证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-114 二、药品的临床试验情况 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"）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》，公司海曲泊帕乙醇 胺片的药品上市许可申请获国家药监局受理，适应症为：适用于既往对糖皮质激 素、免疫球蛋白等治疗反应不佳的持续性及慢性原发免疫性血小板减少症（ITP） 成人及≥6 岁的儿童患者。现将相关情况公告如下： 一、药品的基本情况 药品名称：海曲泊帕乙醇胺片 剂型：片剂 受理号：CXHS2500092、CXHS2500093、CXHS2500094 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（或功能主治）：适用于既往对糖皮质激素、免疫球蛋白等治疗 反应不佳的持续性及慢性原发免疫性血小板减少症（ITP）成人及≥6 岁的儿童 患者。 2025 年 3 月，海曲泊帕乙醇胺片Ⅲ期临床 ...

Core Insights - The article emphasizes the importance of selecting good companies, waiting for reasonable prices, and maintaining long-term investments in the stock market [1][9] Investment Returns - Over the past decade, investments in A-shares yielded nearly five times returns, averaging an annualized return of 16%, which is below the target of tenfold returns set ten years ago [1][2] - A 10% annualized return is significantly more beneficial compared to the current bank interest rates of around 2% [2] Investment Approach - The article advocates for a serious approach to stock investment, highlighting that stocks represent ownership in companies rather than mere trading instruments [3][4] - It suggests that understanding financial statements and key performance indicators (KPIs) is crucial for evaluating companies [7] Long-term Investment Strategy - The long-term performance of various investment assets shows that stocks, particularly those of leading companies, provide substantial returns, with some companies achieving an annualized return of 27.18% [6][7] - The article encourages young investors to set clear investment goals and adopt a diversified asset allocation strategy to mitigate risks [8][9] Recommended Investment Practices - Young investors are advised to start with index funds and gradually explore sector-specific ETFs to benefit from different industry growths [9] - The importance of global investment opportunities is highlighted, suggesting that young investors should not limit themselves to domestic markets [9]

Core Insights - Heng Rui Medicine's subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have their injectable drugs SHR-A1811 and Adalimumab included in the National Medical Products Administration's list of proposed breakthrough therapies, marking the ninth inclusion for SHR-A1811 [1] Group 1: Company Developments - The injectable SHR-A1811 is designed to bind to HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in lysosomes [2] - SHR-A1811 received approval for market launch in May 2025, targeting adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously undergone at least one systemic therapy [2] - Cumulative R&D investment for SHR-A1811 has reached approximately 1.259 billion yuan [2] Group 2: Product Information - Adalimumab injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - Adalimumab injection (brand name: Ailili) was approved for market launch in March 2023, indicated for first-line treatment in extensive-stage small cell lung cancer patients in combination with carboplatin and etoposide [2] - Cumulative R&D investment for Adalimumab injection has reached approximately 901 million yuan [2] Group 3: Industry Context - The incidence of breast cancer is rapidly increasing in China, ranking as the second most common cancer among women [1] - Triple-negative breast cancer (TNBC) accounts for 10% to 15% of all breast cancer cases, with a higher prevalence in younger women and a lower disease-free survival rate [1] - The approval and application of tumor immunotherapy drugs, such as PD-L1 inhibitors, have improved progression-free survival and overall survival for patients with advanced TNBC [1]

Investment Rating - The report maintains a positive outlook on the innovative drug sector, recommending it as a "Buy" due to its potential for long-term growth despite short-term pressures [1]. Core Insights - The pharmaceutical sector experienced a decline of 0.8% this week, ranking last among 31 sub-industries, while the overall market indices showed positive performance [3][6]. - Innovative drug companies have shown strong revenue growth and significant business development (BD) transactions, indicating a trend of expanding market interest [1]. - Major companies like BeiGene and others have reported strong earnings, with BeiGene's revenue for H1 2025 reaching 17.52 billion yuan, a 46% year-on-year increase [1][12]. Market Performance - The overall pharmaceutical index fell by 0.8%, while the Shanghai Composite Index rose by 2.1% [3][5]. - The current valuation of the pharmaceutical sector stands at 32.2 times PE for 2025E, ranking it 6th among 31 primary industries [6][9]. Key Company Updates - BeiGene's H1 2025 revenue was 17.52 billion yuan, with a net profit of 450 million yuan, marking a turnaround from losses [1]. - Other companies like HeYue and Zai Lab also reported positive earnings growth, with HeYue's revenue increasing by 21.5% year-on-year [1][12]. Investment Analysis - The report emphasizes the importance of focusing on innovative drug companies with significant product launches and BD expectations, highlighting companies such as Hengrui Medicine, Betta Pharmaceuticals, and WuXi AppTec [1][12].

Investment Rating - The industry investment rating is "stronger than the market" (预计6个月内，行业指数表现强于市场表现5%以上) [35] Core Viewpoints - The report emphasizes the importance of multi-party collaboration in supporting the development of innovative drugs and medical devices, highlighting the integration of data, policy, and funding as essential elements for growth [4] - The report notes that recent measures from the Financial Supervisory Administration and the Medical Insurance Bureau aim to promote the development of commercial health insurance, which will provide additional support for the innovation and development of drugs and medical devices [4] Summary by Sections Industry Insights - The Medical Insurance Bureau's recent meetings have established a comprehensive support system for innovative drugs and medical devices, involving various stakeholders such as research institutions, enterprises, medical institutions, financial companies, and government departments [4] - The Financial Supervisory Administration has released measures to enhance the quality of commercial health insurance, which will further support the biopharmaceutical industry's innovation [4] Investment Strategy - The report suggests focusing on innovative pharmaceutical companies with rich pipelines, such as 恒瑞医药 (Hengrui Medicine), 百济神州 (BeiGene), and 中国生物制药 (China Biologic Products) [6] - It also highlights companies with significant single-product potential and those leading in advanced technology platforms, recommending关注 (focus on) companies like 凯莱英 (Kailaiying) and 药明康德 (WuXi AppTec) [6] Market Performance - The pharmaceutical sector experienced a decline of 0.84% last week, ranking last among 28 industries, while the Shanghai and Shenzhen 300 Index rose by 1.23% [9][21] - The report indicates that the pharmaceutical sector's valuation is currently at 30.91 times (TTM), with a premium of 37.32% compared to the overall A-shares excluding financials [27]

证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-113 江苏恒瑞医药股份有限公司 | 药品名称 | 注射用瑞康曲妥珠单抗 | 阿得贝利单抗注射液 | | --- | --- | --- | | 受理号 | CXSL2300823 | CXSL2300824 | | 注册分类 | 治疗用生物制品1类 | 治疗用生物制品2.2类 | | 申请日期 | 2025年7月10日 | | | 拟定适应症 | SHR-A1811联合阿得贝利单抗用于PD-L1阳性（CPS≥1） | | | （或功能主治） | 局部复发不可切除或转移性三阴性乳腺癌的一线治疗。 | | | 理由及依据 | 经审核，本申请符合《药品注册管理办法》和《国 | | | | 家药监局关于发布＜突破性治疗药物审评工作程序（试 | | | | 行）＞等三个文件的公告》（2020年第82号）有关要 | | | | 求，同意纳入突破性治疗药物程序。 | | 一、药品的基本情况 二、药品的其他相关情况 根据2022年世界卫生组织国际癌症研究机构（IARC）的统计数据，乳腺癌为 全球第二大恶性肿瘤，是女性最常见的恶性肿瘤，2022年全球女性乳腺癌 ...

人民财讯8月11日电，恒瑞医药（600276）8月11日晚间公告，公司子公司苏州盛迪亚生物医药有限公 司、上海盛迪医药有限公司的注射用瑞康曲妥珠单抗(SHR-A1811)、阿得贝利单抗注射液被国家药监局 药品审评中心纳入拟突破性治疗品种公示名单，公示期7日，这也是瑞康曲妥珠单抗第9次纳入拟突破性 治疗品种公示名单。 ...

型HET AKO R 会使养大师思想、我中学前学班学 融合今今所被誉。或即前往贸合点 足球手机 新天 十八十八十十 《大道至简： 大师投资说》 复利王子 海 天 著 上海财经大学出版社 2025年1月出版 如何穿越投资迷雾 ——读《大道至简：大师投资说》 *** KX+ + %, X 79 : E TH, LED - LEN, DEP - ZER. HIL - 24 的数,的看、方网 · 六年,新城 · 中国、日本区 · 五世界、第8世 · 和智能发展。 苹果, 加入平, 重平, 1800; 品中, 品产, 品质 NAS OF STERNET 大運東同 大原因 ◎墨 云 在复杂多变的股市中，《大道至简：大师投资说》以其独特的视角和深刻的洞见，为投资者提供了一种 回归投资本质的思考方式。本书不仅系统地梳理了价值投资的核心理念，还提出了具有本土化特色的投 资策略和方法论，旨为在市场波动中迷失方向的投资者探索前行的方向。 回归本质与践行长期主义 作者在书中开宗明义地指出，价值投资的核心在于理解股票的本质：股票不仅仅是一张纸或一个代码， 而是企业的一部分。投资者购买股票，实际上是在与企业共同成长，分享企业的长期价值创 ...

Core Insights - China's economy has shown strong resilience and vitality amid complex international environments and domestic transformation pressures, with significant achievements in high-quality development over the past five years [1] - The "Decode Vitality China" series by Securities Times aims to explore the internal driving forces of China's economic development through in-depth reporting on key regions, industries, and leading enterprises [1] Industry Developments - The pharmaceutical industry in China is experiencing a surge in business development (BD) activities, with over $60 billion in BD transactions in the first half of the year, surpassing the total for 2024 [3] - The partnership between Heng Rui Medicine and GlaxoSmithKline could yield a potential total of $12 billion if all projects are executed successfully [3] - From 2015 to 2024, China has entered the top tier of global new drug research and development, surpassing the United States in the number of original new drugs [4] Company Innovations - Guangsheng Tang has invested approximately 999 million yuan in R&D since its listing in 2015, leading to the approval of its innovative drug Tai Zhong Ding in 2023 [5] - Hai Te Biotechnology's new drug Sha Ai Te has entered the medical insurance directory, marking a significant achievement for the company [6] Policy and Market Dynamics - New policies aimed at supporting high-quality development of innovative drugs have been released, addressing key industry pain points such as pricing standards and reimbursement mechanisms [7] - The innovative drug sector has seen a positive market response, with the Innovative Drug 50 ETF rising over 40% in the past year [7] - There are suggestions for policy adjustments regarding the inclusion of combination therapies in medical insurance, which could alleviate patient burdens [8]

Investment Rating - The report maintains an investment rating of "Outperform" with a target price set for leading stocks [3][4]. Core Insights - The innovative drug sector is experiencing fluctuations, but several catalysts are anticipated, including academic conferences, business development achievements, and negotiations for medical insurance [2]. - The National Medical Insurance Administration has updated the data on innovative drugs included in the medical insurance directory, showing rapid hospital admissions for several newly included domestic innovative drugs [2][22]. Summary by Sections Weekly New Drug Market Review - From August 4 to August 10, 2025, the top five companies in the new drug sector by stock price increase were: Beihai Kangcheng (+73.1%), Jiahe Biotech (+39.0%), Gilead Sciences (+30.3%), Heyu Biotech (+21.1%), and Hengrui Medicine (+15.3%). The top five companies with the largest declines were: Hutchison China MediTech (-13.8%), Frontier Biotech (-13.4%), Yifang Biotech (-11.7%), Haichuang Pharma (-9.9%), and Maiwei Biotech (-9.2%) [1][16]. Recommended Stocks to Watch - The report suggests focusing on potential overseas licensing opportunities for significant products, including differentiated GLP-1 assets from companies like Zhongsheng Pharma, Kangyuan Pharma, and Gilead Sciences. Additionally, upgraded PD-1 products from Kangfang Biotech and others are highlighted [2][22]. Key Analysis of the New Drug Industry - The report notes that several innovative drugs newly included in the medical insurance directory are rapidly entering hospitals, with notable growth in hospital admissions for drugs such as Zaiqiang Pharma's recombinant thrombin and Hengrui Medicine's Tazemetostat [2][22][23]. New Drug Approval and Acceptance Status - This week, three new drug applications were approved, including Adalimumab injection from Wuhan Biological Products Research Institute, Dulaglutide injection from Shandong Boan Biotech, and Evinacumab injection from Xi'an Janssen [28][29]. Additionally, four new drug applications were accepted, including Trastuzumab injection from Amgen and others [28][30]. Clinical Application Approval and Acceptance Status - A total of 55 new drug clinical applications were approved this week, while 31 new drug clinical applications were accepted [10][31].