证券代码：688468 证券简称：科美诊断 公告编号：2023-061 科美诊断技术股份有限公司 2023 年半年度募集资金存放与使用情况的专项报告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、募集资金基本情况 （一）实际募集资金金额、资金到账时间 2021 年 2 月 24 日，中国证券监督管理委员会作出《关于同意科美诊断技术 股份有限公司首次公开发行股票注册的批复》（证监许可〔2021〕550 号），同意 科美诊断技术股份有限公司（以下简称"公司"或"科美诊断"）首次公开发行股票 的注册申请。按照《上海证券交易所科创板股票上市规则》的相关规定，上海证 券交易所同意本公司股票在科创板上市交易，公司向社会公众发行人民币普通股 41,000,000 股，每股面值 1.00 元，发行价格为人民币 7.15 元/股，募集资金总额 为人民币 293,150,000.00 元，各项发行费用金额（不含税）为人民币 44,593,051.99 元，扣除发行费用后募集资金净额为人民币 248,556,948.01 元。前述募集资金 ...

本公司监事会及全体监事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 证券代码：688468 证券简称：科美诊断 公告编号：2023-060 本 议 案 所 述 内 容 详 见 公 司 同 日 披 露 于 上 海 证 券 交 易 所 网 站 （ www.sse.com.cn）的《2023 年半年度报告》及《2023年半年度报告摘要》。 一、监事会会议召开情况 科美诊断技术股份有限公司（以下简称"公司"）第二届监事会第四次会议 于2023年8月28日以现场结合通讯方式召开，本次会议通知于2023年8月18日以 邮件方式送达公司全体监事。本次会议由监事会主席练子富先生主持，应参与 表决监事3人，实际参与表决监事3人。本次会议的召集、召开程序符合《中华 人民共和国公司法》等法律、法规、规章、规范性文件和《科美诊断技术股份 有限公司章程》（以下简称"《公司章程》"）的有关规定，会议决议合法、 有效。 二、监事会会议审议情况 经与会监事表决，审议通过以下议案： （一）审议通过《公司2023年半年度报告及其摘要》 监事会认为：公司2023年半年度报告的编制 ...

证券代码：688468 证券简称：科美诊断 公告编号：2023-059 一、医疗器械产品注册证基本情况 二、对公司的影响 上述产品注册证的获得，丰富了公司LiCA®平台检测菜单，有助于提升公司 市场综合竞争力，对公司未来市场的拓展以及生产经营将产生积极影响。 三、风险提示 鉴于上述产品需要在北京市药品监督管理局企业服务平台进行信息登记后 方可上市销售，产品上市后的实际销售情况取决于未来市场的推广效果，目前 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 科美诊断技术股份有限公司（以下简称"公司"）近日获得北京市药品监 督管理局颁发的5项《医疗器械注册证》，现将具体情况公告如下： | 注册人 | 产品名称 | 注册 | 注册证编号 | 注册证 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 名称 | | 类别 | | 有效期 | | | | 透明质酸（HA）测定 试剂盒（光激化学发 | Ⅱ | 京械注准 | 2023/08/10- | 本试剂盒用于体外定量测定人血清 | | ...

证券代码：688468 证券简称：科美诊断 公告编号：2023-058 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 科美诊断技术股份有限公司（以下简称"公司"或"科美诊断"）及全资 子公司科美博阳诊断技术（上海）有限公司（以下简称"科美博阳"）于近日 收到了 2 项国家知识产权局颁发的发明专利证书，现将具体情况公告如下： 一、发明证书的基本情况 | 发明专利名称 | 专利号 | 专利申请日 | 授权公告日 | 专利权人 | 专利期限 | | --- | --- | --- | --- | --- | --- | | 一种白介素 6 的均相 | ZL201911420131.4 | 2019 年 12 月 31 日 | 2023 年 08 月 08 日 | 科美博阳 | 二十年 | | 检测试剂盒及其应用 | | | | 科美诊断 | | | 一种肌酸激酶同工酶 的均相检测试剂盒及 | ZL201911411233.X | 2019 年 12 月 31 日 | 2023 年 08 月 08 日 | 科美博阳 | 二十年 ...

本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 科美诊断技术股份有限公司（以下简称"公司"）全资子公司科美诊断技 术（苏州）有限公司（以下简称"苏州科美"）于近日收到了2项国家知识产权 局颁发的发明专利证书，现将具体情况公告如下： 上述专利保护的技术方案均系公司自主研发，应用于公司全自动化学发光 免疫分析系统和配套检测试剂中。 1.一种肌红蛋白的均相检测试剂盒及其应用专利（ZL201911421896.X）， 属于均相检测技术领域，具体涉及一种肌红蛋白的均相检测试剂盒及其制备方 法和应用。现有化学发光检测试剂盒的特异性不理想，容易出现假阳性现象， 尤其难以兼顾灵敏度和检测量程，不能满足临床诊断的需求。本发明对试剂盒 中 R1 试剂的受体颗粒粒径分布变异系数 C.V 值上下限进行了限定，且每毫克质 量的所述受体颗粒中的糖含量也限定了下限，使得本发明的试剂盒既有较合适 的灵敏度，又有很宽的检测量程。公司使用了该专利保护的技术制备的肌红蛋 白检测试剂盒(光激化学发光法)产品，用于体外诊断主体是否患有心肌损伤， 利用本发明提供的试 ...

证券代码：688468 证券简称：科美诊断 公告编号：2023-056 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 一、诉讼基本情况 科美博阳认为成都爱兴销售的以"肌钙蛋白Ⅰ测定试剂盒（均相化学发光 免疫分析法）"为代表的系列体外诊断试剂盒产品侵犯科美博阳的技术秘密， 科美博阳向上海知识产权法院提交《民事起诉书》，请求判令：1）程敏卓和成 都爱兴立即停止侵害科美博阳秘密的不正当竞争行为；2）程敏卓与成都爱兴赔 偿因技术秘密侵权行为而给科美博阳造成的经济损失 6,800 万元，以及科美博阳 为调查、制止不正当竞争行为所支出的合理费用 100 万元；3）程敏卓和成都爱 兴在国家级官方媒体上向科美博阳赔礼道歉并消除影响。 2020年 9 月 22日，上海知识产权法院作出"（2019）沪 73知民初 429号" 《民事判决书》，判决：1）被告程敏卓、成都爱兴于判决生效之日立即停止侵 1 案件所处的诉讼阶段：再审判决； 公司所处的当事人地位：科美诊断技术股份有限公司（以下简称"公 司"）之全资子公司科美博阳诊断技 ...

证券代码：688468 证券简称：科美诊断 公告编号：2023-036 科美诊断技术股份有限公司 关于召开 2022 年度暨 2023 年第一季度 业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 会议召开时间：2023年6月9日（星期五）下午 13:00-14:00 会议召开地点：上海证券交易所上证路演中心 （网址：http://roadshow.sseinfo.com/） （二）会议召开地点：上证路演中心（网址：http://roadshow.sseinfo.com/） （三）会议召开方式：上证路演中心网络互动 三、参加人员 董事长、总经理：李临先生 会议召开方式：上证路演中心网络互动 投资者可于2023年6月2日（星期五）至6月8日（星期四）16:00前登录上证 路演中心网站首页点击"提问预征集"栏目或通过科美诊断技术股份有限公司（ 以下简称"公司"）邮箱ir@chemclin.com进行提问。公司将在说明会上对投资者 普遍关注的问题进行回答。 公司于 2023 年 4 月 28 日在 ...

Financial Performance - The company's operating revenue for 2022 was ¥465,270,072.25, a decrease of 1.17% compared to ¥470,774,575.26 in 2021[22]. - The net profit attributable to shareholders for 2022 was ¥152,625,664.32, representing an increase of 6.91% from ¥142,757,221.17 in 2021[22]. - The net cash flow from operating activities increased by 29.49% to ¥244,559,713.21 in 2022, up from ¥188,856,812.25 in 2021[22]. - The total assets at the end of 2022 were ¥1,591,166,426.71, an increase of 11.20% from ¥1,430,906,695.48 at the end of 2021[22]. - The basic earnings per share for 2022 was ¥0.38, a 2.70% increase from ¥0.37 in 2021[23]. - The net profit after deducting non-recurring gains and losses was ¥120,116,898.62, a decrease of 3.90% from ¥124,991,122.27 in 2021[22]. - The net assets attributable to shareholders at the end of 2022 were ¥1,380,575,252.76, an increase of 7.97% from ¥1,278,672,724.44 at the end of 2021[22]. - The company's comprehensive gross margin remained stable at 74.37%, but there are risks of decline due to rising labor costs and market competition[91]. - The company reported a significant decrease in financing cash flow by 133.04%, amounting to 79.95 million RMB, mainly due to cash dividends and previous IPO fundraising[114]. Research and Development - The R&D expenditure as a percentage of operating revenue increased to 17.97% in 2022, up from 14.30% in 2021, marking an increase of 3.67 percentage points[23]. - Total R&D investment increased by 24.21% year-on-year to approximately ¥83.62 million, with R&D expenses accounting for 17.97% of operating income, an increase of 3.67 percentage points[65]. - The company has developed a comprehensive core technology system covering reagents, instruments, basic materials, and biological raw materials for in vitro diagnostics[37]. - The company is focusing on enhancing its competitive advantage through technology and product innovation, particularly in the field of chemiluminescence immunodiagnostics[34]. - The company has established a proprietary chemiluminescence technology platform, which has been recognized for its clinical immunodiagnostic system based on light-activated chemiluminescence technology[56]. - The company has developed 70 products in the LiCA® series, covering common clinical detection projects in infectious diseases, tumor markers, thyroid hormones, reproductive endocrine hormones, cardiac markers, and inflammation, achieving performance levels that meet or exceed international first-tier brands[57]. - The company has established a metrological traceability system for small molecule projects, enhancing the reliability of test results[76]. - The company is focusing on the development of innovative technologies to ensure the stability and quality of biological raw materials, which is crucial for cost reduction and efficiency improvement[68]. Market Position and Strategy - The company is positioned to benefit from domestic policies encouraging the procurement of domestic medical devices, accelerating the process of import substitution in the in vitro diagnostic market[60]. - The company aims to transition from a follower to a leader by exploring new biomarkers with clear clinical significance[38]. - The company is focusing on developing diagnostic products that match or exceed the performance of imported brands, targeting a market where imported brands currently hold an 80% share[125]. - The company is actively pursuing opportunities for mergers and acquisitions to drive growth[144]. - The company plans to expand its market presence and enhance product offerings, although specific strategies were not detailed in the report[104]. - The company is committed to attracting and retaining high-quality talent through training and development programs, enhancing its competitive advantage[130]. - The company is expanding its production capacity at the Suzhou base, focusing on automation and smart production methods to enhance efficiency and product quality[130]. Governance and Compliance - The company emphasizes strict quality control in production, adhering to multiple international quality management standards[49]. - The company has established a comprehensive corporate governance structure, including a board of directors and various committees, ensuring clear responsibilities and effective operations[186]. - The company has implemented a stock incentive plan, which was approved in the first extraordinary general meeting of 2022[136]. - The company has no significant differences in governance compared to regulations set by the China Securities Regulatory Commission[135]. - The company has established a governance structure that ensures effective operation and decision-making, safeguarding the interests of shareholders[134]. - The company strictly adhered to information disclosure regulations, ensuring timely and accurate reporting to protect investor interests[135]. - The company has maintained a consistent presence in the biotechnology sector, with several key personnel holding significant positions across various firms[148][149][150]. Environmental Responsibility - The company emphasizes environmental protection and complies with relevant laws and regulations, integrating green practices into its operations[185]. - The company invested approximately 29.85 million yuan in environmental protection during the reporting period[187]. - The company is not classified as a key pollutant discharging unit by environmental protection authorities[188]. - No administrative penalties were incurred due to environmental issues during the reporting period[189]. Product Development and Innovation - The company has successfully launched the LiCA® photochemical luminescence instruments, which include models such as LiCA® 500 and LiCA® 800, demonstrating high sensitivity and specificity in testing[68]. - The company has developed 8 biochemical reagents, with one product already registered and others in progressive development[22]. - The company’s LiCA® series products include 70 registered medical device certificates, covering major clinical testing projects in China[44]. - The company has obtained 49 new patents during the reporting period, including 14 invention patents and 30 utility model patents, bringing the total number of effective patents to 626[63]. - The company has established a first-level traceability system for the LiCA® small molecule project in accordance with the latest international standards, enhancing product reliability[41]. Risk Management - The company has detailed various operational risks in the report, which can be found in the "Management Discussion and Analysis" section[3]. - The company faces risks related to dealer management, product quality, and intensified market competition from both domestic and international players[89]. - The company is subject to risks from national healthcare reforms, which may impact operational performance if not addressed timely[93]. - The company faces risks related to new product development, including a typical 3-5 year timeline for obtaining registration certificates[83].

Financial Performance - The company's operating revenue for Q1 2023 was ¥100,933,657.63, representing a decrease of 16.50% compared to the same period last year[4] - The net profit attributable to shareholders was ¥34,836,760.84, down by 10.92% year-on-year[4] - The net profit after deducting non-recurring gains and losses was ¥30,632,434.37, a decrease of 12.54% compared to the previous year[4] - The basic earnings per share for the period was ¥0.09, a decrease of 10.00% compared to the same period last year[4] - The weighted average return on equity was 2.49%, a decrease of 0.52 percentage points[4] - The total comprehensive income for Q1 2023 was ¥34,836,760.84, compared to ¥39,107,317.86 in Q1 2022[22] - The net profit for Q1 2023 was ¥34,836,760.84, a decline of 10.0% from ¥39,107,317.86 in Q1 2022[21] - The net profit for Q1 2023 was -3,612,514.55 RMB, an improvement from -6,052,137.88 RMB in Q1 2022, indicating a reduction in losses by approximately 40%[30] - Total comprehensive income for Q1 2023 was -3,612,514.55 RMB, compared to -6,052,137.88 RMB in Q1 2022, reflecting a significant improvement in overall financial performance[30] Cash Flow - The net cash flow from operating activities was ¥18,271,622.63, reflecting a significant decline of 68.99% due to reduced sales collections and increased tax and procurement expenses[6] - Cash inflow from operating activities in Q1 2023 was ¥123,823,308.66, down from ¥143,862,718.38 in Q1 2022[22] - The net cash flow from operating activities was CNY 18,271,622.63, down 69.0% from CNY 58,921,042.84 in the previous year[23] - The total cash outflow from operating activities was 33,286,323.62 RMB, compared to 28,125,115.24 RMB in Q1 2022, marking an increase of approximately 18%[34] - The company incurred a tax expense of -2,231,800.27 RMB in Q1 2023, compared to -1,537,773.85 RMB in Q1 2022, reflecting an increase in tax liabilities[30] - The company's cash flow from financing activities resulted in a net outflow of -2,217,334.84 RMB, compared to -12,353,360.41 RMB in Q1 2022, indicating a significant reduction in financing costs[34] Assets and Liabilities - The total assets at the end of the reporting period were ¥1,577,016,660.57, a decrease of 0.89% from the end of the previous year[5] - The total assets as of March 31, 2023, amounted to CNY 1,116,991,175.71, a decrease from CNY 1,131,638,710.08 at the end of 2022[26] - Total liabilities as of Q1 2023 were ¥161,604,646.97, a decrease from ¥210,591,173.95 in the previous period[17] - The company's total liabilities as of March 31, 2023, were CNY 16,347,849.35, down from CNY 27,382,869.17 at the end of 2022[27] Research and Development - Research and development expenses totaled ¥21,574,900.89, which is an increase of 16.60% year-on-year, accounting for 21.38% of operating revenue, up by 6.07 percentage points[4] - The company reported a decrease in research and development expenses to ¥17,088,512.72 in Q1 2023 from ¥18,502,792.33 in Q1 2022[19] - Research and development expenses for Q1 2023 were CNY 10,909,511.00, slightly up from CNY 10,877,795.20 in Q1 2022[29] - The company has 15 products in the research pipeline, with 4 entering clinical stages and 1 obtaining domestic Class III medical device registration during the reporting period[11] - The company secured 8 domestic invention patents during the reporting period, indicating ongoing innovation efforts[12] Inventory and Current Assets - The company reported a total current assets of CNY 1,137,751,671.82 as of March 31, 2023, a decrease from CNY 1,165,252,004.65 at the end of 2022, reflecting a decline of approximately 2.5%[14] - The cash and cash equivalents decreased to CNY 247,051,012.53 from CNY 342,139,661.72, representing a decline of about 27.8%[14] - The accounts receivable decreased to CNY 31,492,953.67 from CNY 34,062,994.04, a decline of about 8.3%[14] - The company’s inventory increased to CNY 113,377,180.33 from CNY 112,560,499.21, reflecting a slight increase of about 0.7%[15] - The company’s inventory increased slightly to CNY 31,153,709.50 from CNY 30,966,985.10 at the end of 2022[26] Investment Activities - Investment activities resulted in a net cash outflow of CNY 120,379,638.70, compared to a smaller outflow of CNY 38,824,910.50 in the previous year[23] - The cash flow from investing activities showed a net outflow of -126,392,250.78 RMB, compared to -152,610,099.14 RMB in Q1 2022, indicating a reduction in cash outflow by approximately 17%[34]

证券代码：688468 证券简称：科美诊断 编号：2022-002 科美诊断技术股份有限公司 投资者关系活动记录表 | --- | --- | --- | |-------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...