Recaticimab for Injection Approved for Marketing by China NMPA
Recently, the Recaticimab for Injection (trade name: 艾心安) of Guangdong Hengrui Pharmaceutical Co., Ltd. is approved for marketing by China NMPA. Indications: On the basis of dietary control, it can be used in combination with statins, or in combination with statins and other lipid-lowering therapies for adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who, despite treatment with moderate or higher doses of statins, still fail to reach the target level of low-density lipoprotein cholesterol (LDL-C). Alternatively, it can be used as monotherapy for adult patients with non-familial hypercholesterolemia and mixed dyslipidemia to reduce the levels of low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and apolipoprotein B (ApoB).
Recaticimab is a fully human monoclonal IgG1 antibody targeting the preprotein convertase subtilisin/kexin type 9 (PCSK9). It 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 drug provides a new treatment option for relevant patients.