Zai Lab's Zejula approved in China for patients with recurrent ovarian cancer

Shares of Chinese biotech Zai Lab (Nasdaq: ZLAB) rose 5.3% to $40.25 on Friday, after it announced the China National Medical Products Administration (NMPA) had approved the New Drug Application (NDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor 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.

Zai Lab in-licensed rights to Zejula for Mainland China, Hong Kong and Macau. The drug is a potent and highly selective PARP1/2 inhibitor that does not require BRCA mutation or other biomarker testing prior to administration that was developed by Tesaro, which licensed it to Zai Labs for certain Asian markets. It was acquired by GlaxoSmithKline (LSE: GSK) GSK along with its  buy of US drugmaker Tesaro for $5.1 billion.

“The NMPA approval of Zejula, our first product to be approved in Mainland China, is a testament to the hard work and dedication of the entire Zai Lab team,” said Dr Samantha Du, founder and chief executive of Zai Lab. “As the first PARP inhibitor with Category 1 designation and manufactured in Mainland China, we are very excited to bring Zejula to Chinese patients following the successful launch in Hong Kong. With enrollment completed with 265 patients, we remain committed to finish our pivotal trial for maintenance therapy for Chinese patients with recurrent ovarian cancer (the NORA study) by third quarter of next year,” she added.