SINTBILO® is the commercial brand name of Tafolecimab Injection, a fully human monoclonal antibody independently developed by Innovent Biologics. It specifically binds to PCSK9, blocks the interaction between PCSK9 and LDL receptors on hepatocytes, increases the quantity of LDL receptors on cell surface, and accelerates the clearance of low-density lipoprotein cholesterol in blood circulation.
Main Indications
For the treatment of adult patients with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia, and mixed dyslipidemia.
Clinical Research
Multiple phase III clinical studies demonstrated that tafolecimab could produce significant and sustained LDL-C reduction in hyperlipidemic patients. Monthly subcutaneous administration achieved stable lipid-lowering efficacy, and the overall safety profile was acceptable, supporting its marketing approval by NMPA.
Common Side Effects
Common adverse reactions include injection site reactions, influenza-like illness, arthralgia, back pain, upper respiratory tract infection and headache.
Approval Status in China
SINTBILO® (Tafolecimab Injection) was officially approved for marketing in China in 2023. It is a domestically innovative prescription PCSK9 inhibitor.
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