中信证券股份有限公司 关于贝达药业股份有限公司 2024 年度募集资金存放与使用情况的核查意见 中信证券股份有限公司（以下简称"中信证券"或"保荐机构"）作为贝达 药业股份有限公司（以下简称"贝达药业"或"公司"）2020 年度向特定对象发 行股票持续督导阶段的保荐机构，根据《深圳证券交易所创业板股票上市规则》、 《上市公司监管指引第 2 号——上市公司募集资金管理和使用的监管要求》等相 关规定履行持续督导职责，对贝达药业 2024 年度募集资金存放与使用情况进行 了核查，现将核查情况及核查意见发表如下： 一、募集资金基本情况 （一）实际募集资金金额、资金到位情况 经中国证券监督管理委员会以证监许可[2020]2213 号《关于同意贝达药业股 份有限公司向特定对象发行股票注册的批复》同意注册，贝达药业股份有限公司 向特定对象发行股票 10,138,621 股，每股发行价格为 98.83 元，募集资金总额为 人民币 1,001,999,913.43 元，扣除保荐及承销费用人民币 5,000,000.00 元(含税)后 的余额人民币 996,999,913.43 元已全部划转至本公司银行账户。公司本次募集资 金总 ...

关于贝达药业股份有限公司 使用暂时闲置募集资金进行现金管理的核查意见 中信证券股份有限公司（以下简称"中信证券"或"保荐机构"）作为贝达药 业股份有限公司（以下简称"贝达药业"或"公司"）的保荐机构，根据《深圳证 券交易所创业板股票上市规则》、《深圳证券交易所上市公司自律监管指引第2号—— 创业板上市公司规范运作》、《上市公司监管指引第2号——上市公司募集资金管理和 使用的监管要求》等相关规定履行持续督导职责，对贝达药业使用暂时闲置募集资 金进行现金管理事项进行了核查，现将核查情况及核查意见发表如下： 一、募集资金基本情况 经中国证券监督管理委员会（以下简称"中国证监会"）《关于同意贝达药业 股份有限公司向特定对象发行股票注册的批复》（证监许可[2020]2213号）同意， 公司向14名特定对象发行人民币普通股（A股）10,138,621股，发行价格为98.83元/ 股，实际募集资金总额为人民币1,001,999,913.43元（大写：人民币壹拾亿零壹佰玖 拾玖万玖仟玖佰壹拾叁元肆角叁分），扣除本次发行费用（不含税）人民币 6,594,538.73元后，实际募集资金净额为人民币995,405,374.70元。 ...

4月24日，在杭州国际博览中心召开的万物生长大会现场，贝达药业董事长丁列明刚下车，准备前 往会场就被半路"拦下"，记者多方沟通联系上了这个"拦路"人，他叫傅聪。"我自己是投资人，长期关 注医疗大健康领域，这次十分唐突拦下丁董事长是有'苦衷'的。"傅聪说。 原来，傅聪的母亲患有2型糖尿病，使用胰岛素二十多年，他关注到杭州瑞普晨创科技有限公司 （以下简称"瑞普晨创"）最新研发的干细胞疗法能够功能性治愈糖尿病，因此他希望自己母亲能加入该 疗法的临床试验。2014年，丁列明与合作伙伴创立瑞普晨创，专注于干细胞与再生医学的医药研发。去 年12月6日，瑞普晨创的RGB-5088胰岛细胞注射液正式获得国家药监局批准进入临床试验阶段。 当天上午，第九届万物生长大会生命健康科技论坛在杭州国际博览中心举行。本次论坛由贝达药 业、贝加资本、贝达梦工场、杭州市创业投资协会主办，汇聚了200余名产、学、研、医及投资界人 士，共探医药创新生态发展的新路径、新机遇。 贝达药业作为国产创新药的代表，已经走过23个年头，贝达药业研发的中国第一个小分子靶向抗癌 药凯美纳为中国医药创新开了一个好头。"我们发现，中国不缺创新药项目，近两年，跨国公司 ...

投资要点 商业化加速：我们看好公司2025 年进入多产品兑现阶段。我们看好公司2025 年进入多产品兑现阶段， 恩沙替尼一线NSCLC、贝福替尼二线+一线NSCLC、埃克替尼术后辅助、CM082、贝伐珠单抗等公司 核心产品有望不断放量，CDK4/6、恩沙替尼ALK 阳性的NSCLC 术后辅助等陆续进入商业化阶段后， 持续驱动公司2025-2027 年收入和利润端高增长。 国际化突破：恩沙替尼美国已获批，EYP-1901 眼底病有潜力1）恩沙替尼：美国已获批，EMA 审批 中。24 年12 月公告恩沙替尼1L ALK+NSCLC 获FDA 批准。2025 年2 月公告EMA 启动恩沙替尼1L ALK+ NSCLC 上市审批程序。我们看好恩沙替尼国际化带来的业绩弹性。2）EYP-1901 /DURAVYU： III 期在推进，期待数据读出。2024 年2 月和2025 年2 月治疗wAMD 和DME 的Ⅱ期临床试验分别达到 主要终点，同步开展的在非增生性糖尿病视网膜病变II 期临床研究已完成入组。wAMD 合作伙伴EYPT 已主持推进Ⅲ期临床研究，期待海外III 期数据读出，国际化再传佳绩。 生态圈：重视生态圈潜 ...

Core Viewpoint - Beida Pharmaceutical reported a revenue growth of 17.74% year-on-year to 2.892 billion yuan in 2024, with a net profit of 403 million yuan, marking a 15.67% increase, and a significant turnaround in profitability with a 55.92% rise in non-net profit [1][2] Financial Performance - The company achieved a revenue of 2.892 billion yuan in 2024, approaching the 3 billion yuan mark, with a net profit of 403 million yuan [1] - The non-net profit reached 410 million yuan, indicating a strong recovery from previous years where revenue growth did not translate into profit [1] - Historical revenue figures from 2021 to 2023 were 2.246 billion yuan, 2.377 billion yuan, and 2.456 billion yuan, with net profits fluctuating significantly [1] Product Portfolio - Beida Pharmaceutical currently has five new drugs in the oncology treatment field, including the first-generation EGFR inhibitor, Alectinib (Kaimena®), and the ALK inhibitor, Ensartinib (Beimina®) [1][2] - The company has expanded its product lineup from a single product to five through independent research and strategic partnerships [2] - Alectinib has generated over 1 billion yuan in annual revenue since its inclusion in the national medical insurance directory in 2017 [2] Market Expansion and Pipeline - The company has one innovative drug under review for market approval and over 20 projects in development, indicating potential for future growth [2][6] - The sales forecast for Beimina in 2024 is expected to approach 800 million yuan, while Kaimena's sales are projected to be between 1.2 billion and 1.4 billion yuan [4][5] - Beida's research and development investment has consistently been high, with R&D expenditures from 2020 to 2024 being 742 million yuan, 861 million yuan, 977 million yuan, 1 billion yuan, and 717 million yuan, respectively [7] Leadership and Strategic Moves - The return of Professor Mao Li as the Chief R&D Officer is a significant development for the company, as he previously held key positions within Beida and has extensive experience in the industry [8][9]

Financial Performance - The company's revenue for Q1 2025 reached ¥917,554,506.92, representing a 24.71% increase compared to ¥735,775,468.80 in the same period last year[6] - Net profit attributable to shareholders was ¥100,089,181.47, a slight increase of 1.99% from ¥98,140,741.56 year-on-year[6] - The net profit after deducting non-recurring gains and losses surged by 83.59% to ¥164,430,292.77 from ¥89,562,834.38 in the previous year[6] - The net cash flow from operating activities improved by 20.35%, amounting to ¥297,535,688.01 compared to ¥247,235,603.12 in the prior year[6] - The company's basic earnings per share increased by 4.35% to ¥0.24 from ¥0.23 in the same period last year[6] - Total operating revenue for the current period reached ¥917,554,506.92, an increase of 24.7% compared to ¥735,775,468.80 in the previous period[25] - Net profit for the current period was ¥95,463,516.48, a slight increase from ¥93,790,802.53 in the previous period, representing a growth of 1.8%[26] - The company reported a net cash flow from operating activities of ¥297,535,688.01, an increase of 20.3% compared to ¥247,235,603.12 in the previous period[28] - Basic and diluted earnings per share were both ¥0.24, up from ¥0.23 in the previous period[26] Assets and Liabilities - Total assets at the end of the reporting period were ¥9,125,518,301.96, down 2.31% from ¥9,341,677,723.81 at the end of the previous year[6] - The total current assets as of March 31, 2025, amounted to CNY 1,301,717,893.56, an increase from CNY 1,224,330,599.97 at the beginning of the period[22] - The total liabilities as of March 31, 2025, were CNY 3,494,218,702.83, down from CNY 3,675,567,489.25 at the beginning of the period[23] - The total assets decreased to CNY 9,125,518,301.96 from CNY 9,341,677,723.81[24] - The total owner's equity as of March 31, 2025, was CNY 5,631,299,599.13, a decrease from CNY 5,666,110,234.56[24] Operating Costs and Expenses - Operating costs increased by 33.65% to ¥171,801,799.66, primarily driven by higher sales volumes of pharmaceuticals[9] - Total operating costs increased to ¥730,520,724.15, up 14% from ¥641,561,760.14 in the previous period[25] - Research and development expenses decreased to ¥113,293,329.82, down 26% from ¥152,750,433.40 in the previous period[25] - The company incurred financial expenses of ¥20,838,891.73, which is an increase of 109.5% compared to ¥9,947,530.44 in the previous period[25] Clinical Developments - The company received FDA approval for its drug, Beimingna (恩沙替尼胶囊), in December 2024, and it was recommended in the NCCN guidelines for NSCLC in January 2025[16] - Xcovery Holdings, Inc. submitted a marketing application to the European Medicines Agency for Beimingna, aiming to provide new treatment options for ALK-positive NSCLC patients[16] - The company’s oral small molecule HIF-2α inhibitor, BPI-452080, has received approval for clinical trials targeting tumors related to von Hippel-Lindau syndrome[16] - DURAVYU™, developed in collaboration with EyePoint Pharmaceuticals, showed significant efficacy in a Phase II trial for diabetic macular edema, with a +7.1 letter improvement in best-corrected visual acuity[17] - In the DURAVYU™ trial, 73% of patients did not require supplemental treatment, compared to 50% in the control group[17] - The company is advancing its clinical trials for DURAVYU™ in both diabetic macular edema and wet age-related macular degeneration[17] - The objective response rate (ORR) for the new MET inhibitor, Bemcentinib, reached 53.3% in patients with advanced NSCLC carrying MET exon 14 skipping mutations[19] - The disease control rate (DCR) for Bemcentinib was reported at 86.7%, with a median progression-free survival (PFS) of 6.0 months and a median duration of response (DoR) of 7.9 months[19] - In patients with ctDNA clearance after 4 weeks, the ORR was 80%, and the median PFS extended to 9.5 months, significantly better than the non-clearance group, which had a median PFS of 2.2 months[19] Non-Recurring Items - The company recorded a total of ¥64,341,111.30 in non-recurring losses, mainly due to fair value changes in financial assets and liabilities[7] - The company recorded a total comprehensive income of -¥42,417,477.67, a significant decline from ¥241,283,970.75 in the previous period[26] Cash and Cash Equivalents - Cash and cash equivalents increased to CNY 548,136,702.10 from CNY 471,682,855.12[22] - Cash and cash equivalents at the end of the period totaled ¥548,136,702.10, a slight decrease from ¥554,020,499.69 at the end of the previous period[28]

证券代码：300558 证券简称：贝达药业 公告编号：2025-034 贝达药业股份有限公司 2025 年第一季度报告披露提示性公告 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"）于 2025 年 4 月 24 日召开第四 届董事会第二十三次会议和第四届监事会第二十次会议，会议审议通过了《2025 年第一季度报告》的议案。 为使投资者全面了解公司 2025 年第一季度的经营成果和财务状况，公司 《2025 年第一季度报告》于 2025 年 4 月 25 日在中国证监会指定的创业板信息披 露网站巨潮资讯网（http://www.cninfo.com.cn）上披露，敬请投资者注意查阅。 特此公告。 贝达药业股份有限公司董事会 2025 年 4 月 24 日 1 ...

Group 1: Company Overview and Performance - The company achieved a revenue of 2.892 billion CNY in 2024, representing a year-on-year growth of 17.74% [12] - The net profit attributable to shareholders was 403 million CNY, an increase of 15.67% year-on-year [17] - The net profit excluding non-recurring items was 409 million CNY, reflecting a significant growth of 55.92% [17] Group 2: Clinical Development and Product Pipeline - BPI-16350, a CDK4/6 inhibitor, is currently undergoing drug registration review, with promising clinical data for treating HR-positive, HER2-negative breast cancer [42] - The RGB-5088 stem cell injection for diabetes has received IND approval and is in clinical trials, marking a significant breakthrough in treatment options [11] - The company has multiple projects in the pipeline, including BPI-520105 and BPI-221351, which have recently received IND approvals [12] Group 3: Market Position and Strategic Initiatives - The company is positioned as a leading player in China's innovative drug sector, with a market capitalization around 20 billion CNY [5] - Strategic collaborations with companies like C4T and EyePoint are aimed at enhancing the product pipeline and market reach [9] - The company emphasizes building an innovative ecosystem through partnerships and investments, which is expected to enrich its product offerings [16] Group 4: Financial Management and Market Challenges - The company reported a 35% quarter-on-quarter decline in revenue for Q4 2024, attributed to various factors affecting sales [18] - The gross margin decreased by 2.15 percentage points due to price reductions after products were included in the national medical insurance [29] - The company is actively managing costs and optimizing its operational efficiency to counteract the impact of reduced margins [11] Group 5: Future Outlook and Growth Drivers - Future growth drivers include expanding market sales of proprietary and collaborative products, focusing on core R&D pipelines, and implementing cost management strategies [11] - The company plans to leverage its innovative capabilities to explore new treatment areas beyond oncology, such as diabetes and cardiovascular diseases [23] - The overall outlook for the pharmaceutical industry remains positive, driven by policy support and advancements in research and development [10]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [4][9] Core Views - The company achieved a revenue of 2.892 billion yuan in 2024, representing a year-on-year growth of 17.74%. The net profit attributable to the parent company was 403 million yuan, up 15.67% year-on-year, while the non-recurring net profit reached 410 million yuan, marking a significant increase of 55.92% [4][11] - The company is expanding the clinical value and evidence of its products, Kai Mei Na and Sai Mei Na, and has successfully included them in the national medical insurance catalog, enhancing patient accessibility [5][6] - The successful overseas launch of Bei Mei Na, which received FDA approval for first-line treatment indications, is expected to further open up market opportunities for the company [5][6] - The company is continuously enriching its pipeline with ongoing research and development, including the acceptance of NDA for its self-developed CDK4/6 inhibitor BPI-16350 [6][7] - The company is actively expanding its innovative ecosystem and has made significant progress in strategic collaborations, including projects related to plant-derived recombinant human serum albumin and stem cell therapy for diabetes [7] Financial Data and Forecast - The company forecasts net profits attributable to the parent company for 2025, 2026, and 2027 to be 534 million, 604 million, and 739 million yuan respectively, with corresponding EPS of 1.28, 1.44, and 1.77 yuan [8][11] - The current stock price corresponds to a PE ratio of 39, 35, and 28 times for the years 2025, 2026, and 2027 respectively [8][11]