Drug intelligence / Profile preview

tolelsimab

Development stage
Phase 4
Lead developer
Innovent Biologics Technology Limited (Shanghai R&D Center)
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

Tolelsimab is a recombinant humanized monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9). By binding to PCSK9, it prevents the degradation of low-density lipoprotein receptors (LDLR) on the surface of hepatocytes, thereby increasing the clearance of low-density lipoprotein cholesterol (LDL-C) from the blood. Developed by Innovent Biologics, it was approved by the National Medical Products Administration (NMPA) in China in August 2023 for the treatment of primary hypercholesterolemia and mixed dyslipidemia. The drug is also being evaluated in clinical trials for its impact on coronary atherosclerotic plaque progression and epicardial adipose tissue in patients undergoing coronary artery bypass grafting (CABG).

Brand names
SINTBILO
Other names
tolelsimab
02

Targets

PCSK9 (Proprotein convertase subtilisin/kexin type 9)

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