本报讯(记者邬霁霞)12月15日，华东医药（000963）股份有限公司(以下简称"华东医药")全资子公司杭 州中美华东制药有限公司(以下简称"中美华东")宣布，其研发的创新多肽类人GLP-1(胰高血糖素样肽-1) 受体和GIP受体(葡萄糖依赖性促胰岛素多肽)的双靶点长效激动剂HDM1005注射液在体重管理适应症中 国Ⅱ期临床试验中取得了积极结果，展现了公司在代谢疾病领域强大的研发实力。 公开资料显示，HDM1005注射液是由中美华东研发并拥有全球知识产权的1类化学新药，为多肽类人 GLP-1受体和GIP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，改善代谢功能，进而改 善血浆容量、减少氧化应激和全身炎症、改善心血管适应性，从而具有降糖、减重、改善代谢相关脂肪 性肝炎(MASH)及射血分数保留心力衰竭(HFpEF)的作用。 此外，华东医药另一款自主研发的靶向人黏蛋白-17(MUC-17)的新型抗体药物偶联物(ADC)HDM2012的 胃癌和胃食管交界癌、胰腺癌两项适应症获得美国食品药品监督管理局 ...

12月15日，华东医药（000963）股份有限公司(以下简称"华东医药"或公司)全资子公司杭州中美华东制 药有限公司(以下简称"中美华东")宣布，其研发的创新多肽类人GLP-1(胰高血糖素样肽-1)受体和GIP受 体(葡萄糖依赖性促胰岛素多肽)的双靶点长效激动剂HDM1005注射液在体重管理适应症中国II期临床试 验中取得了积极结果，展现了公司在代谢疾病领域强大的研发实力。 此外，公司另一款自主研发的ADC创新药注射用HDM2012的胃癌和胃食管交界癌、胰腺癌两项适应症 获得美国食品药品监督管理局(以下简称"美国FDA")孤儿药资格认定(Orphan Drug Designation,ODD)， 证明了其ADC研发创新性获国际认可。 这两大进度这标志着华东医药在新药研发的国际化与前沿探索方面实现了重要跨越，不仅体现了公司以 科研为基础理念的成功实践，更彰显了其在新靶点探索和研发布局上的前瞻性，为华东医药在创新领域 的持续领先奠定了坚实基础。 强效减重临床数据惊艳，创新产品获孤儿药认定 公开资料显示，HDM1005注射液是由中美华东研发并拥有全球知识产权的1类化学新药，为多肽类人 GLP-1受体和GIP受体的双 ...

Core Viewpoint - East China Pharmaceutical announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., has completed the first random dosing of HDM1005 injection, a GLP-1/GIP dual-target long-acting agonist, in the Phase III clinical study for weight loss indication in China [1] Group 1 - The clinical study is identified as HDM1005-301 [1] - The drug is designed to target both GLP-1 and GIP pathways, which are significant in weight management [1] - The completion of the first random dosing marks a critical milestone in the development of HDM1005 [1]

Group 1 - Company announced research results of three innovative GLP-1 drugs at the 85th American Diabetes Association (ADA) Scientific Sessions in 2025 [1] - The self-developed GLP-1/GIP dual-target long-acting agonist HDM1005 was selected for an oral presentation at the conference [1] - HDM1005 is undergoing Phase II clinical trials for weight management and is expected to enter Phase III trials in Q4 2025 [1] Group 2 - HDM1002 is a new oral non-peptide GLP-1 receptor agonist, with a Phase I clinical study focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics in overweight or obese subjects [2] - The Phase III clinical study for weight management indication of HDM1002 has completed the first subject enrollment in April 2025 [2] - The submission for marketing approval of the semaglutide injection for diabetes indication was accepted in March 2025 [2] Group 3 - Company ranked 41st in the "2025 Global Pharmaceutical Companies Top 50" list published by Pharmaceutical Executive magazine, marking a historic high with six Chinese companies on the list [3] - This ranking reflects the company's enhanced comprehensive competitiveness and international recognition [3]

Group 1 - Company announced the research results of three GLP-1 innovative drugs at the 2025 ADA conference, with HDM1005 selected for oral presentation and HDM1002-102 and semaglutide injection results displayed as posters [1][2] - HDM1005 is a dual-target long-acting agonist for GLP-1 and GIP, with a Phase I study showing significant weight loss and metabolic improvements in participants [3][4] - HDM1002, an oral non-peptide GLP-1 receptor agonist, demonstrated good safety and weight loss effects in a Phase 1b study, with further clinical development planned [4] Group 2 - Semaglutide injection's Phase III study involved 494 type 2 diabetes patients, showing comparable efficacy to Novo Nordisk's treatment, with lower adverse event rates [5] - Company has a robust pipeline with 133 projects under development, focusing on endocrine, autoimmune, and oncology fields, with significant R&D investment [5][6] - In the endocrine sector, the company is developing a diverse range of GLP-1 products, including HDM1005 and HDM1002, with ongoing clinical trials [6] Group 3 - In oncology, the company aims to establish a leading drug development platform, with over 30 innovative drug candidates, including ADCs and small molecules [7][8] - The first ADC project, HDM2005, received orphan drug designation from the FDA, with ongoing clinical trials for various cancer indications [8] - The company has a comprehensive pipeline in the autoimmune field, with over 20 products in development, targeting various conditions [9] Group 4 - The company ranked 41st in the "2025 Global Pharmaceutical Companies Top 50" list, marking a significant recognition of its competitive strength [1][10] - The successful presentation of GLP-1 drugs at the ADA conference highlights the company's advancements in metabolic disease treatment [10] - The company continues to focus on innovation and research to provide better solutions for global patients [10]

证券代码：000963 证券简称：华东医药 公告编号：2025-012 华东医药股份有限公司 关于全资子公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 2025 年 3 月 3 日，华东医药股份有限公司（以下简称"公司"） 全资子公司杭州中美华东制药有限公司（以下简称"中美华东"）收到 国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知 书》（通知书编号：2025LP00511 和 2025LP00512），由中美华东申 报的 HDM1005 注射液临床试验申请获得批准，现将有关详情公告如 下： | 产品名称 | HDM1005注射液 | | --- | --- | | 申请事项 | 临床试验 | | 注册分类 | 化学药品1类 | | 受理号 | CXHL2401327；CXHL2401328 | | 适应症 | 本品用于射血分数保留心力衰竭（HFpEF）合并肥胖 | | | 或超重成人患者的治疗 | | 申请人 | 杭州中美华东制药有限公司 | | 结论 | 根据《中华人民共和国药品管理法》及有关规定，经 ...

2025 年 2 月 24 日，华东医药股份有限公司（以下简称"公司"） 全资子公司杭州中美华东制药有限公司（以下简称"中美华东"）收到 国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知 书》（通知书编号：2025LP00440 和 2025LP00441），由中美华东申 报的 HDM1005 注射液临床试验申请获得批准，现将有关详情公告如 下： | 产品名称 | HDM1005注射液 | | --- | --- | | 申请事项 | 临床试验 | | 注册分类 | 化学药品1类 | | 受理号 | CXHL2401329；CXHL2401330 | | 适应症 | 本品用于阻塞性睡眠呼吸暂停（OSA）合并肥胖或超重成人 | | | 患者的治疗 | | 申请人 | 杭州中美华东制药有限公司 | | 结论 | 根据《中华人民共和国药品管理法》及有关规定，经审查， | | | 2024年12月6日受理的HDM1005注射液符合药品注册的有关 | | | 要求，同意（按照提交的方案）开展用于阻塞性睡眠呼吸暂 | | | 停（OSA）合并肥胖或超重的临床研究。 | 一、该药物基本信息 二、该药物研发及注 ...