证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-051 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 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。 审批结论：根据《中华人民共和国药品管理办法》及有关规定，经审查，本 品符合药品注册的有关要求，批准新增适应症，发给药品注册证书。批准的适应 症为"用于常规治疗疗效欠佳的活动性强直性脊柱炎的成人患者"。 二、 药品的其他情况 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司苏州盛迪亚 生物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 发的《药品注册证书》，批准公司自主研发的 1 类创新药夫那奇珠单抗注射液新 增适应症，用于常规治疗疗效欠佳的活动性强直性脊柱炎的成人患者。现将相关 情况公告如下： 一、 药品的基本情况 药品名称：夫那奇珠单抗注射液 剂型：注射剂 规格：预充式安全注射针装：120mg（1ml）/支、 预充式自动注射笔装：120mg（1ml）/支 注册分类：治疗用生物制品 1 类 受理号：CXSS2400017、C ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-050 江苏恒瑞医药股份有限公司 关于 2023 年员工持股计划第一个锁定期解锁 执行完毕的公告 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。 江苏恒瑞医药股份有限公司（以下简称"公司"）2023 年员工持股计划第 一个锁定期解锁股份已全部出售或过户完毕，现将相关情况公告如下： 一、公司 2023 年员工持股计划的实施情况 1、2023 年 11 月 3 日，公司召开第九届董事会第六次会议与第九届监事会 第五次会议，并于 2023 年 11 月 23 日召开 2023 年第二次临时股东大会，审议 通过了公司 2023 年员工持股计划，具体内容详见公司于 2023 年 11 月 4 日、 2023 年 11 月 24 日披露于上海证券交易所网站（www.sse.com.cn）的相关公告。 2、2023 年 12 月 27 日，公司收到中国证券登记结算有限责任公司出具的 《过户登记确认书》，公司回购专用证券账户中所持有的 1,150 万股公司股票 已于 2023 ...

Core Viewpoint - Heng Rui Medicine's subsidiary has received approval for a new indication for its innovative drug, demonstrating the company's ongoing commitment to expanding its product offerings in the biopharmaceutical sector [1] Group 1: Company Developments - The subsidiary, Suzhou Sediya Biopharmaceutical Co., Ltd., has been granted a drug registration certificate by the National Medical Products Administration for the new indication of Funazhuan Injection [1] - Funazhuan Injection is now approved for the routine treatment of adult patients with active ankylosing spondylitis who have inadequate response to conventional therapies [1] - The drug was previously approved for the treatment of moderate to severe plaque psoriasis in adults suitable for systemic therapy or phototherapy [1] Group 2: Financial Aspects - The total research and development investment for the related projects has reached approximately 651 million yuan [1]

Group 1 - The report highlights the recent policy initiatives from Beijing and Shenzhen aimed at supporting the high-quality development of innovative pharmaceuticals and medical devices, emphasizing a full-chain support approach from research and development to clinical application [4][5][6] - The policies include measures to enhance the efficiency of clinical trials, such as reducing the overall time for initiating clinical trial projects to under 20 weeks in Beijing and 25 weeks in Shenzhen, along with financial incentives for successful trials [6][10] - The report notes that these initiatives are a continuation of previous efforts, with significant improvements observed in clinical trial timelines and the establishment of green channels for urgent drug imports, contributing to an 8.7% growth in the pharmaceutical and health industry in Beijing [11][12] Group 2 - The report suggests focusing on key companies in the innovative drug, medical device, and AI sectors, including major players like 恒瑞医药 (Hengrui Medicine), 迈瑞医疗 (Mindray), and 润达医疗 (Runda Medical) [3][14][16] - It provides a valuation table for key companies in the pharmaceutical and medical device sectors, indicating their market capitalization and projected earnings per share (EPS) for 2024 to 2026, which reflects the expected growth and investment potential in these companies [14] - The report emphasizes the importance of artificial intelligence in enhancing pharmaceutical innovation, with both Beijing and Shenzhen promoting AI applications in drug development and clinical trial management [7][8]

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Views - The company is expected to achieve an EPS of 1.06/1.17 CNY for 2025-26, with a new forecast of 1.42 CNY for 2027. The target price is set at 56.18 CNY based on a PE ratio of 53 for 2025 [2] - The company reported a significant revenue increase of 22.63% year-on-year for 2024, reaching 27.985 billion CNY, and a net profit increase of 47.28%, totaling 6.337 billion CNY [9] - The company is actively advancing its internationalization efforts, with several products receiving FDA approval and significant licensing agreements contributing to revenue growth [9] Financial Information Summary - Revenue (in million CNY): - 2023A: 22,820 - 2024A: 27,985 (22.6% YoY growth) - 2025E: 31,684 (13.2% YoY growth) - 2026E: 35,553 (12.2% YoY growth) - 2027E: 40,900 (15.0% YoY growth) [4] - Net Profit (in million CNY): - 2023A: 4,302 - 2024A: 6,337 (47.3% YoY growth) - 2025E: 6,759 (6.7% YoY growth) - 2026E: 7,477 (10.6% YoY growth) - 2027E: 9,060 (21.2% YoY growth) [4] - EPS (in CNY): - 2023A: 0.67 - 2024A: 0.99 - 2025E: 1.06 - 2026E: 1.17 - 2027E: 1.42 [4] - Gross Margin: - 2023A: 84.6% - 2024A: 86.2% - 2025E: 84.5% - 2026E: 84.9% - 2027E: 85.4% [4] - Net Margin: - 2023A: 18.9% - 2024A: 22.6% - 2025E: 21.3% - 2026E: 21.0% - 2027E: 22.2% [4]

Domestic Financial Market - The Ministry of Foreign Affairs emphasizes China's commitment to true multilateralism and the protection of the multilateral trading system centered around the WTO [4] - The Ministry of Commerce held a roundtable meeting with representatives from over 20 US-funded enterprises [4] - The Ministry of Industry and Information Technology hosted a seminar on AI terminal benchmarks and intelligent classification [4] Industry Updates - As of the end of March, China's gold reserves reached 73.7 million ounces, with the central bank expanding its reserves for five consecutive months, impacting related stocks such as Zijin Mining and Chifeng Jilong Gold [5] - The first cross-provincial and cross-border freight station in the country has been officially launched, reducing costs by approximately 30%, affecting stocks like Baoshai Technology and SF Holding [5] - Display panel manufacturers maintained a capacity utilization rate above 80% in Q1 2025, influencing stocks such as BOE Technology Group and TCL Technology [5] Company Focus - Lianhua Holdings reported a significant increase in product sales and revenue in Q1 2025, with net profit expected to grow by 103% to 144% year-on-year [6] - Beijing-Shanghai High-Speed Railway signed a strategic cooperation framework agreement with the China Railway Economic Planning Research Institute [6] - Huaneng Hydropower achieved a power generation of 21.292 billion kWh in Q1 2025, a year-on-year increase of 31.22%, with grid-connected power reaching 21.104 billion kWh, up 31.42% year-on-year [6] - Heng Rui Medicine licensed its self-developed SHR7280 project to Merck KGaA, which will pay an upfront fee of €15 million [6] Market Review and Outlook - On April 7, the Shanghai and Shenzhen markets opened significantly lower due to US tariff policies and declines in external markets, with the Shanghai Composite Index closing down 7.34% at 3096 points and the ChiNext Index dropping 12.5%, marking its largest single-day decline [7] - The market faced accelerated declines due to sudden trade conflicts, but technical analysis suggests that the market may rebound after filling previous gaps [8] - The A-share market remains in a low valuation zone, with the manufacturing PMI returning above the growth line, and expectations for more favorable policies to be introduced [8]

Group 1: Policy Support for Pharmaceutical Innovation - Beijing encourages local production of innovative pharmaceuticals, supporting enterprises in importing significant drug and medical device varieties, and promoting the industrialization and large-scale application of innovative products [1] - Shenzhen offers financial incentives for innovative drugs that complete clinical trials and achieve domestic and international market entry, with rewards up to 30 million yuan based on clinical trial phases [2] Group 2: Company Developments - Heng Rui Medicine grants exclusive commercialization rights of its new drug SHR7280 to Germany's Merck, receiving an upfront payment of 15 million euros and potential milestone payments and sales royalties [3] - East China Pharmaceutical's subsidiary receives approval for clinical trials of DR30206, a novel antibody fusion protein targeting PD-L1, VEGF, and TGF-β, marking a significant advancement in its development [4] Group 3: Market Trends and Opportunities - Blood product stocks, including Wei Guang Bio and Pai Lin Bio, experience a surge due to the rigid demand for blood products and potential price increases from U.S. tariffs, benefiting domestic companies and presenting strategic opportunities for market share growth [6]

4月7日，北京市医疗保障局等九部门印发《北京市支持创新医药高质量发展若干措施（2025年）》。其 中第四条和第十三条提出，加快推进医疗机构自行研制使用体外诊断试剂试点工作，完成5个试点产品 备案，优先将罕见病用诊断试剂纳入试点品种；畅通临床急需进口药械"一次批复、多次通关"方式，持 续扩充罕见病用药品进口品类，推动医疗器械产品通过临床急需进口绿色通道落地实施。 21点评： 文件提到32条新举措，包括持续促进临床试验提质增效、不断提升审评审批效能、持续扩大 创新医药生产流通、持续推动创新医药临床使用、人工智能赋能医药创新发展、加强创新医药投融资支 持、优化创新医药产业布局和保障措施。北京市医疗保障局表示，进一步加强对创新药械研、产、审、 用全链条政策支持，优化要素资源配置，培育优质创新生态，推动创新药、创新医疗器械高质量发展。 国家药监局征求《关于境外已上市药品获批前商业规模批次产品进口有关事宜的公告（征求意见稿）》 意见 政策动向 北京医保局等九部门印发《北京市支持创新医药高质量发展若干措施（2025年）》 天境生物与渤健就CD38单抗达成临床研究合作 4月7日消息，为落实《国务院办公厅关于全面深化药品医疗器 ...

Investment Rating - The report maintains a positive investment rating for the pharmaceutical industry, emphasizing the potential for growth in various segments [4]. Core Insights - The report highlights the impact of U.S. tariff policies on the pharmaceutical sector, with a focus on domestic substitution opportunities and the recovery of pharmaceutical consumption [1][2]. - It emphasizes the importance of innovation in pharmaceuticals, particularly in the context of domestic drug development and export potential [2]. - The report suggests that the domestic pharmaceutical market is poised for recovery, driven by strong demand in traditional Chinese medicine and healthcare services [2][3]. Summary by Sections 1. Weekly Insights - The report discusses the potential for domestic substitution in pharmaceuticals, particularly in blood products, medical devices, and consumables [1]. - It notes the recovery of domestic demand in the CXO sector, with expectations for valuation recovery due to improved order fulfillment [2]. 2. Investment Recommendations - The report recommends focusing on companies with strong export potential, such as Jianyou Co., and those benefiting from domestic substitution opportunities [3]. - It also suggests monitoring companies in the traditional Chinese medicine sector and those involved in innovative drug development [3]. 3. Sector-Specific Insights - **Innovative Drugs**: The report highlights the potential for domestic alternatives to imported drugs and the ongoing development of innovative drugs [2]. - **CXO**: The sector is expected to see valuation recovery due to improved domestic and international demand [2]. - **Traditional Chinese Medicine**: The report emphasizes the strong domestic demand and potential for valuation increases in this sector [2]. - **Blood Products**: The report notes the strong pricing power of manufacturers in the context of geopolitical risks and increasing demand for immunoglobulin products [2]. - **Vaccines**: The report indicates a challenging environment for the vaccine sector but highlights potential growth in specific areas [2]. - **Medical Devices**: The report discusses the push for domestic production of key components and the impact of government policies on the sector [2]. - **IVD**: The report emphasizes the potential for domestic companies to gain market share as import substitution accelerates [2]. - **Healthcare Services**: The report suggests that recent policy changes will positively impact consumer healthcare services [2]. - **Pharmacies**: The report indicates a stabilization in the pharmacy sector, with a focus on companies with strong supply chain capabilities [2]. - **Raw Materials**: The report discusses the stabilization of prices in the raw materials sector and the potential for recovery in specific categories [2]. - **Innovative Devices**: The report highlights the potential for domestic companies to replace foreign manufacturers in high-tech medical devices [2]. 4. Key Company Announcements - The report includes updates on significant company announcements, such as new drug approvals and partnerships that may impact market dynamics [63][64][65].

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-049 江苏恒瑞医药股份有限公司 关于与 Merck KGaA, Darmstadt, Germany 签署 SHR7280 项目授权许可协议的公告 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。 江苏恒瑞医药股份有限公司（以下简称"恒瑞"或"公司"）与 Merck KGaA, Darmstadt, Germany 公司（以下简称"Merck KGaA"）达成协议，将 SHR7280 口 服 GnRH 受体拮抗剂项目有偿许可给 Merck KGaA。 一、许可产品基本信息 SHR7280 作为恒瑞自主研发的新型口服小分子非肽类 GnRH 受体拮抗剂，具 有给药便捷、患者依从性高等特点，有望成为辅助生殖领域全球首个获批的口服 GnRH 受体拮抗剂。 2023 年下半年，该产品启动应用辅助生殖技术治疗的女性受试者中口服 SHR7280 片在控制性超促排卵（COH）过程中的有效性、安全性及耐受性的多中 心、阳性药物对照的双盲研究（SHR7280-302 研究），并于 ...