9月23日，记者获悉，"AI+检验，智启新纪元：血涂片全域分析智能体"成果发布会于近日举办。北京 小蝇科技有限责任公司（以下简称"小蝇科技"）携全国首个获批体外诊断领域人工智能三类医疗器械注 册证的创新产品——Cygnus全自动血细胞形态学分析系统（以下简称"Cygnus分析系统"）亮相。 当患者白细胞减少时，外周血涂片中细胞密度进一步降低，使用传统显微镜对患者进行血涂片分类时， 费时费力，还容易漏掉有价值的异常细胞。而Cygnus分析系统使用"血膜全域扫描模式"，可精准分析外 周血涂片中所有白细胞，大大提高了异常细胞的检出率。在发现异常细胞时，可精准定位外周血涂片中 细胞所在位置，方便镜检人员在显微镜下复核，显著提升样本检测结果的准确性。 "Cygnus分析系统能识别多种异常血细胞，经国家药品监督管理局验证，其准确率≥90%，检测结果不受 检验人员疲劳、经验差异影响，即便样本质量较低也可直接精准分析。"小蝇科技联合创始人伍博深 说，Cygnus分析系统不仅是单纯的技术产品，也已成为区域医疗服务质量提升的"利器"。小蝇科技携 Cygnus分析系统深度参与了北京市海淀区"外周血细胞形态学分析技术科技应用场景项目 ...

Core Viewpoint - Guangzhou Wanfeng Biotechnology Co., Ltd. reported its 2025 semi-annual results, showing a revenue of 1.246 billion yuan and a net profit of 189 million yuan, impacted by intensified competition and demand pressure in the in vitro diagnostic industry [1] Group 1: Financial Performance - The company achieved operating revenue of 1.246 billion yuan and a net profit attributable to shareholders of 189 million yuan in the first half of the year [1] - Revenue from toxicology testing reached 145 million yuan, representing a year-on-year growth of 4.26% [1] Group 2: Product Development and Market Strategy - In the infectious disease testing sector, the company enhanced the coverage of influenza testing products in leading medical terminals and introduced new respiratory detection products [1] - The company is expected to obtain certification for its respiratory triple detection product in the second half of 2025 [1] - In chronic disease management, the company adjusted its strategy to strengthen its hospital base, with significant growth in its chemiluminescence business through specialized projects [1] - The Ucare-6000 fully automated blood gas and biochemical analyzer was launched domestically, providing a cost-effective solution for ICU and respiratory departments [1] Group 3: International Expansion and AI Integration - The company has established a global service network covering over 150 countries and regions, with local production bases in multiple countries [2] - A strategic cooperation agreement was signed with Tencent Health to develop an AI platform for intelligent diagnostics and health management [2] - The company aims to focus on seven major disease categories, leveraging its core technology platforms in immunology, molecular diagnostics, and electrochemistry for future growth [2]

Core Insights - Wanfu Bio reported a revenue of 1.246 billion yuan and a net profit of 189 million yuan for the first half of the year, facing challenges from intensified competition and demand pressure in the in vitro diagnostics (IVD) industry [1] - The company is committed to advancing its IPD transformation to strengthen core competitiveness, focusing on product innovation and consolidating its advantages in the immunology field [1][5] - Wanfu Bio aims to enhance its global presence through domestic and international dual circulation and digital transformation to maximize internal potential and drive business growth [1] Infectious Disease Testing - The company is enhancing the coverage of its influenza testing products in leading medical terminals and is introducing new respiratory testing products, with a three-in-one respiratory test product expected to receive certification by the second half of 2025 [1] - In the U.S. market, Wanfu Bio is rapidly diversifying sales channels for new respiratory testing products, while also achieving breakthroughs in sales of pre-surgical blood screening products in developing countries [1] Chronic Disease Management Testing - The company is implementing strategic adjustments to solidify its hospital base, with its chemiluminescence business making progress in projects related to thrombosis, cytokines, and hypertension [2] - The Ucare-6000, an automated blood gas and biochemical analyzer, has been launched domestically, providing a cost-effective solution for ICU and respiratory departments in hospitals [2] Toxicology Testing - Wanfu Bio achieved revenue of 145 million yuan in the toxicology testing sector, a 4.26% increase year-on-year, and is deepening its integrated layout in the North American toxicology market [2] Maternal and Child Health Testing - The company is strengthening its core competitiveness in the early pregnancy market, with its "Xiu'er" and "Jin Xiu'er" brands receiving multiple recommendations and awards from maternal and infant platforms [2] Research and Development - Wanfu Bio continues to invest heavily in R&D, with an expenditure of 206 million yuan in the first half of the year, resulting in the launch of 95 new products [2] - The company holds 681 product registration certificates, ranking among the top in the IVD industry [2] Chemical Luminescence and Immunofluorescence Platforms - The company launched the LA-6000 laboratory intelligent assembly line based on its FC-9000 high-speed chemiluminescence machine, and has registered over 150 medical device product certificates for its single-use chemiluminescence products globally [3] - New dry fluorescence immunoassay analyzers FS-1000 and FS-2000 have been introduced, along with a rapid screening reagent for the chikungunya virus [3] Pathology Business - Wanfu Bio developed a human microsatellite instability (MSI) testing kit, becoming the first in China to receive approval for this methodology, marking a significant breakthrough in tumor precision detection [3] - The company’s investment in a digital pathology image-assisted diagnosis software for cervical cells has received approval, representing a milestone in the integration of digital pathology and AI-assisted diagnosis [3] AI Platform and Global Expansion - The company has created an intelligent testing AI platform, "Wanfu Smart Testing," which has been applied in various medical scenarios [4] - Wanfu Bio has established a global service network covering over 150 countries and regions, with local production bases in several countries to enhance its international operations [4] Future Outlook - The company plans to focus on three core technology platforms: immunology, molecular, and electrochemistry, targeting seven major disease categories while advancing its strategies of combination, internationalization, and digitalization [5]