上海科华生物工程股份有限公司 第一章 总则 第一条 为了加强上海科华生物工程股份有限公司（以下简称"公司"）与 投资者之间的沟通，增进投资者对公司的了解，倡导理性投资，促进公司治理 结构的改善，提升公司投资价值，根据《中华人民共和国公司法》、《中华人民共 和国证券法》、《深圳证券交易所上市公司自律监管指引第 1 号——主板上市公司规 范运作》等相关法律、法规及规范性文件和《上海科华生物工程股份有限公司章 程》的规定，结合公司实际情况，制定本制度。 第二条 投资者关系管理是指公司通过便利股东权利行使、信息披露、互动 交流和诉求处理等工作，加强与投资者及潜在投资者之间的沟通，增进投资者 对公司的了解和认同，以提升公司治理水平和企业整体价值，实现尊重投资者、 回报投资者、保护投资者目的的相关活动。 投资者关系管理制度 (2023 年 8 月修订) 第二章 投资者关系管理的基本原则 第三条 投资者关系管理工作的基本原则是： （一）合规性原则。公司投资者关系管理应当在依法履行信息披露义务的 基础上开展，符合法律、法规、规章及规范性文件、行业规范和自律规则、公 司内部规章制度，以及行业普遍遵守的道德规范和行为准则； （二 ...

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：002022 | 证券简称：科华生物 | 公告编号：2023-077 | | --- | --- | --- | | 债券代码：128124 | 债券简称：科华转债 | | 上海科华生物工程股份有限公司 关于产品获得医疗器械注册证的公告 特此公告。 上海科华生物工程股份有限公司董事会 2023 年 8 月 12 日 近日，上海科华生物工程股份有限公司（以下简称"公司"）收到国家药品 监督管理局颁发的《医疗器械注册证》（体外诊断试剂）。具体情况如下： | 序号 | 产品名称 | 注册证编号 | 注册证有效期 | 适用范围/预期用途 | | --- | --- | --- | --- | --- | | 1 | 乙型肝炎病毒核酸测定 | 国械注准 | 2023 年 8 月 9 日 | 本试剂盒用于定量检 测人血清或血浆样本 | | | 试剂盒（PCR-荧光探针 | 20233401120 | 至 | | | | 法） | | 2028 年 8 月 8 日 | 中的乙型肝炎病毒核 | | | | | | ...

证券代码：002022 证券简称：科华生物 债券代码：128124 债券简称：科华转债 上海科华生物工程股份有限公司 投资者关系活动记录表 | --- | --- | --- | --- | |----------------|------------------------|------------------------------------------|-------------------| | | | | 编号：2023005 | | 投资者关系活动 | √特定对象调研 | □ 分析师会议 | | | 类别 | □ 媒体采访 | □ 业绩说明会 | | | | □ 新闻发布会 | 路演活动 | | | | □ 现场参观 | | | | | □ 其他 | （请文字说明其他活动内容） | | | 参与单位名称及 | 财通证券 邢卓 | | | | 人员姓名 | 宁涌富基金 韩洲枫 | | | | 时间 | 2023 年 6 月 13 日下午 | 14:30 | | | 地点 | 公司会议室 | | | | 上市公司接待人 | | | | | 员姓名 | 龙 | | | | | | | | | | 为与 ...

证券代码：002022 证券简称：科华生物 债券代码：128124 债券简称：科华转债 上海科华生物工程股份有限公司 投资者关系活动记录表 | --- | --- | --- | |----------------------|-------------------------|------------------------------------------| | | | 编号：2023004 | | 投资者关系活动 | √特定对象调研 | | | 类别 | □ 媒体采访 | | | | □ 新闻发布会 □ | | | | □ 现场参观 | | | | □ 其他 | | | 参与单位名称及 | | | | 人员姓名 | 江海证券 徐圣钧、任沐昕 | | | 时间 | 2023 年 06 月 06 日上午 | | | 地点 | 公司会议室 | | | 上市公司接待人员姓名 | | | | | | | | | 为与会人员交流。 | | | | 一、公司介绍 | | | | 科华生物成立于 | 年，国内首家深交所中小板 IVD 上市 | | | | | | 投资者关系活动 | | | | 主要内容介绍 | | ...

Company Overview - Shanghai Kehua Bio-engineering Co., Ltd. was established in 1981 and is the first company listed on the Shenzhen Stock Exchange's SME board in the IVD sector [2] - The company specializes in the R&D, production, and sales of in vitro diagnostic reagents and medical testing instruments, covering molecular diagnostics, biochemical diagnostics, immunodiagnostics, and point-of-care testing [2] - Kehua's products are distributed across over 30 provinces and municipalities in China, serving more than 12,000 hospitals and over 500 disease control centers, blood centers, blood stations, biopharmaceutical companies, and research institutes, with exports to multiple countries [2] Competitive Advantages - Leading R&D and technical advantages in the IVD field, with a focus on continuous investment in research and development [3] - Strong industry foundation and comprehensive competitive advantages through integrated biotechnological, medical device manufacturing, and collaborative innovation platforms [3] - Strict production and quality control processes, certified by GMP and ISO13485, ensuring high-quality products [3] - A nationwide marketing team with a professional background in biology and medicine, providing a stable customer base and channel resources [3] - International market expansion with products exported to multiple countries, leveraging the sales network of its Italian subsidiary [3] Future Development Directions - Focus on internal capabilities by increasing R&D investment and improving business integration within the IVD industry [3] - Collaborate with international giants as opportunities for cooperation with foreign and domestic companies increase [3] - Actively expand overseas business based on past international experience [3] Industry Trends and Company Positioning - Embracing centralized procurement to optimize the supply chain and enhance cost efficiency in response to rapid market development and national policy advocacy [4] - The acquisition of a major stake by Gree Real Estate signifies a strategic move into the biopharmaceutical and healthcare sectors, supporting long-term stable development [4] - The company has decided not to adjust the conversion price of its convertible bonds, reflecting confidence in its long-term stable growth and intrinsic value [4]

Company Overview - Shanghai Kehua Bio-engineering Co., Ltd. was established in 1981 and is the first company listed on the Shenzhen Stock Exchange's SME board in the IVD sector [2] - The company specializes in the R&D, production, and sales of in vitro diagnostic reagents and medical testing instruments, covering molecular diagnostics, biochemical diagnostics, immunodiagnostics, and rapid diagnostics [2] - Kehua's products are distributed across over 30 provinces and municipalities in China, serving more than 12,000 hospitals and over 500 disease control centers, blood centers, blood stations, biopharmaceutical companies, and research institutes, with exports to over 100 countries and regions [2] Business Strategy - The company aims to achieve full industry chain coverage by enhancing R&D investment, strengthening business integration, and optimizing its supply chain [3] - Future development plans include focusing on internal capabilities, collaborating with international giants, and expanding overseas business [3] Financial and Operational Insights - The company manages customer credit through tiered management, offering 3-6 month payment terms to strong partners while using upfront payment models for new clients [3] - The board decided not to adjust the conversion price of the company's convertible bonds, maintaining confidence in long-term development [4] Market Trends and Challenges - The company embraces centralized procurement and domestic substitution trends, aiming to enhance market influence and optimize costs [4] - In 2023, Kehua plans to focus on core products and leverage opportunities from centralized procurement and domestic substitution [4] Shareholder Matters - A significant arbitration case with minority shareholders of Tianlong Company has been resolved amicably, with both parties committed to the company's high-quality development [4] - In May 2020, Zhuhai Baolian acquired shares of Kehua Bio for 1,725,534,684 yuan, purchasing 95,863,038 ordinary shares [4]

上海科华生物工程股份有限公司 2023 年第一季度报告 | 证券代码：002022 | 证券简称：科华生物 | | --- | --- | | 债券代码：128124 | 公告编号：2023-044 债券简称：科华转债 | 上海科华生物工程股份有限公司 2023 年第一季度报告 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。 重要内容提示： 1.董事会、监事会及董事、监事、高级管理人员保证季度报告的真实、准确、完整，不存在虚假记载、误导性陈述或重大 遗漏，并承担个别和连带的法律责任。 2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明：保证季度报告中财务信息的真实、准确、完 整。 3.第一季度报告是否经审计 □是 否 一、主要财务数据 （一） 主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 □是 否 | | 本报告期 | 上年同期 | 本报告期比上年同期增减（%） | | | --- | --- | --- | --- | --- | | 营业收入（元） | 833,147,693.69 | 420,497,071.93 | ...

Financial Performance - The company's operating revenue for 2022 was ¥6,969,862,627.72, representing a 43.58% increase compared to ¥4,268,011,808.72 in 2021[20] - The net profit attributable to shareholders for 2022 was ¥970,845,080.02, which is a 14.16% increase from ¥721,016,662.06 in 2021[20] - The net cash flow from operating activities reached ¥2,153,632,187.55, marking a significant increase of 99.55% compared to ¥775,342,174.21 in the previous year[20] - Basic earnings per share for 2022 were ¥1.8878, up 14.09% from ¥1.4026 in 2021[20] - The net profit after deducting non-recurring gains and losses was ¥952,357,688.19, reflecting a 13.88% increase from ¥704,501,000.58 in 2021[20] - Total assets increased to ¥8,813,157,013.32, up 26.71% from ¥6,955,215,549.19[21] - Net assets attributable to shareholders rose to ¥4,814,922,149.78, reflecting a 24.34% increase from ¥3,872,397,866.89[21] Dividend and Shareholder Information - The company plans to distribute a cash dividend of ¥6 per 10 shares to all shareholders, with no bonus shares or capital reserve conversion[4] - The proposed cash dividend for the 2022 fiscal year is ¥6 per 10 shares, with no stock dividends or capital reserve transfers planned[152] Market and Industry Insights - The company operates in the in vitro diagnostic market, which is rapidly growing due to factors like aging population and increased healthcare spending[33][34] - The global in vitro diagnostics (IVD) market size was $67.11 billion in 2019 and is projected to reach $91.09 billion by 2027, with a CAGR of 4.8% from 2020 to 2027[35] - China's IVD market grew from approximately RMB 42.75 billion in 2015 to about RMB 80.57 billion in 2019, with a CAGR of 17.2%[36] - By 2030, China's IVD market is expected to reach RMB 288.15 billion, capturing 33.2% of the global market share[36] Product Development and R&D - The company has over 100 projects in different stages of research and development, with more than 260 approved reagents and instruments by the National Medical Products Administration[44] - The company emphasizes R&D investment, having undertaken over 30 major national science and technology projects[44] - The company continues to invest in R&D, focusing on new product development across multiple product lines, including biochemical and molecular diagnostics[48] - Research and development expenses increased by 68.71% to ¥250,493,757.83 in 2022, up from ¥148,472,181.49 in 2021, reflecting a significant increase in R&D investment[64] Sales and Revenue Breakdown - The company's self-produced products accounted for 77.34% of total revenue, with a significant growth of 62.19% year-on-year[53] - Domestic sales contributed 90.48% of total revenue, showing a substantial increase of 68.62% compared to 2021[53] - The total sales volume of self-produced diagnostic reagents reached 13,996,293 boxes in 2022, a year-on-year increase of 58.49% compared to 8,830,845 boxes in 2021[56] - The sales volume of self-produced medical instruments surged to 52,157 units, marking a 159.59% increase from 20,092 units in 2021[56] Corporate Governance and Management - The company has established a transparent performance evaluation and incentive mechanism for directors, supervisors, and senior management to ensure the achievement of development strategies and operational goals[103] - The board of directors consists of seven members, including four independent directors, ensuring compliance with legal and regulatory requirements[102] - The company has implemented a performance evaluation system for senior management, with a new assessment method established for 2022[141] - The company has maintained a stable management structure with no significant changes in senior management during the reporting period[112] Risk Management and Compliance - The company has identified potential risks in its future operations, which are detailed in the management discussion section of the report[4] - The company faces risks from regulatory changes in the in vitro diagnostics industry, which could adversely affect its operations[95] - The company acknowledges the long development cycle for new products, which typically takes 3-5 years, and is implementing measures to mitigate R&D risks[96] - The company has established departments to ensure timely registration of products in domestic and international markets, reducing registration risks[97] Financial Audit and Reporting - The company’s financial statements have been audited by Da Hua Certified Public Accountants[19] - The company has appointed Dahua Accounting Firm for the 2022 annual audit, with an audit fee of ¥2,120,000, marking the first year of service[183] - The internal control audit report for Kehua Bio-engineering Co., Ltd. indicates effective financial reporting internal controls as of December 31, 2022, with a standard unqualified opinion[164] Employee and Compensation Information - The total number of employees at the end of the reporting period is 2,709, with 921 in the parent company and 1,788 in major subsidiaries[143] - Total pre-tax compensation for the company's directors, supervisors, and senior management during the reporting period amounted to CNY 552.03 million[129] - The company has implemented a performance-oriented compensation management system to enhance employee development and satisfaction[169] Strategic Initiatives and Future Plans - The company plans to focus on cardiovascular health, liver disease, kidney disease, infectious diseases, tumors, reproductive health, and maternal and child health, aiming for comprehensive disease management[91] - The company aims to expand into the in vitro diagnostic reagent raw material market, ensuring strategic safety for product development and production[92] - The company is expanding its drug metabolism and genetic disease application areas through the development of new drug gene testing kits, with several products expected to be registered in 2023 and 2024[68] Legal Matters - The company reported a total litigation amount of approximately ¥1,050,433,000 related to arbitration with Tianlong Technology Co., Ltd. and Suzhou Tianlong Biotechnology Co., Ltd.[187] - The company has not faced any significant penalties or rectification measures during the reporting period[189]

Financial Performance - The company's operating revenue for 2021 was ¥4,854,310,523.68, representing a 16.82% increase compared to ¥4,155,428,846.74 in 2020[19] - The net profit attributable to shareholders for 2021 was ¥850,413,412.99, which is a 25.92% increase from ¥675,356,413.28 in 2020[19] - The net profit after deducting non-recurring gains and losses was ¥836,316,794.92, up 26.92% from ¥658,928,540.60 in the previous year[19] - The basic earnings per share for 2021 was ¥1.6546, an increase of 23.99% from ¥1.3345 in 2020[19] - The total assets at the end of 2021 were ¥6,955,215,549.19, reflecting a 16.36% increase from ¥5,977,153,474.43 at the end of 2020[20] - The net assets attributable to shareholders increased by 23.29% to ¥3,872,397,866.89 from ¥3,140,958,791.90 in 2020[20] - The net cash flow from operating activities decreased by 21.06% to ¥1,079,220,264.86 from ¥1,367,198,250.32 in 2020[19] - The weighted average return on net assets for 2021 was 24.17%, slightly down from 24.76% in 2020[19] Revenue Breakdown - The company's total revenue for Q1 was approximately CNY 1.45 billion, with a net profit attributable to shareholders of CNY 342.23 million[23] - In Q2, the revenue decreased to approximately CNY 946.76 million, while the net profit attributable to shareholders was CNY 136.82 million[23] - For Q3, the revenue rebounded to approximately CNY 1.33 billion, with a net profit of CNY 250.04 million[23] - The revenue from self-produced products amounted to ¥3,323,377,102.02, accounting for 68.46% of total revenue, with a year-on-year growth of 23.94%[52] - The company's domestic revenue was ¥3,740,078,291.44, which is 77.05% of total revenue, showing a 13.20% increase from the previous year[53] Market and Product Development - The global in vitro diagnostic market size exceeded USD 111.7 billion in 2021, with a projected CAGR of 6.1% from 2017 to 2024[31] - The domestic in vitro diagnostic industry is experiencing rapid growth, particularly in biochemical, immunological, and molecular diagnostics[32] - The company has over 80 CE-certified products through its Italian subsidiary, TGS, and exports to over 30 countries[33] - The company has a competitive advantage in product lines within the domestic in vitro clinical diagnostic industry[33] - The company is focused on developing new technologies and expanding its market presence in the in vitro diagnostic sector[32] - The company’s immunodiagnostic products include enzyme-linked immunosorbent assay (ELISA) and chemiluminescent immunoassay (CLIA), with a focus on high throughput and rapid detection[35] - The company’s products cover 30 provinces and municipalities in China, serving over 12,000 hospitals and more than 500 high-barrier disease control centers and blood stations[35] - The company has established a professional marketing team with a strong background in biology and medicine, enhancing its brand influence and market share[38] Research and Development - The company has over 100 ongoing research projects and has obtained 260 CFDA registration certificates and more than 50 invention patents[37] - The company is focusing on R&D, with approximately 100 projects at various stages of development, including new products for infectious disease detection and automated laboratory systems[47] - The company aims to enhance its core competitiveness through increased R&D efforts and the continuous launch of new products, aligning with industry trends[91] - The company will continue to invest in R&D, focusing on molecular and immunological fields, and aims to improve product quality and registration efficiency[93] Risk Management - The company has outlined potential risks in its future development outlook, which investors should be aware of[5] - The company faces risks related to the ongoing COVID-19 pandemic, which may impact sales of routine diagnostic products[94] - Regulatory changes in the in vitro diagnostics industry pose a risk, necessitating close monitoring and adjustments to comply with new policies[95] - New product development involves significant risks, including high costs and lengthy approval processes, which could affect the company's competitive position[96] - The company has established departments to ensure timely product registration and compliance with quality management systems in both domestic and international markets[96] Corporate Governance - The company has established a governance structure that includes a board of directors, supervisory board, and various committees to ensure compliance and protect shareholder rights[101] - The company has implemented a transparent performance evaluation and incentive mechanism for its directors and senior management to ensure alignment with long-term strategic goals[103] - The company emphasizes the importance of information disclosure and has committed to improving its transparency in financial reporting and communication with stakeholders[103] - The company maintains complete independence from its major shareholders in terms of business, personnel, assets, institutions, and finance[105] Employee and Management Structure - The total number of employees at the end of the reporting period was 2,257, with 926 in the parent company and 1,331 in major subsidiaries[132] - The company had a total of 669 technical personnel, 591 sales personnel, and 534 production personnel[132] - The company has implemented a performance-oriented compensation system to align employee contributions with rewards[134] - The management team includes experienced professionals with backgrounds in finance, pharmaceuticals, and engineering, indicating a strong leadership structure[113][114] Financial Liabilities and Investments - The company’s financial liabilities remained at zero, indicating no outstanding debts[72] - The company raised a total of ¥738,000,000.00 from the issuance of convertible bonds, with a net amount of ¥718,529,590.53 after deducting issuance costs[81] - The company has not reported any penalties from securities regulatory agencies for its directors, supervisors, and senior management in the past three years[120] Legal and Compliance Issues - The company reported that its 2021 annual audit was not completed due to disputes with minority shareholders, leading to a warning of delisting risk[98] - The company temporarily excluded Tianlong Company from its consolidated financial statements starting October 1, 2021, due to loss of control, but has since regained control and included it back in the financial reports[98] - The company is actively monitoring arbitration cases related to its investments and is seeking to resolve disputes amicably[97] Community Engagement - A team of 22 volunteers was formed to assist in COVID-19 testing efforts, contributing to public health initiatives[161] - The company emphasizes employee rights protection and has developed a comprehensive training and development system[160]