这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 微芯生物预计上半年净利润3006万元 7月17日，微芯生物(688321.SH)公告称，预计2025年半年度归属于母公司所有者的净利润为3006万元， 实现扭亏为盈。报告期因西达本胺新进医保、西格列他钠销售策略优化及"糖肝共管"优势获认可，带动 产品销量大幅增长，第二季度营收和净利润均实现显著增长。 国药现代上半年净利润同比下降6.46% 国家药监局发布《关于医疗器械分类调整有关工作的公告（征求意见稿）》 7月17日，根据国家药监局官网，为进一步优化有关工作要求，国家药监局组织修订了《医疗器械分类 目录动态调整工作程序》，并明确了分类调整后注册备案相关工作要求。现向社会公开征求意见，时间 是2025年7月17日—8月16日。《征求意见稿》提出了医疗器械管理类别调整后注册备案有关要求、由不 作为医疗器械管理调整为按照医疗器械管理产品有关要求、不作为医疗器械管理产品有关要求等内容。 药械审批 悦康药业一注射液获批临床 7月17日，悦康药业(688658.SH)公告称，公司子公司北京悦康科创医药科技股份有限公司、 ...

1、两部门：调整超豪华小汽车消费税政策 重要程度：★★★★★ 据财政部网站，为进一步引导合理消费，经国务院批准，现就超豪华小汽车消费税政策有关事项调整。 其中指出，中超豪华小汽车征收范围调整为"每辆零售价格90万元(不含增值税)及以上的各种动力类型(含 纯电动、燃料电池等动力类型)的乘用车和中轻型商用客车"。规定的超豪华小汽车进口环节消费税的征收 范围相应调整。 2、计算支撑AI，硅是一切的起源!黄仁勋、王坚链博会对话实录来了 重要程度：★★★★ 7月17日，在链博会第二天的活动上，黄仁勋与之江实验室主任、阿里云创始人王坚展开炉边对话。 黄仁勋说，人工智能已经走完了感知智能阶段，生成式人工智能阶段，现在处于推理人工智能阶段，并且 无限接近通用人工智能阶段。算力是AI的基础，硅则是算力的基础，黄仁勋对这个问题的看法是肯定的， 并且强调未来硅基技术集中三个方面：晶体管结构迭代、封装技术迭代、硅光技术迭代。 3、中欧领导人会晤是否将于下周举行?外交部回应 重要程度：★★★★ 在17日的外交部例行记者会上，有媒体提问称，外交部能否确认中欧领导人会晤是否将于下周举行，并提 供相关细节?对此，外交部发言人林剑表示，目前我 ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four drugs, indicating a significant advancement in its oncology pipeline [1][2][3][4] Group 1: Drug Approvals and Clinical Trials - The company and its subsidiaries have been granted clinical trial approval for SHR-8068 injection, Adebali monoclonal antibody injection, Bevacizumab injection, and Apatinib mesylate tablets [1][2][3][4] - SHR-8068 is a fully human anti-CTLA-4 monoclonal antibody aimed at enhancing anti-tumor immune effects, with a cumulative R&D investment of approximately 214 million yuan [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, was approved in March 2023 for first-line treatment of extensive-stage small cell lung cancer, with a cumulative R&D investment of about 887 million yuan [2] - Bevacizumab injection, a humanized anti-VEGF monoclonal antibody, was approved in June 2021, with a cumulative R&D investment of around 345 million yuan [3] - Apatinib mesylate tablets have been approved for three indications, with a cumulative R&D investment of approximately 587 million yuan [4] Group 2: Market Potential and Competitors - The global sales of similar products for SHR-8068, including Ipilimumab and Tremelimumab, are projected to be approximately 3.271 billion USD in 2024 [1] - The combined global sales for Adebali's competitors, Atezolizumab, Avelumab, and Durvalumab, are estimated to be around 9.648 billion USD in 2024 [2] - Bevacizumab's global sales are projected to be about 5.655 billion USD in 2024 [3] - The global sales for Apatinib's competitors, including Sorafenib, Sunitinib, and Pazopanib, are expected to total approximately 543 million USD in 2024 [4]

恒瑞医药(600276.SH)公告称，公司及子公司收到国家药监局核准签发关于SHR-8068注射液、阿得贝利 单抗注射液、贝伐珠单抗注射液、甲磺酸阿帕替尼片的《药物临床试验批准通知书》，将于近期开展临 床试验。SHR-8068注射液是全人源抗CTLA-4单克隆抗体，阿得贝利单抗注射液是自主研发的人源化抗 PD-L1单克隆抗体，贝伐珠单抗注射液是一种人源化抗VEGF单克隆抗体，甲磺酸阿帕替尼片是创新研 发的小分子靶向药物。这些药物的研发投入分别为SHR-8068注射液约2.14亿元，阿得贝利单抗注射液 约8.87亿元，贝伐珠单抗注射液约3.45亿元，甲磺酸阿帕替尼片约5.87亿元。根据相关法律法规要求， 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。 ...

Core Viewpoint - The Chinese biopharmaceutical industry, represented by Baotai Biopharmaceutical Co., Ltd., is enhancing its international competitiveness through innovation amidst a restructuring global medical technology landscape [2]. Group 1: Company Overview - Baotai, established in 2003, focuses on the research and development of innovative drugs and biosimilars, targeting diseases such as cancer and autoimmune disorders [3]. - The company has shown steady revenue growth from 455 million yuan in 2022 to 743 million yuan in 2024, with a compound annual growth rate of 27.8% [3]. Group 2: Product Portfolio and Globalization - Baotai has several marketed products, including Adalimumab injection and Bevacizumab injection, contributing significantly to its revenue [3]. - The company has established commercial partnerships for six products across over 92 countries, with its products receiving regulatory approvals from the FDA and EMA [4]. - Baotai aims to have four products launched globally by 2027, indicating a strong pipeline for future growth [4]. Group 3: Research and Development Strategy - R&D expenditures from 2022 to 2024 were 616 million yuan, 769 million yuan, and 778 million yuan, respectively, reflecting a commitment to maintaining competitive positioning through innovation [6]. - The company is focusing on developing next-generation antibody-drug conjugates (ADCs) and bispecific antibodies in oncology and autoimmune fields [6]. - Baotai emphasizes a dual-track strategy of innovative drugs and biosimilars to drive long-term growth [6]. Group 4: Technological Integration and Future Outlook - Baotai's BAT2206 is expected to receive FDA approval in May 2025, with other products also progressing through regulatory pathways [7]. - The company is integrating AI technology into various stages of drug development, aiming to make it a foundational aspect of R&D and production [7]. - Baotai's supply chain remains resilient against global trade tensions, primarily sourcing raw materials domestically [8].