圣湘生物公告，公司四款产品近日收到国家药品监督管理局颁发的《医疗器械注册证》。其中，两款呼 吸道"小联检"产品具备高灵敏度、高特异性、操作简便等优势，最快30分钟即可出具报告。肺炎链球 菌、流感嗜血杆菌和卡他莫拉菌是社区获得性肺炎及儿童呼吸道感染的主要致病菌，大肠埃希菌、鲍曼 不动杆菌及嗜麦芽窄食单胞菌多见于医院获得性肺炎及呼吸机相关肺炎患者。此外，EB病毒核酸检测 试剂盒实现了重要技术升级，提升了检测灵敏度，并完善了对血浆、全血等多种标本类型的支持能力。 人CYP3A5基因多态性核酸检测试剂盒主要应用于指导移植术后的核心抗排异药他克莫司的临床用药方 案。 ...

Group 1 - The core point of the article highlights that Shengxiang Bio (688289) is actively expanding its investment in the AI medical application and innovative medical device sectors through a new fund, while also achieving significant product certifications [1][3]. Group 2 - On November 7, 2025, Shengxiang Bio's stock closed at 21.75 yuan, with a slight increase of 0.09% and a trading volume of 50,900 shares, amounting to a total transaction value of 111 million yuan [1]. - On the same day, the net outflow of main funds was 13.05 million yuan, accounting for 11.74% of the total transaction value, while retail investors saw a net inflow of 6.67 million yuan, representing 6.0% of the total [1][3]. Group 3 - Shengxiang Bio plans to invest 370 million yuan as a limited partner in a new medical industry fund with a target size of 1 billion yuan, focusing on AI medical applications and innovative medical devices [1][3]. - The company recently obtained three product certifications, including two Class III medical device registrations and one EU CE IVDR certification, for products related to the detection of Norovirus, Rotavirus, and EB virus [1][3].

Core Viewpoint - Shengxiang Biotechnology Co., Ltd. is actively expanding its investment and product portfolio in the medical device sector, focusing on AI medical applications and innovative diagnostic tools [2][4]. Group 1: Company Financials and Market Position - As of November 7, 2025, Shengxiang Biotechnology's stock closed at 21.75 yuan, down 1.36% from the previous week [1]. - The company's current total market capitalization is 12.602 billion yuan, ranking 23rd out of 126 in the medical device sector and 1536th out of 5166 in the A-share market [1]. Group 2: Recent Announcements - Shengxiang Biotechnology plans to establish a medical industry fund with a target fundraising scale of 1 billion yuan, contributing 370 million yuan, which accounts for 37% of the fund [2][4]. - The fund will focus on investing in AI medical applications and innovative medical technology companies with significant market potential [2]. - The company has recently obtained three product certifications, including two Class III medical device registrations and one EU CE IVDR certification, enhancing its diagnostic capabilities for viral infections [2][4].