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 ...

Core Viewpoint - The strategic cooperation agreement between Shengxiang Biotechnology Co., Ltd. and BeiGene (Guangzhou) Innovation Technology Co., Ltd. marks a significant acceleration of Shengxiang's "integrated diagnosis and treatment" strategy [1] Group 1: Cooperation Goals - The collaboration aims to achieve full-link synergy in early screening, precise drug selection, efficacy monitoring, and safety assessment in key areas such as oncology, metabolism, immune inflammation, and children's growth and development [3] - The partnership will leverage large-scale population sample studies to identify suitable intervention targets and optimal timing, enhancing treatment levels in metabolism and immune inflammation while addressing health management challenges related to children's growth and development [3] Group 2: Technological Synergy - The core support for aligning innovative therapies with patient needs lies in precise diagnostic and treatment technologies, which will enhance innovation efficiency and ensure solutions are more aligned with clinical realities [3] - Shengxiang has initiated the construction of an integrated diagnosis and treatment ecosystem, with Shengxiang Haiji serving as the core platform in biopharmaceuticals, facilitating a strong collaboration with BeiGene's innovative research capabilities [3] Group 3: Implementation Framework - The BeiGene Biopharmaceutical Innovation Center will act as the central hub for collaboration, utilizing existing research support, clinical resources, and industrial incubation capabilities to create a comprehensive cooperation chain from technology exploration to clinical validation and practical application [4] - The partnership extends beyond technical collaboration to include joint exploration in children's health and metabolism, as well as coordinated resource layout in the industry, with the potential to expand global cooperation and promote innovative outcomes to more countries and regions [4]