一、 募集资金基本情况 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：2023-071 根据中国证券监督管理委员会《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（2022 年修订）》（证监会公告〔2022〕15 号）、《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》以及《深圳证券交易所创业板上市 公司自律监管指南第 2 号——公告格式（2023 年修订）》的相关规定，本公司就 2023 年半 年度募集资金存放与使用情况作如下专项报告： 贝达药业股份有限公司 2023年半年度募集资金存放与使用情况的专项报告 (一) 实际募集资金金额、资金到位情况 (二) 2023 年半年度募集资金使用情况及结余情况 截止 2023 年 6 月 30 日，公司使用金额情况为： 1、 首次公开发行股票募集资金到位情况 经中国证券监督管理委员会以证监许可[2016]2350 号文《关于核准贝达药业股份有 限公司首次公开发行股票的批复》核准，获准向社会公开发行人民币普通股（A 股 ...

证券代码：300558 证券简称：贝达药业 公告编号：2023-067 贝达药业股份有限公司 第四届董事会第七次会议决议公告 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。 一、董事会会议召开情况 1、本次董事会由董事长丁列明先生召集，会议通知于 2023 年 8 月 14 日以 电话、邮件等形式送达全体董事，董事会会议通知中包括会议的相关材料，同时 列明了会议的召开时间、地点、内容和方式。 2、本次董事会于 2023 年 8 月 25 日在公司杭州总部行政大楼十五楼会议室 召开，采取现场会议和电话会议结合的方式现场投票表决。 3、本次董事会应到 11 人，实际出席会议人数 11 人。 二、董事会会议审议情况 1、会议审议并通过了《2023 年半年度报告全文及摘要》 经审议，董事会认为公司《2023 年半年度报告》及《2023 年半年度报告摘 要》真实、准确、完整地反映了公司 2023 年上半年的财务状况和经营成果，不 存在虚假记载、误导性陈述或重大遗漏。 公司审计委员会已审议并通过了该事项，公司监事会对该事项发表了审核意 见。 《贝达药业股份有限公司 202 ...

贝达药业股份有限公司 2023 年半年度 非经营性资金占用及其他关联资金往来情况汇总表 单位：万元 汇总表 第 1 页 | 非经营性资金占用 | 资金占用方名称 | 占用方与上市公司的关 | 上市公司核算的 | 2023 年期初往来资 | 2023 年半年度往来累计 | 2023 年半年度往来资 | 2023 年半年度偿还 | 2023年半年度期 末往来资金余额 占用形成原因 | 占用性质 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 联关系 | 会计科目 | 金余额 | 发生金额（不含利息） | 金的利息(如有) | 累计发生金额 | | | | 控股股东、实际控制人及其附属企业 | | | | | | | | | 非经营性占用 | | 小计 | | | | | | | | | | | 前控股股东、实际控制人及其附属企业 | | | | | | | | | 非经营性占用 | | 小计 | | | | | | | | | | | 其他关联方及其附属企业 | | | | | | | | | 非经营性占用 | | 小计 ...

贝达药业股份有限公司 独立董事关于第四届董事会第七次会议 1 一、关于公司控股股东及其他关联方资金占用和公司对外担保情况的专项 说明和独立意见 经核查，我们认为：在报告期内，公司与关联方发生的资金往来均为正常经 营资金往来，公司控股股东及其他关联方不存在占用公司资金的情况，也不存在 以前年度发生延续至报告期的占用资金情况。公司不存在为控股股东、实际控制 人及其他关联方、非法人单位或个人提供担保的情形。截至报告期末，公司不存 在对控股子公司之外的担保情形。按照 2022 年年度股东大会的授权，公司与子 公司因日常经营业务开展的需要提供担保的余额为 5.545 亿元，在 2022 年年度 股东大会的授权额度之内。 二、关于《2023 年半年度募集资金存放与使用情况专项报告》的独立意见 经核查，我们认为：公司募集资金的存放、使用情况符合中国证监会、深圳 证券交易所以及公司关于募集资金管理的相关规定，不存在募集资金存放和使用 违规的情形，不存在改变或变相改变募集资金投向和损害股东利益的情况。公司 编制的《2023 年半年度募集资金存放与使用情况专项报告》内容真实、准确、 完整，不存在虚假记载、误导性陈述或重大遗漏。 ...

本公司及监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。 一、监事会会议召开情况 1、本次监事会会议通知于 2023 年 8 月 14 日以电子邮件、电话等形式送达全 体监事，监事会会议通知中包括会议的相关材料，同时列明了会议的召开时间、 地点、内容和方式。 2、本次监事会于 2023 年 8 月 25 日在公司杭州总部 3 楼会议室采取现场会议 的方式召开，现场投票表决。 证券代码：300558 证券简称：贝达药业 公告编号：2023-068 贝达药业股份有限公司 第四届监事会第五次会议决议公告 3、本次监事会应到 3 人，实际出席会议人数为 3 人。 4、本次监事会由监事会主席张洋南先生主持，公司证券事务代表沈剑豪先 生列席了本次会议。 5、本次会议的召集、召开和表决程序符合《中华人民共和国公司法》等法 律法规和《贝达药业股份有限公司章程》的有关规定。 二、监事会会议审议情况 1、会议审核并通过了《2023 年半年度报告全文及摘要》 经审核，监事会认为公司董事会编制、审核《2023 年半年度报告》及《2023 年半年度报告摘要》的程序符合法律、行政法规和中国证监会的 ...

证券代码：300558 证券简称：贝达药业 公告编号：2023-066 贝达药业股份有限公司 关于股东减持股份计划期限届满暨实施情况的公告 公司股东浙江贝成投资管理合伙企业（有限合伙）保证向本公司提供的信息 内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一 致。 公司于今日收到股东贝成投资的《关于股份减持计划期限届满暨实施情 况的告知函》，截至本公告披露日，贝成投资本次减持计划期限已届满，现将 减持计划实施情况公告如下： 一、股东减持情况 1、股东减持股份情况 | 股东名称 | 减持方式 | | 减持期间 | | | | 减持均价 （元/股） | 减持股数 （股） | 减持股数占 总股本比例 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 贝成投资 | 集中竞价交易 | 2 月 | 15 月 | 日-3 | 10 | 日 | 57.47 | 2,465,568 | 0.59% | | | 大宗交易 | 3 月 | 1 月 | 日-3 | 10 | 日 | ...

证券代码：300558 证券简称：贝达药业 2.贝达上市十多年了，每年的研发费用都在增长，管线里号称有 40 多款 项目，可是到现在也才三款上市药品，这么多钱都用到哪里去了？ 答：您好！创新药研发具有投入大、周期长、风险高等特点，从研发项 目的早期研究、临床试验、申报上市到投入市场，各个环节都会有不确 定因素。公司已建立完整的创新药物研发体系，在杭州、北京分别设有 新药研发中心和临床研究办事机构，能独立高效地完成从靶点确定、化 合物设计与筛选优化到 IND 申报等临床前研发任务，具有独立完成各阶 段临床研究（包括国际多中心研究）以及 NDA/BLA 申报上市的经验和能 力。同时，公司建立了专业的新药项目评估机制，在新药项目立项、临 床推进等各个重要节点充分评估、论证产品的差异化优势、未来商业化 的潜力后作出科学的决策。目前公司产品管线中，拥有埃克替尼（一 线、二线、术后辅助适应症）、恩沙替尼（一线、二线适应症）、贝伐珠 单抗三款已上市产品，为公司带来了充沛的现金流。另外，贝福替尼 （一线、二线适应症）、伏罗尼布（二线适应症）两款处于药品注册审评 审批中的产品，BPI-16350、MCLA-129、恩沙替尼（术 ...

Financial Performance - The company's revenue for Q1 2023 was ¥531,618,547.85, a decrease of 9.08% compared to ¥584,705,632.04 in the same period last year[5] - Net profit attributable to shareholders was ¥51,396,813.71, down 38.58% from ¥83,678,928.89 year-on-year[5] - The net profit after deducting non-recurring gains and losses was ¥18,263,590.71, a significant decline of 75.50% from ¥74,547,457.21 in the previous year[5] - The company reported a net profit of CNY 35,503,476.58 for Q1 2023, down from CNY 95,809,100.26 in Q1 2022[20] - The total comprehensive income attributable to the parent company was ¥15.18 million, a decrease of 73.4% from ¥57.00 million in the previous year[21] - The company's other comprehensive income after tax was negative ¥36.21 million, compared to negative ¥26.67 million in the previous year[21] Cash Flow and Liquidity - The net cash flow from operating activities increased by 370.96% to ¥138,024,453.30, compared to ¥29,306,885.70 in the same period last year[7] - Cash and cash equivalents decreased to CNY 584,972,093.29 from CNY 731,284,859.68 at the beginning of the year, a decline of 20.1%[18] - Cash and cash equivalents at the end of the period were ¥584.97 million, down from ¥683.40 million at the end of Q1 2022[23] - The company incurred a net cash outflow from investing activities of approximately ¥534.31 million, compared to a net outflow of ¥567.12 million in the previous year[23] - The cash inflow from financing activities was approximately ¥1.14 billion, significantly higher than ¥438.02 million in Q1 2022[23] - The company paid approximately ¥709.57 million in cash related to financing activities, compared to ¥1.09 million in the previous year[23] Research and Development - R&D expenses rose by 62.91% to ¥175,355,803.09, reflecting increased investment in research projects[7] - In Q1 2023, the company invested CNY 245.87 million in R&D, a year-on-year increase of 52.74%[11] - R&D expenses surged to CNY 175,355,803.09, compared to CNY 107,640,306.79 in the previous year, indicating a focus on innovation[20] - The product Enasidenib was included in the National Basic Medical Insurance Drug List for first-line treatment indications[11] - The application for the registration of Bafetinib capsules for first-line treatment was accepted[11] - Clinical trial approvals were granted for multiple products, including BPB-101 and BPI-472372 tablets[11] Shareholder Information - The company has a total of 24,143 common shareholders at the end of the reporting period[8] - The largest shareholder, Ningbo Kaiming Investment Management Partnership, holds 19.18% of the shares[8] - The total number of restricted shares at the end of the period was 1,914,385 shares, with an increase of 289,800 shares during the period[10] - The company plans to release restricted shares for departing executives on May 22, 2023[10] - The company completed the cancellation of unexercised stock options from the 2018 incentive plan, totaling 44,586 shares[13] - The company reported a reduction in share pledges and a new pledge by shareholders in early 2023[16] Assets and Liabilities - Total assets at the end of the reporting period were ¥7,979,049,580.53, a slight increase of 0.87% from ¥7,910,146,931.81 at the end of the previous year[5] - The company's total liabilities stood at CNY 2,980,876,476.83, slightly up from CNY 2,952,445,102.86[19] - The equity attributable to shareholders rose to CNY 4,893,721,514.96 from CNY 4,849,061,292.23, showing a modest increase[19] - Inventory levels increased to CNY 378,811,100.51 from CNY 372,172,656.68, indicating potential stockpiling or slower sales[18] - The company has a long-term investment of CNY 356,295,068.65, significantly up from CNY 107,767,074.61, suggesting strategic investments in growth[18] Operating Costs - Operating costs increased to CNY 531,203,279.54, up from CNY 498,844,724.48, reflecting a rise in operational expenses[20] - The total revenue from operating activities was ¥675.28 million, up 37.6% from ¥490.54 million in the previous year[22] Return on Equity - The weighted average return on equity decreased to 1.05%, down from 1.81% in the same period last year[5] - The company reported a basic and diluted earnings per share of ¥0.12, down from ¥0.20 in Q1 2022[21]

证券代码：300558 证券简称：贝达药业 公告编号：2023-048 关于举行 2022 年度网上业绩说明会的公告 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"）2022 年年度报告全文及摘要 已于 2023 年 4 月 24 日刊登于中国证监会指定信息披露网站巨潮资讯网 （http://www.cninfo.com.cn）。 为使广大投资者全面、深入地了解公司 2022 年生产经营情况，加强公司与 投资者的沟通交流，公司将于 2023 年 5 月 12 日（星期五）15:00-17:00 采用网 络远程的方式举行 2022 年度业绩说明会（以下简称"本次年度业绩说明会"）。 本次年度业绩说明会通过深圳证券交易所提供的"互动易"平台举行，投资者 可登录"互动易"网站（http://irm.cninfo.com.cn，下同），进入"云访谈"栏 目参与本次年度业绩说明会。 贝达药业股份有限公司 为充分尊重投资者、提升交流的针对性，现就本次年度业绩说明会提前向 投资者公开征集问题。投资者可于本次年度业绩说明会召开日前五个交 ...

Financial Performance - The company reported a cash dividend of 0.7 RMB per 10 shares for a total of 417,467,045 shares, with no bonus shares issued[4]. - The company experienced a decline in performance during the reporting period, with specific details provided in the management discussion section[4]. - The company's operating revenue for 2022 was ¥2,376,629,657.36, representing a 5.82% increase compared to ¥2,245,855,591.46 in 2021[13]. - The net profit attributable to shareholders for 2022 was ¥145,420,319.09, a decrease of 62.04% from ¥383,067,840.44 in 2021[13]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥30,252,549.47, down 91.25% from ¥345,680,213.55 in 2021[13]. - The net cash flow from operating activities for 2022 was ¥306,739,633.83, a decline of 41.75% compared to ¥526,630,893.24 in 2021[13]. - The total assets at the end of 2022 were ¥7,910,146,931.81, an increase of 26.13% from ¥6,271,432,076.94 at the end of 2021[13]. - The net assets attributable to shareholders at the end of 2022 were ¥4,849,061,292.23, up 6.32% from ¥4,560,887,934.57 at the end of 2021[13]. - The company reported a basic earnings per share of ¥0.35 for 2022, down 61.96% from ¥0.92 in 2021[13]. - The company experienced a significant decline in quarterly net profit, with the fourth quarter showing a profit of ¥42,613,811.52 compared to ¥83,678,928.89 in the first quarter[14]. Research and Development - The company is actively engaged in new drug research and development, with a focus on oncology treatments[5]. - The company has consistently increased its R&D investment, focusing on innovative drug development and commercialization, with a notable shift from generic drugs to original innovations[23]. - The company has over 40 ongoing R&D projects, demonstrating a strong commitment to innovation and product development[40]. - R&D investment reached 97,730.47 million CNY, a 13.56% increase compared to the previous year, with R&D expenses rising by 23.67% to 69,990.43 million CNY[40]. - The company is advancing multiple key R&D projects, including the third-phase clinical trials for new drugs targeting ALK-positive NSCLC and EGFR-TKI resistant mutations[66][67]. - The company aims to expand its product pipeline with several new drug candidates currently in various stages of clinical trials, which are expected to contribute to future revenue growth[66][67]. Product Development and Market Strategy - The company has successfully launched multiple innovative drugs, including the first domestically developed small molecule targeted anti-cancer drug, demonstrating its leadership in the industry[27]. - The company aims to enhance its commercialization capabilities by optimizing marketing strategies and exploring diverse payment methods to sustain growth in the innovative drug market[26]. - The company is actively expanding its international presence, seeking partnerships for collaborative research and sales, and has seen several of its innovative drugs authorized for overseas markets[24]. - The company has reported a significant increase in the efficiency of drug market access, with many innovative drugs entering the National Medical Insurance list in the same year of launch[23]. - The company is focusing on enhancing its commercialization capabilities by leveraging the successful experience of its first drug, Kaimena, to promote Beimu and Beianting[37]. Clinical Trials and Drug Efficacy - Kai Mei Na (凯美纳) is the first domestic small molecule targeted anti-cancer drug with complete independent intellectual property rights, approved for multiple indications including first-line treatment for EGFR mutation-positive NSCLC[28]. - The EVIDENCE study demonstrated that Kai Mei Na significantly extended the median disease-free survival (DFS) to 47.0 months compared to 22.1 months for standard chemotherapy, with a 3-year DFS rate of 63.9% vs. 32.5%[29]. - The incidence of grade 3 or higher adverse events for Kai Mei Na was only 10.9%, compared to 61.2% for standard chemotherapy, indicating a much better safety profile[29]. - The company has conducted over 100 clinical studies related to Kai Mei Na, resulting in more than 250 SCI papers published, with a total impact factor exceeding 1,000[29]. - Ensha Tai Ni (贝美纳) is the first domestic class 1 new drug for treating ALK-positive advanced NSCLC, recently included in the National Medical Insurance Directory[30]. Market Competition and Risks - The company is subject to market competition and risks related to new drug development, as detailed in the future outlook section[4]. - The company faces market competition risks, particularly from other EGFR-TKI and ALK inhibitors, and plans to implement differentiated competition strategies[95]. - The company emphasizes the importance of understanding the differences between plans, forecasts, and commitments in its communications with investors[4]. Corporate Governance and Compliance - The company has established a robust internal audit system to oversee compliance and risk management, enhancing operational standards[108]. - The board of directors consists of 11 members, including 4 independent directors, ensuring compliance with legal and regulatory requirements[106]. - The company prioritizes the protection of minority shareholders' rights, implementing measures for fair voting and decision-making processes[104]. - The company has maintained independence from its controlling shareholders in terms of personnel, assets, finance, organization, and business operations[112]. - The company has a clear organizational structure with defined responsibilities across various functional departments, ensuring effective management[112]. Environmental Responsibility - The company is classified as a key pollutant discharge unit by environmental protection authorities, indicating a focus on environmental compliance[165]. - The company has obtained pollution discharge permits for its facilities, with the latest permit for the Xingzhong Road plant valid until June 19, 2027[168]. - The company has implemented measures to manage and monitor its environmental impact, including maintaining a pollution discharge management plan[166]. - The company has established an emergency response plan for environmental incidents, with the Wuzhou Road plant registered on March 30, 2020, and the Xingzhong Road plant re-registered on November 23, 2021[178]. Employee Engagement and Development - The company has developed a talent cultivation system, including programs like "Eagle Plan" and "Flying Eagle Plan," to support the growth of employees from entry-level to management positions[146]. - The company has established partnerships with universities for talent development, including a specialized training program with Shenyang Pharmaceutical University, involving 57 employees[146]. - The company has implemented a comprehensive compensation and benefits policy, including performance bonuses and stock incentive plans, to enhance employee motivation and retention[145]. Social Responsibility and Community Engagement - The company is committed to social responsibility, focusing on providing quality medicines to improve public health[193]. - The company has established 15 cultural clubs involving nearly 2,000 employees across various locations, promoting employee engagement and cultural development[182]. - The company has been recognized for its contributions to improving public welfare and traditional cultural heritage through its pharmaceutical innovations[200].