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 announcement highlights that East China Pharmaceutical's subsidiary, Zhejiang Daor Biotechnology, has developed a groundbreaking drug, DR10624, which has been included in the list of breakthrough therapies for severe hypertriglyceridemia (sHTG) by the National Medical Products Administration (NMPA) of China [1][4]. Drug Information - Drug Name: DR10624 Injection - Registration Category: Class 1 Biopharmaceutical - Acceptance Number: CXSB2300148 - Indication: Severe hypertriglyceridemia (sHTG) [1]. R&D and Registration Status - DR10624 is a globally innovative long-acting tri-specific agonist targeting FGF21R, GCGR, and GLP-1R, with clinical research approvals from both China CDE and the US FDA for sHTG [2]. - The Phase II clinical study (DR10624-201) results showed 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 experienced TG reductions exceeding 50%, and 89.5% had TG levels below 500 mg/dL [2]. - DR10624 also demonstrated significant improvements in lipid profiles and liver fat content, with a median percentage reduction of up to 67% in liver fat [2][3]. Clinical Advantages - DR10624's innovative tri-target mechanism provides strong lipid-lowering effects and good safety profiles, making it a promising treatment option for sHTG patients [3]. - The drug's efficacy in reducing liver fat and regulating metabolic syndrome is highlighted as a significant clinical advantage [3]. Market Context - sHTG, defined as TG levels exceeding 500 mg/dL, poses significant health risks, including cardiovascular diseases and pancreatitis, with a rising prevalence globally [4]. - Traditional lipid-lowering medications have limited efficacy in reducing TG levels below 500 mg/dL, indicating a clinical need for more effective treatments like DR10624 [4]. Future Steps - Following its inclusion in the breakthrough therapy list, DR10624 must complete further clinical trials and receive approval from the NMPA before market launch [5]. - The company is committed to advancing the drug's development in accordance with national regulations and will keep investors informed of progress [5].