江苏恒瑞医药股份有限公司 关于获得药品注册证书的公告 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-141 甲磺酸阿帕替尼片已获批三个适应症，分别为：2014 年 10 月获批单药用于 既往至少接受过 2 种系统化疗后进展或复发的晚期胃腺癌或胃-食管结合部腺癌 患者的治疗；2020 年 12 月获批单药用于既往接受过至少一线系统性治疗后失败 或不可耐受的晚期肝细胞癌患者的治疗；2023 年 1 月获批联合注射用卡瑞利珠 单抗用于不可切除或转移性肝细胞癌患者的一线治疗。 三、 药品的其他情况 根据 2020 年世界卫生组织国际癌症研究机构（IARC）发布的数据，乳腺癌 已成为全球第一大恶性肿瘤，是女性最常见的恶性肿瘤之一[1]。目前国内患者乳 腺癌发病率增长迅速，已经位列女性肿瘤发病谱首位，并且近 50%患者治疗后会 出现复发和转移。人类乳腺癌易感基因（BRCA）是人体内重要的抑癌基因，包括 BRCA1、BRCA2 等。相较于一般人群，BRCA1 和 BRCA2 基因突变携带者乳腺癌发病 风险提高了 10-20 倍[2]。而在乳腺癌患者中，约 5%-10%的患者携带突变的 BRCA 基因[ ...

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 2024 年 5 月 15 日召开 第九届董事会第八次会议审议通过了《关于以集中竞价交易方式回购公司股份方 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 67.38 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 所 网 站 （www.sse.com.cn）的《关于以集中竞价交易方式回购股份的回购报告书》（公告 编号：临 2024-063）。 二、 回购股份的进展情况 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-140 江苏恒瑞医药股份有限公司 关于股份回购进展公告 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。 重要内容提示： | 回购方案首次披露日 | 2024/5/16 | | --- | --- ...

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。 根据国家医保局、人力资源社会保障部关于印发《国家基本医疗保险、工伤 保险和生育保险药品目录（2024 年）》的通知（"《国家基本医疗保险、工伤保 险和生育保险药品目录》"以下简称"国家医保目录"），江苏恒瑞医药股份有 限公司（以下简称"恒瑞医药"或"公司"）部分产品纳入国家医保目录。 通过医保谈判，富马酸泰吉利定注射液、奥特康唑胶囊、恒格列净二甲双胍 缓释片(Ⅰ)(Ⅱ)首次纳入国家医保目录；氟唑帕利胶囊通过简易续约规则新增适 应症纳入国家医保目录；注射用卡瑞利珠单抗通过简易续约规则续约成功并新增 适应症纳入国家医保目录；羟乙磺酸达尔西利片、瑞维鲁胺片、普瑞巴林缓释片 通过简易续约规则续约成功保留在国家医保目录；脯氨酸恒格列净片续约成功并 新增适应症保留在国家医保目录；昂丹司琼口溶膜续约成功保留在国家医保目录； 盐酸艾司氯胺酮注射液、盐酸右美托咪定鼻喷雾剂调整至常规目录管理。具体情 况如下： 一、 药品情况 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-139 ...

Investment Rating - The report initiates coverage on Hengrui Medicine with a "Buy" rating and a target price of RMB 61 [1][2] Core Views - Hengrui Medicine's innovative drug revenue has become a strong engine for its performance growth, with a 22% YoY increase in 2023 and a 33% YoY increase in 1H24 [2] - The company's ADC pipeline is one of the most abundant in China, with 12 differentiated ADC molecules in clinical stages, and the first ADC product, SHR-A1811, is expected to be approved in 2025 [2] - Hengrui Medicine is accelerating its internationalization efforts, with increasing out-licensing deals and partnerships with global pharmaceutical companies such as Merck KGaA and GSK [2] - The company is expected to achieve revenue of RMB 27.2 billion, RMB 29.7 billion, and RMB 33.4 billion in 2024E, 2025E, and 2026E, respectively, with net profits of RMB 6.0 billion, RMB 6.5 billion, and RMB 7.7 billion [2] Financial Performance and Forecast - In 2023, Hengrui Medicine's revenue was RMB 22.8 billion, a 7.3% YoY increase, with net profit of RMB 4.3 billion, a 10.1% YoY increase [6] - For 2024E, the company is expected to achieve revenue of RMB 27.2 billion, a 19.1% YoY increase, and net profit of RMB 6.0 billion, a 40.2% YoY increase [6] - The company's innovative drug revenue accounted for 46% of total revenue in 1H24, up from 38% in 2022 [2][19] Pipeline and R&D - Hengrui Medicine has 17 innovative drugs approved in China, covering oncology, hematology, anesthesia, and chronic diseases [22] - The company's ADC pipeline includes 12 differentiated molecules, with 4 in Phase 3 clinical trials, and the first ADC product, SHR-A1811, is expected to be approved in 2025 [2] - Key late-stage assets include SHR-A1811 (HER2 ADC), SHR-A1921 (TROP2 ADC), SHR-A1904 (Claudin 18.2 ADC), and SHR-1701 (PD-L1/TGF-β bispecific antibody) [37] Internationalization - Hengrui Medicine has accelerated its out-licensing efforts since 2023, with deals including HRS-1167 and SHR-A1904 to Merck KGaA and TSLP to OneBio, which was later acquired by GSK [2] - The company is exploring new models for internationalization, such as forming NewCos for GLP-1 drugs with Hercules, allowing it to retain influence and benefit from potential valuation gains [2] - The appointment of Jens Bitsche-Norhave, with over 20 years of BD experience in multinational pharmaceutical companies, is expected to further accelerate the company's internationalization efforts [2]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-138 SHR-1819 注射液是公司自主研发的一种靶向人 IL-4Rα的重组人源化单克 隆抗体，能够同时阻断 IL-4 和 IL-13 的信号传导，拟用于治疗 2 型炎症相关疾 病。目前全球仅有2款同靶点药物获批上市。Dupilumab(商品名Dupixent)自2017 年以来在美国、欧盟和日本等多个国家和地区获批上市，并于 2020 年 6 月在中 国获批上市，适应症包括慢性鼻窦炎伴鼻息肉、特应性皮炎、哮喘、结节性痒疹 以及嗜酸性食管炎；Stapokibart(商品名：康悦达)于 2024 年 9 月在中国获批上 一、 药物的基本情况 药物名称：SHR-1819 注射液 剂 型：注射剂 申请事项：临床试验 受 理 号：CXSL2400594 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 9 月 4 日受理的 SHR-1819 注射液临床试验申请符合药品注册的有关要求，同 意本品开展Ⅰb/Ⅱ期临床试验。申请的适应症为 6-17 岁儿童和青少年特应性皮 炎。 二、药物的其他情况 江苏恒瑞医药股份有限公司 关于获 ...

Investment Rating - The report assigns a "Buy" rating for the company, indicating an expected relative increase of over 15% compared to the CSI 300 index within the next six months [2][14]. Core Views - The company, known for its innovative drug development pipeline, is expected to continue enriching its product offerings, positioning itself as a leader in the domestic innovative drug sector [5]. - For the first three quarters of 2024, the company achieved a revenue of 20.189 billion yuan, representing a year-on-year growth of 18.67%, and a net profit attributable to shareholders of 4.620 billion yuan, up 32.98% year-on-year [2]. - The report highlights significant clinical value from innovative results, benefiting more patients, and includes a notable income recognition from a licensing agreement with Merck Healthcare [2]. Financial Performance Summary - Revenue for 2024 is projected at 26.612 billion yuan, with a growth rate of 16.62% [6]. - Net profit for 2024 is estimated at 5.774 billion yuan, reflecting a growth rate of 34.21% [6]. - Earnings per share (EPS) are forecasted to be 0.91 yuan for 2024, with corresponding dynamic price-to-earnings ratios of 55.45, 45.81, and 39.66 for 2024, 2025, and 2026 respectively [5][6]. R&D and Product Pipeline - The company has successfully advanced its innovative drug pipeline, with several new drug applications expected between 2024 and 2026, including a new drug for moderate to severe plaque psoriasis and a JAK1 inhibitor for severe alopecia areata [2]. - The innovative drug segment is identified as a key growth driver for the company moving forward [2].

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-137 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。 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 剂 型：胶囊剂 申请事项：临床试验 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司上海恒瑞医 药有限公司和山东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 HRS-6208 胶囊的《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： 受 理 号：CXHL2400848、CXHL2400849 一、 药物的基本情况 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 8 月 16 日受理的 HRS-6208 胶囊临床试验申请符合药品注册的有关要求，同意 本品单药在实体瘤患者中开展临床试验。 药物名称：HRS-6208 胶囊 二、药物的其他情况 HRS-6208 是一种新型、高效、选择性的小分子抑制剂，能够强效且高选择 性地抑制靶点的磷酸化激活，影响细胞周期 ...

Investment Rating - The report assigns a "Buy-A" rating for the company, indicating a strong potential for price appreciation over the next 6-12 months [4]. Core Insights - The company is a leader in innovative pharmaceuticals, with a significant acceleration in the commercialization of new drugs. The metabolic and autoimmune pipelines are entering a harvest phase, contributing to revenue growth [4]. - The company has 17 innovative drugs already on the market, with nearly 10 new drug NDA applications under review. It is expected to launch 15 new drugs from 2024 to 2026, providing substantial growth momentum [4]. - Revenue projections for 2024-2026 are estimated at 26.94 billion, 31.23 billion, and 36.07 billion yuan, representing year-on-year growth of 18.0%, 15.9%, and 15.5% respectively. Net profit is projected to be 6.08 billion, 7.04 billion, and 8.01 billion yuan, with year-on-year growth of 41.3%, 15.7%, and 13.9% respectively [4][7]. Financial Performance - For the first three quarters of 2024, the company reported revenue of 20.19 billion yuan, an increase of 18.7%, and a net profit of 4.62 billion yuan, up by 33.0% [1]. - The third quarter alone saw revenue of 6.59 billion yuan, a 12.7% increase, and a net profit of 1.19 billion yuan, which is a modest increase of 1.9% [1]. - The company’s R&D expenses for the first three quarters were 4.55 billion yuan, with an R&D expense ratio of 22.5%, reflecting increased investment in late-stage clinical pipelines [1]. Market Data - As of November 18, 2024, the company's closing price was 47.20 yuan, with a year-to-date high of 57.53 yuan and a low of 35.51 yuan [1]. - The company has a circulating A-share market capitalization of 301.09 billion yuan [1]. Growth Potential - The innovative drug business is expected to grow rapidly, with several new drugs entering the medical insurance list, leading to increased hospital admissions [1]. - The company has multiple new drugs in late-stage clinical trials, including small molecules, ADCs, and bispecific antibodies, which are anticipated to contribute to future revenue [1][3].

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-135 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。 申请事项：临床试验 受 理 号：CXHL2400839 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 8 月 15 日受理的 HRS-5632 注射液临床试验申请符合药品注册的有关要求，同 意本品开展治疗脂蛋白紊乱的临床试验。 二、药物的其他情况 HRS-5632 注射液是公司自主研发的 1 类化学药物，临床前数据显示， HRS-5632 给药后可有效改善脂蛋白紊乱，安全性良好。目前国内外暂无同类药 物获批上市，截至目前，HRS-5632 注射液相关项目累计已投入研发费用约为 2,938 万元。 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。 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 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2024-136 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。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司广东恒瑞医 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 SHR-2173 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： 申请事项：临床试验 受理号：CXSL2400546 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 8 月 16 日受理的 SHR-2173 注射液临床试验申请符合药品注册的有关要求，同 意本品开展原发免疫性血小板减少症（ITP）的临床试验。 二、药物的其他情况 SHR-2173 注射液是公司自主研发的治疗用生物制品，能够通过靶向异常激 活的免疫细胞，发挥抗炎和抑制免疫的生物学效应，有望降低自身抗体水平，改 善 ITP 患者的疾病活动状态，为患者带来新的治疗选择。目前国内外尚无 ...