Core Viewpoint - The collaboration between Shengxiang Bio and Alibaba Health represents a deep synergy of the company's "three-in-one" model and the "medical-testing-pharmacy integration" ecosystem, aiming to enhance home-based medical services and promote standardized health testing solutions [1] Group 1: Collaboration and Services - The partnership focuses on the "Respiratory Virus and Bacteria 12-in-1 Testing" project, allowing users to complete professional-level testing from home, with reports generated in an average of 3 hours, thereby alleviating the pressure on healthcare systems during flu seasons [1] - Future initiatives will include the standardization and nationwide promotion of home rapid testing services, as well as the exploration of additional home-based applications for infectious disease testing [1] Group 2: Health Ecosystem Development - The collaboration aims to drive the precision and accessibility of serious medical services, transitioning health demands towards proactive and consumer-oriented approaches [1] - The goal is to lead health consumption towards a more serious, scientific, and personalized direction, ensuring tailored health management solutions benefit every individual [1]

Product Registration - The company has received medical device registration certificates for four products from the National Medical Products Administration [1] - Two of the approved respiratory "small joint inspection" products offer high sensitivity, specificity, and ease of operation, providing reports in as fast as 30 minutes [1] - The "small joint inspection" series has now expanded to 10 products, enhancing the company's "6/3+X respiratory infection nucleic acid rapid detection" system [1] Clinical Impact - The approved respiratory products are crucial for early identification of pathogens in respiratory infections, which is vital for precise medication and reducing antibiotic resistance [1] - The EB virus nucleic acid detection kit has undergone significant technical upgrades, improving detection sensitivity and supporting various specimen types [2] - The CYP3A5 gene polymorphism nucleic acid detection kit is the ninth product in the company's drug genome series, aimed at optimizing clinical medication plans for transplant patients [2]

智通财经APP讯，圣湘生物(688289.SH)发布公告，公司的四款产品于近日收到由国家药品监督管理局 颁发的《医疗器械注册证》，产品名称分别为：大肠埃希菌、鲍曼不动杆菌、嗜麦芽窄食单胞菌核酸检 测试剂盒(荧光PCR法);肺炎链球菌、流感嗜血杆菌、卡他莫拉菌核酸检测试剂盒(荧光PCR法);人 CYP3A5基因多态性核酸检测试剂盒(PCR-荧光探针法);EB病毒核酸检测试剂盒(荧光PCR法)。 ...

圣湘生物科技股份有限公司 关于自愿披露相关产品取得医疗器械注册证 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。 圣湘生物科技股份有限公司（以下简称"公司"或"圣湘生物"）的四款产品于近日 收到由国家药品监督管理局颁发的《医疗器械注册证》，现将相关情况公告如下： | 注册 | | | | | | | 注册 | 注册 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 人名 称 | | 注册证编号 | | | 产品名称 | 预期用途 | 类别 | 证有 效期 | | | | | | | 大肠埃希菌、鲍曼不 | 本试剂盒用于定性检测人痰液样 | | | | | 国 | 械 | 注 | 准 | 动杆菌、嗜麦芽窄食 | 本的大肠埃希菌、鲍曼不动杆菌、 | | | | | | 20253402567 | | | 单胞菌核酸检测试 | 嗜麦芽窄食单胞菌核酸。 | | | | | | | | | 剂盒（荧光 PCR 法） | | | | | 圣湘 | | | | ...

Core Viewpoint - The company has received medical device registration certificates from the National Medical Products Administration for four products, indicating regulatory approval and potential market entry [1] Group 1: Product Details - Two respiratory "small joint inspection" products have high sensitivity, high specificity, and ease of operation, capable of providing results in as fast as 30 minutes [1] - The products target major pathogens responsible for community-acquired pneumonia and pediatric respiratory infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis [1] - The company has upgraded its EB virus nucleic acid detection kit, enhancing detection sensitivity and supporting various specimen types such as plasma and whole blood [1] - The CYP3A5 gene polymorphism nucleic acid detection kit is designed to guide clinical medication plans for the core anti-rejection drug tacrolimus post-transplant [1]

Group 1: Industry Trends and Innovations - The "2025 Fifth China Health Industry Development and Rehabilitation Service Conference" was held in Beijing, focusing on integrating resources and exploring development paths in the health industry [1] - The conference featured discussions on cutting-edge topics such as innovative drugs, brain-machine interfaces, AI in healthcare, and the transformation of traditional Chinese medicine [1] - A series of innovative case studies were presented, showcasing advancements in areas like ESG, biotechnology, and AI healthcare, reflecting the vitality and innovation in the health sector [1] Group 2: Company Highlights - Gan Li Pharmaceutical is the first company in China to master the industrial production of recombinant insulin analogs, recently achieving significant milestones with its insulin injection and a commercial agreement for a GLP-1 receptor agonist [2] - Shengxiang Bio focuses on integrated diagnostic and therapeutic solutions, having developed over 1,000 products and served more than 30 billion tests globally, emphasizing its commitment to making life sciences accessible [3] - Nanjing Xinbai has established a dual-driven model in cell therapy and clinical transformation, with significant advancements in immunotherapy for prostate cancer and a leading position in umbilical cord blood storage [4][5] - Mirxes has developed a non-invasive gastric cancer screening solution, filling a technological gap in China and demonstrating significant clinical applicability and commercial potential [9] - Ruixi Bio specializes in micro-ecological medical solutions, having built a comprehensive database and developed a novel theory for precision medical interventions in chronic diseases [12][13]

智通财经APP讯，圣湘生物(688289.SH)发布公告，公司的产品全自动核酸处理系统(S-S13E-P/S-S13E- P1)于近日获得欧盟CEIVDR认证。该设备可实现从样本到报告的全流程自动化，包括样本管开盖、移 液、核酸提取、PCR体系构建、封膜扩增及结果分析，具有处理高效、检测精准、智能控制、广泛兼容 等特点。检测项目丰富，涵盖HPV、性病、血源、呼吸道、虫媒、药物基因组等类别，适配实验室、医 院、检验中心等各类专业应用场景，在有限空间内高效满足样本检测、实验分析等多元化需求。 该款仪器本次获得欧盟CEIVDR认证，标志着公司在分子诊断技术国际化与标准化进程迈出关键一步。 这一里程碑不仅体现了产品的卓越性能与安全标准，更展现了公司引领行业创新、服务全球市场的坚定 承诺。未来，公司将持续推动技术革新与方案融合，赋能全球医疗机构与公共卫生体系，助力构建更高 效、精准、可靠的健康防控新生态。 ...

圣湘生物(688289.SH)发布公告，公司的产品全自动核酸处理系统(S-S13E-P/S-S13E-P1)于近日获得欧盟 CEIVDR认证。该设备可实现从样本到报告的全流程自动化，包括样本管开盖、移液、核酸提取、PCR 体系构建、封膜扩增及结果分析，具有处理高效、检测精准、智能控制、广泛兼容等特点。检测项目丰 富，涵盖HPV、性病、血源、呼吸道、虫媒、药物基因组等类别，适配实验室、医院、检验中心等各类 专业应用场景，在有限空间内高效满足样本检测、实验分析等多元化需求。 该款仪器本次获得欧盟CEIVDR认证，标志着公司在分子诊断技术国际化与标准化进程迈出关键一步。 这一里程碑不仅体现了产品的卓越性能与安全标准，更展现了公司引领行业创新、服务全球市场的坚定 承诺。未来，公司将持续推动技术革新与方案融合，赋能全球医疗机构与公共卫生体系，助力构建更高 效、精准、可靠的健康防控新生态。 ...

该设备可实现从样本到报告的全流程自动化，包括样本管开盖、移液、核酸提取、PCR 体系构建、封 膜扩增及结果分析，具有处理高效、检测精准、智能控制、广泛兼容等特点。检测项目丰富，涵盖 HPV、性病、血源、呼吸道、虫媒、药物基因组等类别，适配实验室、医院、检验中心等各类专业应用 场景，在有限空间内高效满足样本检测、实验分析等多元化需求。 该款仪器本次获得欧盟 CE IVDR 认证，标志着公司在分子诊断技术国际化与标准化进程迈出关键一 步。这一里程碑不仅体现了产品的卓越性能与安全标准，更展现了公司引领行业创新、服务全球市场的 坚定承诺。未来，公司将持续推动技术革新与方案融合，赋能全球医疗机构与公共卫生体系，助力构建 更高效、精准、可靠的健康防控新生态。 格隆汇12月11日丨圣湘生物(688289.SH)公布，公司的产品全自动核酸处理系统(S-S13E-P/S-S13E-P1)于 近日获得欧盟 CE IVDR 认证。 获批主体：圣湘生物科技股份有限公司，证书编号：CMB 1012-2025，预期用途：全自动核酸处理系统 （S-S13E-P/S-S13E-P1）用于临床样本中核酸的提取和纯化，并进行聚合酶链式反应（PC ...

证券代码：688289 证券简称：圣湘生物 公告编号：2025-078 圣湘生物科技股份有限公司 关于自愿披露相关产品获得欧盟 CE 认证的公告 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。 圣湘生物科技股份有限公司（以下简称"公司"）的产品全自动核酸处理系统 （S-S13E-P/S-S13E-P1）于近日获得欧盟 CE IVDR 认证，现将相关情况公告如下： | 获批主体 | 圣湘生物科技股份有限公司 | | --- | --- | | 证书编号 | CMB 1012-2025 | | 证书类型 | 欧盟CE IVDR注册证 | | 产品名称 | 英文名称：Fully Automated Nucleic Acid Processing System | | | 中文名称：全自动核酸处理系统 全自动核酸处理系统（S-S13E-P/S-S13E-P1）用于临床样本中核酸的 | | | 提取和纯化，并进行聚合酶链式反应（PCR）扩增、荧光检测以及数 | | 预期用途 | 据分析。适用于血清、血浆、咽拭子、肛拭子、粪便、生殖道 ...