Pharma Focus Asia

Innovent Biologics Receives NMPA Approval of SINTBILO® for Hypercholesterolaemia Treatment

Thursday, August 17, 2023

Innovent Biologics announced the approval of SINTBILO® (tafolecimab injection, an anti-PCSK9 monoclonal antibody) by China's National Medical Products Administration (NMPA).

This approval is specifically for the treatment of adult individuals dealing with primary hypercholesterolaemia, which includes both heterozygous familial and non-familial hypercholesterolaemia, as well as mixed dyslipidemia.

SINTBILO® (tafolecimab injection) is a fully human monoclonal antibody of the IgG2 type. It precisely binds to PCSK9, which results in a reduction in LDL-C levels. This is achieved by stopping PCSK9-mediated endocytosis of low-density lipoprotein receptors (LDLR), leading to better clearance of LDL-C and ultimately lowering its levels.

SINTBILO® (tafolecimab injection) is used alongside dietary measures and in combination with statins or other lipid-lowering therapies. It is intended for adult patients dealing with primary hypercholesterolaemia (including both familial and non-familial cases) as well as mixed dyslipidemia.

The approval is based on findings from three Phase 3 clinical trials (CREDIT-1, CREDIT-2, and CREDIT-4). These trials showed that different dosing plans - 150 mg every 2 weeks, 450 mg every 4 weeks, and 600 mg every 6 weeks - all effectively lower LDL-C, total cholesterol, non-HDL-C, apolipoprotein B, and lipoprotein a levels. These results from the Phase 3 trials offer various treatment options, allowing cardiologists and patients to choose the best fit for their needs.

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