Core Viewpoint - The company has received a change registration document from the National Medical Products Administration for its HPV nucleic acid detection kit, which is expected to enhance market expansion capabilities and positively impact future operations [1] Group 1 - The company has completed the change of registration for the "HPV Nucleic Acid Detection and Typing Kit (Fluorescent PCR Method)" [1] - The kit is designed for qualitative detection of 14 types of HPV nucleic acids in cervical exfoliated cells, specifically typing HPV16 and HPV18 [1] - This change aims to better meet the diverse testing needs of end customers [1]

Core Viewpoint - The company, Tuojing Life (300642), has received a change registration document from the National Medical Products Administration for its HPV nucleic acid detection kit, indicating an expansion in the product's intended use [1] Group 1: Product Changes - The product's new intended use includes qualitative detection of 14 high-risk HPV types in cervical exfoliated cells and specific typing for HPV16 and HPV18 [1] - The kit can be used for screening patients with ASC-US results from cervical cytology to determine the need for colposcopy [1] - For women aged 30 and above, the product can be combined with cytological history and other risk factors for cervical cancer primary screening, joint screening, and patient management [1]

证券代码：300642 证券简称：透景生命 公告编号：2025-086 上海透景生命科技股份有限公司 关于取得医疗器械变更注册（备案）文件的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 上海透景生命科技股份有限公司（以下简称"公司"）于近日收到由国家药 品监督管理局颁发的《医疗器械变更注册（备案）文件》，公司已完成"人乳头 瘤病毒核酸检测与 16/18 分型试剂盒（荧光PCR法）"产品原注册证相关事项的 变更，具体情况如下： | 产品名称 | 注册证编号 | 注册分类 | 变更后的预期用途 | | --- | --- | --- | --- | | | | | 本试剂盒用于定性检测人宫颈脱落细胞中 14 种人乳头 瘤病毒(Human papillomavirus,HPV)核酸（具体包括 | | | | | HPV16、HPV18、HPV31、HPV33、HPV35、HPV39、HPV45、 | | | | | HPV51、HPV52、HPV56、HPV58、HPV59、HPV66、HPV68）， | | | | | 并对其中HPV16、HPV18 进行 ...

本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 一、对外投资概述 上海透景生命科技股份有限公司（以下简称"公司"或"透景生命"）基于 长期战略发展规划，与惠和生物技术（上海）有限公司（以下简称"惠和生物"）、 上海欣百诺生物科技有限公司、上海路思何企业管理合伙企业（有限合伙）、朱 化星、黄应峰等分别签署《关于惠和生物技术（上海）有限公司之增资协议》（以 下简称"《增资协议》"）和《关于惠和生物技术（上海）有限公司之股东协议》 （以下简称"《股东协议》"，与《增资协议》单独或合称"《协议》"），约 定以自有资金人民币6,800万元认购惠和生物新增注册资本人民币17.5992万元。 本次投资完成后，公司将持有惠和生物 9.2141%的股权。具体内容请详见公司于 2025 年 10 月 23 日在巨潮资讯网（www.cninfo.com.cn）披露的《关于对外投资 参股公司的公告》（公告编号：2025-078）。 二、对外投资的进展情况 证券代码：300642 证券简称：透景生命 公告编号：2025-085 上海透景生命科技股份有限公司 关于对外投资参股公司的进展公 ...

Core Points - The company, Toujing Life, announced that its subsidiary, Wuhan Kanglu Biotechnology Co., Ltd., has received acceptance for its domestic in vitro diagnostic reagent registration application from the National Medical Products Administration [2] Group 1 - The product name is PML/RARA fusion gene detection kit (fluorescence in situ hybridization method) [2]

Core Viewpoint - The company,透景生命, has recently received a patent certificate from the National Intellectual Property Administration of the People's Republic of China for an invention related to hybridoma cell lines and their secreted antibodies [2]. Group 1 - The patent awarded is for the application of hybridoma cell lines 10B9E3-1 and 2D5C12-1 along with their secreted antibodies [2].

Core Viewpoint - The company announced that its subsidiary, Wuhan Kanglu Biological Technology Co., Ltd., has received acceptance for its application for the registration of an in vitro diagnostic reagent for the PML/RARA fusion gene detection kit, which is significant for the diagnosis of acute promyelocytic leukemia (APL) [1] Group 1 - The PML/RARA fusion gene is a critical molecular mechanism in the development of APL, with over 90% of APL patients exhibiting a specific chromosomal translocation t(15;17)(q24;q12) [1] - The detection of the PML/RARA fusion gene provides a reference for the molecular typing of leukemia, although the results should not be the sole basis for patient diagnosis [1] - The acceptance of this product application enhances the company's molecular diagnostic product line, which is expected to strengthen its leading position in the domestic pathology market and improve market competitiveness [1]

Core Viewpoint - The company announced that its subsidiary, Wuhan Kanglu Biological Technology Co., Ltd., has received acceptance for its application for the registration of an in vitro diagnostic reagent for the PML/RARA fusion gene detection kit, which is significant for the diagnosis of acute promyelocytic leukemia (APL) [1] Group 1 - The PML/RARA fusion gene is a critical molecular mechanism in the development of APL, with over 90% of APL patients exhibiting a specific chromosomal translocation t(15;17)(q24;q12) [1] - The detection of the PML/RARA fusion gene provides a reference for the molecular typing of leukemia, although the results should not be the sole basis for patient diagnosis [1] - The acceptance of this product application enhances the company's molecular diagnostic product line, contributing to a comprehensive market offering and strengthening its competitive position in the domestic pathology market [1]

证券代码：300642 证券简称：透景生命 公告编号：2025-084 上海透景生命科技股份有限公司 本次获得受理的产品属于分子病理领域产品，有利于丰富公司及控股子公司 的分子诊断产品线布局。丰富、齐全的产品线有助于公司全方位的满足市场需求， 巩固公司及控股子公司在国内病理市场的领先地位，进一步提高公司的市场竞争 力。 三、注册所处阶段 目前所处的审批阶段为注册申请受理阶段，后续尚需履行的审批流程为技术 审评、行政审批、核发批件。 四、主要风险 关于子公司申报医疗器械注册获得受理的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 上海透景生命科技股份有限公司（以下简称"公司"）控股子公司武汉康录 生物技术股份有限公司（以下简称"康录生物"或"控股子公司"）申报的境内 体外诊断试剂注册申请于近日获得了国家药品监督管理局的受理，具体情况如 下： 一、基本情况 | 产品名称 | 注册分类 | 预期用途 | | --- | --- | --- | | PML/RARA 融合基因检测试剂盒 | 第三类体外 | 本产品适用于定性检测白血病患者骨髓样本中 PML/RAR ...

上海透景生命科技股份有限公司（以下简称"透景生命"或"公司"）及全 资子公司上海透景诊断科技有限公司（以下简称"透景诊断"或"全资子公司"） 于近期收到中华人民共和国国家知识产权局颁发的 1 项发明专利证书，具体情况 如下： | | | 专利名称 | | | | 专利号 | | 专利权人 | 专利类型 | 申请日期 | | 有效期 | | 证书号 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 杂 交 瘤 | 细 | 胞 株 | | 10B9E3-1 | 和 | ZL | 2021 1 | 透景生命； | | 2021 | 年09 | | | | | | | | | | | | | | | 发明专利 | | | 20 年 | 第 | 8399030 | 号 | | 2D5C12-1 | | | 及其分泌抗体的应用 | | | 1081542.2 | | 透景诊断 | | 月 15 | 日 | | | | | 上述专利提供了一对抗平滑肌肌球蛋白重链(SM ...