Financial Performance - The company reported a total revenue of RMB 1.2 billion for the first half of 2023, representing a year-on-year increase of 15%[13]. - The net profit attributable to shareholders was RMB 300 million, up 20% compared to the same period last year[13]. - The company's operating income for the reporting period was ¥1,313,877,968.81, representing a 4.83% increase compared to ¥1,253,336,956.19 in the same period last year[19]. - Net profit attributable to shareholders was ¥148,306,337.19, a significant increase of 56.58% from ¥94,717,355.06 year-on-year[19]. - The net cash flow from operating activities reached ¥360,360,814.25, marking a substantial increase of 181.69% compared to ¥127,926,882.21 in the previous year[19]. - The management has set a revenue target of RMB 2.5 billion for the full year 2023, reflecting a growth rate of 18%[13]. - The company achieved a revenue of RMB 1,313.88 million, representing a year-on-year growth of 4.83%[63]. - The company reported a total of 1,722,702,427.68 CNY in construction in progress, which accounted for 20.02% of total assets, up from 18.30%[97]. Research and Development - The company has allocated RMB 200 million for research and development in new drug technologies, focusing on targeted therapies[13]. - The company plans to expand its product pipeline with three new drug applications expected to be submitted by the end of 2023[13]. - The company’s R&D investment for the first half of 2023 reached CNY 534.67 million, a 16.43% increase year-over-year, accounting for 40.69% of total revenue[67]. - The company has over 40 innovative drug projects in development, with 18 in clinical trials and 4 in Phase III trials, including a global Phase III trial for a lung cancer targeted therapy[83]. - The company is actively pursuing clinical trials for multiple new drug candidates, including BPI-452080 and BPI-472372, both targeting advanced solid tumors[78]. - The company is exploring potential mergers and acquisitions to enhance its market position and product offerings[13]. - The company is committed to timely evaluations and adjustments of its research projects, adhering to regulatory disclosure obligations[78]. Product Development and Pipeline - The company has successfully expanded its product pipeline, with five new drugs including Kai Meina and Bei Meina, which are gaining market traction[26]. - Kai Meina has been approved for multiple indications, including first-line treatment for EGFR mutation-positive NSCLC, and is included in the National Medical Insurance Directory[26]. - The company has successfully included the postoperative adjuvant indication of Camrelizumab in the medical insurance catalog, achieving full coverage of indications for lung cancer patients[32]. - The company has launched the third-generation EGFR-TKI, BPI-D0316, which has been approved for second-line treatment of NSCLC with T790M mutation[40]. - The company has successfully launched new products, including the third-generation EGFR-TKI Semina and the kidney cancer drug Fumina, contributing to revenue growth[65]. - The company is exploring combination therapies for BPI-D0316, including first-line treatment studies and postoperative adjuvant therapy[41]. - The company is advancing multiple key projects in clinical trials, including the Phase III project for Ensartinib, which targets ALK-positive NSCLC patients and is expected to contribute new revenue streams[76]. Market Expansion - Market expansion efforts have led to a 30% increase in sales in international markets, particularly in Europe and North America[13]. - User data indicates that the number of patients treated with the company's products has increased by 25% in the first half of 2023[13]. - The company aims to strengthen the market positioning of its innovative drugs, Kaimena and Beimana, focusing on differentiated competition strategies and expanding market reach[125]. Financial Strategy and Investments - The company has invested RMB 21 million in a venture capital partnership to enhance its competitive edge in the biopharmaceutical industry[59]. - The company completed a significant equity investment of 716,490,862.42 CNY in Xcovery Holdings, Inc., holding a 94.15% stake[105]. - The total investment during the reporting period was 1,250,881,479.98 CNY, reflecting a 24.35% increase compared to the previous year[102]. Environmental Compliance and Management - The company complies with the "Comprehensive Wastewater Discharge Standard" (GB8978-1996) for wastewater management[147]. - The company has established a pollution discharge management plan in accordance with HJ 1259-2022 guidelines[145]. - The company has implemented a comprehensive environmental management system with 22 management regulations to ensure compliance with national environmental laws[194]. - The company has received multiple environmental approvals for its facilities, ensuring compliance with regulatory requirements[146]. - The company reported no exceedances in pollutant discharge limits during the reporting period[150]. Corporate Governance and Culture - The company held one shareholders' meeting and five board meetings during the reporting period, discussing 29 proposals including the appointment of executives and amendments to the articles of association[164]. - The company actively promotes corporate culture through various initiatives, including the establishment of 13 cultural clubs involving nearly 2,000 employees[159]. - The company emphasizes a "people-oriented" approach, focusing on improving product quality to meet the growing demands of customers[178]. - The company has achieved a 100% labor contract signing rate with employees, ensuring compliance with labor laws and regulations[170]. Risk Management - Risks related to market competition and drug development have been identified, with strategies in place to mitigate these risks[6]. - The company recognizes the risks associated with new drug development, including high costs and unpredictable factors that may affect regulatory approval[126]. - The company is facing challenges related to the loss of key technical personnel, which could impact ongoing projects and product competitiveness[128]. Employee Engagement and Training - Over 30% of employees are covered by the company's equity incentive program, promoting shared growth and benefits from research achievements[171]. - In the first half of 2023, 174 new employees completed pharmacovigilance knowledge training, and 1,948 employees participated in the annual pharmacovigilance training[192]. - The company organized one emergency evacuation drill and multiple fire safety training sessions in the first half of 2023, enhancing employee safety awareness[172].

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 ...