药品名称：HRS9531 注射液 剂型：注射剂 受理号：CXHS2500106、CXHS2500107、CXHS2500108、CXHS2500109、 CXHS2500110、CXHS2500111、CXHS2500112、CXHS2500113、CXHS2500114 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-134 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。 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"）下发的《受理 通知书》，公司 HRS9531 注射液的药品上市许可申请获国家药监局受理。现将相 关情况公告如下： 一、药品的基本情况 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 易受到一些不确定性因素的影响，敬请广大投资者谨慎决策，注意防范投资风险。 公司将按国家有关规定积极推进上述研发项目，并及时对项目后续进展情况履行 信 ...

Core Viewpoint - The company has received acceptance for the drug listing application of HRS9531 injection, which is aimed at long-term weight management for adults with obesity or overweight conditions [1] Group 1: Product Development - HRS9531 injection is intended for adults with an initial body mass index (BMI) of ≥28 kg/m² or those with a BMI of ≥24 kg/m² accompanied by at least one weight-related comorbidity [1] - The drug achieved all primary and key secondary endpoints in the Phase III clinical trial conducted in July 2025, demonstrating good safety and tolerability [1] - The total research and development investment for the HRS9531 project has reached approximately 452 million yuan [1] Group 2: Regulatory and Future Plans - The company will advance the project development in accordance with national regulations and will disclose progress in a timely manner [1]

Group 1 - The chemical pharmaceutical sector increased by 3.54% on September 1, with Maiwei Biotech leading the gains [1] - The Shanghai Composite Index closed at 3875.53, up 0.46%, while the Shenzhen Component Index closed at 12828.95, up 1.05% [1] - Notable gainers in the chemical pharmaceutical sector included Maiwei Biotech, which rose by 20.00% to a closing price of 57.60, and Xingqi Eye Medicine, which increased by 14.65% to 77.54 [1] Group 2 - The chemical pharmaceutical sector saw a net inflow of 1.245 billion yuan from main funds, while retail funds experienced a net outflow of 41.1167 million yuan [2] - The top stocks by main fund inflow included Heng Rui Medicine with 474 million yuan and Fuxing Medicine with 256 million yuan [3] - Conversely, stocks like Duorui Medicine and ST Suwu experienced significant declines, with Duorui Medicine down 9.36% to 41.17 [2][3]

每经AI快讯，有投资者在投资者互动平台提问： 请问2025年上半年扣除对外许可收入后的营业额和利 润增长率是多少？ 恒瑞医药（600276.SH）9月1日在投资者互动平台表示，公司2025年上半年营业收入157.6亿元，其中对 外许可收入19.9亿元。公司归属于上市公司股东的净利润44.5亿元，同比增长29.7%。详细信息请查阅 公司2025年半年度报告"经营情况的讨论与分析"部分内容。 （文章来源：每日经济新闻） ...

Group 1 - Pharmaceutical stocks in Hong Kong have shown strong performance, with notable gains in companies such as 加科思-B (up 23.18%), 三叶草生物-B (up 22.09%), and others [1] - The overall performance of Hong Kong pharmaceutical companies in the first half of the year has been robust, with 恒瑞医药 achieving record high revenue and profit, and 翰森制药 exceeding revenue expectations [1] - Upcoming major conferences, including the World Lung Cancer Conference (WCLC) and the European Society for Medical Oncology (ESMO), will showcase research results from innovative domestic drugs [1] Group 2 - 海通国际 maintains a positive outlook on Hong Kong pharmaceutical companies due to their stable cash flow, rich R&D pipelines, and normalizing external licensing revenues [2] - The recent slight pullback in the Hong Kong pharmaceutical sector is attributed to rapid fund rotation, with expectations of short-term fluctuations [2] - The long-term value reassessment logic in the pharmaceutical industry remains unchanged, supported by the engineer dividend and a rich catalyst environment in the innovative drug industry [2]

Core Viewpoint - The healthcare sector is showing signs of recovery after a period of adjustment, driven by policy support and technological advancements, with innovative drugs and high-end medical equipment leading the growth [1][4]. Group 1: Market Performance - As of September 1, 2025, the healthcare ETF Taikang (159760) rose by 2.35%, with a trading volume of 2.7428 million yuan [1]. - The index tracking the National Certificate Public Health and Healthcare Index (980016) increased by 2.54%, with significant gains in constituent stocks such as Changchun High-tech (000661) up 10.00%, and Health元 (600380) up 9.98% [1]. - The healthcare industry is experiencing a "first suppressed, then rising" trend, with signs of bottoming out since the second quarter of 2025 [1]. Group 2: Policy and Innovation - The State Council approved the "Biopharmaceutical Full Industry Chain Open Innovation Development Plan" on August 18, 2025, promoting innovation across all stages from approval to production [2]. - The drug regulatory authority is accelerating the establishment of review centers, reducing the approval cycle for innovative drugs and devices to 30 working days, enhancing market entry efficiency [2]. - The shift in procurement policy from "lowest price" to "quality + reasonable price" has alleviated profit pressures on companies [2]. Group 3: Company Performance - Major companies like Heng Rui Medicine reported innovative drug and licensing revenues of 9.561 billion yuan, accounting for 60.66% of total revenue, and secured a $12 billion collaboration with GSK [3]. - Mindray Medical's AI devices saw a 35% increase in installation in overseas high-end markets [3]. - WuXi AppTec's TIDES business revenue surged by 141.6% year-on-year, with a 48.8% increase in orders on hand [3]. Group 4: Future Outlook - The healthcare sector is emerging from a two-year adjustment period, with innovative drugs and high-end equipment leading the charge [4]. - The healthcare ETF (159828) serves as a comprehensive investment tool, allowing investors to capitalize on structural opportunities arising from the industry's recovery [4]. - Upcoming catalysts include overseas licensing progress for innovative drug companies and clinical data disclosures at the World Lung Cancer Conference, which may further bolster market confidence [4].

Core Insights - The article highlights the significant role of technological innovation in driving high-quality development for companies, particularly in the context of the ongoing technological revolution and industrial transformation [1][2]. R&D Investment and Performance - In the first half of the year, listed companies in China accelerated their innovation efforts, with R&D investment exceeding 810 billion yuan, a year-on-year increase of 3.27% [2]. - The overall R&D intensity reached 2.33%, with notable figures for different boards: 4.89% for the ChiNext, 11.78% for the Sci-Tech Innovation Board, and 4.63% for the Beijing Stock Exchange [2]. - 113 listed companies invested over 1 billion yuan in R&D, while 926 companies had an R&D intensity exceeding 10% [2]. - BYD topped the list with R&D investment of 30.88 billion yuan, followed by several companies like China State Construction, ZTE, and China Mobile, each investing over 5 billion yuan [2]. Company Innovations - BYD's R&D investment grew by 53.05% year-on-year, leading to the launch of groundbreaking technologies and products, including the world's first mass-produced passenger car high-voltage architecture [3]. - Hikvision focused on multi-dimensional perception, AI, and big data technologies, enhancing product innovation and expanding its smart IoT business [3]. - Shenyang Chemical achieved a turnaround with a net profit of 62.42 million yuan, emphasizing product innovation and market responsiveness [4]. Industry Leaders and Their Impact - Industry leaders play a crucial role in driving innovation and technological breakthroughs, particularly in sectors like new energy and innovative pharmaceuticals [4][6]. - CATL, a leader in the new energy sector, has established multiple R&D centers and manufacturing bases globally, launching innovative products in both passenger and commercial vehicle segments [5][6]. AI Integration in Business - AI has become a focal point for R&D among listed companies, with significant advancements reported in cloud computing and home appliance sectors [7][8]. - Companies like Industrial Fulian and Gree Electric have seen substantial growth in AI-related revenues, with Gree's AI dynamic energy-saving products experiencing a 360% increase in sales [7][8]. - The government's policies are encouraging the integration of AI into business strategies, aiming to enhance operational efficiency and drive innovation across industries [8].

Policy Developments - Guangzhou's "Sui Xin Bao" has added 60 innovative drugs and 6 hospitals, enhancing its coverage to include local innovative drugs and those not covered by medical insurance [1] - Shandong Province has implemented a funding management method to support the consistency evaluation of generic drug quality and efficacy, offering up to 2 million yuan for qualifying products [2] Drug Approvals - Sanofi's covalent inhibitor Wayrilz (rilzabrutinib) has been approved by the FDA for treating adult patients with immune thrombocytopenia (ITP) [3] - Heng Rui Medicine's new drug Zemeituosita tablets has been approved, marking it as the first domestic EZH2 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma [4] Financial Reports - Shanghai Laishi reported a revenue of 3.952 billion yuan for the first half of 2025, a decrease of 7.06%, with a net profit of 1.03 billion yuan, down 17% [5] - Beijing Tongrentang achieved a revenue of 9.769 billion yuan in the first half of 2025, with a net profit of 945 million yuan, a decrease of 7.39% [6][8] - Shapuaisi turned a profit with a net profit of 21.86 million yuan, recovering from a loss in the previous year [7] - Yixin Hall reported a revenue of 8.914 billion yuan, down 4.20%, with a net profit of 250 million yuan, down 11.44% [9] - Changchun High-tech reported a revenue of 6.603 billion yuan, down 0.54%, with a net profit of 983 million yuan, down 42.85% [10] Corporate Actions - Maiwei Biotech has re-submitted its application for H-share listing on the Hong Kong Stock Exchange [11] - Olin Biotech plans to acquire a 15% stake in its subsidiary Xin Nuo Ming Biotech to enhance control and management efficiency [12] - Meinian Health signed a cooperation framework agreement with Guofu Quantum and Jingbeifang to explore digital asset business in the health sector [13] Industry Events - Hainan Lecheng signed cooperation agreements with 13 leading biopharmaceutical companies, with expected total investments of no less than 3 billion yuan [14] - Novo Nordisk has invested up to $5.5 billion in a partnership with Replicate Bioscience to develop new therapies for metabolic diseases [15]

Core Insights - The A-share listed companies' 2025 semi-annual reports reveal a robust "innovation map," showcasing significant innovation achievements that bolster market confidence [1] - Technological innovation is identified as the core driver for high-quality development, with companies increasingly focusing on R&D to enhance their competitive edge [1] R&D Innovation Driving Business Growth - R&D is recognized as the long-term sustainable development engine for companies, crucial for value creation and core competitiveness [2] - In the first half of the year, listed companies accelerated innovation momentum with R&D investments exceeding 810 billion yuan, a year-on-year increase of 3.27% [2] - The overall R&D intensity reached 2.33%, with notable figures for different boards: 4.89% for the ChiNext, 11.78% for the Sci-Tech Innovation Board, and 4.63% for the Beijing Stock Exchange [2] - 113 companies invested over 1 billion yuan in R&D, while 926 companies had an R&D intensity exceeding 10% [2] Leading Companies in R&D Investment - BYD topped the list with a semi-annual R&D investment of 30.88 billion yuan, marking a year-on-year growth of 53.05% [3] - Hikvision is advancing in AI and big data technologies, enhancing product innovation and efficiency in R&D [3] - Shenyang Chemical achieved a net profit of 62.42 million yuan, transitioning from loss to profit, and is focusing on customized high-end product development [4] Industry Leaders as Innovation Benchmarks - Industry leaders play a crucial role in driving innovation and technological breakthroughs, particularly in sectors like new energy and innovative pharmaceuticals [6] - CATL, a prominent player in the new energy sector, has established multiple R&D centers and manufacturing bases globally, launching innovative products in various applications [6] Pharmaceutical Sector Growth - The pharmaceutical sector, led by companies like Heng Rui Medicine, has shown remarkable growth, with Heng Rui achieving a revenue of 15.76 billion yuan and a net profit of 4.45 billion yuan in the first half of the year [7] - Heng Rui's R&D investment reached 3.87 billion yuan, focusing on unmet medical needs and high-growth potential areas [7] AI Empowering Business Development - AI technologies are becoming focal points for R&D innovation among listed companies, with significant revenue growth in AI-related sectors [8] - Gree Electric's AI dynamic energy-saving products saw a sales increase of 360% in the first half of the year, reflecting strong market demand [9] - Companies are leveraging AI to enhance operational and R&D efficiency, with applications across various sectors [10]

Summary of Hengrui - A Conference Call Company Overview - **Company**: Hengrui - **Industry**: Pharmaceuticals - **Market Cap**: Approximately $57.83 billion [11] Key Financial Highlights - **1H25 Performance**: Strong fundamentals with solid innovative product sales and out-licensing deals [2] - **Revenue Estimates**: - FY24A: Rmb 27,985 million - FY25E: Rmb 32,366 million - FY26E: Rmb 35,285 million [24] - **Adjusted EPS Growth**: - FY25E: Rmb 1.35 (up from Rmb 1.23) - FY26E: Rmb 1.46 [7][12] - **Price Target**: Increased to Rmb 69 (from Rmb 52) based on a 48x P/E for FY26E [2][5] Core Business Insights - **Innovative Pipeline**: - 4 innovative drugs under NDA review in China - 18 new molecules in Phase 3 development (6 in oncology) - Approximately 30 in Phase 2 (16 in oncology) [2] - **Out-Licensing Strategy**: - Licensing income expected to become a recurring revenue component, estimated to reach ~Rmb 6 billion by 2033 [19] - Management highlighted successful global development of out-licensed assets, including trials by partners like GSK and IDEAYA [9] - **Global Expansion**: - Strategy to conduct clinical development and commercialization overseas independently [18] - Establishment of a global commercial and strategy team to evaluate market opportunities [18] Operational Efficiency - **R&D and S&M Expenses**: - R&D expense ratio expected to remain below 30% - S&M expense ratio anticipated to decline as product sales increase [19] - **Efficiency Improvements**: Focus on improving operational efficiency rather than expanding the S&M team significantly [19] Valuation and Risks - **Valuation Methodology**: DCF valuation with a terminal growth rate of 4% and WACC of 9.6% [21] - **Key Risks**: - Downside risks include potential rejection of PD-1 marketing application by the FDA and underperformance of ADC program clinical data [22] - Upside risks include stronger-than-expected sales growth and earnings [22] Market Performance - **Stock Performance**: - Year-to-date increase of 41.6% - 12-month relative performance of 13.6% [11] Conclusion - **Investment Rating**: Neutral due to high current valuation compared to peers, despite strong fundamentals and growth potential [12][20]