Workflow
神经系统系列诊断试剂产品
icon
Search documents
复星凯瑞CAR-T产品上市申报获受理;恒瑞医药一产品实现BD
Policy Developments - The National Healthcare Security Administration (NHSA) has announced a public solicitation for information on innovative medical consumables, including brain-machine interface technologies and surgical robots, to streamline the coding process for these products [2] Drug and Device Approvals - Fosun Pharma's subsidiary, Fosun Kary, has had its drug registration application for Brexucabtagene Autoleucel accepted by the National Medical Products Administration, aimed at treating relapsed or refractory B-cell acute lymphoblastic leukemia in adults [4] - Novogene's subsidiary has received medical device registration certificates for several neurodiagnostic reagents, which can assist in diagnosing Alzheimer's and Parkinson's diseases [5] Capital Market Activities - Hengrui Medicine has signed a licensing agreement for its innovative drug SHR-A1811, receiving an upfront payment of $18 million and potential milestone payments up to $1.093 billion, which will enhance its overseas market presence [7] - Yong'an Pharmaceutical plans to acquire a 49.20% stake in its subsidiary Ling'an Technology for 27 million yuan, aiming to strengthen control and reduce management costs [8] Industry Events - The NHSA hosted discussions with domestic and international investment institutions, emphasizing support for the high-quality development of innovative drugs and the implementation of policies to facilitate this growth [10] - Illumina has announced partnerships with several global pharmaceutical companies to develop companion diagnostics based on its TruSight Oncology genomic testing platform, focusing on KRAS gene mutations [11] Regulatory and Governance Updates - The former deputy director of the Henan Provincial Medical Security Bureau is under investigation for serious violations of discipline and law [13] - Shareholder Wang Xiaopeng of Huyou Pharmaceutical plans to reduce his stake by up to 3% due to personal financial needs [14] - Independent director Huang Zhengming of Qidi Pharmaceutical has resigned due to work reasons, which may affect the board's composition [15]
诺唯赞(688105.SH)子公司产品取得医疗器械注册证
智通财经网· 2025-09-24 09:46
智通财经APP讯,诺唯赞(688105.SH)发布公告,公司全资子公司南京诺唯赞医疗科技有限公司开发的 多个神经系统系列诊断试剂产品,于近日取得我国多项《医疗器械注册证》。 依托自有抗体技术平台,公司根据全球权威指南,持续丰富AD血检系列产品,同时围绕中枢神经系统 重大疾病领域重点布局,创新开发帕金森病、脑损伤等精准检测、诊断类创新产品,致力于解决神经疾 病领域未被满足的临床需求,不断提升公司化学发光平台的产品力和影响力,助力我国脑健康与认知障 碍疾病诊疗服务水平提升,积极践行"健康中国战略"。本次产品注册证的取得仅代表公司相关产品获得 国内市场准入资格。 ...
诺唯赞子公司产品取得医疗器械注册证
Zhi Tong Cai Jing· 2025-09-24 09:44
依托自有抗体技术平台,公司根据全球权威指南,持续丰富AD血检系列产品,同时围绕中枢神经系统 重大疾病领域重点布局,创新开发帕金森病、脑损伤等精准检测、诊断类创新产品,致力于解决神经疾 病领域未被满足的临床需求,不断提升公司化学发光平台的产品力和影响力,助力我国脑健康与认知障 碍疾病诊疗服务水平提升,积极践行"健康中国战略"。本次产品注册证的取得仅代表公司相关产品获得 国内市场准入资格。 诺唯赞(688105.SH)发布公告,公司全资子公司南京诺唯赞医疗科技有限公司开发的多个神经系统系列 诊断试剂产品,于近日取得我国多项《医疗器械注册证》。 ...