贝达药业股份有限公司 证券代码：300558 证券简称：贝达药业 公告编号：2024-061 2、股东股份累计质押情况 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 | 股东 | 是否为控 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 | | | | | | | | ...

Investment Rating - The report gives a "Buy" rating for the company, indicating a positive outlook for future performance [6]. Core Views - The company is expected to enter a high growth phase as revenue reaches an inflection point, driven by the gradual narrowing of price reductions for its key product, Alectinib, and the anticipated volume increase post-inclusion in the medical insurance directory for lung cancer treatments [6][12]. - The company has a robust pipeline with several products in late-stage clinical trials, including new indications for existing drugs, which are expected to contribute to revenue growth in the coming years [10][24]. - The report highlights the company's strong market position in lung cancer treatment and its ongoing efforts to expand into new therapeutic areas, such as eye diseases, which represent significant market opportunities [12][24]. Summary by Sections Financial Performance - The company reported revenues of 2,456 million yuan in 2023, with a projected growth rate of 26.0% for 2024 and 26.1% for 2025 [6]. - Net profit is expected to reach 348 million yuan in 2023, with a significant increase of 139.3% year-over-year [6]. - Earnings per share are projected to grow from 0.83 yuan in 2023 to 1.22 yuan in 2024 [6]. Product Pipeline - The company has several products in advanced stages of development, including Ensartinib, which has received NDA acceptance in the U.S. and is expected to be a leading treatment for ALK-positive NSCLC [11][13]. - The CDK4/6 inhibitor, BPI-16350, is in the registration phase and is anticipated to be approved in the next 1-2 years, targeting HR+/HER2- breast cancer [24]. Market Position and Strategy - The company has established a strong brand in the lung cancer treatment market, with its first small molecule targeted therapy, Alectinib, being widely recognized and utilized [6][7]. - The report emphasizes the company's strategic focus on expanding its product offerings and enhancing marketing synergies among its existing products to maximize revenue potential [12][24].

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。 证券代码：300558 证券简称：贝达药业 公告编号：2024-060 贝达药业股份有限公司 截至本公告披露日，公司控股股东及其一致行动人累计质押股份数量占其所持公司股份 数量比例为 50.53%，此外： 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、凯铭投资股份解除质押情况 | 股东 | 是否为控股股东或 第一大股东及其 | 本次解除质押 | 占其所持 | 占公司总 | 起始日 | 解除日期 | 质权人 | | --- | --- | --- | --- | --- | --- | --- | --- | | 名称 | 一致行动人 | 股份数量（股） | 股份比例 | 股本比例 | | | 中信建投证券股份有限 | | 投资 | | 2,590,000 500,000 780,700 | 3.23% 0.62% ...

证券代码：300558 证券简称：贝达药业 公告编号：2024-059 贝达药业股份有限公司 关于公司及控股子公司通过美国 FDA 现场核查的公告 公司名称：Xcovery Holdings, Inc 地址：美国佛罗里达州，迈阿密市，一大街东南 168 号 11 楼 检查事由：美国 FDA 对恩沙替尼 NDA（New Drug Application，新药申请）的 批准前检查 检查范围：恩沙替尼临床Ⅰ、Ⅱ、Ⅲ期研究的 BIMO FDA FEI：3030490112 检查时间：2024 年 5 月 7 日至 2024 年 5 月 14 日 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"）及控股子公司 Xcovery Holdings, Inc（以下简称"Xcovery"）分别于 2024 年 5、6 月接受了美国食 品药品监督管理局（以下简称"美国 FDA"）的临床 BIMO（Bioresearch Monitoring，生物研究监测）相关 PAI（Pre-Approval Inspection，批准前检查） 现场核查、原 ...

公 司 研 究 [Table_Reportdate] 2024年08月07日 [Table_invest] 买入（维持） 报告原因：业绩点评 [证券分析师 Table_Authors] 杜永宏 S0630522040001 dyh@longone.com.cn 证券分析师 伍可心 S0630522120001 wkx@longone.com.cn 联系人 付婷 futing@longone.com.cn | --- | --- | |-------------------------|-------------| | 数据日期 Table_cominfo] | 2024/08/06 | | 收盘价 | 36.22 | | 总股本(万股) | 41,849 | | 流通A股/B股(万股) | 41,718/0 | | 资产负债率(%) | 39.14% | | 市净率(倍) | 2.72 | | 净资产收益率(加权) | 4.16 | | 12个月内最高/最低价 | 63.09/30.43 | [Table_QuotePic] -44% -30% -16% -2% 12% 26% 40% 54% 23-08 2 ...

Investment Rating - The investment rating for the company is "Buy" [1] Core Views - The company reported a revenue of 1.501 billion yuan for the first half of 2024, representing a year-on-year growth of 14.22%. The net profit attributable to shareholders was 224 million yuan, up 51.00% year-on-year, while the net profit excluding non-recurring items reached 217 million yuan, marking a significant increase of 144.98% year-on-year [1] - The company has maintained a rapid growth in profits and improved operational efficiency, with the ratio of period expenses to operating income decreasing from 77.14% to 67.25%, a decline of 9.89 percentage points [1] - The market performance of Beimeina and Saimeina has shown significant growth, with Beimeina's clinical application potential being continuously explored and its market accessibility greatly improved after being included in medical insurance [1][2] - The company has a robust pipeline with over 40 projects under development, including the self-developed CDK4/6 inhibitor BPI-16350, which has received NDA acceptance from NMPA [2][4] Summary by Sections Financial Performance - In the first half of 2024, the company achieved a revenue of 1.501 billion yuan, with a year-on-year growth of 14.22%. The net profit attributable to shareholders was 224 million yuan, reflecting a 51.00% increase year-on-year. The net profit excluding non-recurring items was 217 million yuan, up 144.98% year-on-year [1] - The operating cash flow for the first half of 2024 was 522 million yuan, a year-on-year increase of 44.77% [1] Product Development - The company is focusing on the commercialization of its products, with Beimeina and Saimeina showing strong market growth. Beimeina's postoperative adjuvant therapy is progressing well in clinical trials, and its market space is expected to expand further [1][2] - The self-developed CDK4/6 inhibitor BPI-16350 has received NDA acceptance, and the company is actively pursuing multiple clinical trials for various indications [2][4] Future Outlook - The company is expected to achieve net profits of 420 million yuan, 547 million yuan, and 665 million yuan for the years 2024, 2025, and 2026, respectively, with corresponding EPS of 1.00 yuan, 1.31 yuan, and 1.59 yuan [5] - The current stock price corresponds to a P/E ratio of 36, 28, and 23 for the years 2024, 2025, and 2026, indicating a favorable valuation [5]

证券研究报告 非金融公司|公司点评|贝达药业（300558） 收入稳健增长，利润表现亮眼 请务必阅读报告末页的重要声明 glzqdatemark1 2024年08月06日 证券研究报告 |报告要点 贝达药业发布 2024 年半年报，上半年实现收入 15.01 亿元（同比+14.22%），实现归母净利润 2.24 亿元（同比+51.00%），实现扣非归母净利 2.17 亿元（同比+144.98%）。业绩符合预期。 |分析师及联系人 夏禹 郑薇 SAC：S0590518070004 SAC：S0590521070002 请务必阅读报告末页的重要声明 1 / 5 非金融公司|公司点评 glzqdatemark2 2024年08月06日 贝达药业(300558) 收入稳健增长，利润表现亮眼 | --- | --- | |------------|-------------------| | 行 业： | 医药生物/化学制药 | | 投资评级： | 增持（维持） | | 当前价格： | 34.44 元 | 基本数据 总股本/流通股本(百万股) 418.49/417.16 流通 A 股市值(百万元) 14,366.85 ...

Investment Rating - The investment rating for the company is maintained at "Buy - A" with a target price of 51.34 CNY per share [2][3]. Core Insights - The company reported a revenue of 1.501 billion CNY for the first half of 2024, representing a year-on-year growth of 14.22%. The net profit attributable to shareholders was 224 million CNY, up 51.00% year-on-year, and the net profit excluding non-recurring items was 217 million CNY, reflecting a significant increase of 144.98% [1]. - The company is expected to benefit from the upcoming negotiations for the inclusion of Beifu in the National Medical Insurance catalog for first-line treatment of NSCLC, which could lead to substantial sales growth in 2025 [1]. - The company is actively advancing multiple products, including Ensartinib and CDK4/6 inhibitors, with significant clinical research progress noted [1]. Financial Performance - Revenue growth is projected at 24.78%, 24.90%, and 23.04% for 2024, 2025, and 2026 respectively, with net profit growth expected at 23.46%, 25.59%, and 22.23% for the same periods [2]. - The earnings per share (EPS) are forecasted to be 1.03 CNY, 1.29 CNY, and 1.58 CNY for 2024, 2025, and 2026 respectively, with corresponding price-to-earnings (PE) ratios of 33.5, 26.7, and 21.9 [2][7]. Product Pipeline and Clinical Research - The company has several products in various stages of development, including Ensartinib for ALK-positive NSCLC and CDK4/6 inhibitors for HR+/HER2- breast cancer, both of which have received regulatory acceptance [1]. - Ongoing clinical trials include Ensartinib for postoperative adjuvant therapy and Beifu for postoperative adjuvant therapy, with positive data reported for the EGFR/cMET dual antibody MCLA-129 [1].

Investment Rating - The report maintains a "Hold" rating for the company [1] Core Views - The company reported a strong performance in the first half of 2024, with revenue of 1.5 billion yuan, representing a 14.2% increase year-on-year, and a net profit of 220 million yuan, up 51% [2] - The significant profit growth is attributed to improved management of operating expenses and a focus on cost reduction and efficiency [2] - The company is advancing its innovative drug pipeline, with potential FDA approval for Ensatinib expected by the end of the year and ongoing applications for other products [2] - The company has a robust clinical trial pipeline, with several promising candidates progressing through the approval process [2] Summary by Sections Financial Performance - In the first half of 2024, the company achieved a net profit of 220 million yuan, a 145% increase in net profit after deducting non-recurring items [2] - The proportion of operating expenses to revenue decreased from 77.14% to 67.25%, a reduction of 9.89 percentage points [2] - The net cash flow from operating activities reached 521.69 million yuan, a year-on-year increase of 44.77% [2] Product Development - Ensatinib is expected to receive FDA approval by the end of 2024, and the company is progressing with the application for recombinant human serum albumin [2] - The company has received IND approvals for several new drug candidates, including EYP-1901 and pan-EGFR inhibitors [2] Earnings Forecast - The forecast for net profit for 2024-2026 is 450 million yuan, 580 million yuan, and 740 million yuan, respectively, with corresponding PE ratios of 32, 25, and 20 [3] - The core product, Alectinib, is expected to maintain stable performance, while new products like Ensatinib are anticipated to contribute to revenue growth [3] Market Position - The company has a total market capitalization of 14.41 billion yuan and a total asset value of 9.14 billion yuan [6] - The stock price has fluctuated between 30.78 yuan and 61.65 yuan over the past 52 weeks [6]

业绩简评 2024 年 8 月 5 日，公司公告，2024 年上半年营收 15.01 亿元，同比 增长 14.22%，归母/扣非净利润 2.24/2.17 亿元，同比增长 51.00%/ 144.98%。2024 年二季度营收 7.65 亿，同比下降 2.21%，归母/扣非 净利润 1.26/1.27 亿元，同比增长 29.82%/81.06%。业绩符合预期。 点评 深耕肺癌，凯美纳稳健，贝美纳接力，国内放量与美国获批值得期待。 （1）业绩：销售稳健，费用下降，利润高增长。公司已有五款药品 在售：凯美纳（埃克替尼）作为公司基石产品销量保持稳定，贝美纳 （恩沙替尼）和贝安汀（贝伐珠单抗）营收贡献增长明显，赛美纳（贝 福替尼）伏美纳（伏罗尼布）纳入医保后加快放量。公司上半年研发 费用 2.56 亿，同比下降 23%。（2）凯美纳，是国内首个原研小分子 肺癌靶向药，其一线、二线及术后辅助适应症全线纳入《国家医保目 录》后，产品生命周期进一步延长。作为三代 EGFR（表皮生长因子受 体）肺癌靶向药的赛美纳，其放量也值得关注。（3）贝美纳，是第 一个用于 ALK（间变性淋巴瘤激酶）阳性晚期非小细胞肺癌的国产 1 类新药 ...