Core Viewpoint - The article discusses the evolving landscape of the medical device industry in China, highlighting the importance of business development (BD) strategies that go beyond mere numbers to encompass strategic partnerships, market expansion, and technological integration [1][24]. Group 1: Key Trends in Medical Device BD - The primary keywords for the period from July to September include cross-border introduction and global distribution, strategic cooperation, and capital and cross-industry integration [2]. - Companies are accelerating market expansion and ecosystem building through transactions across various fields, including cardiovascular, neuro-intervention, ophthalmology, IVD, and critical care [3]. Group 2: Representative Events - A total of 20 significant events were summarized, showcasing a "multi-line advancement" scenario in the industry [4]. - Notable collaborations include: - Nanjing Jianxin Medical and Heqi Family Office focusing on medical device R&D and wealth management [6]. - Olympus and Xingchenhai Medical signing a global distribution agreement for disposable urology products [6]. - He’s Eye Group and Zeiss China Medical forming a strategic partnership to enhance ophthalmic surgical technology [6]. Group 3: Cross-Border and Global Distribution - Cross-border transactions remain a hot topic, with domestic companies leveraging global markets for growth while foreign giants introduce Chinese innovations [9]. - The partnership between Ruichao Dinkai Group and Beijing Amite focuses on vascular intervention products, marking a new phase in safety standards [7]. Group 4: Strategic Cooperation and Channel Expansion - Strategic cooperation is increasingly focused on building ecosystems rather than single product breakthroughs, with companies forming partnerships in fields like ophthalmology, IVD, and diagnostics [19]. - The collaboration between Wanfu Biological and Beiden Medical aims to match products with non-public medical channels effectively [15]. Group 5: Capital Support and Cross-Industry Integration - Capital is becoming an invisible driver of medical device BD, with partnerships exploring new models for medical device distribution [20]. - The collaboration between Beijing Huamai Supply Chain Management and Hongyi Consulting aims to create a one-stop service for medical device distribution [20]. Group 6: Smart Hospitals and Full-Chain Coordination - The focus on smart hospitals and full-chain coordination is becoming a priority for large enterprises, integrating supply chains, academic promotion, and clinical needs [23]. - Collaborations like that of Ruibo Zehou Technology and China National Pharmaceutical Group aim to develop automated systems for smart hospitals [21]. Conclusion - The medical device industry in China is transitioning from a "single product-driven" phase to a more diversified approach supported by capital, channels, and ecosystems, indicating a long-term growth trajectory [24].

南方财经记者程浩 东莞报道 "昂拉地韦的诞生贯穿从临床需求反哺基础研究，再通过企业转化实现成果落地，形成从研发、验证到上市的高效闭环。"广州呼吸健康研究院党总支书记黄 庆晖介绍，这款全球首个流感RNA聚合酶PB2蛋白抑制剂正是广州国家实验室与医药企业深度协同，广东医工融合实现医疗创新的一个缩影。 当前，在医疗创新与科技进步的大潮中，科技成果转化已成为推动医疗健康产业高质量发展的关键因素之一，而医学与现代工程技术的深度融合正成为引领 医疗创新变革的关键力量。从设备研发到真正医疗方案落地，通过临床需求反向推动技术创新，到多学科协同攻关，医工融合为医学发展拓展边界注入新的 动能。 广东省药监局副局长邱楠表示，近年来全省持续深化审评审批改革，创新药械获批数量逐年快速增长，通过制定临床价值筛选评价标准、建立项目收集筛选 机制、搭建广东临床转化平台等措施，进一步促进医疗器械科研成果在广东转化落地。 东莞生物医药产业在历经十余年发展，产业生态日趋成熟。受访单位供图。 为促进医工融合和产销对接，此次东莞专场活动设置了企业和医疗机构双向推介环节。东阳光药业、众生药业、博迈医疗、普门生物等企业集中推介了伊非 尼酮、来瑞特韦片、冠 ...

据介绍，甲型流感病毒、乙型流感病毒与呼吸道合胞病毒(RSV)是引起全球急性呼吸道感染的主要病原 体。分子诊断更是作为万孚生物战略布局的前沿技术平台，是精准医疗的核心驱动力。该产品是公司在 呼吸道病原体检测领域的重要突破，可与现有产品线形成协同，进一步完善呼吸道疾病检测矩阵，强化 公司在体外诊断领域的综合竞争力。 此外，8月21日，万孚生物自主研发的U-CardDx200全自动核酸扩增分析仪获NMPA第三类医疗器械注 册批准上市。U-CardDx200依托经典的磁珠法核酸提取与实时荧光定量PCR技术，通过技术与设计创 新，将全流程核酸检测时间缩短至15分钟。一台仪器就是一个分子诊断实验室，既能满足日常检测所 需，又能应对高峰期的紧急检测需求。 中证报中证网讯(王珞)9月10日晚间，万孚生物（300482）发布公告称，公司甲型流感病毒/乙型流感病 毒/呼吸道合胞病毒核酸检测试剂盒(荧光PCR法)收到国家药品监督管理局颁发的医疗器械注册证。 ...

格隆汇9月10日丨万孚生物(300482.SZ)公布，近日收到国家药品监督管理局颁发的医疗器械注册证，名 称：甲型流感病毒/乙型流感病毒/呼吸道合胞病毒核酸检测试剂盒(荧光PCR法)。甲型流感病毒、乙型 流感病毒与呼吸道合胞病毒（RSV）是引起全球急性呼吸道感染的主要病原体。分子诊断更是作为万孚 生物战略布局的前沿技术平台，是精准医疗的核心驱动力。该产品是公司在呼吸道病原体检测领域的重 要突破，可与现有产品线形成协同，进一步完善呼吸道疾病检测矩阵，强化公司在体外诊断领域的综合 竞争力。 ...

特此公告。 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 广州万孚生物技术股份有限公司（以下简称"万孚生物"或"公司"）近日 收到国家药品监督管理局颁发的医疗器械注册证，具体信息如下： | 名称 | 注册证号 | 有效期至 | 预期用途 | | | | | --- | --- | --- | --- | --- | --- | --- | | 甲型流感病毒/乙型 | 本试剂盒用于体外定性检测人咽拭子样本中甲型 | 流感病毒/呼吸道合 | 国 | 械 | 注 | 准 | | 流感病毒、乙型流感病毒和呼吸道合胞病毒的核 | 2030/09/04 | 胞病毒核酸检测试剂 | 20253401810 | 酸。 | | | | 盒(荧光 | 法) | PCR | | | | | 甲型流感病毒、乙型流感病毒与呼吸道合胞病毒（RSV）是引起全球急性呼 吸道感染的主要病原体。分子诊断更是作为万孚生物战略布局的前沿技术平台， 是精准医疗的核心驱动力。该产品是公司在呼吸道病原体检测领域的重要突破， 可与现有产品线形成协同，进一步完善呼吸道疾病检测矩阵，强化公司在体外诊 断领域的 ...

Group 1 - The fentanyl concept sector increased by 0.65%, ranking first among concept sectors, with two stocks rising, including Renfu Pharmaceutical which hit the daily limit [1] - The main funds net inflow into the fentanyl concept sector was 577 million yuan, with Renfu Pharmaceutical receiving the largest net inflow of 571 million yuan [2][3] - The net inflow ratios for leading stocks in the fentanyl concept were 18.07% for Renfu Pharmaceutical, 8.67% for Enhua Pharmaceutical, and 2.06% for Lingrui Pharmaceutical [3] Group 2 - The stocks with the largest declines in the fentanyl concept sector included Dongfang Biology, Wanfu Biology, and Botuo Biology, with declines of 1.88%, 1.54%, and 1.36% respectively [1][2] - The trading volume and turnover rates for the leading stocks in the fentanyl concept were notable, with Renfu Pharmaceutical showing a turnover rate of 9.23% [3]

证券日报网讯万孚生物（300482）8月28日在互动平台回答投资者提问时表示，公司深耕体外诊断领域 30年，万孚生物持续响应社会对肝炎防治的健康需求，联动胶体金、免疫荧光、化学发光等平台上市了 超10款肝病检测产品，覆盖甲肝、乙肝、丙肝、戊肝及肝癌等，可为肝炎防治提供全面检测方案。随 着"星火计划"在广东及全国推进，相关创新成果将在更大范围内发挥作用，为更多地区肝炎筛查和防治 提供有力支持。 ...

Core Viewpoint - Wanfu Bio has developed multiple detection products for the chikungunya virus, utilizing its colloidal gold and molecular diagnostic technology platforms, creating a closed-loop system for rapid screening, precise diagnosis, and monitoring [1] Group 1 - The company has responded quickly to investor inquiries regarding its chikungunya virus detection products [1] - The detection products aim to provide reliable monitoring solutions for disease control and inspection at ports [1] - Currently, there is no sales data available for these products [1]

Core Viewpoint - The company, Wanfu Biology, has significantly advanced its global layout, with products sold in over 150 countries and regions, and aims to increase its overseas revenue to approximately 40% by the end of 2024 [1] Group 1: Global Expansion - The company has established a global presence, with products reaching over 150 countries and regions [1] - The effectiveness of the global layout has been notable in recent years, contributing to the company's growth [1] - The company plans to continue its international development strategy to further enhance business growth [1] Group 2: Product Development - The company focuses on chemiluminescence as a primary development platform, offering a full range of high, medium, and low throughput products [1] - The growth of the luminescence business is primarily driven by specialized projects such as the Thrombosis Six Items [1]

Core Insights - Wanfu Bio has received NMPA Class III medical device registration approval for its self-developed U-CardDx 200 fully automated nucleic acid amplification analyzer, which has also obtained EU CE IVDR certification and is already in use in several overseas countries [2] Group 1 - The U-CardDx 200 significantly reduces the molecular testing process to just 15 minutes by utilizing classic magnetic bead nucleic acid extraction and real-time fluorescence quantitative PCR technology [2] - The device functions as a complete molecular diagnostic laboratory, capable of meeting routine testing needs as well as urgent testing demands during peak times [2] - The company plans to continuously expand its product offerings based on the U-CardDx 200 platform [2]