从国家药监局获悉，国家药监局、财政部和市场监管总局发布公告，即日起对药品医疗器械研制、生 产、经营企业和使用单位，药品医疗器械网络交易第三方平台提供者以及其他组织的内部员工、相关知 情人，向药品监督管理部门实名举报药品医疗器械质量安全重大违法行为，药品监督管理部门实施奖 励。 ...

思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 即将召开： 2025年6月12日，首届全球医美科技大会 2025年7月17日，第二届全球医疗科技大会 2025年9月4-5日，第三届全球手术机器人大会 2025年6月3日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第5号），有 6款产品 进入创新通道。 其中包括， 西安敦博医疗器械有限公司 （简称" 敦博医疗 "）申请的 经导管植入式无导线心脏起搏器 。 敦博医疗创始人 何玉平 曾经表示： "无导线心脏起搏器作为起搏器最新一代技术，具有 更小体积、更便 捷、更安全 的优点，在心脏病的治疗中应用前景广阔。敦博医疗通过 自主研发芯片 ，实现了无导线心脏 起搏器关键技术的突破，不仅赶超了世界最高水平，且又向前多跨了一小步。在技术层面，进一步缩小了 起搏器的体积，大幅度降低了起搏器静态功率，并延长了起搏器的使用寿命，从而使无导线心脏起搏器在 临床中的应用变得更便捷和安全。" # 关于心脏再同步治疗（CRT） 心力衰竭 是一种全球性健康问题，影响着数以千万计的人群。 它是由于 各类心脏疾病导致心脏泵血能力 下降，不能 ...

Group 1 - The core viewpoint of the news highlights the financial performance and market position of Jianfan Biological Technology Group Co., Ltd, indicating a decline in revenue and net profit in the latest quarterly report [2] - As of June 5, the closing price of Jianfan Biotech was 21.77 yuan, with a rolling PE ratio of 24.01 times, and a total market capitalization of 17.386 billion yuan [1] - The company ranks 51st in the medical device industry, which has an average PE ratio of 50.97 times and a median of 36.67 times [1][3] Group 2 - Jianfan Biotech specializes in the research, production, and sales of biomaterials and high-tech medical devices, with key products including various blood purification devices and consumables [2] - The latest quarterly report for Q1 2025 shows that the company achieved an operating income of 548 million yuan, a year-on-year decrease of 26.40%, and a net profit of 189 million yuan, down 33.71% year-on-year, with a gross profit margin of 80.74% [2] - As of March 31, 2025, the number of shareholders increased to 52,502, with an average holding value of 352,800 yuan and an average holding quantity of 27,600 shares [1]

国家药监局、财政部、市场监管总局发布《关于对药品医疗器械质量安全内部举报人举报实施奖励的公 告》。其中提出，内部举报人获得举报奖励应当同时符合下列条件：（一）有明确的被举报对象和具体 违法事实或者违法犯罪线索，并提供了关键证据；（二）举报事项事先未被药品监督管理部门掌握； （三）举报事项经药品监督管理部门查处结案并被行政处罚，或者依法移送司法机关被追究刑事责任。 国家药监局 财政部 市场监管总局 关于对药品医疗器械质量安全内部举报人举报实施奖励的公告 （2025年第41号） 为进一步发挥药品医疗器械产业链质量安全内部监督作用，及时发现和控制药品医疗器械安全风险，根 据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》《医疗器械监督管理条例》《市场监 管领域重大违法行为举报奖励暂行办法》（国市监稽规〔2021〕4号，以下简称《办法》）等规定，现 就药品医疗器械质量安全内部举报人举报奖励有关事项公告如下。 一、药品医疗器械研制、生产、经营企业和使用单位，药品医疗器械网络交易第三方平台提供者以及其 他组织（以下统称企业及相关单位）的内部员工、相关知情人，向药品监督管理部门实名举报药品医疗 器械质量安全重大违法 ...

据了解，成都未来医学城近年来持续加强双城区域协同交流合作：去年10月，川渝医药产业发展药品注 册技术系列培训班在成都东部新区举行，为川渝地区生物制品相关医药企业和有关单位提供专业的技术 指导和政策解读；去年11月，天府锦城实验室（未来医学城）与重庆金凤实验室正式建立战略合作，聚 焦生物芯片等领域协同创新，为成渝地区新质生产力培育注入新动能；园区企业成都万众未来生物科技 有限公司、孔确(成都)科技有限公司与重庆医院、科研机构开展联合研发，推动跨区域成果转化…… 成都东部新区相关负责人表示，将以未来医学城为主阵地，促进川渝医疗器械创新生态协同，推动"临 床痛点"转化为"创新亮点"，推广社区示范应用，助力创新价值落地。 四川省药监局相关负责人介绍，社区旨在为临床研究者、技术专家和产品开发者搭建协作平台，通过及 时反馈器械使用问题、发布临床需求、共享研究成果，推动企业精准研发高价值产品，加速临床成果转 化，助力产业高质量发展。 值得关注的是，今年4月成都未来医学城成功挂牌川渝首个"医疗器械领先用户社区应用示范点"，本次 活动也是应用示范点建设打造的具体落实和深化推进，将推动未来医学城加速构建医疗器械创新生态。 园区着 ...

"以旧换新"正为医疗器械行业注入强劲动能。今年来，各地卫健委密集开展市场调研，医疗设备集采大 单频传。截至5月底，相关招标公告数量同比增近六成。据统计，前4个月，多个细分领域医疗设备市场 规模显著上扬，业内人士预计，全年设备更新订单总量有望达数百亿元。 政策东风之下，一轮新的增长周期开启，医疗器械板块上市公司摩拳擦掌抢占市场。随着订单陆续落 地，业内预计三季度行业营收将迎来较为明显的增长。 集采大单频现 2025年是医疗器械公司的市场经理们异常忙碌的一年。一个令他们十分熟悉的场景是，在给定的20分钟 时间内，快速介绍公司产品的核心技术和先进性，并宣讲公司的服务能力、售后维保、市占率等情况， 接受采购方的询问，在互动答疑中发现市场需求点，并快速调整方案。 今年以来，类似这样的市场调研活动在全国各地密集展开。这类活动的发起方，通常是各省市卫健委。 通过市场调研，各地卫健委可以全面掌握市场信息，为后面的集采方案做准备。企业通过采购单位发布 的预算价，可以提前准备更适配的产品，提高中标概率。 据证券时报记者从中国政府采购网上统计，截至5月31日，中央和地方的医疗设备采购公开招标公告共 计3832条，相比去年同期的24 ...

天眼查App显示，近日，国创质谱（江苏）生物科技有限公司成立，法定代表人为马庆伟，注册资本 1000万人民币，由北京毅新博创生物科技有限公司全资持股。 企业名称国创质谱（江苏）生物科技有限公司法定代表人马庆伟注册资本1000万人民币国标行业制造业 >专用设备制造业>电子和电工机械专用设备制造地址中国（江苏）自由贸易试验区连云港片区经济技 术开发区黄海大道63号10号楼2楼252室企业类型有限责任公司营业期限2025-6-4至无固定期限登记机关 连云港经济技术开发区市场监督管理局 序号股东名称持股比例1北京毅新博创生物科技有限公司100% 来源：金融界 经营范围含许可项目：第三类医疗器械生产；第三类医疗器械租赁；第三类医疗器械经营；第二类医疗 器械生产（依法须经批准的项目，经相关部门批准后方可开展经营活动，具体经营项目以审批结果为 准）第一类医疗器械生产；第一类医疗器械销售；第二类医疗器械销售；第一类医疗器械租赁；第二类 医疗器械租赁；技术推广服务；自然科学研究和试验发展；电子产品销售；技术服务、技术开发、技术 咨询、技术交流、技术转让、技术推广；社会经济咨询服务；电子、机械设备维护（不含特种设备）； 机械设备 ...

Group 1 - The 27th China Beijing International Science and Technology Industry Expo successfully concluded, featuring over 800 domestic and foreign enterprises and institutions, with a focus on technology-driven innovation and global cooperation [1] - The forum discussed the theme of "New Quality Productivity and Global Technological Cooperation," exploring cutting-edge technology and industry development trends [1] Group 2 - Aiko Medical showcased its core product, the Lattice flow-directed stent, which significantly improves the treatment of intracranial aneurysms, utilizing cobalt-chromium alloy and innovative technologies [2] - The Lattice stent is currently in use in over 500 hospitals across China, receiving high recognition from clinicians and expanding access to remote areas [2] Group 3 - Aiko Medical revealed its core technology system and clinical achievements, emphasizing its commitment to technological innovation, with 9 products approved by NMPA and 132 patent applications [3] - The Lattice stent has been recognized as an "innovative medical device" by the National Medical Products Administration and has been fast-tracked for market approval [3] Group 4 - During the expo, Aiko Medical engaged in deep exchanges with industry experts and representatives, aiming to provide comprehensive innovative solutions for cerebrovascular disease patients [4] - The company plans to increase R&D investment to develop more internationally competitive medical devices, contributing to the high-quality development of China's medical device industry [4]

Core Viewpoint - Increasingly, Chinese companies with a global vision, advanced technology, compliant operations, and high-quality products are emerging in the internationalization process, showcasing their international influence, particularly in the medical device sector, with companies like United Imaging and Mindray accelerating their overseas expansion [1][3]. Group 1: Market Impact - Following recent news, shares of major medical device companies faced pressure, with United Imaging (688271.SH) dropping nearly 6%, Mindray (300760.SZ) down nearly 2%, and Yuyue Medical (002223.SZ) falling nearly 3% [1]. - The European Union plans to impose restrictive measures on Chinese enterprises under the "International Procurement Instrument," potentially limiting their participation in EU public tender projects for medical devices valued over 5 million euros in the next five years [1][3]. Group 2: Industry Growth - The global medical device industry is rapidly developing, characterized by active trade and high product added value, providing significant opportunities for Chinese medical device companies to expand internationally [3]. - Chinese medical device exports are shifting from low-value products to a growing number of innovative devices entering overseas markets, indicating a move towards higher-end products in the industry [3][4]. Group 3: Innovation and Quality - High-quality clinical data is essential for gaining global market recognition, as demonstrated by a Shanghai-developed transcatheter aortic valve system that achieved significant clinical milestones, offering new treatment options for millions of patients [4]. - The Chinese medical device sector is transitioning from "Made in China" to "Intelligent Manufacturing in China," with products meeting international clinical standards and defining new treatment paradigms globally [4]. - Chinese companies are leading innovation in the global medical device field, with some products and technologies reaching a level of global originality and strong competitiveness, making them indispensable in the market [4].

Group 1 - The core viewpoint of the articles highlights the performance and valuation of Haohai Biological Technology Co., Ltd. in the medical device industry, noting its current stock price and market capitalization [1][2] - As of June 3, the company's stock closed at 53.32 yuan, with a rolling PE ratio of 30.09, marking a new low in 28 days, and a total market value of 12.434 billion yuan [1] - The average PE ratio for the medical device industry is 50.80, with a median of 36.71, positioning Haohai Biological at the 66th rank within the industry [1][2] Group 2 - The latest quarterly report for Q1 2025 shows that the company achieved a revenue of 619 million yuan, reflecting a year-on-year decrease of 4.25%, and a net profit of 90.31 million yuan, down 7.41% year-on-year, with a gross margin of 69.52% [1] - As of the Q1 2025 report, three institutions hold shares in Haohai Biological, with a total of 2.4635 million shares valued at 146 million yuan [1]