华东医药股份有限公司 关于控股子公司获得药物临床试验批准通知书的公告

Core Viewpoint - The approval of clinical trial for DR10624 injection by NMPA marks a significant advancement in the drug development process for Zhejiang Daor Bio, enhancing the company's competitiveness in the endocrine treatment field [1][4]. Drug Information - Drug Name: DR10624 injection - IND Acceptance Number: CXSL2501013 - Indication: Hypertriglyceridemia (HTG) - Applicant: Zhejiang Daor Bio - Conclusion: The clinical trial application for DR10624 injection has been approved to conduct trials for HTG [1][2]. R&D and Registration Status - DR10624 is a first-in-class long-acting tri-specific agonist targeting FGF21R, GCGR, and GLP-1R, developed independently by Daor Bio [2]. - The drug has successfully completed Phase II clinical studies for severe hypertriglyceridemia (sHTG) with positive topline results, showing a maximum liver fat reduction of 89% and over 70% relative reduction in triglycerides [3]. - The drug's Phase II clinical study results for sHTG were presented at AHA Scientific Sessions 2025, demonstrating significant reductions in triglyceride levels and liver fat content compared to placebo [3]. - DR10624 has also received approval for clinical trials in China for indications related to type 2 diabetes and weight management [3]. Impact on the Company - The approval of the clinical trial for DR10624 injection is a crucial step in the product's development, which is expected to enhance the company's core competitiveness in the endocrine treatment sector [4].