广东凯普生物科技股份有限公司董事会 证券代码：300639 证券简称：凯普生物 公告编号：2023-085 广东凯普生物科技股份有限公司 关于变更保荐代表人的公告 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。 广东凯普生物科技股份有限公司（以下简称"公司"）经中国证券监督管理 委员会证监许可[2020]1713号文核准，于2020年9月16日向特定对象发行股票并 上市。公司聘请中信证券股份有限公司（以下简称"中信证券"）担任公司向特 定对象发行股票的保荐人，其委派洪立斌先生和胡朝峰先生具体负责公司的持续 督导相关工作，持续督导期至2022年12月31日止。鉴于公司目前募集资金尚未使 用完毕，中信证券需继续履行募集资金相关的持续督导职责。 近日，公司收到中信证券出具的《关于更换保荐代表人的函》，因保荐代表 人胡朝峰先生工作变动，不再负责公司的持续督导工作，由赵洞天先生接替胡朝 峰先生担任公司的保荐代表人，履行相关职责和义务。 本次保荐代表人变更后，公司向特定对象发行股票持续督导期的保荐代表人 为洪立斌先生和赵洞天先生（简历详见附件）。 公司董事会对胡朝峰先生在 ...

证券代码：300639 股票简称：凯普生物 公告编号：2023-083 住 所：广东省潮州市经济开发试验区北片高新区D5-3-3-4 统一社会信用代码：91445100761585197P 法定代表人：谢龙旭 企业负责人：翁丹容 广东凯普生物科技股份有限公司 关于全资子公司变更医疗器械生产许可证的公告 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。 近日，广东凯普生物科技股份有限公司全资子公司潮州凯普生物化学有限公 司收到了由广东省药品监督管理局换发的《医疗器械生产许可证》。本次变更主 要涉及生产地址，变更后的生产许可证具体内容如下： 许可证编号：粤食药监械生产许20041040号 企业名称：潮州凯普生物化学有限公司 生产地址：广东省潮州市经济开发试验区北片高新区D5-3-3-4；潮州市湘桥 区创北路1号凯普综合楼第三层、第四层、第五层、第六层B区。 生产范围：旧版：III类6840体外诊断试剂。新版：II类22临床检验器械-11 采样设备和器具。 许可期限：自2019年01月09日至2024年01月08日 发证日期：2023年08月18日 特此公告。 广东凯 ...

广东凯普生物科技股份有限公司 关于全资子公司取得医疗器械注册证书的公告 证券代码：300639 证券简称：凯普生物 公告编号：2023-084 二、对公司业绩的影响及风险提示 广东凯普生物科技股份有限公司（以下简称"公司"）的全资子公司广州凯普 医药科技有限公司近日取得国家药品监督管理局颁发的《中华人民共和国医疗器 械注册证（体外诊断试剂）》。具体情况如下： | 产品名称 | 注册 | 注册证编号 | | 注册证有效 | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | | | 分类 | | 期 | | | 本试剂盒用于体外定性检测 | | | | | | | | 人体静脉全血样本中的载脂 蛋白 E（APOE）基因 388 位 | | 和 APOE SLCO1B1 | | | | | | | | 基因多态性检测试 | III | 国械注准 | 2023 | 年 | 8 月 | 点（c.388T＞C）、526 位点 | | | 类 | | 31 日至 | | 2028 | （c.526C＞T）和有机阴离子 | | 剂盒（荧光 PCR 熔 | | 20233 ...

Financial Performance - In the first half of 2023, the company's operating revenue decreased to 606.635 million yuan, a year-on-year decline of 78.66%, but an increase of 91.33% compared to the same period in 2019 [4] - The net profit attributable to shareholders was 122.8428 million yuan, down 87.44% year-on-year, but up 105.17% compared to 2019 [4] - The net profit after deducting non-recurring gains and losses was 102.2808 million yuan, a year-on-year decline of 89.45%, but an increase of 82.53% compared to 2019 [4] Product and Service Development - The company’s HPV testing products were used by nearly 5 million people in the first half of 2023, representing a year-on-year increase of 27.99% and a 60.28% increase compared to 2019 [4] - The company’s core business includes the promotion of HPV testing for cervical cancer screening, with the HPV12+2 product receiving regulatory approval for expanded uses [4] - The company invested over 490 million yuan in R&D over the past three years, with a 60.61% compound annual growth rate [5] Market Strategy and Expansion - The company is actively building a digital management system and enhancing team capabilities, with a total workforce of 2,733 as of June 2023, a 103.96% increase compared to 2019 [5] - The company is expanding its upstream and downstream supply chain in the health sector, with ongoing construction of a comprehensive production base for nucleic acid testing [5] - Strategic partnerships have been established with industry leaders to enhance collaborative development across three major business segments [5] Accounts Receivable Management - As of June 2023, the company’s accounts receivable balance was 2,399.7066 million yuan, a decrease of 321.8212 million yuan from the beginning of the period [5] - The company expects to receive over 1.2 billion yuan in cash from sales of goods and services from January to August 2023 [5] Regulatory and Market Challenges - The company views long-term medical anti-corruption efforts as beneficial for industry health, while acknowledging potential short-term impacts on hospital access [6] - The company supports national healthcare cost control measures, preparing for potential centralized procurement policies in the IVD sector [6] Future Opportunities - The company aims to leverage new policies promoting cervical cancer screening to expand its market presence, targeting a screening rate of 50% by 2025 [7] - The company is focusing on molecular diagnostics, particularly in maternal and child health, and is developing a range of methylation detection products for early cancer screening [8]

Financial Performance - The company's operating revenue for the first half of 2023 was ¥606,634,951.95, a decrease of 78.66% compared to ¥2,842,527,465.39 in the same period last year[23]. - The net profit attributable to shareholders of the listed company was ¥122,842,813.31, down 87.44% from ¥978,312,557.32 year-on-year[23]. - The net cash flow from operating activities was ¥72,086,054.92, representing a decline of 80.50% compared to ¥369,684,405.88 in the previous year[23]. - Basic earnings per share decreased by 87.40% to ¥0.1881 from ¥1.4929 in the same period last year[23]. - Total assets at the end of the reporting period were ¥6,170,051,159.88, down 8.34% from ¥6,731,125,843.21 at the end of the previous year[23]. - The net assets attributable to shareholders of the listed company were ¥4,848,036,921.10, a decrease of 1.19% from ¥4,906,567,446.27 at the end of the previous year[23]. - The weighted average return on net assets was 2.63%, down from 23.31% in the previous year[23]. - The company's operating revenue for the reporting period was CNY 606.635 million, a year-on-year decrease of 78.66%, but an increase of 91.33% compared to the same period in 2019[31]. - The net profit attributable to shareholders was CNY 122.843 million, down 87.44% year-on-year, but up 105.17% compared to the same period in 2019[31]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was CNY 102.280 million, a year-on-year decrease of 89.45%, but an increase of 82.53% compared to the same period in 2019[31]. Product Development and Innovation - The company focuses on molecular diagnostics, with key development areas including tumor gene testing, infectious disease testing, and genetic disease testing[31]. - The company has developed a range of nucleic acid testing products for various diseases, including HPV and genetic disorders, utilizing proprietary and internationally recognized technologies[33]. - The company aims to expand its market presence in clinical diagnostics and public health prevention through its innovative product offerings[31]. - The company reported a significant increase in the number of high-risk HPV nucleic acid test kits, with 13 types available for cervical cell detection[34]. - The introduction of new products includes a series of nucleic acid test kits for sexually transmitted infections, enhancing diagnostic capabilities[35]. - The company is expanding its product line to include genetic testing kits for conditions such as Mediterranean anemia and G6PD deficiency, targeting specific genetic mutations[35]. - The company has developed automated nucleic acid extraction and purification instruments to streamline laboratory processes, improving efficiency[35]. - Future product development will focus on advanced diagnostic technologies, including rapid testing solutions for infectious diseases[35]. - The company is committed to expanding its market reach both domestically and internationally, targeting new customer segments[35]. - The company plans to invest in research and development to innovate and improve existing product offerings, ensuring competitive advantage[35]. Market Expansion and Strategic Partnerships - The company aims to enhance its market presence through strategic partnerships and collaborations in the healthcare sector[35]. - The company has established 34 third-party medical laboratories across various cities in China, providing over 2,000 specialized testing projects and serving more than 4,000 medical institutions with 24/7 professional technical services[37]. - The company is actively enhancing its international business layout, including team restructuring and product registration for overseas markets[86]. - The company has established strategic collaborations with industry leaders, including Mindray Medical and United Imaging, to enhance product solutions and expand international market reach[83][84]. - The company is committed to integrating molecular diagnostics with other medical diagnostic methods to create a comprehensive early screening and diagnosis system for diseases[78]. Research and Development - The company has invested in the construction of clinical mass spectrometry detection platforms, including liquid chromatography-tandem mass spectrometry, nucleic acid mass spectrometry, and rapid microbial identification mass spectrometry, to provide personalized diagnostic solutions for various diseases[57]. - The company has invested over 450 million RMB in R&D from 2020 to 2022, with a compound annual growth rate of 60.61%, and the R&D expenditure for the reporting period was 79.045 million RMB, accounting for 13.03% of revenue[61]. - The company is focusing on research and development of new products and technologies, as well as market expansion strategies[168]. - The company is enhancing its R&D capabilities through partnerships with domestic and international research institutions[101]. - The company is actively pursuing research and development projects aimed at innovative diagnostic solutions, with several projects currently in the registration stage[111]. Corporate Governance and Management - The company emphasizes the importance of risk awareness regarding future plans and forecasts[3]. - The management has stated that all board members attended the meeting to review the semi-annual report[3]. - The company has established a comprehensive management system to address potential management risks associated with rapid expansion into new business areas[163]. - The company is enhancing its governance and management practices to improve operational efficiency and financial health[170]. - The company has implemented strict compliance measures to prevent financial misconduct, including fraud and insider trading, enhancing internal approval processes for fund usage[190]. Social Responsibility and Community Engagement - The company donated a total of RMB 1,000,000 to the Chinese Red Cross for disaster relief efforts in Turkey and Syria following two earthquakes[198]. - The company pledged to donate no less than RMB 1,000,000 in cash and materials to a public welfare plan for hearing health, aimed at supporting disadvantaged hearing-impaired patients[198]. - The company contributed RMB 5,000,000 to the "Yang Fuzhi Research Talent Development Fund" at the University of Nottingham Ningbo China to attract and cultivate international innovative talents[199]. - The company provided RMB 150,000 to the Chaozhou Youth Palace for cultural training opportunities for 1,000 children from specific community groups[199]. Financial Management and Asset Control - The company has implemented measures to strengthen accounts receivable management, focusing on high-balance regions[89]. - The company is enhancing its accounts receivable management to mitigate risks associated with extended customer settlement periods and potential bad debts[165]. - The cash received from sales of goods and services from January to August 2023 is expected to exceed 1.2 billion yuan, with 948.95 million yuan received during the reporting period[166]. - The company plans to continue its strategy of asset disposal and impairment recognition to manage financial performance effectively[130]. - The company has implemented strict controls over asset access, allowing only authorized personnel to handle assets[136].

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、 误导性陈述或者重大遗漏。 证券代码：300639 证券简称：凯普生物 公告编号：2023-075 广东凯普生物科技股份有限公司 关于公司及子公司获得授予发明专利权通知书的公告 二〇二三年八月三十日 上述发明专利权的取得不会对公司目前的经营状况产生重大的影响，但有利于进一 步完善公司的知识产权体系，充分发挥公司的知识产权优势，促进公司产品结构的不断 丰富，提升公司的核心竞争力。 公司将严格依照办理登记手续通知书的内容办理登记手续，在按期办理登记手续后， 国家知识产权局将作出授予专利权的决定，颁发发明专利证书，并予以登记和公告，专 利权自公告之日起生效，有效期自申请日起二十年。 特此公告。 广东凯普生物科技股份有限公司董事会 近日，广东凯普生物科技股份有限公司（以下简称"公司"或"凯普生物"）、公 司全资子公司潮州凯普生物化学有限公司（以下简称"凯普化学"）、广州凯普医药科 技有限公司（以下简称"凯普医药"）以及控股子公司南京凯普医学检验实验室有限公 司（以下简称"南京凯普检验实验室"）收到国家知识产权局下发的《授予发明专利权 通知书》，具 ...

证券代码：300639 证券简称：凯普生物 公告编号：2023-074 广东凯普生物科技股份有限公司 关于全资子公司完成工商设立登记的公告 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。 广东凯普生物科技股份有限公司近期完成了全资子公司广东凯普大健康产 业有限公司的工商设立登记并取得由潮州市湘桥区市场监督管理局核发的《营业 执照》，相关登记信息如下： 5、法定代表人：王健辉 6、注册资本：人民币贰仟万元 7、成立日期：2023年08月16日 8、经营范围：一般项目：医学研究和试验发展（除人体干细胞、基因诊断 与治疗技术开发和应用）；技术服务、技术开发、技术咨询、技术交流、技术转 让、技术推广；以自有资金从事投资活动；自有资金投资的资产管理服务；医院 管理；品牌管理；企业管理；企业管理咨询；园区管理服务；远程健康管理服务； 健康咨询服务（不含诊疗服务）；信息咨询服务（不含许可类信息咨询服务）； 信息技术咨询服务；咨询策划服务；会议及展览服务；市场营销策划；租赁服务 （不含许可类租赁服务）；非居住房地产租赁；办公设备租赁服务；工程管理服 务；软件开发；软件销售。（ ...

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、误导性陈述或者重大遗漏。 广东凯普生物科技股份有限公司（以下简称"公司"）的全资子公司广州凯 普医药科技有限公司近日取得国家药品监督管理局颁发的《中华人民共和国医疗 器械注册证（体外诊断试剂）》。具体情况如下： 证券代码：300639 证券简称：凯普生物 公告编号：2023-073 广东凯普生物科技股份有限公司 关于全资子公司取得医疗器械注册证书的公告 叶酸代谢基因检测市场具有临床价值明确、收费价格合理等特点。目前，除 公司产品获得医疗器械注册证外，国内外同行业部分厂家已取得类似产品的注册 或认证。公司本次获证产品通过检测人体静脉全血样本中叶酸代谢通路关键酶— —5,10-亚甲基四氢叶酸还原酶（MTHFR）c.677C>T 位点的基因多态性，从而辅助 医生对患者叶酸代谢能力进行风险评估，进而指导叶酸增补剂量合理调整，减少 因叶酸增补不足或增补过量引起的危害。本次获证产品采用荧光 PCR 熔解曲线 法，可以实现一个检测通道可区分一个检测位点的野生型、纯合突变型和杂合突 变型，在同一反应管中检测所有位点，支持自动判读，方便快捷。 二、对公司 ...

证券代码：300639 证券简称：凯普生物 公告编号：2023-072 广东凯普生物科技股份有限公司 关于公司及子公司获得授予发明专利权通知书的公告 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、误导性陈述或者重大遗漏。 近日，广东凯普生物科技股份有限公司（以下简称"公司"或"凯普生物"） 以及全资子公司广州凯普医药科技有限公司（以下简称"凯普医药"）、广东凯 普科技智造有限公司（以下简称"凯普智造"）收到国家知识产权局下发的《授 予发明专利权通知书》，具体情况如下： | 发明创造名称 | 申请号/专利号 | 专利 类型 | 专利申请日 | | | 专利权人 | | --- | --- | --- | --- | --- | --- | --- | | 一种用于活体细胞分选 | 202310694083.8 | 发明 | 2023 年 6 | | 月 | 凯普生物、凯普医药、 | | 的微流控芯片 | | 专利 | 13 | 日 | | 凯普智造 | 本发明属于细胞分选技术领域，涉及一种用于活体细胞分选的微流控芯片， 已应用于公司在研项目"关于宫颈脱落细胞分选装置的研制"。本发明为 ...

证券代码：300639 证券简称：凯普生物 公告编号：2023-071 公司将严格依照办理登记手续通知书的内容办理登记手续，在按期办理登记 手续后，国家知识产权局将作出授予专利权的决定，颁发发明专利证书，并予以 登记和公告，专利权自公告之日起生效，有效期自申请日起二十年。 特此公告。 广东凯普生物科技股份有限公司 关于公司及子公司获得授予发明专利权通知书的公告 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、误导性陈述或者重大遗漏。 近日，广东凯普生物科技股份有限公司（以下简称"公司"或"凯普生物"） 以及全资子公司广州凯普医药科技有限公司（以下简称"凯普医药"）、控股子 公司汕头凯普医学检验实验室有限公司（以下简称"汕头凯普检验实验室"）收 到国家知识产权局下发的《授予发明专利权通知书》，具体情况如下： | 发明创造名称 | 申请号/专利号 | 专利 类型 | 专利申请日 | | 专利权人 | | --- | --- | --- | --- | --- | --- | | 一种膀胱癌快速检测试 | 202310813634.8 | 发明 | 2023 7 月 | 年 | 凯普生物、 ...