SAL003 (Shenzhen Salubris Pharmaceuticals Co., Ltd.)

SAL003 is a recombinant fully human monoclonal antibody (IgG4) developed by Salubris Pharmaceuticals as a biosimilar to evolocumab. It targets proprotein convertase subtilisin/kexin type 9 (PCSK9) for the treatment of hypercholesterolemia and mixed dyslipidemia. By binding to PCSK9, SAL003 prevents the protein from interacting with low-density lipoprotein receptors (LDLR) on the surface of hepatocytes, thereby preventing receptor degradation and increasing the clearance of LDL cholesterol from the blood. The drug has completed Phase 2 clinical trials, where it demonstrated pharmacokinetic properties comparable to the reference product and significant efficacy in reducing lipid levels, both as a monotherapy and in combination with statins.

Other names

recombinant human anti-PCSK9 monoclonal antibodyevolocumab biosimilar