Zai Lab Receives Priority Review for Zejula’s (niraparib) NDA from NMPA (CFDA), in China

 Zai Lab Receives Priority Review for Zejula’s (niraparib) NDA from NMPA (CFDA), in China

Zai Lab Receives Priority Review for Zejula’s (niraparib) NDA from NMPA (CFDA), in China

Shots:

  • The priority review is granted to Zai Lab’s Zejula as a maintenance treatment for recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete or partial response to Pt-based CT in adults
  • The NMPA’s Priority Review is granted to the drugs to accelerate drug’s registration and approval in China for multiple thaerapy areas
  • Zejula (niraparib,ZL-2306) is a qd poly (ADP-ribose) PARP1/2 inhibitor and has received FDA & EMA approval for women with recurrent epithelial ovarian, fallopian tube, primary peritoneal cancer in Mar,2017 & Nov,2017 respectively. In Sept, 2016 Zai Lab in-licensed Zejula from Tesaro to commercialize it in China

 Click here to read full press release/ article | Ref: Zai Lab | Image:Pharma