Sanofi(US:SNY) GLP1减重宝典·2026-01-12 04:07Core Viewpoint - The approval of Praluent (普乐司兰钠) by the NMPA marks a significant advancement in the treatment of familial chylomicronemia syndrome (FCS) in China, filling a long-standing gap in the rare lipid metabolism disease sector and highlighting progress in RNA-targeted therapies for rare diseases [4][6]. Group 1: Drug Approval and Mechanism - Praluent is the first small interfering RNA drug targeting APOC3 mRNA, which plays a crucial role in lipid metabolism by inhibiting lipoprotein lipase activity, leading to elevated triglyceride levels in the blood [4]. - The drug has shown a remarkable efficacy, with fasting triglyceride levels decreasing by approximately 80% from baseline in FCS patients, and a similar reduction in the incidence of acute pancreatitis compared to placebo [6]. Group 2: Clinical Data and Treatment Burden - Clinical data indicates that Praluent requires administration only four times a year, significantly reducing the treatment burden and improving long-term medication adherence among patients [6]. - The global Phase III clinical trials confirm the safety and applicability of Praluent, showing no significant difference in overall adverse event rates compared to placebo, and a lower incidence of severe adverse events [7]. Group 3: Market Strategy and Future Potential - Sanofi's acquisition of development and commercialization rights for Praluent in Greater China from Arrowhead Pharmaceuticals reflects confidence in RNA drug platforms and the metabolic disease sector [6]. - The FDA has granted breakthrough therapy designation for Praluent for severe hypertriglyceridemia, indicating potential expansion beyond rare disease populations to a broader high-risk metabolic disorder patient base by December 2025 [6]. Group 4: Broader Implications for Metabolic Health - The approval of Praluent signifies a shift in lipid metabolism treatment from merely controlling indicators to precise regulation of key pathways, offering new therapeutic possibilities for complex metabolic disorders [7].