证券代码：300558 证券简称：贝达药业 公告编号：2026-008 贝达药业股份有限公司 关于股东股份质押变动的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 贝达药业股份有限公司（以下简称"公司"）今日接到股东宁波凯铭投资管理合伙企业 （有限合伙）（以下简称"凯铭投资"）函告，获悉凯铭投资持有本公司的部分股份发生质 押变动，现将具体情况公告如下： 一、股东股份质押基本情况 1、凯铭投资股份新增质押情况 | | 是否为控 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | 股股东或 | 本次质押 | 占其所 | 占公司 | 是否为 | 是否为 | 质押 | 质押 | | 质押 | | 名称 | 第一大股 | 数量 | 持股份 | 总股本 | 限售股 | 补充质押 | 起始日 | 到期日 | 质权人 | 用途 | | | 东及其一 | （股） | 比例 | 比例 | | | | | | | | | 致行动人 | | ...

内容概要：抗肿瘤药物是抑制肿瘤细胞生长、杀伤肿瘤细胞以治疗恶性肿瘤的药物总称，是恶性肿瘤全 身性治疗的核心手段，广泛应用于肿瘤治疗全周期。全球范围内，受人口老龄化等因素影响，癌症发病 居高不下，肺癌等为主要高发瘤种，推动免疫治疗、ADC等创新疗法落地，带动全球市场持续扩容， 治疗方式已从传统化疗向精准靶向治疗转型。国内方面，癌症高发带来庞大刚性需求，国家出台多项政 策从审评审批、医保支付等多方面支撑行业发展，市场以本土创新为核心驱动力，规模快速增长，治疗 结构逐步与国际接轨，靶向治疗成为主流。行业形成跨国药企引领高端、本土药企突围崛起的竞争格 局，本土药企在核心赛道成效显著。未来，行业将向源头创新、国产主导、生态优化方向发展，聚焦前 沿技术，推进产业链自主可控，提升创新药可及性，向高质量、全球化转型。 上市企业：恒瑞医药（600276.SH）、艾力斯（688578.SH）、贝达药业（300558.SZ）、翰森制药 （03692.HK）、来凯医药-B（02105.HK） 相关企业：正大天晴药业集团股份有限公司、百济神州（苏州）生物科技有限公司、再鼎医药（上海） 有限公司、赛诺菲（中国）投资有限公司、南京绿叶制药 ...

麓鹏制药董事长兼CEO谭芬来博士。 工作中的谭芬来博士。 在中国创新药发展版图中，创新药老兵谭芬来博士是一个独特的存在。 七年前，在由其主导临床研发的中国首个小分子靶向抗癌药埃克替尼(凯美纳)惠及数十万患者、首个 ALK靶点创新药恩沙替尼蓄势待发之时，他却选择卸下荣光，创立了一家连名字都直抒高远之志的创 新药企业——麓鹏制药。 七年后的今天，他带领团队交出了一份份令人满意的阶段性成绩单：全球首个且唯一共价兼非共价布鲁 顿酪氨酸激酶(BTK)抑制剂洛布替尼，成为中国首个被认定为弥漫大B细胞淋巴瘤(DLBCL)突破性疗法 的BTK抑制剂，并已启动关键性注册Ⅱ期临床研究；针对复发或难治性套细胞淋巴瘤(R/R MCL)的新药 上市申请(NDA)，获国家药品监督管理局药品审评中心(CDE)受理并纳入优先审评程序；启动治疗复发 或难治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(R/R CLL/SLL)的全球三期头对头临床试验，正面挑战国 际制药巨头礼来公司的第三代BTK抑制剂匹妥布替尼，直面全球化竞争。 从杭州西子湖畔到广州黄埔科学城，谭芬来完成的不只是一次地理上的回归，更是一场从"创中国首 个"到"创全球首个"的信念升级。在 ...

Core Viewpoint - China National Pharmaceutical Group (国药控股) experienced a decline on February 20, 2026, primarily due to short-term market sentiment, liquidity factors, and industry environment [1] Stock Performance - On February 20, the stock opened at HKD 20.60, down 4.1% from the previous closing price of HKD 21.48, with an intraday low of HKD 20.60. The closing price was HKD 20.98, reflecting a daily decline of 2.33% and a trading volume of approximately HKD 1.00 billion. The Hang Seng Index fell by 1.10%, with the pharmaceutical distribution sector declining by 5.13%, making China National Pharmaceutical Group one of the worst performers among Hang Seng Index constituents [2] Reasons for Stock Price Movement - Liquidity vacuum amplified selling pressure: The southbound trading (港股通) was closed on that day, preventing mainland funds from entering the market, leading to weak buying interest. A small amount of selling pressure caused a rapid decline in stock price, particularly evident in the pharmaceutical sector [3] - Industry policy and performance expectations were lackluster: No positive developments were observed in the pharmaceutical industry during the Spring Festival holiday, and concerns about policy adjustments, such as volume-based procurement, persisted. Additionally, the company's revenue for the first three quarters of 2025 decreased by 2.47%, although net profit slightly increased by 0.53%, leading to investor skepticism regarding short-term performance improvement [3] - Weight stocks dragged down and sector rotation occurred: Funds shifted from high-valuation sectors like pharmaceuticals and technology to defensive sectors such as energy and real estate, resulting in concentrated selling of China National Pharmaceutical Group as a pharmaceutical heavyweight. Concurrently, major tech stocks like Baidu and Alibaba also experienced significant declines, exacerbating market risk aversion [3] - External market transmission: Chinese concept stocks in the U.S. experienced widespread declines during the Spring Festival holiday, leading to a correction in the Hong Kong market. This was compounded by delayed expectations for U.S. Federal Reserve interest rate cuts and heightened geopolitical risks in the Middle East, putting pressure on global growth stock valuations [3] Capital and Technical Analysis - Capital flow: Southbound funds have been consistently reducing holdings, with a net reduction of 3.45 million shares on February 12 and a cumulative net reduction of 33.64 million shares over the past 20 trading days. However, Lazard Asset Management increased its holdings by 1.163 million shares on February 2, raising its stake to 11.06% [4] - Technical indicators: The stock price fell below the 20-day moving average (HKD 21.037), with the MACD histogram turning negative at -0.041 and the KDJ J-line dropping to 53.64, indicating weak short-term momentum [4] Future Development - Recent strategic actions include a partnership with Betta Pharmaceuticals (贝达药业) focused on supply chain optimization as of January 4, 2026. However, the medical device distribution business continues to be impacted by centralized procurement, and overall performance recovery will depend on subsequent policy and demand changes [5]

Investment Rating - The industry maintains a "Neutral" rating, with specific company ratings of "Buy" for Heng Rui Pharmaceutical (600276) and "Increase" for WuXi Biologics (603259) [46] Core Insights - The recent national drug procurement has been stable, with active participation from companies and continued benefits for patients [8][9] - The issuance of the "National Basic Drug Directory Management Measures" aims to enhance the management of essential medicines [10][11] - Heng Rui Pharmaceutical reported positive top-line results for its GLP-1/GIP dual receptor agonist, indicating significant weight loss in clinical trials [12] - The approval of Mu Feng Da® for the treatment of adult type 2 diabetes marks a significant development in the market [12] Industry News - The national drug procurement involved 316 commonly used drugs across 26 therapeutic areas, with a high participation rate from over 5,100 medical institutions and 1,091 companies [8][9] - The procurement process has been standardized, allowing companies to bid online once for nationwide sales, significantly reducing costs [9] - The management measures for the national basic drug directory have been revised to include legal policy bases and optimize the directory structure [10][11] Company Announcements - Innovent Biologics has entered a global strategic partnership with Eli Lilly to advance new drug development in oncology and immunology [26] - Kelun Pharmaceutical's TROP2 ADC has received approval for a fourth indication from the NMPA [27] - Heng Rui Pharmaceutical's drug has been included in the list of breakthrough therapy products, and its application for marketing approval has been accepted for priority review [28] - WuXi Biologics has forecasted a positive earnings outlook, expecting a revenue increase of approximately 16.7% [30] Market Review - The Shanghai Composite Index rose by 1.43%, while the Shenzhen Component Index increased by 2.37%, with the SW Pharmaceutical and Biotech Index up by 0.23% [36] - The industry’s price-to-earnings ratio (TTM) stands at 51.17, with a valuation premium of 259% compared to the CSI 300 [40] Weekly Strategy - The report suggests focusing on investment opportunities in innovative drugs, CXO, and upstream life sciences, while also monitoring performance recovery indicators [46]

Group 1: Pharmaceutical and Biotechnology Industry - The pharmaceutical and biotechnology sector saw an overall increase of 0.14% last week, outperforming the CSI 300 index by 1.47 percentage points, with a current PE valuation of 29.43 times, which is at a historical mid-low level, representing a 120% premium over the CSI 300 [6][7] - Notable individual stock performances included Guangshengtang, which surged by 29.83%, followed by Haixiang Pharmaceutical at 18.64%, and Meidisi at 18.04% [6] - A significant collaboration was announced between Saint Gene and Gene Tech, involving a global R&D cooperation and licensing agreement for an RNAi therapy, with an upfront payment of $200 million and potential milestone payments totaling $1.5 billion [7][8] - The investment recommendation focuses on three main lines: biotech firms with core delivery technology and international collaboration potential, industry leaders in chronic disease areas with advanced pipelines, and key companies in the small nucleic acid supply chain benefiting from global commercialization [8] Group 2: Machinery and Equipment Industry - In January 2026, excavator sales reached 18,708 units, a year-on-year increase of 49.5%, with domestic sales up 61.4% and exports up 40.5% [11][12] - Loader sales also saw significant growth, with a total of 11,759 units sold in January, reflecting a 48.5% increase year-on-year, driven by major domestic projects [13] - The demand for excavators is expected to continue recovering due to upcoming large-scale projects in various sectors, including mining and water conservancy [12][14] - Companies like LiuGong are projected to see steady profit growth, with a forecasted net profit of 1.526 to 1.659 billion yuan for 2025, marking a 15-25% increase year-on-year [13] Group 3: Electronics Industry - The electronics sector is experiencing a recovery, with significant capital expenditure increases from major CSP manufacturers, expected to reach $670 billion in 2026, a 60% year-on-year increase [16][17] - The global semiconductor industry is projected to achieve record sales of $791.7 billion in 2025, with a 25.6% year-on-year growth, driven by demand from AI and IoT technologies [18] - Price increases are spreading from memory chips to power, analog, and MCU chips, indicating a comprehensive price surge in the semiconductor market [18] - Investment recommendations include focusing on companies benefiting from strong domestic and international demand in the AIOT sector, as well as those involved in semiconductor equipment and materials [21]

Core Viewpoint - The approval of the new indication for TROP2 ADC drug Sacituzumab (sac-TMT) marks a significant advancement in the treatment of HR+/HER2- breast cancer, highlighting its clinical value and market urgency [1][5][13]. Group 1: Drug Approval and Indications - Sacituzumab has been approved for treating adults with unresectable locally advanced or metastatic HR+ and HER2- breast cancer who have previously received endocrine therapy and other systemic treatments [1][5]. - The approval is based on positive data from the OptiTROP-Breast02 Phase III study, which demonstrated significant survival benefits and manageable safety in a difficult-to-treat patient population [7][13]. Group 2: Drug Characteristics and Development - Sacituzumab is an innovative ADC targeting TROP2, composed of a humanized monoclonal antibody, a cleavable linker, and a novel topoisomerase I inhibitor, with a drug-antibody ratio (DAR) of 7.4, indicating strong drug delivery capabilities [5]. - The drug has multiple approved indications, including treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) [5][6]. Group 3: Global Collaboration and Market Strategy - In May 2022, a strategic collaboration was established with MSD, granting exclusive rights for development and commercialization of Sacituzumab outside Greater China, indicating a global expansion strategy [8]. - MSD has initiated 16 global Phase III clinical studies across various cancer types, aiming to position Sacituzumab as a broad-spectrum ADC [8]. Group 4: Competitive Landscape - Currently, three TROP2 ADCs have been approved globally, including Sacituzumab, highlighting the competitive nature of the ADC market [9]. - In the domestic market, in addition to Sacituzumab, three other products are in Phase III clinical trials, intensifying competition [10]. Group 5: Market Demand and Future Outlook - HR+/HER2- breast cancer accounts for approximately 70% of all breast cancer cases, with significant unmet clinical needs due to treatment resistance and multiple lines of therapy failures [13]. - The approval of Sacituzumab not only enhances treatment options for this patient population but also strengthens the position of domestic ADCs in the international market [13][14]. - The future of the ADC industry will focus on maintaining first-mover advantages, expanding combination therapies, and improving patient accessibility [14].

格隆汇2月6日丨贝达药业(300558.SZ)公布，收到国家药品监督管理局（简称"国家药监局"）签发的《药 品注册证书》，国家药监局批准公司与杭州博之锐生物制药有限公司（浙江博锐生物制药股份有限公司 之全资子公司，统称"博锐生物"）合作的帕妥珠单抗注射液（商品名：贝泽汀®，简称"贝泽汀®"）上 市。贝泽汀®是由公司合作伙伴博锐生物自主研发的帕妥珠单抗（帕捷特®）生物类似药，用于治疗早 期乳腺癌、转移性乳腺癌。 ...

贝达药业公告，公司收到国家药监局签发的《药品注册证书》（药品批准文号：国药准字 S20260009），批准公司与杭州博之锐生物制药有限公司合作的帕妥珠单抗注射液（商品名：贝泽汀 ®）上市。贝泽汀®适用于早期乳腺癌及转移性乳腺癌患者。该药品为博锐生物自主研发的帕妥珠单抗 生物类似药，用于治疗早期乳腺癌、转移性乳腺癌。取得药品注册证书后，公司即可落实推进贝泽汀® 商业 化工作。 ...

剂型：注射剂 证券代码：300558 证券简称：贝达药业 公告编号：2026-007 贝达药业股份有限公司 关于国家药品监督管理局批准帕妥珠单抗注射液上市的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 今日，贝达药业股份有限公司（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"）签发的《药品注册证书》（药品批准文 号：国药准字 S20260009），国家药监局批准公司与杭州博之锐生物制药有 限公司（浙江博锐生物制药股份有限公司之全资子公司，以下统称"博锐生 物"）合作的帕妥珠单抗注射液（商品名：贝泽汀®，以下简称"贝泽汀®"） 上市，现将具体情况公告如下： 一、申请注册药品的基本情况 药物名称：帕妥珠单抗注射液 规格：420 mg（14ml）/瓶 药品注册分类：治疗用生物制品 3.3 类 申请事项：药品上市许可申请 适应症：本品适用于早期乳腺癌及转移性乳腺癌患者。 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。 二、药品基本情况及同类药品市场状况 贝泽汀®是由公 ...