[Table_ReportDate] 2025 年 11 月 24 日 [Table_ReportType] 医药生物行业周报（11 月第 3 周） [Table_S 行业ummary 观点：] [Table_Author] 分析师：王俐媛 执业证书号：S1030524080001 电话：0755-83199599 邮箱：wangly1@csco.com.cn 研究助理：徐伊琳 电话：0755-23602217 邮箱：xuyl@csco.com.cn 公司具备证券投资咨询业务资格 证券研究报告 医药生物 G IVD 巨头共识下注肿瘤早筛 请务必阅读文后重要声明及免责条款 [Table_Industry] [Table_BaseData] 1) 周度回顾。上周（11 月 17 日-11 月 21 日）医药生物 板块收跌 6.88%，跑输 Wind 全 A（-5.13%）和沪深 300 （-3.77%）。从细分板块来看，所有子板块均收跌，原 料药（-8.6%）、线下药店（-8.58%）和其他生物制品 领跌（-7.99%）领跌。从个股来看，海南海药（23.8%）、 *ST 长药（19.7%）和*ST 苏吴（15.5 ...

以前，中国企业在全球医药行业中主要被视为高性价比的原料药生产供应商。现在，中国已经成为全球 药物创新的重要来源。 "十五五"规划建议明确提出"支持创新药和医疗器械发展"。从顶层设计入手推动医药产业创新，这意味 着我国医药产业将迎来拔节起势、蓬勃发展，具有更强的创新创造力和全球竞争力。 2024年，中国创新药上市申请审评平均时长225个工作日，其中，获得优先审评的创新药审评平均时长 仅162个工作日，审评审批速度显著提升。 一次性使用压力监测心脏脉冲电场消融导管获批上市、胸腹主动脉覆膜支架系统获批上市……进入11月 以来，国家药监局已批准了三种医疗器械创新产品注册申请。 "十四五"以来，我国医药工业全行业研发投入年均增长23%，在研新药数量跃居全球第二位，自主创新 成果加速惠及更多民众，小分子靶向治疗、PD-1、免疫治疗、细胞治疗等创新药"出海"取得实质性进 展，全球市场对中国创新药的认可度正在不断提高。 在刚闭幕的第八届进博会上，越来越多的外国医药企业把创新产品的首展首秀放在中国，更愿意加码在 华投资，深化本土化合作。中国医药行业市场已经增长成为世界第二大市场，越来越多的跨国企业正在 关注中国。 近年来，我国 ...

关于一次性使用压力监测心脏脉冲电场消融导管 获批上市的自愿披露公告 证券代码：688351 证券简称：微电生理 公告编号：2025-028 上述注册申请的取得仅代表一次性使用压力监测心脏脉冲电场消融导管获得国内市场准入资格，产品上 市后的实际销售情况受到多重因素影响，目前尚无法预测其对公司未来业务的具体影响。敬请广大投资 者谨慎投资，注意投资风险。 上海微创电生理医疗科技股份有限公司 特此公告。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 近日，上海微创电生理医疗科技股份有限公司（以下简称"公司"）一次性使用压力监测心脏脉冲电场消 融导管获得国家药品监督管理局注册申请（国械注准20253012351）。该产品基于应变片原理的压力传 感器设计，结合脉冲电场技术、磁场定位技术、盐水灌注技术，与心脏脉冲电场消融设备配合使用，可 用于心律失常治疗；与三维心脏电生理标测系统配合使用，可提供导管在心内的位置信息以及进行导管 头端和心壁之间触点压力的实时测量。上述医疗器械注册证的取得，实现了公司"射频+冷冻+脉冲"三 大消融能量产品 ...

证券日报网讯 11月21日晚间，微电生理发布公告称，近日，上海微创电生理医疗科技股份有限公司 （以下简称"公司"）一次性使用压力监测心脏脉冲电场消融导管获得国家药品监督管理局注册申请（国 械注准20253012351）。 （文章来源：证券日报） ...

Group 1: Shareholding Changes - Company Zhaoyi Innovation announced that several directors and senior management personnel plan to reduce their holdings by a total of 249,000 shares, with specific reductions from the vice chairman and general manager, as well as other vice presidents [1] - Company Super Aerospace announced a stock suspension due to its controlling shareholders planning a significant matter that may lead to a change in control [2] - Company Haosai is under investigation by the China Securities Regulatory Commission (CSRC) for suspected violations of information disclosure laws [5] Group 2: Major Contracts and Projects - Company Dajin Heavy Industry's wholly-owned subsidiary signed a contract worth approximately 1.339 billion yuan for a European offshore wind farm project, which represents 35.41% of the company's audited revenue for 2024 [3] - Company Ruifeng New Materials plans to increase capital by 200 million yuan in a related party to advance a lithium hexafluorophosphate project [6] Group 3: Regulatory Actions - Company Jushi Chemical received a notice from the CSRC regarding an investigation for suspected violations of information disclosure laws [4] - Company Huosai is also under investigation by the CSRC for similar reasons [5] Group 4: Investment and Acquisitions - Company Gao Neng Environment plans to acquire 45.2% equity in three mining companies [7] - Company Aerospace Electric intends to purchase 32% equity in Shenzhen Aerospace Electric Motor System Co., Ltd. through public bidding [8]

Core Viewpoint - The company has received registration approval from the National Medical Products Administration for its single-use pressure monitoring cardiac pulsed electric field ablation catheter, enhancing its product portfolio in arrhythmia treatment [1] Group 1: Product Development - The newly approved product utilizes a strain gauge-based pressure sensor design combined with pulsed electric field technology, magnetic field positioning technology, and saline infusion technology [1] - This catheter is designed to work in conjunction with cardiac pulsed electric field ablation devices for arrhythmia treatment [1] Group 2: Market Positioning - The product can provide real-time measurement of contact pressure between the catheter tip and the heart wall, as well as positional information within the heart when used with a three-dimensional cardiac electrophysiology mapping system [1] - The registration of this medical device allows the company to synergize its three major ablation energy products: radiofrequency, cryoablation, and pulsed electric field, thereby offering more treatment options for arrhythmia [1] - This development is expected to enhance the company's core competitiveness and market expansion capabilities [1]