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HLX16 is a proposed biosimilar of evolocumab (Repatha), a human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). Developed by Shanghai Henlius Biotech, HLX16 is designed to treat primary hypercholesterolemia, including heterozygous familial and non-familial types. By binding to PCSK9, the antibody prevents it from interacting with low-density lipoprotein receptors (LDLR) on the surface of hepatocytes, thereby preventing LDLR degradation and increasing the clearance of low-density lipoprotein cholesterol (LDL-C) from the bloodstream. In August 2026, Henlius entered into a strategic collaboration with Sandoz, granting Sandoz exclusive commercialization rights for HLX16 in all markets outside of China, while Henlius retains development, manufacturing, supply, and China rights. The candidate is currently in preclinical development.
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