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].