Background
HeFH, metabolic disorders
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, HYPERCHOLESTEROLEMIA, CARDIOVASCULAR DISEASES, METABOLIC DISORDERS
Heterozygous familial hypercholesterolemia (HeFH) is one of the most common inherited metabolic disorders in humans, with an estimated prevalence of 1:311 worldwide and 1:500 to 1:200 in China in the general population [Clinical practice guidelines recommend the initiation of lipid-lowering therapy as soon as possible after the diagnosis of HeFH to reduce LDL-C levels and future risk of cardiovascular diseases. Unfortunately, HeFH is largely underdiagnosed and undertreated worldwide [Tafolecimab is a fully human IgG2 PCSK9 monoclonal antibody developed in China. In the phase 1a study in Chinese healthy volunteers, a single dose of tafolecimab reduced LDL-C levels up to 72%. In the phase 1b study in Chinese patients with hypercholesterolemia, tafolecimab reduced LDL-C levels up to 71.6% and by more than 50% at week 12 for all tafolecimab dose regimens. In both studies, tafolecimab was well tolerated and showed an overall favorable safety profile similar to other PCSK9 antibodies [