Core Viewpoint - Guohai Securities' report indicates that East China Pharmaceutical's dual-target GLP-1 is progressing smoothly, with a positive outlook on the weight loss market development [1] Group 1: Clinical Trial Results - The company's wholly-owned subsidiary, Zhongmei East China, has developed an innovative long-acting agonist HDM1005, targeting both GLP-1 and GIP receptors, which has shown positive results in Phase II clinical trials for weight management in China [1] - The weight loss effects of HDM1005 were significant, with the 0.5mg, 1.0mg, 2.0mg, and 4.0mg groups showing weight changes of -7.47%, -9.73%, -13.31%, and -13.28% respectively after 22 weeks, compared to a -2.46% change in the placebo group [1] - In addition to weight reduction, HDM1005 also demonstrated significant improvements in other cardiovascular and metabolic indicators, including glucose metabolism, blood pressure, and blood lipids [1] Group 2: Company Positioning - The company is recognized as a leading domestic prescription drug enterprise, with a rich product pipeline and industry-leading channel and brand capabilities [1] - The company is expected to achieve coordinated growth through both internal and external development strategies [1]

Core Viewpoint - The article highlights the positive results of the Phase II clinical trial for HDM1005, a GLP-1R/GIPR dual agonist developed by Huadong Medicine, demonstrating significant weight loss efficacy and good safety profile [4][9]. Mechanism of Action - HDM1005 activates both GLP-1R and GIPR, promoting cAMP production, which enhances insulin secretion, suppresses appetite, delays gastric emptying, and improves overall metabolic function [5]. - The drug also shows potential benefits in reducing plasma volume, lowering oxidative stress and systemic inflammation, and improving cardiovascular adaptability, indicating multiple therapeutic values including weight loss and glycemic control [5]. Phase II Study Design - The Phase II clinical trial included 243 participants over a 22-week treatment period, with a balanced comparison of baseline metrics such as weight, waist circumference, and BMI across dosage groups [6]. - The study employed a dose-escalation strategy with four dosage groups (0.5 mg, 1.0 mg, 2.0 mg, and 4.0 mg) compared to a placebo group [6]. Significant Weight Loss Results - The results indicated that participants in the highest dosage group (4.0 mg) experienced a weight reduction of 13.28% from baseline, while the placebo group saw a decrease of only 2.46% [7]. - The proportion of participants achieving a weight loss of ≥10% was notable: 75.0% in the 2.0 mg group and 70.8% in the 4.0 mg group, compared to 6.1% in the placebo group [7]. - Improvements in waist circumference (6.3–10.3 cm reduction) and BMI (2.4–4.2 kg/m² reduction) were also observed, alongside significant enhancements in various metabolic indicators [7]. Safety Profile - HDM1005 demonstrated a good safety and tolerability profile, with adverse events primarily being mild to moderate, and no serious treatment-related adverse events reported [8]. - Common side effects included decreased appetite and gastrointestinal reactions, with nausea and vomiting rates varying across dosage groups [8]. Overall Summary - HDM1005 shows strong weight loss effects, a clear dose-response relationship, and a favorable safety profile, positioning it for differentiated development within the competitive landscape of GLP-1 drugs [9].

Core Viewpoint - East China Pharmaceutical's subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., has achieved positive results in the Phase II clinical trial of its innovative dual-target long-acting agonist HDM1005 for weight management, showcasing the company's strong R&D capabilities in metabolic diseases [1][2]. Group 1: HDM1005 Development - HDM1005 is a novel class of chemical drug that acts as a dual-target long-acting agonist for GLP-1 and GIP receptors, with preclinical studies indicating its potential to improve metabolic functions, reduce oxidative stress, and enhance cardiovascular adaptability [1]. - The clinical development of HDM1005 is progressing systematically, with the Phase III trial for weight management expected to complete the first subject enrollment by October 2025, and the Phase II trial for diabetes having completed subject enrollment by July 2025 [2]. - Applications for clinical trials of HDM1005 in multiple indications, including metabolic-associated fatty liver disease (MAFLD) and metabolic-associated fatty liver inflammation (MASH), have been approved in both China and the United States, indicating a comprehensive global clinical development strategy [2]. Group 2: HDM2012 Development - HDM2012, a novel antibody-drug conjugate targeting MUC-17, has received orphan drug designation from the FDA for gastric cancer and pancreatic cancer, highlighting the international recognition of the drug's innovative R&D [2]. - HDM2012 is the first ADC product targeting MUC-17 and is currently the only ADC drug in clinical research for this target, which is highly expressed in gastric, colorectal, and pancreatic cancers but has limited expression in normal organs [2]. - Preclinical results for HDM2012 demonstrate good drug-like properties, safety, and efficacy, with clinical trials in China and the U.S. receiving approval in July and June 2025, respectively, for advanced malignancies [3].

Core Insights - The company has achieved significant progress in drug development with its innovative long-acting dual-target agonist HDM1005 and the orphan drug designation for HDM2012, showcasing its strong R&D capabilities in metabolic diseases [1][2][4][10] Group 1: HDM1005 Development - HDM1005 is a first-class chemical new drug targeting GLP-1 and GIP receptors, showing promising results in a Phase II clinical trial for weight management, with a total of 243 participants [2][3] - The trial results indicate that weight loss in the HDM1005 groups (0.5mg, 1.0mg, 2.0mg, 4.0mg) was -7.47%, -9.73%, -13.31%, and -13.28% respectively, significantly outperforming the placebo group at -2.46% [3] - The drug also demonstrated improvements in waist circumference and BMI, with reductions of 6.3-10.3cm and 2.4-4.2kg/m respectively, compared to the placebo group [3] Group 2: HDM2012 Orphan Drug Designation - HDM2012, an ADC targeting MUC-17, has received orphan drug designation from the FDA for gastric and pancreatic cancers, highlighting its innovative potential [1][4][5] - It is the first ADC product targeting MUC-17 and shows promise in treating MUC-17 positive cancers, with clinical trials approved in both China and the U.S. [4][5] Group 3: Market Context and Company Strategy - The obesity and overweight issue in China is a significant health challenge, with adult overweight and obesity rates at 34.3% and 16.4% respectively, affecting approximately 600 million people [3] - The company is advancing its clinical development of HDM1005 and has a systematic approach to expanding indications, indicating a robust global clinical development framework [4][10] - The company has established a comprehensive pipeline around GLP-1 targets, including both oral and injectable formulations, enhancing its competitive edge in metabolic treatments [6][8] Group 4: Future Outlook - The dual breakthroughs of HDM1005 and HDM2012 signify the company's transition into a phase of scalable output in its innovation system [10] - The company is expected to continue leveraging its forward-looking target layout and differentiated R&D strategies to deliver more advanced treatment options for global patients [10]

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 ...