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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
Core Viewpoint - The company, Novogene (688105.SH), has announced that its wholly-owned subsidiary, Nanjing Novogene Medical Technology Co., Ltd., has obtained multiple medical device registration certificates for its series of diagnostic reagents for the nervous system in China [1] Group 1: Product Development and Innovation - The company is leveraging its proprietary antibody technology platform to continuously enrich its Alzheimer's disease blood test product series based on global authoritative guidelines [1] - The company is focusing on the central nervous system's major diseases by innovatively developing precise detection and diagnostic products for conditions such as Parkinson's disease and brain injuries [1] Group 2: Market Position and Strategy - The newly obtained product registration certificates signify that the company's related products have received market access qualifications in China [1] - The company aims to address unmet clinical needs in the field of neurological diseases, enhancing the product strength and influence of its chemiluminescence platform [1] - The company is committed to improving the diagnosis and treatment services for brain health and cognitive disorders in alignment with the "Healthy China Strategy" [1]
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
Core Viewpoint - The company, NuoVance (688105.SH), has announced that its wholly-owned subsidiary, Nanjing NuoVance Medical Technology Co., Ltd., has obtained multiple medical device registration certificates for its series of diagnostic reagents for neurological systems, indicating market entry approval in China [1] Group 1: Product Development and Innovation - The company is leveraging its proprietary antibody technology platform to continuously enrich its Alzheimer's disease blood test series products based on global authoritative guidelines [1] - The focus is on developing innovative products for precise detection and diagnosis of major central nervous system diseases, including Parkinson's disease and brain injuries, addressing unmet clinical needs in the field of neurological diseases [1] Group 2: Strategic Goals and Market Impact - The company aims to enhance the product strength and influence of its chemiluminescence platform, contributing to the improvement of brain health and cognitive disorder diagnosis and treatment services in China [1] - The acquisition of these product registration certificates represents a significant step in actively implementing the "Healthy China Strategy" [1]