China-based Innovent Biologics Inc. (HKG: 1801) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its tafolecimab (IBI306), a recombinant fully human anti-PCSK-9 monoclonal antibody (mAb). The approved indication is for primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia, as well as mixed dyslipidemia.
Tafolecimab: A Milestone in Lipid-Lowering Therapy
Innovent’s tafolecimab, the first home-grown PCSK9 inhibitor to reach the market, is an lgG2 mAb that specifically binds to PCSK-9, reducing low-density lipoprotein cholesterol (LDL-C) levels by inhibiting PCSK-9-mediated low-density lipoprotein receptor (LDL-R) endocytosis. This mechanism subsequently enhances the clearance of LDL-C, a key factor in managing lipid levels.
Phase III Regulatory Studies Support Approval
The approval of tafolecimab is based on the results of three Phase III regulatory studies, which involved three approved medication regimes: 150 mg every two weeks (Q2W), 450 mg every four weeks (Q4W), and 600 mg every six weeks (Q6W). These studies demonstrated the drug’s efficacy in reducing levels of LDL-C, total cholesterol (TC), non-high-density lipoprotein cholesterol (non HDL-C), apolipoprotein B (ApoB), and lipoprotein a, solidifying its potential as a treatment option for patients with hypercholesterolemia and dyslipidemia.-Fineline Info & Tech
