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抗磷脂酶A2受体IgG抗体测定试剂盒(化学发光法)
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全国首例“医保价”脑机接口手术完成;李西廷增持迈瑞医疗股份
Policy Developments - The State Council, led by Li Qiang, held a meeting to advance the provincial coordination of basic medical insurance [2] Medical Device Approvals - Yuhanglong received two medical device registration certificates for diagnostic kits related to primary biliary cholangitis and idiopathic membranous nephropathy, enhancing its product line in liver and kidney disease diagnostics [4] - Hengrui Medicine announced the approval of clinical trial notifications for five drugs, including the humanized anti-PD-L1 monoclonal antibody Abedilizumab, with total R&D investments amounting to approximately 1.1 billion yuan [5] Capital Market Activities - Mindray Medical's chairman, Li Xiting, plans to increase his stake in the company by 200 million yuan, having already purchased shares worth approximately 30 million yuan [7] - Huayu Pharmaceutical intends to establish a private equity fund focused on the biomedical sector, with an initial commitment of 150 million yuan from the company [8][9] Industry Milestones - The first brain-computer interface surgery in China was successfully completed, utilizing a device from Wuhan Zhonghua Brain-Machine Fusion Technology Co., with the procedure priced according to government regulations [11] Clinical Trials and Collaborations - Buchang Pharmaceutical's subsidiary signed a contract for clinical trials of a new product, with a total cost of approximately 60 million yuan, aimed at enhancing the company's drug development capabilities [12] - Jincheng Pharmaceutical terminated negotiations with Giskit Pharma B.V. regarding exclusive commercialization rights, with no financial impact expected [14]
亚辉龙:取得两款医疗器械注册证,丰富发光产品线
Xin Lang Cai Jing· 2025-11-27 08:50
Core Viewpoint - The company, Aihuilong, has received medical device registration certificates for two products from the Guangdong Provincial Drug Administration, enhancing its product line in the field of liver and kidney disease diagnostics [1] Group 1: Product Registration - The two registered products are the anti-gp210 IgG antibody test kit and the anti-phospholipase A2 receptor IgG antibody assay kit, both utilizing chemiluminescence technology [1] - The registration certificates are valid until November 25, 2030, and both products are classified as Class II medical devices [1] Group 2: Diagnostic Applications - The products are intended for auxiliary diagnosis of primary biliary cholangitis and idiopathic membranous nephropathy [1] Group 3: Market Impact - The company has obtained a total of 176 domestic medical device registration certificates for chemiluminescence reagents [1] - The new certifications will help enrich the fully automated chemiluminescence product line, but the sales performance of these products is subject to market conditions, making the impact on financial performance difficult to predict [1]