万孚生物：全资子公司9款检测试剂盒新品获批上市

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]