全自动化学发光免疫分析仪

Search documents
东方海洋(002086.SZ)子公司取得一项医疗器械注册证
智通财经网· 2025-09-18 11:35
智通财经APP讯,东方海洋(002086.SZ)公告,公司全资子公司艾维可生物科技有限公司自主研发的全自 动化学发光免疫分析仪于近日取得了山东省药品监督管理局的注册批准,获得医疗器械注册证。 ...
东方海洋(002086.SZ):全自动化学发光免疫分析仪取得医疗器械注册证
Ge Long Hui A P P· 2025-09-18 11:17
格隆汇9月18日丨东方海洋(002086.SZ)公布,全资子公司艾维可生物科技有限公司自主研发的全自动化 学发光免疫分析仪于近日取得了山东省药品监督管理局的注册批准,获得医疗器械注册证,产品名称: 全自动化学发光免疫分析仪。 ...
普门科技(688389.SH):全自动化学发光免疫分析仪取得医疗器械注册证
Ge Long Hui A P P· 2025-09-04 08:06
Core Viewpoint - Pumen Technology (688389.SH) has recently received a medical device registration certificate from the Guangdong Provincial Drug Administration for its fully automated chemiluminescence immunoassay analyzer, enhancing its product portfolio and market competitiveness [1] Product Details - The newly registered eCL8600 and eCL8800 series analyzers utilize a tridentate ruthenium-based electrochemical luminescence immunoassay technology [1] - The analyzers have testing speeds of 200 tests/hour and 260 tests/hour respectively, supporting batch testing and intelligent scheduling [1] - The devices can provide initial results in as fast as 9 minutes and allow for continuous operation with non-stop consumable replacement [1] - The analyzers employ biomimetic mixing technology to improve mixing efficiency, which is expected to enhance testing efficiency and convenience for end hospitals [1]
普门科技:全自动化学发光免疫分析仪取得医疗器械注册证
Zheng Quan Shi Bao Wang· 2025-09-04 08:02
Group 1 - The company, Pumen Technology (688389), received a medical device registration certificate from the Guangdong Provincial Drug Administration for its fully automated chemiluminescence immunoassay analyzer [1] - The product is intended for qualitative or quantitative detection of analytes in human serum and plasma samples when used with corresponding testing reagents [1]
普门科技获全自动化学发光免疫分析仪医疗器械注册证
Xin Lang Cai Jing· 2025-09-04 07:58
Core Viewpoint - Shenzhen Pumen Technology Co., Ltd. has received a medical device registration certificate for its fully automated chemiluminescence immunoassay analyzer, enhancing its product portfolio and market competitiveness [1] Group 1: Product Registration - The product is classified as Class II medical device with a validity period until September 2, 2030 [1] - The analyzer can perform tests at speeds of 200 and 260 tests per hour, showcasing significant efficiency [1] Group 2: Market Position and Impact - The company has obtained 103 registration certificates for electrochemical luminescence testing reagents and 3 registration certificates for analyzers domestically [1] - The new certification is expected to strengthen the company's competitive edge and facilitate market expansion [1] - However, the sales of the product are influenced by market promotion efforts, making the impact on performance difficult to predict [1]
利德曼筹划收购先声祥瑞
Bei Jing Shang Bao· 2025-07-31 16:40
Core Viewpoint - Lidman is planning to acquire up to 70% of shares in Beijing Xiansheng Xiangrui Biological Products Co., Ltd. to restructure its business amid financial losses, which has positively impacted its stock price [1][2]. Group 1: Acquisition Details - The acquisition will be financed through a combination of self-owned funds and bank loans, with the goal of gaining control over Xiansheng Xiangrui, which will become a subsidiary of Lidman [2]. - The transaction is expected to be classified as a major asset restructuring under relevant regulations [2]. - Xiansheng Xiangrui is currently in the process of preparing for an IPO on the Beijing Stock Exchange [5]. Group 2: Financial Performance - Lidman reported a net loss of approximately 75.1 million yuan in 2024, a significant decline of 589.66% year-on-year, with revenues dropping by 19.79% to about 370 million yuan [8]. - In Q1 of the current year, Lidman also experienced a net loss of approximately 125,170 yuan, although this represented a 53.73% improvement compared to the same period last year [9]. Group 3: Business Operations - Lidman specializes in in vitro diagnostic reagents, diagnostic instruments, and biochemical raw materials, with a focus on biochemical and immunological diagnostic products [8]. - The acquisition of Xiansheng Xiangrui is expected to enhance Lidman's IVD business by adding tuberculosis diagnostic and treatment capabilities [3].
看上先声药业创始人旗下企业 业绩承压的利德曼重组谋自救
Bei Jing Shang Bao· 2025-07-31 13:36
Core Viewpoint - Lidman is planning a restructuring by acquiring up to 70% of Beijing Xiansheng Xiangrui Biological Products Co., Ltd. to improve its financial performance amid recent losses [1][4]. Group 1: Restructuring and Acquisition - Lidman announced its intention to acquire a majority stake in Xiansheng Xiangrui, which is in the process of preparing for an IPO on the Beijing Stock Exchange [1][6]. - The acquisition is expected to enhance Lidman's IVD (in vitro diagnostics) business by adding tuberculosis diagnostic and treatment capabilities [5][10]. - Following the announcement, Lidman's stock price hit the daily limit up, closing at 7.04 yuan per share, a 19.93% increase with a trading volume of 114 million yuan [3][4]. Group 2: Financial Performance - Lidman reported a net loss for 2024, with revenues of approximately 370 million yuan, a year-on-year decrease of 19.79%, and a net profit of -75.1 million yuan, a decline of 589.66% [9]. - In Q1 of this year, Lidman also experienced a net loss, but it was a reduction compared to the same period last year, with revenues of about 78.9 million yuan, down 16.61%, and a net profit of -1.25 million yuan, an improvement of 53.73% year-on-year [10]. - The company attributed its losses to price reductions in diagnostic reagents and a decline in main business income and gross profit due to changes in hospital diagnostic activities [9][10]. Group 3: Background of Target Company - Xiansheng Xiangrui specializes in in vitro diagnostic reagents and human vaccines, with key products used in tuberculosis screening and treatment [4][6]. - The company is currently undergoing a listing advisory process for the Beijing Stock Exchange, with some governance and regulatory improvements still needed [6][7]. - The majority shareholder of Xiansheng Xiangrui is Shanghai Baijiahui Investment Management Co., Ltd., which holds over 85.89% of the company, and its founder, Ren Jinsheng, is a notable figure in the pharmaceutical industry [7].
看上先声药业创始人旗下企业,业绩承压的利德曼重组谋自救
Bei Jing Shang Bao· 2025-07-31 13:25
Core Viewpoint - Lidman is planning to acquire up to 70% of shares in Beijing Xiansheng Xiangrui Biological Products Co., Ltd. to restructure its business amid financial losses, which has led to a significant increase in its stock price [1][3]. Group 1: Acquisition Details - The acquisition will be financed through a combination of the company's own funds and bank loans, with the goal of gaining control over Xiansheng Xiangrui, which will become a subsidiary [3]. - The deal is expected to be classified as a major asset restructuring under relevant regulations [3]. - Xiansheng Xiangrui is primarily engaged in the production of in vitro diagnostic reagents and human vaccines, with key products used in tuberculosis screening and treatment [3][4]. Group 2: Financial Performance - Lidman reported a net loss for 2024, with revenues of approximately 370 million yuan, a year-on-year decrease of 19.79%, and a net profit of approximately -75.1 million yuan, a decline of 589.66% [8]. - In the first quarter of this year, Lidman also experienced a net loss, but it was a reduction compared to the same period last year, with revenues of about 78.9 million yuan, down 16.61%, and a net profit of approximately -1.25 million yuan, an improvement of 53.73% year-on-year [9]. Group 3: Market Context - The target company, Xiansheng Xiangrui, is currently in the process of preparing for an IPO on the Beijing Stock Exchange, indicating its ambition for growth and expansion [5]. - The acquisition is seen as a potential opportunity for Lidman to enhance its business operations and financial performance by diversifying into tuberculosis diagnosis and treatment [9].
万孚生物上市九项新品
Zheng Quan Ri Bao Wang· 2025-07-30 00:45
Core Insights - Guangzhou Wondfo Biotech Co., Ltd. has received approval from the National Medical Products Administration and the Guangdong Provincial Medical Products Administration for nine self-developed test kits [1] - The newly approved thrombus five-item test and tumor marker test kits will provide a richer testing menu and more convenient combinations for clinical use [1] Group 1: Product Development - The thrombus five-item test, including D-Dimer, aids in the auxiliary diagnosis of thrombotic diseases, early diagnosis of DIC, monitoring of thrombolytic and anticoagulant drug efficacy, and diagnosis of vascular endothelial system damage [1] - Wondfo Biotech has launched multiple fully automated chemiluminescence immunoassay analyzers with varying throughput, catering to different application scenarios [1] Group 2: Market Position and Future Plans - The company has obtained over 150 medical device product registrations globally, covering nine major areas including cardiac markers, inflammation, thrombosis, thyroid, sex hormones, anemia, bone metabolism, tumors, and infectious disease testing [1] - Wondfo Biotech aims to continue leveraging its high-level, global R&D innovation system, focusing on technological, product, and service innovations to benefit the public [1]
万孚生物:全资子公司9款检测试剂盒新品获批上市
Zhong Zheng Wang· 2025-07-29 14:45
Group 1 - Wanfu Bio's subsidiary, Tianshen Medical, has recently received approval from the National Medical Products Administration and Guangdong Provincial Medical Products Administration for 9 self-developed test kits, including thrombosis and tumor marker test kits, enhancing clinical testing options [1] - Tianshen Medical specializes in cardiovascular diagnostics and offers a comprehensive range of cardiac marker testing products, including hs-Tnl, cTnl, Myo, CK-MB, BNP, NT-proBNP, D-Dimer, and H-FABP [1] - The newly approved thrombosis five-item test (TAT, PIC, TM, t-PAIC, FDP) is designed for whole blood samples and provides early indicators of changes in the vascular endothelium, coagulation, and fibrinolysis systems, making it suitable for thrombotic risk assessment and early diagnosis [1] Group 2 - The newly approved thrombosis five-item test combined with D-Dimer will aid in the auxiliary diagnosis of thrombotic diseases, early diagnosis of DIC, monitoring of thrombolytic and anticoagulant drug efficacy, and diagnosis of vascular endothelial system damage, offering clinicians more comprehensive and precise diagnostic tools [2] - As of July 2025, Wanfu Bio's single-use chemiluminescence system has obtained 16 medical device registration certificates for tumor marker testing, making it the most comprehensive small-scale luminescence system in China [2] - Wanfu Bio has launched various fully automated chemiluminescence immunoassay analyzers with different throughput for diverse applications, holding over 150 medical device registration certificates globally, covering 9 major testing areas including cardiac markers, inflammation, thrombosis, thyroid, sex hormones, anemia, bone metabolism, tumors, and infectious diseases [2] - The company plans to continue leveraging its high-level, global R&D innovation system, focusing on technological, product, and service innovations [2]