关于全资子公司获得美国FDA新药临床试验批准通知的公 证券代码：000963 证券简称：华东医药 公告编号：2024-090 华东医药股份有限公司 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。 近日，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"）收到美国食品药 品监督管理局（以下简称"美国 FDA"）通知，由中美华东申报的 HDM1005 注射液药品临床试验申请已获得美国 FDA 批准，可在美国 开展 I 期临床试验，现将有关详情公告如下： 一、该药物基本信息 药物名称：HDM1005 注射液 HDM1005 注射液是由杭州中美华东制药有限公司研发并拥有全 球知识产权的 1 类化学新药，是多肽类人 GLP-1（胰高血糖素样肽- 1）受体和 GIP（葡萄糖依赖性促胰岛素多肽）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，改善脂肪代谢，具有降糖、减重及治疗 MASH 的作用； ...

Investment Rating - The report maintains a "Recommended" rating for the company with a target price of 46.6 CNY, while the current price is 36.0 CNY [1]. Core Views - The company's performance in the first three quarters of 2024 met expectations, with total revenue of 31.478 billion CNY (+3.56%) and a net profit attributable to shareholders of 2.562 billion CNY (+17.05%) [1]. - The pharmaceutical manufacturing segment showed strong performance, with Q3 revenue of 3.243 billion CNY (+10.32%) and net profit of 755 million CNY (+20.44%) [2]. - The company is advancing its innovative research and development, currently having over 70 new products in various stages, including small molecules and ADCs [2]. Financial Summary - For 2024-2026, the company is expected to achieve net profits of 3.39 billion CNY, 3.94 billion CNY, and 4.52 billion CNY, representing growth rates of 19.3%, 16.4%, and 14.7% respectively [3]. - The estimated valuation for the pharmaceutical manufacturing segment in 2025 is 63.1 billion CNY, with a total company valuation of 81.8 billion CNY [3]. - Key financial metrics include total revenue projections of 44.838 billion CNY for 2024, with a year-on-year growth rate of 10.4% [7].

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The company’s subsidiary, Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the marketing authorization of Ustekinumab injection (Selokimab®), the first biosimilar of Ustekinumab in China, for the treatment of moderate to severe plaque psoriasis in adults [1][10] - Ustekinumab's original drug sales exceed $10 billion annually, indicating a significant market opportunity for the company's biosimilar [1][10] - The company has over 70 innovative products in its pipeline, focusing on endocrine, autoimmune, and oncology fields, with several products in advanced clinical stages [1][3] Summary by Relevant Sections Business Analysis - Ustekinumab's original drug, Stelara®, developed by Johnson & Johnson, achieved global sales of $10.858 billion in 2023 [10][12] - The company’s innovative pipeline includes over 30 oncology products, with a notable ADC new drug application currently under review [1][3] - The company’s oral GLP-1 receptor agonist, HDM1002, has completed Phase II clinical trials for weight management in overweight or obese populations [1][3] Financial Forecasts and Valuation - The company is expected to achieve net profits of RMB 3.36 billion (+18%), RMB 3.94 billion (+17%), and RMB 4.57 billion (+16%) for the years 2024 to 2026, respectively [1][3] - Corresponding EPS for 2024-2026 is projected to be RMB 1.92, RMB 2.25, and RMB 2.61, with current P/E ratios of 18, 15, and 13 times [1][3]

Investment Rating - The investment rating for Huadong Medicine is "Buy" (maintained) [1]. Core Views - The approval of Ustekinumab injection (Seluixin®) marks a significant milestone for the company, being the first biosimilar of Ustekinumab approved in China, aimed at treating moderate to severe plaque psoriasis in adults [1][13]. - The original drug, Stelara®, generated over $10.85 billion in global sales in 2023, indicating a substantial market opportunity for the biosimilar [1][15]. - The company has a robust pipeline with over 70 innovative products, focusing on endocrine, autoimmune, and oncology fields, which are expected to contribute to revenue growth [1][4]. Summary by Sections Company Overview - Huadong Medicine's subsidiary received approval for Seluixin®, a biosimilar to Stelara®, which is a human monoclonal antibody targeting IL-12 and IL-23 [1][13]. - The company is actively expanding its innovative product pipeline, particularly in oncology, with over 30 innovative drug candidates [1][4]. Financial Performance - The company is projected to achieve net profits of RMB 3.36 billion (+18%), RMB 3.94 billion (+17%), and RMB 4.57 billion (+16%) for the years 2024 to 2026, respectively [1][4]. - Earnings per share (EPS) are expected to be RMB 1.92, RMB 2.25, and RMB 2.61 for the same period, with corresponding price-to-earnings (P/E) ratios of 18, 15, and 13 times [1][4]. Market Potential - There are over 7 million psoriasis patients in China, with plaque psoriasis being the most common type, highlighting a significant market for the newly approved biosimilar [1][5]. - The approval of Seluixin® is expected to enhance the company's market position and revenue potential in the growing biopharmaceutical sector [1][4]. R&D and Innovation - The company has a strong focus on innovation, with ongoing clinical trials for various products, including those targeting obesity and autoimmune diseases [1][4]. - The successful development and approval of Seluixin® are expected to provide a competitive edge in the market, leveraging the company's existing capabilities in drug commercialization [1][16].

有望为国内银屑病患者提供更可负担的用药选择。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，11月5日，华东医药（000963.SZ）发布公告，其下属杭州中美华东制药有限公 司（下称"中美华东"）收到国家药监局（NMPA）核准签发的《药品注册证书》，由中美华东与荃 信生物（2509.HK）联合开发的乌司奴单抗注射液赛乐信（研发代码：HDM3001/QX001S）的上 市许可申请获得批准，用于治疗成年中重度斑块状银屑病，成为国内首个乌司奴单抗注射液生物类似 药。 赛乐信是原研产品Stelara（喜达诺，乌司奴单抗注射液）的生物类似药，为一款白介素IL-12/23 单抗药物。据强生公司2023年报，2023年Stelara在全球的销售额为108.58亿美元（约767.29亿 元人民币）。米内网数据显示，2023年喜达诺在中国的销售额为13.22亿元人民币。 此次赛乐信获批上市，有望为国内银屑病患者带来更可负担的用药选择。 本文由公众号IPO早知道（ID：ipozaozhidao）原创撰写，如需转载请联系C叔↓↓↓ QX001S最初由荃信生物自主研发，2020年8月， ...

2024年11月5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《药品注册证书》，由中美 华 东 申 报 的 乌 司 奴 单 抗 注 射 液 （ 赛 乐 信 ® ） （ 研 发 代 码 ： HDM3001/QX001S）的上市许可申请获得批准，用于治疗成年中重 度斑块状银屑病。现将有关详情公告如下： 一、该药物基本信息内容 证券代码：000963 证券简称：华东医药 公告编号：2024-088 华东医药股份有限公司 关于全资子公司获得药品注册证书的公告 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。 药品通用名称：乌司奴单抗注射液 英文名/拉丁名：Ustekinumab Injection 商品名称：赛乐信 剂型：注射剂 规格：预充式注射器：45mg（0.5ml）/支 申请事项：药品注册（境内生产） 注册分类：治疗用生物制品 受理号：CXSS2300065 证书编号：2024S02620 药品批准文号：国药准字S20240050 1 适应症：斑块状银屑病。本 ...

Investment Rating - The report assigns a "Buy" rating for Huadong Medicine (000963.SZ) for the first time [2][5]. Core Views - Huadong Medicine is positioned at a critical stage where its pharmaceutical and medical aesthetics sectors are expected to enter a rapid growth phase, leveraging its strong commercial resources accumulated from its generics sales [3][4]. - The company has achieved a compound annual growth rate (CAGR) of 8% in revenue and 11% in net profit from 2021 to 2023, indicating robust performance [10]. - The report anticipates revenue of 431 billion yuan, 462 billion yuan, and 488 billion yuan for 2024, 2025, and 2026 respectively, with net profits of 36 billion yuan, 43 billion yuan, and 52 billion yuan for the same years [5][3]. Summary by Sections Company Profit Forecast and Valuation - Revenue (in million yuan) is projected to grow from 40,624 in 2023A to 48,751 in 2026E, with a year-on-year growth rate of 8%, 6%, 7%, and 5% respectively [1]. - Net profit (in million yuan) is expected to increase from 2,839 in 2023A to 5,173 in 2026E, with a year-on-year growth rate of 14%, 28%, 19%, and 20% respectively [1]. - Earnings per share (in yuan) are forecasted to rise from 1.62 in 2023A to 2.95 in 2026E [1]. Pharmaceutical Industry - The pharmaceutical segment has completed its bottoming process, with innovative products entering the monetization phase. Key products include Bailing capsules and Acarbose tablets, which have faced price reductions and increased competition [10][15]. - The company has made significant strides in R&D, with a focus on chronic diseases and oncology, and has several innovative products in the pipeline [15][22]. Medical Aesthetics - The medical aesthetics business has shown rapid growth, with a comprehensive product line that includes over 40 high-end aesthetic products, of which 26 are already launched [25][26]. - The company has established a strong presence in the medical aesthetics market through strategic acquisitions and partnerships, enhancing its product offerings in non-surgical aesthetic procedures [25][26]. Investment Theme - Huadong Medicine is leveraging its extensive experience in the pharmaceutical industry to optimize its business structure, focusing on high-margin sectors such as manufacturing and medical aesthetics [4][10].

Investment Rating - The report maintains a "Buy" rating for the company [1][4]. Core Views - The company has demonstrated steady revenue growth, with a reported revenue of RMB 31.478 billion for Q1-Q3 2024, reflecting a year-on-year increase of 3.56%. The net profit attributable to shareholders reached RMB 2.562 billion, up 17.05% year-on-year [3][4]. - The medical aesthetics segment is experiencing overall positive growth, with domestic revenue increasing steadily despite challenges in overseas markets. The domestic subsidiary, Xinkeli Aesthetics, reported revenue of RMB 909 million, a 10.31% increase year-on-year [4]. - The company continues to invest in research and development, with R&D expenditure of RMB 1.607 billion in Q1-Q3 2024, representing 11.69% of the pharmaceutical industrial revenue. The innovative product pipeline has exceeded 70 projects [4]. Summary by Sections Financial Performance - For Q1-Q3 2024, the company achieved revenue of RMB 31.478 billion, a 3.56% increase year-on-year, and a net profit of RMB 2.562 billion, up 17.05% year-on-year. In Q3 2024 alone, revenue was RMB 10.513 billion, a 5.03% increase year-on-year, with a net profit of RMB 866 million, up 14.71% year-on-year [3][4]. - The pharmaceutical industrial segment reported revenue of RMB 9.941 billion for Q1-Q3 2024, a 10.53% increase year-on-year, while the pharmaceutical commercial segment achieved revenue of RMB 20.571 billion, a 1.38% increase year-on-year [4]. Market Segments - The medical aesthetics segment reported revenue of RMB 1.909 billion for Q1-Q3 2024, a 1.90% increase year-on-year. The UK subsidiary, Sinclair, faced a revenue decline of 20.30% to approximately RMB 776 million due to global economic challenges, while the domestic subsidiary saw a 10.31% increase in revenue [4]. Research and Development - The company invested RMB 1.607 billion in R&D for Q1-Q3 2024, with direct R&D spending of RMB 1.149 billion. The focus areas for innovation include endocrinology, autoimmune diseases, and oncology, with over 70 projects in the pipeline [4]. Valuation - The projected net profits for 2024, 2025, and 2026 are RMB 3.447 billion, RMB 4.113 billion, and RMB 4.975 billion, respectively, with corresponding EPS of RMB 1.96, RMB 2.34, and RMB 2.84. The price-to-earnings ratios are expected to be 17.2x, 14.4x, and 11.9x for the respective years [4][5].

证券代码：000963 证券简称：华东医药 编号：2024-009 华东医药股份有限公司投资者关系活动记录表 | --- | --- | --- | |------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------| | | □特定对象调研 | □分析师会议 | | 投资者关系 | □媒体采访 | □业绩说明会 | | 活动类别 | □新闻发布会 | □路演活动 | | | □现场参观 | ☑ 其他 华东医药 2024 年三季度业绩交流会 | | | | 参与单位：国联证券、中金公司、兴业证券、中信建投、银河证券、国 | | | | 金证券、华福证券、广发证券、中信证券、海通证券、太平洋证券、西 | | | | 部证券、东方财富证券、德邦证券、华创证券、天风证券、华西证券、 | | | | 中欧基金、贝莱德资产、嘉实基金、汇添富基金、建信基金 ...

Investment Rating - The report maintains a "Recommended" rating for Huadong Medicine [1][6] Core Views - The company reported a revenue of 31.478 billion yuan for the first three quarters of 2024, representing a year-on-year growth of 3.56%. The net profit attributable to shareholders was 2.562 billion yuan, up 17.05% year-on-year [2] - The pharmaceutical industrial segment showed robust growth, with revenue reaching 9.941 billion yuan in the first three quarters, a 10.53% increase year-on-year [3] - The company is actively expanding its product pipeline, with over 70 innovative products in development, focusing on endocrine, autoimmune, and oncology fields [4] - The company is expected to achieve net profits of 3.342 billion yuan, 3.874 billion yuan, and 4.414 billion yuan for 2024, 2025, and 2026 respectively, with growth rates of 17.71%, 15.94%, and 13.93% [5][6] Financial Performance Summary - For the first three quarters of 2024, the company achieved a net profit of 2.562 billion yuan, with a quarterly net profit of 866 million yuan, reflecting a 14.71% increase year-on-year [2] - The pharmaceutical industrial segment's revenue for the third quarter was 3.243 billion yuan, a 10.32% increase year-on-year, with a net profit of 755 million yuan, up 20.44% [3] - The company’s R&D investment in the pharmaceutical industrial segment was 1.607 billion yuan, a 0.60% increase year-on-year, with direct R&D expenses accounting for 11.69% of the segment's revenue [4] - The projected revenue for 2024 is 43.665 billion yuan, with a growth rate of 7.49% [6]