Ongericimab Injection Approved for Marketing by China NMPA
Recently, the Ongericimab Injection (trade name: 君适达/Junshida) of Shanghai Junshi Biosciences Co., Ltd. is approved for marketing by China NMPA. The indication is: for the treatment of adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia, who cannot achieve the recommended target of low density lipoprotein cholesterol (LDL-C) even after receiving moderate or high doses of statin therapy. It is used in combination with statins, or with statins and Ezetimibe.
Ongericimab is a fully human monoclonal IgG1 antibody targeting the preprotein convertase subtilisin/kexin type 9 (PCSK9), which blocks the binding of PCSK9 to the low-density lipoprotein receptor (LDLR) by specifically binding to PCSK9, preventing PCSK9-mediated degradation of the LDLR, and increasing the number of LDLRs on the surface of the cells, thereby reducing serum LDL-C levels. The marketing of this product provides a new treatment option for lipid-lowering treatment.