Is Niraparib domestically produced or imported?

In December 2019, the National Medical Products Administration approved the launch of Zai Lab's Class 1 innovative drug niraparib tosylate capsules (trade name: Zele) through relevant regulations. It is an innovative commercial-stage biopharmaceutical company headquartered in China and the United States. Niraparib was approved as a maintenance treatment for platinum-sensitive recurrent ovarian cancer and was approved as a first-line maintenance treatment in China in October 2020. It is an imported drug.

In the early stages of the study, for financial reasons, niraparib was often reserved as a last resort when patients were resistant or intolerant to chemotherapy. In January 2022, niraparib was included in China’s national reimbursed drug list, thus improving the affordability and utilization rate of early treatment. Niraparib is the potentially best PARP inhibitor for patients with ovarian cancer because of its compelling clinical data, once-daily dosing and pharmacokinetic properties, including its ability to cross the blood-brain barrier. As maintenance therapy for recurrent ovarian cancer (NOVA study), treatment with niraparib reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations and by 55% in patients without germline BRCA mutations.

NiraparibAfter the original drug is included in medical insurance, reimbursement is limited to eligible patients. Common specificationsThe price of each box of 100mg*30 tablets may be more than 5,000 yuan. The original niraparib drug marketed overseas is more expensive than domestically. There are also generic niraparib drugs produced in other countries. Their pharmaceutical ingredients are basically the same as those of the original niraparib drug sold domestically and abroad. The price of 100mg*30 tablets per box produced by a Bangladesh pharmaceutical factory may be more than 1,000 yuan (the price may fluctuate due to exchange rates).