HUADONG MEDICINE(000963)

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华东医药董秘陈波:完成体重管理适应症临床III期研究首例受试者入组
全景网· 2025-06-04 04:39
陈波介绍,GLP-1R/GIPR双靶点长效多肽类激动剂HDM1005(poterepatide)注射液,正在开展体重管 理适应症II期临床试验,已于2025年4月完成II期全部受试者入组,预计2025年Q4进入III期临床研究。 此外,糖尿病适应症II期临床试验已于2025年4月完成首例受试者入组。报告期内,HDM1005注射液新 适应症IND申请先后获得NMPA批准,分别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、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。 互动交流环节,华东医药董事会秘书陈波表示,口服小分子GLP-1受体激动剂HDM1002 (conveglipron),已于2025年4月完成体重管理适应症临床III期研究的首例受试者入组,计划于2025年 6月底前完成全部受试者入组。此外,糖尿病适应症临床II期研究正在顺利开展中,预计2025年Q3获得 顶线结果,并于2025年下半年进入III期临床研究。 他指出,FGF21R/GCGR/GLP-1R三靶点激动剂DR10624注射液目前正在中国开展治疗合并肝纤维化高 风险的代谢相关脂肪性肝病以及代谢合并酒精相关脂 ...
华东医药:公司深度报告:创新转型再出发,多产品步入收获期-20250603
开源证券· 2025-06-03 00:23
医药生物/化学制药 华东医药(000963.SZ) 创新转型再出发,多产品步入收获期 2025 年 06 月 02 日 投资评级:买入(维持) | 日期 | 2025/5/30 | | --- | --- | | 当前股价(元) | 44.70 | | 一年最高最低(元) | 45.30/25.96 | | 总市值(亿元) | 784.07 | | 流通市值(亿元) | 783.12 | | 总股本(亿股) | 17.54 | | 流通股本(亿股) | 17.52 | | 近 3 个月换手率(%) | 50.78 | 股价走势图 数据来源:聚源 -32% -16% 0% 16% 32% 48% 2024-06 2024-10 2025-02 华东医药 沪深300 相关研究报告 | ——公司深度报告 | | --- | | 余汝意(分析师) | 余克清(分析师) | 刘艺(联系人) | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | liuyi1@kysec.cn | | 证书编号:S0790523070002 | 证书编号:S079052 ...
开源证券:给予华东医药买入评级
证券之星· 2025-06-02 23:31
开源证券股份有限公司余汝意,余克清,刘艺近期对华东医药(000963)进行研究并发布了研究报告《公司深度报 告:创新转型再出发,多产品步入收获期》,给予华东医药买入评级。 公司聚焦肿瘤、内分泌及自免三大核心领域,差异化布局ADC和PROTAC技术,ROR1ADC以及HPK1PROTAC已 经进入临床阶段;治疗消化道肿瘤的自研Cpd3-ADC均计划2025Q2/Q3递交中国和美国的IND申请。公司降糖减重 管线布局口服小分子GLP-1药物HDM1002;GLP-1R/GIPR双靶点的HDM1005,其肥胖适应症已在2025年4月完成 全部受试者入组,2型糖尿病于2025年4月完成首例患者入组;FGF21R/GCGR/GLP-1R激动剂DR10624,预计 2025Q3获得重度高甘油三酯血症的2期顶线结果。公司有望在更多适应症上实现布局。 华东医药 创新转型再出发,多产品步入收获期,维持"买入"评级 医药工业经营趋势稳健,医美多产品矩阵有望保证公司长周期向上 风险提示:临床研发失败风险、竞争格局恶化风险、销售不及预期风险等。 最新盈利预测明细如下: 公司聚焦慢病、肿瘤以及免疫等领域,覆盖医药工业、医药商业、医美、 ...
华东医药(000963):公司深度报告:创新转型再出发,多产品步入收获期
开源证券· 2025-06-02 13:43
| 日期 | 2025/5/30 | | --- | --- | | 当前股价(元) | 44.70 | | 一年最高最低(元) | 45.30/25.96 | | 总市值(亿元) | 784.07 | | 流通市值(亿元) | 783.12 | | 总股本(亿股) | 17.54 | | 流通股本(亿股) | 17.52 | | 近 3 个月换手率(%) | 50.78 | 股价走势图 数据来源:聚源 -32% -16% 0% 16% 32% 48% 2024-06 2024-10 2025-02 华东医药 沪深300 相关研究报告 医药生物/化学制药 华东医药(000963.SZ) 创新转型再出发,多产品步入收获期 2025 年 06 月 02 日 投资评级:买入(维持) | ——公司深度报告 | | --- | | 余汝意(分析师) | 余克清(分析师) | 刘艺(联系人) | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | liuyi1@kysec.cn | | 证书编号:S0790523070002 | 证书编号:S079052 ...
华东医药(000963) - 关于全资子公司收到药品注册受理通知书的公告
2025-06-02 07:46
证券代码:000963 证券简称:华东医药 公告编号:2025-044 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 5 月 29 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)签发的《受理通知书》(受理号: CXSS2500055),由中美华东申报的雷珠单抗注射液(研发代码: HJY28)上市许可申请获得受理。现将有关详情公告如下: 一、该药物基本信息内容 药物名称:雷珠单抗注射液 申请事项:境内生产药品注册上市许可 注册分类:治疗用生物制品 3.3 类 规格:10mg/ml,每瓶装量 0.20ml 华东医药股份有限公司 关于全资子公司收到药品注册受理通知书的公告 雷珠单抗注射液适用于早产儿: • 用于治疗 I 区(1+、2+、3 或 3+期)、II 区(3+期)早产儿视网 膜病变(ROP)和 AP-ROP(急进性后极部 ROP)。 申请人:杭州中美华东制药有限公司 结论:根据《中华人民共和国行政许可法》第三十二条的规定, 经审查,决定予以受理。 二 ...
华东医药:雷珠单抗注射液上市许可申请获受理
快讯· 2025-06-02 07:35
Core Viewpoint - The announcement indicates that East China Pharmaceutical's subsidiary has received a notice of acceptance for the marketing authorization application of Ranibizumab injection, marking a significant progress in the drug's development [1] Company Summary - East China Pharmaceutical's wholly-owned subsidiary, Hangzhou Zhongmei East China Pharmaceutical Co., Ltd., has submitted a marketing authorization application for Ranibizumab injection, which has been accepted by the National Medical Products Administration [1] - The total investment in the research and development of Ranibizumab injection amounts to approximately 220 million yuan [1] - The acceptance of the application is an important milestone in the drug's development process, which is expected to enhance the company's core competitiveness in the treatment of various retinal diseases in the long term [1] Industry Summary - Ranibizumab injection is indicated for the treatment of various retinal diseases in adults and premature infants, highlighting its potential market relevance [1] - The acceptance of the marketing application is a positive development for the industry, as it reflects ongoing innovation and progress in the treatment of eye diseases [1]
华东医药(000963) - 2024年年度权益分派实施公告
2025-05-27 10:15
证券代码:000963 证券简称:华东医药 公告编号:2025-043 华东医药股份有限公司 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。 华东医药股份有限公司(以下简称 "本公司"或"公司")2024 年年度权益分派方案已获 2025 年 5 月 15 日召开的公司 2024 年度股 东大会审议通过,现将权益分派事宜公告如下: 一、股东大会审议通过利润分配方案情况 1、公司 2024 年度股东大会审议通过的利润分配方案为:以公司 现有总股本 1,754,077,048 股为基数,向全体股东每 10 股派 5.8 元人 民币现金(含税),不送红股,不以公积金转增股本,总计派发现金 红利 1,017,364,687.84 元(含税),剩余未分配利润结转以后年度分 配。如本次利润分配预案实施前,公司总股本发生变动的,按照分配 总额不变的原则调整每股分配比例。 2、自分配方案披露至实施期间公司股本总额未发生变化。 3、本次实施的分配方案与公司 2024 年度股东大会审议通过的分 配方案一致。 2024年年度权益分派实施公告 4、本次实施分配方案距离股东大会审议通过 ...
华东医药(000963) - 2025年5月15日投资者关系活动记录表(投资者接待日活动)
2025-05-16 11:24
Group 1: Financial Performance - In 2024, the company achieved a revenue growth of 21.24% and a net profit growth of 52.59% compared to 2021, reaching historical highs [2] - The company completed its seventh three-year plan successfully and is now entering the eighth three-year plan with higher goals [14] Group 2: Innovation and R&D - The company has over 80 innovative drug pipelines, with nearly 50 self-developed projects, focusing on oncology, endocrinology, and immunology [3] - In 2024, the company received 4 NDA/BLA approvals and 14 clinical approvals in China and the U.S. [3] - The R&D team consists of over 330 members, with more than 60% holding advanced degrees [3] Group 3: Key Product Developments - The company launched several innovative products, including the first ADC drug for platinum-resistant ovarian cancer and the first biosimilar of ustekinumab in China [2] - The GLP-1 receptor agonist HDM1002 has over 800 participants in clinical trials, showing good safety and efficacy [5][6] - The ADC project HDM2005 for treating advanced malignancies has completed initial dosing stages without dose-limiting toxicity [9] Group 4: AI and Technology Integration - The company established an AI drug design platform, enhancing drug development efficiency through deep integration of AI and traditional methods [10] Group 5: Aesthetic Medicine Sector - The aesthetic medicine division has developed a comprehensive product matrix, covering various treatment methods and achieving significant growth since its inception [12][13] - The company aims to become a leading provider of comprehensive aesthetic solutions globally, with a focus on innovative product launches [12] Group 6: Market Strategy and Future Outlook - The company plans to balance R&D investments with revenue growth, focusing on enhancing project quality and efficiency [15][16] - The domestic aesthetic medicine market is expected to grow, supported by new product launches and increasing consumer demand [19] - The company is optimistic about its industrial microbiology segment, aiming for accelerated development in the next three years [20]
华东医药股份有限公司2024年度股东大会决议公告
中国证券报-中证网· 2025-05-15 23:03
Meeting Overview - The shareholder meeting was held on May 15, 2025, from 14:00 to 15:00 at the new building of East China Pharmaceutical Co., Ltd. in Hangzhou, Zhejiang Province [3][4] - The meeting was conducted through a combination of on-site and online voting [4] Attendance - A total of 837 shareholders attended the meeting, representing 1,178,101,216 shares, which is 67.1636% of the total voting shares [5] - Among them, 31 shareholders voted on-site, representing 1,019,862,337 shares (58.1424%), while 806 shareholders voted online, representing 158,238,879 shares (9.0212%) [5][6] - 835 minority shareholders participated, representing 159,163,059 shares (9.0739%) [7] Proposal Voting Results - The following proposals were approved with significant majority votes: - The 2024 Annual Board Work Report received 99.9694% approval [10][11] - The 2024 Annual Supervisory Board Work Report received 99.9696% approval [13][14] - The 2024 Financial Settlement Report received 99.9674% approval [15][16] - The 2024 Annual Report and its summary received 99.9696% approval [17][18] - The 2024 Profit Distribution Plan received 99.9794% approval [19][20] - The reappointment of the accounting firm received 99.6448% approval [22][23] - The proposal for providing guarantees for subsidiaries in 2025 received 99.9741% approval [24][25] - The proposal for expected daily related transactions for 2025 (Yuan Da Group) received 99.9196% approval [26][27] - The proposal for expected daily related transactions for 2025 (other related parties) received 99.9705% approval [28][29] - The authorization for the board to formulate the 2025 interim dividend plan received 99.9812% approval [30][31] Legal Opinion - The legal opinion provided by Zhejiang Tian Ce Law Firm confirmed that the meeting's convening, procedures, and voting were in compliance with legal and regulatory requirements [32]
华东医药: 浙江天册律师事务所关于华东医药股份有限公司2024年度股东大会的法律意见书
证券之星· 2025-05-15 12:20
Core Viewpoint - The legal opinion letter from Zhejiang Tiance Law Firm confirms the legality and validity of the procedures, qualifications of attendees, and voting results for the 2024 annual general meeting of Huadong Medicine Co., Ltd. [1][6] Group 1: Meeting Procedures - The annual general meeting was proposed and convened by the board of directors, with the notice published on April 18, 2025, in designated media and on the Shenzhen Stock Exchange website [2][3] - The meeting utilized a combination of on-site and online voting, with the on-site meeting held at the company's new building on the third floor [2][3] - The specific times for online voting through the Shenzhen Stock Exchange platform were set for May 15, 2025, from 9:15 to 9:25, 9:30 to 11:30, and 13:00 to 15:00 [3] Group 2: Attendee Qualifications - Attendees included all registered ordinary shareholders of the Shenzhen branch, who could appoint proxies to attend and vote [4][5] - The qualifications of the shareholders and their proxies were verified against identification and authorization documents, confirming compliance with relevant laws and regulations [5] Group 3: Voting Procedures and Results - The voting was conducted in a named manner, with specific provisions for related shareholders to abstain from voting on certain proposals [6] - All proposals presented at the meeting were approved, and no additional matters not listed in the notice were voted on [6] - The voting procedures adhered to the requirements of the Company Law, Shareholder Meeting Rules, and the company's articles of association, ensuring the legality and validity of the results [6]