Group 1 - The Ministry of Finance and the State Taxation Administration have released a draft for public consultation regarding the implementation regulations of the Value-Added Tax Law, which clarifies definitions and taxpayer categories [1] - The Central Securities Depository Company has simplified the account opening process for foreign central bank institutions by eliminating the requirement for a signed commitment letter [1][7] - The China Association of Automobile Manufacturers reported that from January to July, sales of new energy vehicles reached 8.22 million units, a year-on-year increase of 38.5% [4] Group 2 - Trust companies have begun receiving the latest regulatory ratings for 2024, with the highest known rating being level 2, indicating a focus on risk management and operational stability [5] - Shanghai Clearing House has also simplified the account opening materials for foreign institutions, enhancing the investment environment in the bond market [7] - Several companies are making significant moves, such as *ST Bio planning to acquire a 51% stake in Huize Pharmaceutical, and Chang'an Automobile's executives planning to increase their shareholdings [8]

Core Viewpoint - Heng Rui Medicine announced that its subsidiaries Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have had their injectable drugs SHR-A1811 and Adebali monoclonal antibody included in the list of proposed breakthrough therapies by the National Medical Products Administration [1] Group 1: Product Information - SHR-A1811 is indicated for first-line treatment of PD-L1 positive (CPS≥1) locally recurrent unresectable or metastatic triple-negative breast cancer [1] - SHR-A1811 works by binding to HER2-expressing tumor cells, inducing cell cycle arrest and apoptosis through toxin release in the lysosome [1] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody, approved for first-line treatment in combination with carboplatin and etoposide for extensive-stage small cell lung cancer patients [1] Group 2: Regulatory Approval - Both injectable drugs have received market approval and are now part of the regulatory framework for breakthrough therapies in China [1]

经济观察网 据恒瑞医药（600276）微信公众号8月11日消息，近日，恒瑞医药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抗体偶联药物（ADC）创新药注射用瑞康曲妥珠单抗、阿得贝 利单抗注射液被国家药品监督管理局药品审评中心纳入拟突破性治疗品种公示名单，适应症为瑞康曲妥 珠单抗联合阿得贝利单抗用于PD-L1阳性（CPS≥1）局部复发不可切除或转移性三阴性乳腺癌的一线治 疗。这是瑞康曲妥珠单抗第9次纳入拟突破性治疗品种，充分体现了该药物在多个治疗领域的临床潜 力。此次也是阿得贝利单抗注射液首次纳入拟突破性治疗品种。 ...

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]

Core Viewpoint - Heng Rui Medicine's subsidiary has two products, SHR-A1811 and Abedilizumab, included in the list of proposed breakthrough therapies by the National Medical Products Administration, marking the ninth inclusion for SHR-A1811 [1] Group 1: Market Context - Breast cancer is the second most common malignant tumor globally, with approximately 2.297 million new cases reported in 2022 [1] - In China, breast cancer accounts for 15.6% of all malignant tumors, with around 357,000 new cases and 75,000 deaths in 2022 [2] - Triple-negative breast cancer (TNBC) represents 10%-15% of all breast cancer cases, predominantly affecting younger women and exhibiting high invasiveness and poor prognosis [2] Group 2: Product Information - SHR-A1811 is an injectable drug that targets HER2-positive tumors, approved for use in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior systemic therapy [3] - The global sales of similar products, Kadcyla and Enhertu, are projected to reach approximately $6.557 billion in 2024 [3] - The total R&D investment for SHR-A1811 has reached approximately 1.259 billion yuan [3] Group 3: Competitive Landscape - Abedilizumab is a humanized anti-PD-L1 monoclonal antibody, approved for first-line treatment of extensive-stage small cell lung cancer [4] - Similar products like Atezolizumab, Avelumab, and Durvalumab are projected to have a combined global sales of approximately $9.648 billion in 2024 [4] - The total R&D investment for Abedilizumab has reached approximately 901 million yuan [4]

Core Viewpoint - Heng Rui Medicine's subsidiary has two products included in the list of proposed breakthrough therapies by the National Medical Products Administration, indicating significant progress in their development pipeline [1] Group 1: Product Development - The injection of SHR-A1811 (Rui Kang Qu Mo Zhu) has been included in the proposed breakthrough therapy list for the ninth time, highlighting its potential in treating non-small cell lung cancer (NSCLC) [1] - SHR-A1811 is designed to bind to HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release within the tumor cells [1] - The product has received approval for market launch in May 2025, specifically for adult patients with unresectable locally advanced or metastatic NSCLC who have previously undergone at least one systemic therapy [1] Group 2: New Drug Approvals - The injection of Adalimumab (Aide Beili) is a humanized anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] - Adalimumab was approved for market launch in March 2023, with its indication for first-line treatment in extensive-stage small cell lung cancer patients in combination with carboplatin and etoposide [1]

格隆汇8月11日丨恒瑞医药(01276.HK)发布公告，近日，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 ...

智通财经APP讯，恒瑞医药(01276)发布公告，近日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品监督管理局药品 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。 注射用瑞康曲妥珠单抗可通过与HER2表达的肿瘤细胞结合并内吞，在肿瘤细胞溶酶体内通过蛋白酶剪 切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细胞凋亡。公司注射用瑞康曲妥珠单抗已于2025年 5月获 批上市，适用于治疗存在 HER2 (ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除的局部晚 期或转移性非小细胞肺癌(NSCLC)成人患者。 阿得贝利单抗注射液是公司自主研发的人源化抗PD-L1单克隆抗体，能通过特异性结合PD-L1分子从而 阻断导致肿瘤免疫耐受的PD-1/PD-L1通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目 的。公司阿得贝利单抗注射液(商品名：艾瑞利)已于2023年3月获批上市，获批的适应症为与卡铂和依 托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。 ...

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 ...