贝达药业(300558)11月26日午间公告，公司收到国家药品监督管理局（简称"NMPA"）签发的《受理通 知书》，公司申报的盐酸恩沙替尼胶囊（商品名：贝美纳®）拟用于"间变性淋巴瘤激酶（ALK）阳性 的IB期至IIIB期非小细胞肺癌（NSCLC）患者的术后辅助治疗，患者须既往接受过手术切除治疗，并由 医生决定接受或不接受辅助化疗"的上市许可申请已获得NMPA受理。 ...

证券代码：300558 证券简称：贝达药业 公告编号：2025-072 贝达药业股份有限公司 关于盐酸恩沙替尼胶囊术后辅助治疗适应症药品注册申请获得受理的 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"贝达药业"或"公司"）收到国家 药品监督管理局（以下简称"NMPA"）签发的《受理通知书》（受理号： CXHS2500142、CXHS2500143），公司申报的盐酸恩沙替尼胶囊（商品名：贝美 纳®，以下简称"恩沙替尼"）拟用于"间变性淋巴瘤激酶（ALK）阳性的 IB 期 至 IIIB 期非小细胞肺癌（NSCLC）患者的术后辅助治疗，患者须既往接受过手术 切除治疗，并由医生决定接受或不接受辅助化疗"的上市许可申请已获得 NMPA 受理，现将具体情况公告如下： 一、申请注册药品的基本情况 产品名称：盐酸恩沙替尼胶囊 恩沙替尼"适用于 ALK 阳性的局部晚期或转移性的 NSCLC 患者的治疗"（新增 一线适应症）于 2022 年 3 月获得 NMPA 批准。2023 年 12 月，恩沙替尼纳入《国 家基本医疗保险、工伤保险和生 ...

11月26日，贝达药业盘中上涨2.14%，截至10:02，报50.52元/股，成交6811.19万元，换手率0.32%，总 市值212.55亿元。 资金流向方面，主力资金净流入438.16万元，大单买入1300.33万元，占比19.09%，卖出862.17万元，占 比12.66%。 分红方面，贝达药业A股上市后累计派现6.69亿元。近三年，累计派现1.84亿元。 机构持仓方面，截止2025年9月30日，贝达药业十大流通股东中，兴全商业模式混合(LOF)A（163415） 位居第五大流通股东，持股582.70万股，为新进股东。易方达创业板ETF（159915）位居第六大流通股 东，持股545.55万股，相比上期减少91.23万股。兴全合润混合A（163406）位居第七大流通股东，持股 540.17万股，为新进股东。中欧医疗健康混合A（003095）、南方中证500ETF（510500）退出十大流通 股东之列。 责任编辑：小浪快报 资料显示，贝达药业股份有限公司位于浙江省杭州市临平区经济技术开发区兴中路355号,香港铜锣湾希 慎道33号利园1期19楼1919室，成立日期2003年1月7日，上市日期2016年11月 ...

把握回调后的机会，积极布局 2026 年 医药生物 证券研究报告/行业定期报告 2025 年 11 月 24 日 执业证书编号：S0740519040001 Email：zhujq@zts.com.cn | 上市公司数 | 498 | | --- | --- | | 行业总市值(亿元) | 70,594.11 | 消费多点开花》2025-11-17 2、《医保国谈落下帷幕；关注乳腺 癌创新疗法动向》2025-11-10 3、《改善趋势延续，积极把握底部 反转机会》2025-11-07 | 评级： | 增持（维持） | | | 重点公司基本状况 | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | 简称 | 股价 | | | EPS | | | | | PE | | | 评级 | | 分析师：祝嘉琦 | | | | （元） | 2023A | 2024A | 2025E | 2026E | 2027E | 2 ...

Core Points - Boda Pharmaceutical's stock price decreased by 2.08% on November 21, reaching 49.06 CNY per share, with a market capitalization of 20.641 billion CNY [1] - The company has experienced a year-to-date stock price decline of 8.69%, with a 9.68% drop over the last five trading days and a 23.44% decline over the past 60 days [1] - As of September 30, 2025, Boda Pharmaceutical reported a revenue of 2.717 billion CNY, a year-on-year increase of 15.90%, while the net profit attributable to shareholders decreased by 23.86% to 317 million CNY [2] Financial Performance - The company has distributed a total of 669 million CNY in dividends since its A-share listing, with 184 million CNY distributed over the last three years [3] - As of September 30, 2025, the number of shareholders decreased by 7.99% to 29,500, while the average number of circulating shares per person increased by 8.68% to 14,198 shares [2] Shareholder Structure - Among the top ten circulating shareholders, Xingshan Commercial Model Mixed Fund A is the fifth largest with 5.827 million shares, marking a new entry [3] - E Fund's Growth Enterprise Board ETF, ranked sixth, reduced its holdings by 912,300 shares to 5.456 million shares [3] - Xingshan Helun Mixed Fund A is the seventh largest shareholder with 5.402 million shares, also a new entry [3]

Core Viewpoint - Benda Pharmaceutical's stock has experienced a decline in recent trading sessions, with a notable drop in both share price and market capitalization, indicating potential challenges in the company's performance and investor sentiment [1][2]. Company Performance - As of September 30, Benda Pharmaceutical reported a revenue of 2.717 billion yuan, reflecting a year-on-year growth of 15.90%. However, the net profit attributable to shareholders decreased by 23.86% to 317 million yuan [2]. - The company's stock price has fallen by 5.40% year-to-date, with a 5.71% decline over the past five trading days, a 12.75% drop over the last 20 days, and a significant 27.60% decrease over the past 60 days [1]. Shareholder Information - The number of shareholders decreased by 7.99% to 29,500, while the average number of circulating shares per person increased by 8.68% to 14,198 shares [2]. - Benda Pharmaceutical has distributed a total of 669 million yuan in dividends since its A-share listing, with 184 million yuan distributed over the past three years [3]. Institutional Holdings - As of September 30, 2025, notable institutional shareholders include Xingquan Commercial Model Mixed Fund (LOF) A, which is the fifth-largest shareholder with 5.827 million shares, and E-Fund's Growth Enterprise Board ETF, which has reduced its holdings by 912,300 shares [3].

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Views - The report emphasizes three core investment directions: 1) Breakthroughs in cutting-edge technologies (e.g., First-in-class drugs in oncology, weight loss, autoimmune fields, and innovative devices like brain-machine interfaces); 2) Clinical validation and commercialization potential (focus on the progress of domestic innovative drugs going abroad and the clinical development progress post-BD transactions); 3) Efficiency advantages in the industry chain (CXO leaders and high-value consumables' global layout) [8] Industry Review - The pharmaceutical and biotechnology industry index increased by 0.81%, ranking 21st among 31 primary industries, outperforming the CSI 300 index which decreased by 0.27% [5][16] - The sub-industries of pharmaceutical circulation and in vitro diagnostics saw significant gains of 7.61% and 5.32% respectively, while medical research outsourcing and medical devices experienced declines of 3.49% and 1.76% [5][16] - As of November 14, 2025, the industry PE (TTM overall method, excluding negative values) was 30.89x, up from 30.67x in the previous period, indicating an upward valuation trend that remains below the average [21] - The top three PE ratios among the sub-industries were for vaccines (50.42x), hospitals (43.67x), and medical devices (37.84x), while pharmaceutical circulation had the lowest valuation at 15.46x [21] Important Industry News - The National Health Commission and others issued implementation opinions to promote and regulate the application of "AI + healthcare" [7] - The NMPA released a new version of the "Medical Device Production Quality Management Specifications" [7] - Novartis received NMPA approval for its first radioligand therapy drug "Pluvicto®" for dual indications [7] - Sanofi's innovative targeted nano-antibody "Cablivi®" was approved by NMPA for treating immune-mediated thrombotic thrombocytopenic purpura [7] - The U.S. government reached a drug price control agreement with Eli Lilly and Novo Nordisk, leading to significant price reductions for GLP-1 drugs [7]

Core Viewpoint - The article discusses the surge in IPO applications from pharmaceutical companies in Hong Kong, highlighting the competitive landscape and the challenges faced by these companies in securing investors amid a crowded market [3][5][10]. Group 1: IPO Market Dynamics - As of November 14, 2023, 23 healthcare companies have successfully listed on the Hong Kong stock market this year, compared to only 8 in the same period last year [3]. - Over 40 healthcare companies have applied for IPOs in Hong Kong this year, with 8 applications submitted in just the first half of November [3]. - The increase in IPO applications has led to heightened competition among companies to attract suitable investors, resulting in a more complex negotiation landscape between companies and institutional investors [3][5]. Group 2: Case Study of Baillie Gifford - Baillie Gifford's planned global offering was delayed due to market conditions, with reports suggesting that investor demand did not meet expectations [4][5]. - The company aimed to attract long-term value investors rather than those focused on short-term price fluctuations, indicating a strategic approach to its IPO [5][6]. - The IPO process involves cornerstone placements, book-building, and public offerings, with cornerstone investors playing a crucial role in validating the company's value [6]. Group 3: Market Sentiment and Trends - The pharmaceutical sector has seen significant stock price increases this year, leading investors to focus on new IPOs rather than existing stocks [7]. - The introduction of new IPO pricing mechanisms by the Hong Kong Stock Exchange has increased the participation of cornerstone investors in pharmaceutical IPOs [9]. - Despite a recent cooling in the secondary market, the enthusiasm for IPO applications remains strong, with expectations of multiple companies going public in the first quarter of the following year [10][11]. Group 4: Investment Focus Areas - Certain sectors within the pharmaceutical industry, such as siRNA and ADC drugs, are attracting more attention from investors, indicating a trend towards specialized investment opportunities [11]. - The competition among major pharmaceutical companies for acquisitions, particularly in the GLP-1 drug space, has heightened interest in related IPOs [11]. - The article notes that while many IPOs are being pursued, the quality of the offerings and their pricing will be critical in attracting investor interest [13].

Core Insights - On November 14, 2023, Benda Pharmaceutical conducted a block trade of 69,000 shares, amounting to 3.007 million yuan, which represented 0.98% of the total trading volume for the day [1][2] - The transaction price was 43.58 yuan per share, reflecting a discount of 19.77% compared to the market closing price of 54.32 yuan [1] Summary by Category Trading Activity - The block trade involved 69,000 shares of Benda Pharmaceutical [1][2] - The total transaction value was 3.007 million yuan [1][2] Price Analysis - The executed price of 43.58 yuan per share was significantly lower than the market closing price, indicating a discount of 19.77% [1] Brokerage Information - The buyer was Guangfa Securities Co., Ltd., and the seller was Founder Securities Co., Ltd. [2]

Core Viewpoint - The company emphasizes that its business development is a long-term endeavor that requires addressing various challenges and difficulties proactively [2] Group 1: Business Development - Since its listing on the Growth Enterprise Market, the company has steadily developed its business, transitioning from a single product to a multi-product sales model [2] - Revenue and net assets have continued to grow, indicating a positive financial trajectory [2] Group 2: Strategic Focus - The company remains committed to innovation and hard work, aiming to strengthen its strategic direction through four key areas: research and development, market expansion, strategic partnerships, and ecosystem development [2] - There is a focus on embracing change and driving transformation by optimizing research strategies, enhancing research efficiency, and strengthening the layout of cutting-edge technologies [2] Group 3: Long-term Value Creation - The company aims to enhance its innovative vitality and accelerate the realization of the value of its innovative achievements, thereby achieving long-term growth in company value [2]