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Ebronucimab Injection Approved for Marketing by China NMPA

CCFDIE| Updated: 2025-02-19

     

Recently, the Ebronucimab Injection (trade name: 伊喜宁) of Kangrong Dongfang (Guangdong) Pharmaceutical Co., Ltd. is approved for marketing by China NMPA. The indication is: for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) 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 other lipid-lowering therapies.

Ebronucimab 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.