行业深度研究 | 医疗器械 IVD 国内短期承压，头部企业积极出海 IVD 体外诊断相关医疗器械行业报告 全球的 IVD 行业始于 20 世纪 50 年代，由美国科学家率先应用于胰岛素的测 定，随着全球医疗科技水平的提升和人类对医疗健康的需求不断增大，全球 IVD 行业在 20 世纪 70~80 年代得到了快速的发展。根据弗若斯特沙利文报 告，2018 至 2030 年，全球体外诊断市场规模呈增长趋势，预测由 2018 年 667 亿美元增长至 2030 年 1,861 亿美元，年均复合增长率为 8.9%。 我国体外诊断行业的发展起步较晚，在较短的时间内经历了市场导入和快速 发展期，并逐步进入到升级取代期。这期间体外诊断产品技术呈多元化发展 趋势，形成了生化、免疫、POCT、分子、病理等多种诊断技术并行发展的 局面，推动临床精准诊断能力持续提升。 近几年来，化学发光免疫诊断技术在免疫诊断市场份额中的占比不断扩大。 根据 Eshare 医械汇测算，2021 年-2023 年，我国免疫诊断的市场规模由 373 亿元增长至 503 亿元，期间年复合增长率为 16.13%，处于快速增长阶段。 生化诊断的技术门槛相对不 ...

证券日报网讯12月9日晚间，科华生物（002022）发布公告称，近日，上海科华生物工程股份有限公司 全资子公司科华(西安)生物工程有限公司收到陕西省药品监督管理局颁发的医疗器械注册证，产品为全 自动化学发光免疫分析仪，注册证编号陕械注准20252220247，有效期至2030年12月02日。 ...

（记者 王瀚黎） 截至发稿，科华生物市值为33亿元。 每经头条（nbdtoutiao）——处方药变"瘾品"：国内首次报告普瑞巴林滥用致成瘾病例，网络平台暴 露"无病历可购药"漏洞，列管与否尚需科学考量 每经AI快讯，科华生物（SZ 002022，收盘价：6.4元）12月9日晚间发布公告称，近日，上海科华生物 工程股份有限公司全资子公司科华（西安）生物工程有限公司收到陕西省药品监督管理局颁发的医疗器 械注册证。产品名称为"全自动化学发光免疫分析仪"。 2025年1至6月份，科华生物的营业收入构成为：生物制品业占比100.0%。 ...

人民财讯12月9日电，科华生物（002022）12月9日公告，近日，公司全资子公司科华(西安)生物工程有 限公司收到陕西省药品监督管理局颁发的医疗器械注册证，产品为全自动化学发光免疫分析仪。 ...

科华生物（002022）(002022.SZ)公告，公司全资子公司科华(西安)生物工程有限公司收到陕西省药品监 督管理局颁发的医疗器械注册证，产品名称为：全自动化学发光免疫分析仪。 ...

智通财经APP讯，科华生物(002022.SZ)公告，公司全资子公司科华(西安)生物工程有限公司收到陕西省 药品监督管理局颁发的医疗器械注册证，产品名称为：全自动化学发光免疫分析仪。 ...

中新网郑州11月26日电 河南省政府新闻办26日举行2025河南省民营经济高质量发展系列第二场新闻发 布会通报称，截至目前，河南省民营企业中，高新技术企业数量达到12649家，科技型中小企业数量达 到27796家。 今年前三季度，河南规上高新技术产业增加值累计增速10.5%，规上高新技术企业以占规上工业23.3% 的比重贡献了34.2%的产值，高新技术产业增加值占规上工业增加值比重达到52%。这一数据足以说 明，创新赋能河南民营经济高质量发展工作取得了较好成效，企业创新发展意愿不断增强。 在河南省科学技术厅党组成员、副厅长陶曼晞看来，这一系列成绩的取得，得益于该省从突出"政策助 企""服务助企""特色助企""人才助企""金融助企""成果助企"等多个方面对民营经济高质量发展进行了赋 能。 河南省工业和信息化厅二级巡视员任伟军在新闻发布会上介绍称，近年来，河南主动融入新一轮科技革 命和产业变革，将数字化转型作为加快民营经济提质升级的重要抓手，坚持企业、行业、区域分类推 进，强化要素支撑，有力推动了民营经济高质量发展。 "河南省科学院服务的近万家企业中，80%以上是民营企业。"河南省科学院党委委员、副院长邱士可介 ...

Core Viewpoint - The Chinese Academy of Sciences' Institute of Basic Medicine and Oncology has announced multiple government procurement intentions for laboratory equipment, with a total budget of 156 million yuan [2][3]. Procurement Summary - The procurement includes five main types of equipment: electroporation instruments, third-generation nanopore sequencers, small animal in vivo three-dimensional optical imaging systems, high-performance liquid chromatographs, and fully automated chemiluminescence immunoassay analyzers [3][4]. - The expected procurement period is from August to November 2025 [3]. Equipment Details - **Fully Automated Chemiluminescence Immunoassay Analyzer**: A high-precision detection device used for quantitative analysis of trace substances in biological samples, such as proteins and tumor markers [4]. - **Radioactive Thin Layer Chromatography Scanner**: A specialized analytical device for quantifying radioactive labeled compounds, applicable in nuclear medicine and toxicology [5]. - **Near-Infrared Raman Endoscopic Microscopy**: An advanced diagnostic device that combines Raman spectroscopy with endoscopic imaging for label-free analysis of tissue chemical composition [6]. Detailed Procurement List - The procurement list includes various equipment with specific budget allocations, such as: - Electroporation instrument: 200,000 yuan - Third-generation nanopore sequencer: 300,000 yuan - Small animal in vivo three-dimensional optical imaging system: 3,800,000 yuan - High-performance liquid chromatograph (3 units): 1,250,000 yuan - Fully automated chemiluminescence immunoassay analyzer: 1,200,000 yuan - Radioactive thin layer chromatography scanner: 450,000 yuan [9].

Core Viewpoint - Lideman plans to acquire 70% of Xiansheng Xiangrui for 1.733 billion yuan, marking a significant asset restructuring that will enhance its financial position and market presence in the biopharmaceutical industry [1][4]. Group 1: Acquisition Details - The transaction involves cash payment to Shanghai Baijiahui Investment Management Co., Nanjing Baijiarui Enterprise Management Consulting Partnership, and Hainan Xiansheng Baijiahui Technology Development Co. for 70% of Xiansheng Xiangrui [1]. - The acquisition will allow Lideman to consolidate Xiansheng Xiangrui into its financial statements, as the asset totals exceed 50% of Lideman's assets, revenue, and net assets [1]. Group 2: Company Overview - Lideman specializes in the research, production, and sales of in vitro diagnostic reagents, diagnostic instruments, and biochemical raw materials, with products widely used in clinical diagnostics across various healthcare institutions [2]. - Xiansheng Xiangrui, a member of Xiansheng Investment Group, focuses on biopharmaceuticals, particularly in vitro diagnostic reagents and vaccines, with a strong market position in tuberculosis screening [2][3]. Group 3: Financial Impact - Lideman's revenue for 2023, 2024, and the first three quarters of 2025 is projected at 462 million yuan, 370 million yuan, and 252 million yuan, respectively, with net profits showing a decline in 2024 and 2025 [4]. - Post-acquisition, Lideman expects to improve its financial metrics significantly, with Xiansheng Xiangrui projected to generate revenues of 653 million yuan, 582 million yuan, and 228 million yuan for the same periods, despite a downward trend [4]. - Xiansheng Xiangrui has committed to achieving a minimum net profit of 166 million yuan, 186 million yuan, and 208 million yuan for 2025, 2026, and 2027, respectively, totaling at least 560 million yuan over three years [4].

Core Viewpoint - Lidman plans to acquire 70% of Xiansheng Xiangrui for 1.733 billion yuan, aiming to enhance its position in the biopharmaceutical industry and improve financial performance [2][5][7]. Group 1: Transaction Details - The acquisition involves cash payment for 70% equity of Xiansheng Xiangrui, with a transaction value of 1.733 billion yuan [2]. - The assets of Xiansheng Xiangrui exceed 50% of Lidman's total assets, constituting a major asset restructuring [3]. - Following the transaction, Lidman will consolidate Xiansheng Xiangrui into its financial statements [2][7]. Group 2: Company Background - Lidman specializes in the research, production, and sales of in vitro diagnostic reagents, diagnostic instruments, and biochemical raw materials [4]. - Xiansheng Xiangrui, a member of Xiansheng Investment Group, focuses on biopharmaceuticals, particularly in vitro diagnostic reagents and vaccines, with a strong market position in tuberculosis screening [4][5]. Group 3: Financial Impact - The acquisition is expected to enhance Lidman's revenue and net profit, improving its overall financial condition [6][7]. - Projected revenues for Xiansheng Xiangrui are 6.53 billion yuan, 5.82 billion yuan, and 2.28 billion yuan for 2023, 2024, and the first three quarters of 2025, respectively [6][7]. - Xiansheng Xiangrui has committed to achieving a minimum net profit of 1.66 billion yuan, 1.86 billion yuan, and 2.08 billion yuan for the years 2025, 2026, and 2027 [7].