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FY101 is an investigational monoclonal antibody developed by Beijing Fuyuan Pharmaceutical Co., Ltd. as a Class 1 biological new drug in China. It targets proprotein convertase subtilisin/kexin type 9 (PCSK9), a key regulator of cholesterol metabolism. PCSK9 normally binds to low-density lipoprotein receptors (LDLR) on the surface of hepatocytes, leading to their degradation and a subsequent increase in circulating LDL cholesterol (LDL-C) levels. By binding to and inhibiting PCSK9, FY101 prevents LDLR degradation, thereby increasing the density of these receptors on the liver cell surface and enhancing the clearance of LDL-C from the blood. FY101 is currently in Phase I clinical development for the treatment of hyperlipidemia and dyslipidemia, with studies evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics following subcutaneous injection.
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