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
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