or fallopian tube cancer who have partially responded to platinum-based chemotherapy, or whose cancer was undetectable after receiving treatment.

China had about 51,000 newly diagnosed ovarian cancer cases and 23,000 deaths in 2014.

On the sidelines of a Dec. 12 press event in Hong Kong, CEO Samantha Du told S&P Global Market Intelligence that Zai Lab aims to bring Zejula to mainland China before 2020, and targets to have the therapy included in China's drug reimbursement list.

The Chinese government has also been working on increasing the accessibility and affordability of cancer therapies in recent years, including 17 cancer medicines in the nation's drug reimbursement list in 2018 and slashing their average prices by 57%.

Zai Lab bought the rights to develop and commercialize Zejula in Greater China from Tesaro Inc. in 2016, which itself licensed the drug from Merck & Co. Inc.

Zejula is already approved in the U.S. and Europe as a therapy for recurrent platinum-sensitive ovarian cancer. Zai Lab also launched the medicine in Hong Kong in December. The company is testing the drug for other indications, including small-cell lung cancer in China.