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智氪 | 一季度狂揽50亿刀,替尔泊肽凭什么成为减肥顶流?
3 6 Ke· 2025-06-25 09:48
图:礼来股价长期表现;资料来源:wind,36氪 作者 | 黄绎达 编辑 | 郑怀舟 诺和诺德司美格鲁肽是近年来的一款"网红药物",在介入减肥领域后,凭借其优秀的药效和名人的示范效应,一时风头无两。礼来的同类型药物替尔泊肽 作为后起之秀,在近两年的表现亦颇为亮眼,曝光度不次于司美格鲁肽。 体现在销售数据上,礼来财报显示,替尔泊肽凭借降糖(Mounjaro)和减重(Zepbound)两项适应症,在2025Q1合计实现收入50亿美元,约占同期公司 收入的39%,同比增速更是超过了100%。 在替尔泊肽如此炸裂的销售业绩驱动下,礼来的股价亦是水涨船高。尽管礼来的股价在今年有所调整,但长期表现依然相当优异,自替尔泊肽在2022年5 月获批上市,礼来股价从彼时至今的涨幅高达180%。 那么,替尔泊肽凭借什么实现了销售额的长期高增长?替尔泊肽在未来将面临哪些挑战呢? 01 替尔泊肽业绩持续高增都有哪些原因? 替尔泊肽在2022年在美国获批上市后,处方量持续快速增长,而且增速水平远超同期的司美格鲁肽,由此驱动替尔泊肽的市占率快速提升。IQVIA数据显 示,截至2025Q1,礼来(包含替尔泊肽、度拉糖肽等相关产品)在美国肠促 ...
花旗:中国制药业_未来催化剂_参与 2025 年美国糖尿病协会(ADA)会议的中国企业
花旗· 2025-06-16 03:16
Flash | 12 Jun 2025 08:08:06 ET │ 9 pages China Pharmaceuticals Catalysts ahead: Chinese companies in ADA 2025 CITI'S TAKE The American Diabetes Association (ADA) meeting (6/20-6/23; Chicago) will happen next week, and we summarize the expected presentations from the China companies due to attend. Innovent will likely present mazdutide DREAMS-1 Ph3 study for T2D and the preclinical data for the GLP-1/GIP/GCG/PCSK9 candidate. Oral GLP-1 data including ASC30 (Ph1a), HDM1002(Ph1b) and RGT-075 (Ph2a), as well a ...
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
Quan Jing Wang· 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 ...
开源证券:给予华东医药买入评级
Zheng Quan Zhi Xing· 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) - 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]
重磅!华东医药FIC新药DR10624 1b/2a期试验成效卓越,入选EASL 2025最新突破
Quan Jing Wang· 2025-05-12 11:42
Core Insights - The announcement by East China Pharmaceutical (华东医药) regarding its subsidiary Zhejiang Daer Biotechnology's (道尔生物) innovative long-acting triple agonist DR10624 has garnered significant attention due to its promising clinical trial results for treating obesity with hypertriglyceridemia [1][2][9] Group 1: Clinical Trial Results - DR10624 has shown remarkable efficacy in reducing liver fat content (LFC) in a Phase Ib/IIa clinical trial, with reductions of 51.9%, 77.8%, 79.0%, and 75.8% for the 12.5 mg, 25 mg, 50 mg, and 75 mg dosage groups respectively, compared to a placebo group reduction of 26.3% [2][4] - In subjects with baseline LFC ≥8%, the relative reductions were even more pronounced, with reductions of 58.3%, 83%, 89.2%, and 87.2% for the respective dosage groups, again significantly outperforming the placebo group [4][5] - A notable 66.7%, 88.9%, 100%, and 85.7% of subjects in the respective dosage groups achieved a relative reduction of LFC ≥50%, indicating a high likelihood of histological resolution of steatohepatitis [6] Group 2: Drug Development and Pipeline - DR10624 is currently undergoing additional clinical trials in China for treating metabolic-associated fatty liver disease with liver fibrosis and severe hypertriglyceridemia, with results expected in the third quarter of 2025 [6][9] - The company has a robust pipeline of over 80 innovative drug candidates, focusing on endocrine, autoimmune, and oncology fields, with significant advancements in GLP-1 targeted products [7][9] - The oral small molecule GLP-1 receptor agonist HDM1002 has completed its first subject enrollment for weight management in a Phase III trial, with further studies in diabetes also progressing [7][8] Group 3: Market Position and Future Outlook - East China Pharmaceutical is positioning itself as a leader in the endocrine field, with DR10624's breakthrough results and ongoing development of other GLP-1 related products enhancing its competitive edge [9] - The increasing focus on multi-target agonists, particularly those targeting GLP-1, GCGR, and FGF21R, is expected to drive future growth and innovation within the company [6][9] - The company's commitment to R&D is reflected in its significant investment, with a reported R&D expenditure of 2.678 billion yuan, marking a 16.77% year-on-year increase [8]
华东医药(000963) - 2025年4月25日投资者关系活动记录表
2025-04-27 09:08
证券代码:000963 证券简称:华东医药 华东医药股份有限公司投资者关系活动记录表 12.29%,环比2024年第四季度增长24.37%,整体经营符合第一季度计 划目标。国内医美全资子公司欣可丽美学积极拓展国内市场,报告期 内实现营业收入2.54亿元,同比下降1.36%,环比2024年第四季度增长 10.64% 。公司持续深化国内高端医美产品布局,高端玻尿酸 MaiLi®Extreme(商品名:魅俪®朔盈®)将于2025年5月正式实现商业化 销售;多功能面部皮肤管理平台Préime DermaFacial也将于2025年内正 式实现商业化销售。此外,重组A型肉毒毒素YY001、能量源设备V30 及Ellansé®伊妍仕®M型等核心医美产品国内上市申请均已获受理,有 望于2026年获批。依托国内差异化医美产品矩阵的持续丰富,叠加消 费升级带来的市场需求扩容,公司国内医美业务成长潜能将加速释放。 编号:2025-002 | | □特定对象调研 □分析师会议 | | --- | --- | | 投资者关系 | □业绩说明会 □媒体采访 | | 活动类别 | □新闻发布会 □路演活动 | | | □现场参观 ☑其他 ...
华东医药(000963) - 2025年4月18日投资者关系活动记录表
2025-04-18 14:58
Financial Performance - In 2024, the company achieved a revenue of CNY 41.906 billion, a year-on-year increase of 3.16% [4] - The net profit attributable to shareholders was CNY 3.512 billion, up 23.72% year-on-year [4] - The net profit after deducting non-recurring gains and losses was CNY 3.352 billion, reflecting a growth of 22.48% [4] - Compared to 2021, revenue and net profit grew by 21.24% and 52.59%, respectively [4] Business Segments Performance Pharmaceutical Industry - The pharmaceutical segment generated a revenue of CNY 13.811 billion, with a year-on-year growth of 13.05% [5] - The net profit for this segment was CNY 2.876 billion, increasing by 29.04% [5] - R&D investment in the pharmaceutical industry reached CNY 2.678 billion, a 16.77% increase [5] Aesthetic Medicine - The domestic aesthetic medicine subsidiary reported a revenue of CNY 1.139 billion, growing by 8.32% [6] - The UK subsidiary, Sinclair, generated approximately CNY 0.967 billion, a decline of 25.81% due to global economic challenges [6] Industrial Microbiology - The industrial microbiology segment achieved a revenue of CNY 0.711 billion, a significant increase of 43.12% [25] - Growth rates for specific areas included 38% for specialty raw materials and intermediates, 20% for xRNA, and 142% for health and biological materials [25] R&D and Product Development - The company has over 80 innovative drug candidates in its pipeline [5] - The oral small molecule GLP-1 receptor agonist HDM1002 has shown promising results in clinical trials, with over 800 participants [17] - The ADC pipeline includes more than 12 projects, with ongoing clinical trials for several candidates [14] Market Strategy and Future Outlook - The company plans to actively participate in medical insurance negotiations for new products [6] - There is a focus on expanding market presence in both domestic and international markets, particularly in the aesthetic medicine sector [26] - The company anticipates a gradual recovery in overseas aesthetic medicine markets [26] Investor Relations and Communication - The annual performance meeting was attended by 381 institutional and individual investors [2] - The chairman emphasized the commitment to high-quality development and strategic goals for the upcoming three-year plan [27]
华东医药(000963) - 关于全资子公司获得药物临床试验批准通知书的公告
2025-02-24 09:00
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 ...