DR10624

▎药明康德内容团队编辑 11月19日，华东医药发布公告称，该公司两款1类新药获批新的临床试验默示许可，分别为：长效三靶点激动剂DR10624在中国获批临床，拟开发治疗代谢相关脂肪性肝病/代谢相关脂肪性肝炎；双靶点长效激动剂HDM1005在美国获批临床，拟开发治疗代谢相关脂肪性肝炎（MASH）。 长效三靶点激动剂DR10624在中国获批临床 华东医药控股子公司道尔生物申报的DR10624注射液在中国获批临床，拟治疗适应症为代谢相关脂肪性肝病/代谢相关脂肪性肝炎。DR10624为道尔生物自主研发的一款长效三靶点激动剂，其为靶向FGFR1c/Klothoβ（FGF21R）、GLP-1受体（GLP-1R）和GCG受体（GCGR）的候选创新蛋白药物。 DR10624由N端靶向GLP1R/GCGR的嵌合肽段与工程化改造的IgG1 Fc融合，并在Fc的C末端融合重组的FGF21突变体。临床前研究结果显示，DR10624具有较强的代谢调节和改善的药效。 根据华东医药公告，DR10624此前已经先后在中国获批临床，针对适应症包括体重管理、2型糖尿病和重度高甘油三酯血症。目前该产品正在开展重度高甘油三酯血症的中国2期临床试验，正在受试者入组阶段。 双靶点长效激动剂HDM1005在美国获批临床 华东医药全资子公司中美华东申报的HDM1005注射液药品临床试验申请获得美国 FDA批准，可在美国开展1期临床试验，针对适应症为代谢相关脂肪性肝炎（MASH）。HDM1005 注射液是中美华东研发的1类化学新药，是多肽类人GLP-1（胰高血糖素样肽1）受体和 GIP（葡萄糖依赖性促胰岛素多肽）受体的双靶点长效激动剂。 临床前研究显示，HDM1005可通过激活GLP-1受体和GIP受体，促进环磷酸腺苷（cAMP）产生，增加胰岛素分泌，抑制食欲，延迟胃排空，改善脂肪代谢，具有降糖、减重及治疗MASH的作用；同时，现有数据显示 HDM1005具有良好的成药性和安全性。 根据华东医药公告，HDM1005注射液此前已经在中国获批临床，适应症包括2型糖尿病、超重或肥胖人群的体重管理。该产品目前正在中国开展的1a期、1b期临床试验进展顺利，预计于2024年Q4获得1a期临床研究报告、1b期（第一部分）临床试验的顶线结果，并计划于2025年初启动2期临床试验。HDM1005注射液体重管理适应症的美国临床试验申请于2024年4月获得FDA批准。 参考资料： [1]华东医药关于控股子公司获得药物临床试验批准通知书的公告. Retrieved Nov 19, 2024, from http://www.cninfo.com.cn/new/disclosure/detail?stockCode=000963&announcementId=1221767328&orgId=gssz0000963&announcementTime=2024-11-19 [2]华东医药关于全资子公司获得美国FDA新药临床试验批准通知的公告. Retrieved Nov 19, 2024, from http://www.cninfo.com.cn/new/disclosure/detail?stockCode=000963&announcementId=1221767327&orgId=gssz0000963&announcementTime=2024-11-19 本文来由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

HANGZHOU, China I September 30, 2024 I Zhejiang Doer Biologics Co., Ltd. (“Doer Bio”), a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers, today announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon-like peptide-1 receptor (GLP-1R), and Glucagon receptor (GCGR) has completed the dosing of the first patient in the Phase 2 study of DR10624 for the treatment of severe hypertriglyceridemia (SHTG). The Phase 2 study is a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of three dose levels of DR10624 in adult SHTG patients, who have mean fasting triglycerides of greater than or equal to 5.65 mmol/L (500 mg/dL) at screening. A total of 72 participants will be enrolled in the study. “DR10624 is a first-in-class long-acting tri-agonist targeting FGF21R, GLP-1R, and glucagon receptor (GCGR). Developed using Doer Bio’s proprietary MultipleBody® platform technology, DR10624 was engineered to exhibit balanced activity for metabolic diseases. In non-clinical studies, DR10624 has demonstrated extraordinary potency in reducing body weight, lowering triglycerides, normalizing blood lipids, and improving liver function.” said Yanshan Huang, Ph.D., founder and Chief Executive Officer of Doer Bio. “We’re excited to announce the dosing of first patient in our Phase 2 study of DR10624 for the treatment of severe hypertriglyceridemia. Patients with SHTG, particularly those with uncontrolled hypertriglyceridemia, face a heightened risk of developing acute pancreatitis and atherosclerotic cardiovascular disease (ASCVD). This Phase 2 study is designed to identify the optimal dose for pivotal Phase 3 clinical trials. We are eager to advance DR10624 as a potential treatment for patients struggling with SHTG”. commented Yongliang Fang, Ph.D., Chief Operating Officer of Doer Bio. More information about the Phase 2 clinical trial is available at clinicaltrials.gov (NCT06555640) About Doer Bio Zhejiang Doer Biologics Co., Ltd. (“Doer Bio”) is a clinical stage biopharmaceutical company that focuses on the discovery and development of multi-domain based multi-specific biotherapeutics to address unmet medical need in the field of metabolic diseases and cancers. Doer Bio has developed multiple proprietary platform technologies, including xLONGylation®, MultiBody®, AccuBody®, and SMART-VHHBody. For more information about Doer Bio, please visit www.doerbio.com . SOURCE: Zhejiang Doer Biologics Co.