纳入突破性治疗品种 华东医药创新药研发取得新进展

Core Viewpoint - The announcement highlights the inclusion of DR10624, a novel long-acting tri-target agonist developed by Zhejiang Daor Bio, in the list of breakthrough therapies for severe hypertriglyceridemia (sHTG), indicating significant potential for addressing this public health issue [1]. Group 1: Product Development and Clinical Research - DR10624 is a first-in-class tri-specific agonist targeting FGF21R, GCGR, and GLP-1R, with clinical research approvals from China's CDE and the US FDA for sHTG [1]. - The Phase II clinical study (DR10624-201) results are set to be presented at the 2025 American Heart Association Scientific Sessions, showcasing its innovative approach in treating sHTG [1]. Group 2: Clinical Efficacy and Safety - Clinical data from the DR10624-201 study demonstrate strong lipid-lowering effects and good safety profiles, with additional benefits in reducing liver fat and metabolic regulation [2]. - Traditional lipid-lowering medications have limited efficacy in reducing triglyceride levels below 500 mg/dL, highlighting the need for more effective treatments like DR10624 [2]. Group 3: Public Health Implications - The increasing prevalence of hypertriglyceridemia, with approximately 10% of adults affected globally, underscores the urgent need for better therapeutic options for sHTG, which is associated with serious health risks [2][3]. - DR10624's potential to significantly lower triglycerides and improve inflammatory lipid profiles positions it as a promising innovative therapy for sHTG and related metabolic diseases [3].