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Tafolecimab Injection Approved for Marketing by China NMPA

CCFDIE| Updated: 2023-08-16

Recently, the Tafolecimab Injection (trade name: SINTBILO®) of Innovent Biologics (Suzhou) Co., Ltd. is approved 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.

The Tafolecimab Injection is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. By inhibiting PCSK9, blocking the binding of plasma PCSK9 to low density lipoprotein receptor (LDLR), thereby preventing the endocytosis and degradation of LDLR, it increases the expression level and quantity of LDLR on the cell surface, increases LDLR reuptake of LDL-C, reduces circulating LDL-C levels and ultimately achieves the goal of reducing blood lipids. The marketing of this variety provides new treatment options for lipid-lowering treatment.