华东医药股份有限公司 关于控股子公司产品纳入突破性治疗品种名单的公告

Core Viewpoint - The company’s subsidiary, Zhejiang Daor Biological Technology Co., Ltd., has developed a first-in-class long-acting tri-target agonist, DR10624, which has been included in the breakthrough therapy category for the treatment of severe hypertriglyceridemia (sHTG) [1][2]. Drug Information - Drug Name: DR10624 Injection - Registration Category: Class 1 Biologic Product - Acceptance Number: CXSB2300148 - Indication: Severe hypertriglyceridemia - Reason for Inclusion: The drug meets the criteria for breakthrough therapy as per the regulatory guidelines [1]. R&D and Registration Status - DR10624 is a globally innovative tri-specific agonist targeting FGF21R, GCGR, and GLP-1R, with clinical research approvals from China CDE and the US FDA expected in October 2023 and October 2025, respectively [2]. - The Phase II clinical study (DR10624-201) results are set to be presented at the AHA Scientific Sessions 2025, showcasing significant triglyceride (TG) reductions: 74.5% in the 12.5mg group, 66.2% in the 25mg group, and 68.9% in the 50mg titration group [2]. - 78.5% of participants in the treatment group experienced TG reductions exceeding 50%, and 89.5% had TG levels below 500 mg/dL [2]. - DR10624 also demonstrated efficacy in improving lipid profiles related to atherosclerosis and significantly reducing liver fat content, with a median percentage reduction of up to 67% [2]. Clinical Advantages - DR10624 exhibits strong lipid-lowering effects and good safety profiles, making it a promising treatment option for sHTG patients [3]. - The drug's ability to lower liver fat and regulate metabolic syndromes adds to its clinical value [3]. Market Context - The prevalence of sHTG is increasing, with approximately 10% of adults affected globally, and 1% suffering from severe cases [4]. - Traditional lipid-lowering medications have limited efficacy in reducing TG levels below 500 mg/dL, highlighting the need for innovative treatments like DR10624 [5]. - The public health threat posed by sHTG is gaining attention, necessitating better therapeutic options [5]. Future Considerations - Following its inclusion in the breakthrough therapy list, DR10624 must complete further clinical trials and receive regulatory approval before market launch [4]. - The drug development process is characterized by high investment, long timelines, and significant risks, with various factors influencing clinical trial outcomes and market competition [4].