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 ...