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上海发布高端医疗器械产业重磅方案,“7+X”重点产品有哪些
Di Yi Cai Jing· 2025-09-15 10:25
Core Viewpoint - Shanghai is promoting the orderly opening and application of clinical data to enhance the development of the high-end medical device industry, which is considered one of the three leading industries in the city [1][7]. Group 1: Action Plan Overview - On September 15, Shanghai released a three-year action plan aimed at promoting the full-chain development of the high-end medical device industry, with goals set for 2027 [2]. - The action plan targets the approval of over 500 new domestic Class III medical device registrations and over 100 medical device products approved in overseas markets [2]. - The plan aims to cultivate two leading enterprises with an annual output value exceeding 10 billion and establish three high-end medical device industry clusters [2]. Group 2: Industry Development and Focus Areas - The medical device industry in Shanghai has rapidly developed, with a manufacturing output value of 55.51 billion, accounting for 27.6% of the biopharmaceutical output [3]. - The action plan outlines seven areas of focus, deploying 20 key tasks related to innovation, clinical empowerment, review and approval, hospital application, enterprise cultivation, industrial ecology, and international development [3]. Group 3: Key Product Development - The action plan emphasizes the development of "7+X" key products, including high-end medical imaging products, high-end implantable products, high-end surgical systems, high-end in vitro diagnostic products, high-end radiation therapy products, high-end rehabilitation products, high-end artificial intelligence medical devices, and future innovative devices [6]. - Shanghai aims to enhance its innovation capabilities by tackling cutting-edge technologies such as brain-computer interfaces and integrated diagnosis and treatment [6]. Group 4: Regulatory and Financial Support - The action plan proposes to strengthen pre-guidance services for the registration review of Class II and III innovative medical devices, aiming to reduce the average review time for Class II devices to within 40 working days [8][9]. - Financial support will be provided through collaboration between leading industry funds and biopharmaceutical merger funds, focusing on disruptive and cutting-edge technology innovations [10]. - Shanghai Guotou will prioritize investments in key areas such as brain-computer interfaces and high-end medical equipment, providing capital support for core technology development and process optimization [10].
透景生命上涨9.28%,报28.38元/股
Jin Rong Jie· 2025-08-25 06:19
8月25日,透景生命盘中上涨9.28%,截至13:29,报28.38元/股,成交5.25亿元,换手率14.3%,总市值 46.13亿元。 资料显示,上海透景生命科技股份有限公司位于上海市浦东新区汇庆路412号,公司主要从事高端体外 诊断产品的研发、生产、推广和销售,以流式荧光技术、化学发光技术、多重荧光PCR技术和液相色谱 串联质谱技术为主要技术平台,主要应用方向包括肿瘤全程监测、自身免疫、心血管疾病、病原体感染 及生殖健康等。至今,公司已累计获得近300项医疗器械注册证,并于2017年成功上市,股票代码为 300642。 截至3月31日,透景生命股东户数1.7万,人均流通股8081股。 2025年1月-3月,透景生命实现营业收入7489.31万元,同比减少19.53%;归属净利润47.17万元,同比增 长110.51%。 ...