证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-053 江苏恒瑞医药股份有限公司 二、药物的其他情况 注射用 HRS5580 通过拮抗 NK-1 受体发挥止吐作用，具有溶解度高、安全性 好的优点。经查询，国外同类 NK-1 受体拮抗剂中仅 HERON 公司的阿瑞匹坦注射 乳剂获批上市，用于预防术后恶心和呕吐。目前，国内尚无同类注射剂产品上市。 截至目前，注射用 HRS5580 相关项目累计已投入研发费用约 2,087 万元。 三、风险提示 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司福建盛迪医 药有限公司收到国家药品监督管理局（以下简称"国家药监局"）核准签发关于 注射用 HRS5580 的《药物临床试验批准通知书》，将于近期开展临床试验。现将 相关情况公告如下： 一、 药物的基本情况 药物名称：注射用 HRS5580 剂 型：注射剂 申请事项：临床试验 受 理 号：CXHL2400182 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审 ...

| 回购方案首次披露日 | 2023/5/16 | | --- | --- | | 回购方案实施期限 | 待董事会审议通过后 12 个月 | | 预计回购金额 | 万元 60,000 万元~120,000 | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 □用于转换公司可转债 | | | □为维护公司价值及股东权益 | | 累计已回购股数 | 1,435.19 万股 | | 累计已回购股数占总股本比例 | 0.22% | | 累计已回购金额 | 63,466.58 万元 | | 实际回购价格区间 | 41.09 元/股~47.01 元/股 | 一、 回购股份的基本情况 江苏恒瑞医药股份有限公司（以下简称"公司"）于 2023 年 5 月 15 日召开 第九届董事会第三次会议审议通过了《关于回购公司股份方案的议案》，同意公 司使用自有资金，以集中竞价交易方式回购公司股份用于实施员工持股计划。回 购价格不超过人民币 70.14 元/股（含），回购资金总额不低于人民币 6 亿元且不 超过 12 亿元。回购期限为自董事会审议通过回购股份方案之日起 12 个月以内。 具体内容详见公司披露于上海证券交易 ...

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [2][5]. Core Insights - The company is entering a new growth phase driven by innovation and international expansion, having successfully transitioned into a comprehensive innovation stage with a well-structured pipeline of innovative drugs [1][5]. - The pressure from centralized procurement has largely been alleviated, with only a few key generic drugs remaining outside of procurement, leading to a gradual decrease in reliance on generics [1][5]. - The company has a robust pipeline with over 20 innovative drugs in the late stages of development, expected to drive significant revenue growth in the coming years [1][5][23]. Summary by Sections Company Overview - Founded in 1970 and listed in 2000, the company has evolved into a leading innovative pharmaceutical enterprise focusing on high-quality drug development across various therapeutic areas [10][11]. Procurement Impact - The impact of centralized procurement has been mostly resolved, with only a few key products remaining outside of procurement, allowing for a gradual reduction in the company's reliance on generics [1][5][15]. Innovative Drug Portfolio - The company has launched 17 innovative drugs, with significant sales growth expected from key products that have recently entered the market [16][18]. - The innovative drug sales accounted for 44% of total sales in the first half of 2023, projected to reach 50% in 2024 [1][5]. Research and Development Pipeline - The company has over 20 innovative drugs in the NDA or Phase III stages, covering a wide range of diseases, with expectations to submit at least 25 new drug applications by 2025 [23][25]. - The pipeline includes drugs targeting oncology, metabolic diseases, autoimmune diseases, and chronic diseases, indicating a diversified approach to drug development [23][30]. International Expansion - The company is accelerating its international strategy, having initiated nearly 20 international clinical trials and formed strategic partnerships with global pharmaceutical giants [1][6][31]. - A significant milestone was achieved with a partnership with Merck in October 2023, marking the company's first collaboration with a multinational corporation [6][31]. Financial Projections - Revenue projections for 2023-2025 are estimated at 23.2 billion, 25.9 billion, and 29.7 billion yuan, with corresponding growth rates of 8.9%, 12.0%, and 14.6% [2][5]. - Net profit forecasts for the same period are 4.6 billion, 5.6 billion, and 7.0 billion yuan, with growth rates of 16.9%, 21.8%, and 26.7% [2][5].

近日，江苏恒瑞医药股份有限公司（以下简称"公司"）收到国家药品监督 管理局（以下简称"国家药监局"）下发的《受理通知书》，公司氟唑帕利胶囊、 甲磺酸阿帕替尼片的药品上市许可申请获国家药监局受理，且拟被纳入优先审评 品种公示名单，公示期 7 日。现将相关情况公告如下： | 药品名称 | 氟唑帕利胶囊 甲磺酸阿帕替尼片 | | --- | --- | | 剂型 | 胶囊剂 片剂 | | 受理号 | CXHS2400032 CXHS2400030、CXHS2400031 | | 申报阶段 | 上市 | | 申请人 | 江苏恒瑞医药股份有限公司 | | 拟定适应症 | 氟唑帕利单药或联合甲磺酸阿帕替尼用于伴有胚系 | | BRCA （或功能主治） | 突变（gBRCAm）的 HER2 阴性乳腺癌患者的治疗。 | 一、 药品的基本情况 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-050 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 甲磺酸阿帕替尼 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-051 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 受 理 号：CXSL2400058 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2024 年 1 月 24 日受理的门冬胰岛素注射液符合药品注册的有关要求，同意本品按生 物类似药开展临床试验。 二、药物的其他情况 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）收到国家药品监督 管理局（以下简称"国家药监局"）核准签发关于门冬胰岛素注射液的《药物临 床试验批准通知书》，将于近期开展临床试验。现将相关情况公告如下： 一、 药物的基本情况 药物名称：门冬胰岛素注射液 剂 型：注射剂 申请事项：临床试验 三、风险提示 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。 药品从研制、临床试验报批到投产的周期长、环节多，药品研发及至上市容 易受到一些 ...

Investment Rating - The investment rating for the company is "Buy" [4][9] Core Views - The company achieved a revenue of 22.82 billion yuan in 2023, representing a year-on-year growth of 7.26%, with a net profit attributable to shareholders of 4.30 billion yuan, up 10.14% year-on-year [1] - In Q1 2024, the company reported a revenue of 5.99 billion yuan, a year-on-year increase of 9.2%, and a net profit of 1.37 billion yuan, reflecting a growth of 10.48% year-on-year [1] - The revenue from innovative drugs reached 10.64 billion yuan in 2023, growing by 22.1% year-on-year, accounting for 46.61% of total revenue [1] - The company has a rich pipeline in oncology and has expanded its research into various therapeutic areas including autoimmune diseases, pain management, cardiovascular diseases, metabolic diseases, infectious diseases, respiratory diseases, hematological diseases, and neurological diseases [2] - The company maintained a high level of R&D investment, totaling 6.15 billion yuan in 2023, with 4.95 billion yuan classified as expensed R&D [3] - The company has established five licensing agreements in 2023, with a total transaction value exceeding 4 billion USD, indicating a strong commitment to international collaboration [3] Summary by Sections Financial Performance - In 2023, the company reported a basic earnings per share (EPS) of 0.68 yuan, an increase of 11.48% year-on-year [1] - The company’s total revenue for 2023 was 22.82 billion yuan, with a net profit of 4.30 billion yuan [1] - For Q1 2024, the basic EPS was 0.21 yuan, reflecting a year-on-year growth of 10.53% [1] R&D and Product Pipeline - The company has 14 applications for new drug listings accepted by NMPA in 2023, with 12 progressing to Phase III clinical trials and 35 to Phase II [2] - The company’s innovative drugs are expected to drive future revenue growth due to their significant efficacy and improved accessibility through national insurance coverage [1][2] Market Position and Strategy - The company is recognized as a leading innovative drug enterprise in China, with a comprehensive and rational R&D layout [7] - The company’s internationalization strategy is progressing steadily, with ongoing efforts to seek partnerships with global pharmaceutical leaders [3]

Investment Rating - The report maintains a "Buy" rating for the company [3]. Core Views - The company's performance meets expectations, with a significant increase in the proportion of revenue from innovative drugs and a continuous push for globalization [1][2]. - In 2023, the company achieved a revenue of 22.82 billion yuan, a year-on-year increase of 7.26%, and a net profit attributable to shareholders of 4.30 billion yuan, up 10.14% year-on-year [1][2]. - The innovative drug revenue reached 10.64 billion yuan in 2023, growing by 22.1% year-on-year, accounting for 46.61% of total revenue, an increase of 6.13 percentage points compared to 2022 [1][2]. Financial Performance - The company reported quarterly revenues of 54.92 million yuan, 56.76 million yuan, 58.45 million yuan, and 58.06 million yuan in 2023, with year-on-year growth rates of 0.25%, 19.51%, 2.24%, and 8.93% respectively [1]. - The fourth quarter net profit was 8.29 billion yuan, a year-on-year increase of 13.05% [1]. - The company’s R&D investment totaled 6.15 billion yuan in 2023, accounting for 26.95% of revenue, with over 90 innovative drugs in development [1][2]. Product and Segment Analysis - The oncology segment generated revenue of 12.22 billion yuan, with a gross margin of 91.82%, while the anesthesia segment achieved revenue of 3.74 billion yuan with a gross margin of 85.22% [1]. - Despite a slight decline in revenue from generic drugs due to price reductions and bidding impacts, sales of analgesics and new generic drugs showed positive trends [1]. Future Outlook - The company is expected to see net profits of 4.94 billion yuan, 5.68 billion yuan, and 6.73 billion yuan for 2024, 2025, and 2026 respectively, with growth rates of 14.9%, 14.8%, and 18.6% [2][3]. - The report anticipates that the commercialization of innovative drugs will continue to enhance revenue contributions, supporting long-term growth [1].

Investment Rating - The report maintains a "Buy" rating for the company [1][5][7] Core Insights - The company has seen steady growth in innovative drug revenue, with 2023 revenue reaching 10.637 billion yuan, a year-on-year increase of 22.1% [2][4] - The company has successfully launched multiple innovative drugs, enhancing its clinical advantages and brand value, contributing to stable sales growth [2][3] - The company has established various technical platforms for drug development and is actively exploring international collaborations to accelerate the transformation of research results [3][4] Financial Performance - In 2023, the company achieved an operating income of 22.820 billion yuan, a year-on-year growth of 7.26%, and a net profit attributable to shareholders of 4.302 billion yuan, up 10.14% [4][5] - For Q1 2024, the company reported a revenue of 5.998 billion yuan, a year-on-year increase of 9.20%, with a net profit of 1.369 billion yuan, up 10.48% [4] - The company forecasts operating revenues of 25.407 billion yuan, 28.998 billion yuan, and 33.104 billion yuan for 2024, 2025, and 2026 respectively, with corresponding net profits of 5.093 billion yuan, 6.792 billion yuan, and 8.299 billion yuan [5][6][7] Market Position and Strategy - The company has made significant progress in its innovative drug pipeline, with multiple new drugs approved for sale, enhancing its market competitiveness [2][3] - The company has engaged in five licensing transactions in 2023, with a total transaction value exceeding 4 billion USD, indicating strong international collaboration [3][5] - The company is focused on expanding its innovative drug offerings and improving accessibility through national insurance listings, which has positively impacted its revenue [2][4]

证券研究报告·公司点评报告·化学制药 恒瑞医药（600276） 2023 年报和 2024 一季报点评：创新药收入 2024年 04月 24日 占比持续增加，国际化进程稳步推进 证券分析师 朱国广 买入（维持） 执业证书：S0600520070004 zhugg@dwzq.com.cn [Table_EPS] 盈利预测与估值 2022A 2023A 2024E 2025E 2026E 股价走势 营业总收入（百万元） 21,275 22,820 26,243 30,311 35,160 同比（%） (17.87) 7.26 15.00 15.50 16.00 恒瑞医药 沪深300 归母净利润（百万元） 3,906 4,302 5,381 6,632 8,172 2% -1% -4% 同比（%） (13.77) 10.14 25.06 23.25 23.24 -7% -10% EPS-最新摊薄（元/股） 0.61 0.67 0.84 1.04 1.28 -13% -16% -19% P/E（现价&最新摊薄） 71.97 65.34 52.25 42.39 34.40 -22% -25% [ [TT aab bl ...

[Table_MainInfo] 公司研究/医药与健康护理/化学制药 证券研究报告 恒瑞医药（600276）公司研究报告 2024年04月23日 [Table_InvestInfo] 投资评级 优于大市 维持 业绩企稳，创新药收入持续增长 股票数据 [Table_Summary] 0[4Ta月b2le3_日S收to盘ck价（In元fo）] 44.07 投资要点： 52周股价波动（元） 35.51-50.50 总股本/流通A股（百万股） 6379/6374 总市值/流通市值（百万元） 281123/280911  收入增长稳健，创新药持续放量。公司2023年总收入228.20亿元（+7.26%）。 相关研究 主营业务医药制造业收入 223.77 亿元（+5.49%），其中创新药含税收入 [《Ta上b半le年_R创e新p药or收tI入nf近o] 50亿，仿药收入基本 106.37 亿元（+22.1%），我们预测税后收入占比达 45%；仿制药收入同比 略有下滑，主要系第二批集采品种白蛋白紫杉醇和醋酸阿比特龙续约丢标及 持平》2023.08.20 《业绩短期承压，股权激励继续加码创新》 2022 年 11 月开始执 ...