Niraparib is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) polymerase 1/2, or PARP 1/2, inhibitor for treatment across multiple solid tumor types. In 2016, we obtained an exclusive license for the development and commercialization of niraparib in mainland China, Hong Kong (China) and Macau (China) from TESARO, Inc. We believe that niraparib has the potential to be a best-in-class Category 1 drug in China. Currently we are conducting clinical trials to evaluate niraparib in several indications, including ovarian cancer and small cell lung cancer.
In 2017, niraparib was approved by the FDA and EMA as a maintenance treatment for women with recurrent platinum-sensitive ovarian cancer. In October 2018, niraparib was approved in Hong Kong (China) for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in a complete or partial response to platinum-based chemotherapy, without the need of BRCA testing. In December 2018, the China National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for niraparib. In January 2019, the NDA was granted priority review status. In December 2019, the China NMPA approved the NDA for ZEJULA (niraparib) 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.
Mechanism of Action
PARP is a family of proteins playing a key role in the DNA repair pathway. PARP inhibitors appear most effective when used to treat tumors with underlying defects in DNA repair, such as those with mutations in the BRCA1 and BRCA2 genes, or when combined with another DNA-damaging agent. PARP inhibitors also have an additional mechanism of action known as “PARP trapping”, the effect of which is to stabilize PARP-1 and PARP-2 at sites of DNA damage leading to double-strand breaks of DNA during replication and death of tumor cells.