Innovent Biologics has secured approval from China’s National Medical Products Administration (NMPA) for SINTBILO (tafolecimab injection, anti-PCSK9 monoclonal antibody) to treat adult patients with primary hypercholesterolemia and mixed dyslipidemia.
SINTBILO can be used to treat primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia.
It is an lgG2 fully human monoclonal antibody which can attach to PCSK9 and reduce LDL-C levels by preventing PCSK9-mediated low-density lipoprotein receptor (LDLR) endocytosis.
Approved dosing regimens include 150mg Q2W, 450mg Q4W, and 600mg Q6W.
These regimens have been proven effective in lowering levels of LDL-C, total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), lipoprotein A (Lp(a)) and apolipoprotein B (ApoB).
Approval from the NMPA is based on results from Phase III CREDIT-1, CREDIT-2 and CREDIT-4 registrational studies.
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Innovent clinical development vice-president Dr Lei Qian stated: “As the first PCSK9 antibody with proprietary intellectual property rights in China, the clinical development of tafolecimab condensed the efforts of many domestic experts and demonstrated the recognition from the regulatory authorities and the strength and capabilities of Innovent in the field of cardiovascular diseases.
“The approval of tafolecimab marks a meaningful milestone for Innovent’s strategic position in the cardiovascular and metabolism area.”
SINTBILO is the first drug from the company to enter the cardiovascular field.
Cardiovascular diseases are on the rise in China, with atherosclerotic cardiovascular disease responsible for over 40% of deaths among Chinese residents.