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透景生命(300642.SZ):骨髓增生异常综合征染色体及基因异常检测试剂盒(荧光原位杂交法)医疗器械注册获受理
智通财经网· 2026-01-12 10:05
上述受理产品主要应用于骨髓增生异常综合征中常见染色体及基因异常的检测,其检测结果仅供临床参 考,不应作为患者诊断的唯一依据,临床医生应结合临床其他检测指标等因素对检测结果进行综合判 断。骨髓增生异常综合征是一组起源于造血干细胞的异质性髓系克隆性疾病,其特点是髓系细胞发育异 常,表现为无效造血、难治性血细胞减少,高风险向急性髓系白血病转化。40%-70%的原发性骨髓增生 异常综合征患者在初诊时便存在染色体异常。染色体核型异常是骨髓增生异常综合征维也纳诊断标准中 主要标准之一。应用骨髓增生异常综合征组套探针进行荧光原位杂交检测,可提高部分患者细胞遗传学 异常检出率。 智通财经APP讯,透景生命(300642.SZ)发布公告,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,涉及产品:"骨髓增生异常综合征染色体及基因异常检测试剂盒(荧光原位杂交法)"。 ...
透景生命:骨髓增生异常综合征染色体及基因异常检测试剂盒(荧光原位杂交法)医疗器械注册获受理
智通财经网· 2026-01-12 08:57
Core Viewpoint - The announcement indicates that the company's subsidiary, Wuhan Kanglu Biological Technology Co., Ltd., has had its application for a domestic in vitro diagnostic reagent accepted by the National Medical Products Administration, focusing on a kit for detecting chromosomal and genetic abnormalities in myelodysplastic syndromes [2] Group 1: Product Details - The accepted product is a "Chromosomal and Genetic Abnormality Detection Kit for Myelodysplastic Syndromes (Fluorescence In Situ Hybridization Method)" [2] - This kit is primarily used for detecting common chromosomal and genetic abnormalities in myelodysplastic syndromes, with results intended for clinical reference only and not as the sole basis for patient diagnosis [2] Group 2: Clinical Relevance - Myelodysplastic syndromes are heterogeneous myeloid clonal diseases originating from hematopoietic stem cells, characterized by ineffective hematopoiesis and refractory cytopenia, with a high risk of transformation to acute myeloid leukemia [2] - 40%-70% of primary myelodysplastic syndrome patients present chromosomal abnormalities at initial diagnosis, making chromosomal karyotype abnormalities a major criterion in the Vienna diagnostic standards for myelodysplastic syndromes [2] Group 3: Detection Improvement - The use of the myelodysplastic syndrome probe set for fluorescence in situ hybridization can enhance the detection rate of cytogenetic abnormalities in certain patients [2]
透景生命:控股子公司申报医疗器械注册获得受理
Mei Ri Jing Ji Xin Wen· 2026-01-12 08:41
每经AI快讯,1月12日,透景生命(300642.SZ)公告称,公司控股子公司康录生物申报的境内体外诊断试 剂注册申请近日获得国家药品监督管理局受理,产品适用于定性检测5号、7号、8号、17号、20号、Y 染色体及相关基因的异常,仅用于患者的辅助诊断。该产品属于分子病理领域,有利于丰富公司及控股 子公司的分子诊断产品线布局,巩固其在国内病理市场的领先地位。 (文章来源:每日经济新闻) ...
透景生命(300642) - 关于子公司申报医疗器械注册获得受理的公告
2026-01-12 08:26
证券代码:300642 证券简称:透景生命 公告编号:2026-001 上海透景生命科技股份有限公司 关于子公司申报医疗器械注册获得受理的公告 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 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 | | --- | --- | --- | | | | 本产品适用于定性检测 5 号、7 号、8 号、17 号、20 号、 | | 骨髓增生异常综合征染色体及 | ...
透景生命跌2.03%,成交额3991.50万元,主力资金净流出367.40万元
Xin Lang Cai Jing· 2025-12-26 03:36
Core Viewpoint - The stock of TuoJing Life has experienced fluctuations, with a current market value of 3.062 billion yuan and a year-to-date increase of 34.84% [1] Group 1: Stock Performance - As of December 26, TuoJing Life's stock price is 18.84 yuan per share, down 2.03% during the trading session [1] - The stock has seen a trading volume of 39.915 million yuan, with a turnover rate of 1.53% [1] - Year-to-date, the stock has increased by 34.84%, but has decreased by 4.37% over the past 20 days and 17.48% over the past 60 days [1] Group 2: Financial Performance - For the period from January to September 2025, TuoJing Life reported operating revenue of 258 million yuan, a year-on-year decrease of 19.73% [2] - The net profit attributable to shareholders for the same period was 5.775 million yuan, down 76.33% year-on-year [2] Group 3: Shareholder Information - As of September 30, 2025, TuoJing Life had 18,800 shareholders, an increase of 17.52% from the previous period [2] - The average number of circulating shares per shareholder is 7,330, which is a decrease of 14.91% from the previous period [2] - The company has distributed a total of 264 million yuan in dividends since its A-share listing, with 81.3647 million yuan distributed in the last three years [3] Group 4: Institutional Holdings - As of September 30, 2025, several new institutional shareholders have entered, including Guangfa Medical Health Stock A, holding 1.9535 million shares, and Guangfa Medical Health Mixed A, holding 1.8988 million shares [3] - Other new institutional shareholders include Changcheng Medical Industry Selected Mixed Fund and Invesco Great Wall Medical Health Mixed A, holding 1.7617 million shares and 1.3924 million shares, respectively [3] - CITIC Prudential Multi-Strategy Mixed Fund has exited the top ten circulating shareholders list [3]
透景生命:取得杂交瘤细胞株1C2B8-2发明专利
Zheng Quan Ri Bao Zhi Sheng· 2025-12-23 11:38
Core Viewpoint - The company announced the issuance of a patent for a hybridoma cell line and its application, which targets Calponin1 for early screening and prognosis assessment of acute aortic dissection [1] Group 1: Patent Announcement - The company and its wholly-owned subsidiary have been granted a patent for "Hybridoma Cell Line 1C2B8-2 and Its Secreted Antibody Application" with a patent number of ZL202111082848.X, valid for 20 years [1] - The antibody developed targets Calponin1, which is significant for the early screening and prognosis evaluation of acute aortic dissection [1] Group 2: Impact on Business - The company stated that the patent will not have a significant impact on its performance at this time [1] - The issuance of the patent is expected to strengthen the company's intellectual property barriers [1]
透景生命(300642) - 关于部分股票期权注销完成和部分限制性股票回购注销完成的公告
2025-12-23 08:50
证券代码:300642 证券简称:透景生命 公告编号:2025-093 上海透景生命科技股份有限公司 关于部分股票期权注销完成和部分限制性股票回购注销完成的公告 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。 特别提示: 1、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") 本次注销的股票期权(透景 JLC2)涉及 2 人,注销的股票期权(透景 JLC2)数 量共计 54,000 份。 2、公司本次回购注销的限制性股票涉及 2 人,回购注销的股份数量共计 12,000 股,占回购注销前公司总股本 162,556,041 股的 0.0074%,回购价格为 10.65 元/股,本次限制性股票回购总金额为 127,800 元。 3、截至本公告披露日,公司在中国证券登记结算有限责任公司深圳分公司 全部办理完成上述股票期权的注销和限制性股票的回购注销手续。 4、本次限制性股票回购注销完成后,公司股份总数由 162,556,041 股减少 至 162,544,041 股。 一、本次注销股票期权和回购注销限制性股票审批情况 公司于 2025 年 10 月 22 ...
透景生命(300642) - 关于取得发明专利证书的公告
2025-12-23 07:42
证券代码:300642 证券简称:透景生命 公告编号:2025-092 上述发明专利系公司及全资子公司自主研发,未应用于公司产品。上述专利 证书的取得不会对公司业绩产生重大影响,但在一定程度上有利于发挥公司及全 资子公司的自主知识产权优势,完善知识产权保护体系,形成持续创新机制,提 升公司的核心竞争力。 特此公告。 上海透景生命科技股份有限公司 关于取得发明专利证书的公告 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"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 | 1C2B8-2 | 及 | ZL | 2021 1 | ...
透景生命:全资子公司取得5项医疗器械注册证
Zheng Quan Ri Bao Zhi Sheng· 2025-12-19 15:13
Core Viewpoint - The company, Tsinghua Tongfang, announced that its wholly-owned subsidiary, Shanghai Tsinghua Tongfang Diagnostic Technology Co., Ltd., has obtained five medical device registration certificates from the Shanghai Municipal Medical Products Administration [1] Group 1: Medical Device Registration - The five registered medical devices include: 1. Anti-double-stranded DNA antibody IgG test kit (flow cytometry method) 2. Anti-complement 1q antibody IgG test kit (flow cytometry method) 3. Anti-M2-3E antibody IgG test kit (flow cytometry method) 4. Anti-phospholipid syndrome IgA antibody test kit (flow cytometry method) 5. Anti-nucleosome antibody IgG test kit (flow cytometry method) [1]
透景生命子公司取得医疗器械注册证
Zhi Tong Cai Jing· 2025-12-19 11:57
透景生命(300642)(300642.SZ)公告,公司全资子公司上海透景诊断科技有限公司近日取得上海市药 品监督管理局颁发的5项医疗器械注册证,产品包括:抗双链DNA抗体IgG测定试剂盒(流式荧光发光 法)、抗补体1q抗体IgG测定试剂盒(流式荧光发光法)、抗M2-3E抗体IgG测定试剂盒(流式荧光发光法)、 抗磷脂综合征IgA抗体测定试剂盒(流式荧光发光法)、抗核小体抗体IgG测定试剂盒(流式荧光发光法)。 ...