雷递网 雷建平 12月15日 轻松健康集团（股票代码："2661"）今日开启招股，准备2025年12月23日在港交所上市。 轻松健康拟全球发售2654万股，最高发售价22.68港元，预计募资总额为6亿港元，扣除发行应付上市费 用，募资净额5.13亿港元。 | | | | 假設超额配股權 | | 假設超额配股權 | | | --- | --- | --- | --- | --- | --- | --- | | | | | 尚未行使 | | 獲悉數行使 | | | | | | | 估紧隙 | | 估紧圆 | | | | | | 全球發售 | | 全球發售 | | | | | | 元成後 | | 元成後 | | | | 將予 | | 已發行 | | 已發行 | | 總投资 | | 認購的 | 估發售 | 股本總額 | 佔發售 | 股本塑额 | | 基石投资者 | 金额(1) | 發售股份 | 股份概约 | 概 约 | 股份概约 | 概 釣 | | 名稱 | (百萬元) | 题目(3) | 百分比 | 百分比 | 百分比 | 百分比 | | 按發售價22.68港元計算 | | | | | | | | 澳琴合鸣 | 人 ...

在乐城执业，我感受最深的是从"政策高地"向"平台高地"的实质性转变。这里不仅建成了全国首个 区域性真实世界数据平台，更聚集了30多家医疗机构，构建了"政产学研"融合的创新生态，让前沿研究 得以高效转化。 12月18日，海南自贸港即将启动全岛封关，这意味着更开放的政策环境、更便利的国际资源流动， 将为乐城带来"医疗特区"的升级机遇。我们期待乐城能借此进一步打通国际创新药械引进的链条，吸引 全球顶尖医疗人才与资源，并依托真实世界研究，加速成果转化，真正建成国际先进医疗技术进入中国 的"门户"，让更多患者早日用上全球药械创新成果。(整理/王子豪) 从"海外求医"到"乐城就医"，患者治疗成本大幅节省。在乐城使用同款创新药械的总花费通常仅为 直接出国就医的50%至70%，部分项目还可衔接国内医保，大大减轻患者经济负担的同时，也免去了办 理签证、国际飞行、预约就医所需的漫长周期。 ...

身处乐城，截至今年9月底，瑞金海南医院已成功落地特许药械项目186项，特医食品2项，生物医 学新技术5项，惠及患者超2.68万人次。让我印象深刻的是，伏索利肽作为治疗软骨发育不全的全球独 家新药，在欧盟上市后不到一年时间，便在我们医院完成了全国首例治疗。 如果说乐城"特许药械"解决了"用得上"的问题，那么真实世界研究则加速了"用得好、用得广"的进 程。我们通过开展高质量的临床真实世界数据研究，为国际创新药械在中国的注册上市创造了令业界瞩 目的"乐城速度"。 身处全国唯一的"医疗特区"，我们将充分发挥公立医院的平台优势，赋能区域医疗生态，助推海南 自贸港医疗健康产业高质量发展，加快实现"立足海南、服务全国、辐射东南亚"的国家区域医疗中心建 设目标。(整理/王子豪) ...

海南日报全媒体见习记者 王子豪 "我们的全飞秒设备在博鳌乐城开展了国际标准的真实世界研究，仅用了17个月就走完了通常需要 48个月的审批流程。" 在不久前举办的第八届中国国际进口博览会上，蔡司中国屈光业务负责人李宁向客商介绍"全飞秒 VISUMAX 800"设备，语气中难掩兴奋。这台外观"科技范"十足、10秒内就能完成单眼扫描的设备，刚 一亮相便成为国内外客商的关注焦点。但在李宁眼中，比设备令他兴奋的，是其背后的"乐城速度"。 从进博会展台到医院手术台，乐城正在通过真实世界研究这一关键制度创新，为国际创新药械进入 中国市场搭建"快车道"——今年以来，卡尔蔡司公司的飞秒激光角膜屈光治疗机、赛诺菲旗下抗CD38 单抗赛可益和罗氏诊断公司的FOLR1(FOLR1-2.1)抗体检测试剂(免疫组织化学法)等3款乐城真实世界研 究试点产品接连在国内获批上市。这意味着，告别漫长的传统注册审批周期，部分患者在国内就能同步 用上国际最先进的药械产品。 大屏幕上，机械臂正以肉眼不易察觉的细微动作缓慢推进，每一次操作都精确至毫厘之间;屏幕之 外，坐在线下观摩席的专家学者屏息凝神，唯有偶尔响起的相机快门声和低沉的专业探讨声。 创新药 ...

罗小平也表示，近年来，我国在创新药物治疗领域发展迅速，在细胞治疗、基因治疗及传统生物治疗方 面已取得突破性成果。其中，真实世界的临床数据均源自我国患者的用药实践，我国专家也在积极参与 该领域国际指南和共识的制定。"医学会及相关组织将继续根据循证医学证据制定各类疾病诊疗方案， 并推动诊疗指南和规范的应用；临床一线的医生也应做到遵循指南规范诊疗和结合说明书合理用 药。"罗小平提出，"数据库是安全、合理用药的重要支撑，只有通过长期积累临床数据、提供循证医学 证据，才能明确药物的长期安全性与有效性，为儿童疾病的长期管理和治疗提供保障。" 会议期间还启动了"中青年医生成长计划——繁星满天科普工程"，为儿科医疗人才培养与儿童用药科普 注入新动能。 "儿科医生对患者的健康管理需要覆盖从受精卵、胎儿时期，到18-20岁的完整成长阶段。儿童时期的生 长发育状况，将为其成年后的全生命周期健康奠定基础。"中华医学会儿科学分会候任主委、华中科技 大学同济医学院附属同济医院儿童医院院长罗小平教授提出，"我们强调从整体入手，以全生命周期为 主线提供服务，同时倡导以患儿和家长为中心的医患共同决策模式，实现疾病的长期管理。" 在儿童用药方面 ...

Core Insights - The article highlights the increasing importance of high-quality data in the biopharmaceutical industry, especially following the NIH's ban on certain researchers accessing critical biological databases, emphasizing that data is now a core strategic resource [1] - The establishment of the National Data Bureau in China marks a significant step in promoting data governance and the integration of medical data as a valuable resource for innovation and efficiency in healthcare [2] Group 1: Data Governance and Integration - The strategic position of data has been elevated at the national level, with data now recognized as a key production factor alongside traditional elements like land and labor [2] - The Shanghai city has initiated the "Shanghai Urban Trusted Data Space" project, attracting nearly 300 companies and developing over 300 data products, showcasing the active efforts in building a trusted data ecosystem [2] - Medical data is transitioning from being a byproduct of patient treatment to a powerful driver for medical innovation and resource optimization [3] Group 2: Real-World Data and Drug Development - The construction of a big data platform for late-stage pancreatic cancer has gathered data from 100,000 patients across 31 provinces, providing a solid foundation for precision treatment [5] - Real-world evidence (RWE) is becoming crucial in drug development, allowing for faster and more efficient research processes compared to traditional clinical trials [6][7] - The use of historical real-world data can significantly reduce the time required for drug approval, enabling quicker access to new treatments for patients [7] Group 3: Challenges and Innovations - Despite the abundance of real-world data in China, the quality of this data varies, presenting challenges for effective data governance and utilization [7] - The issue of "data silos" and the need for improved communication between data providers and users are highlighted as significant barriers to achieving effective data flow [8][10] - Innovations such as the MDT intelligent system developed by Roche and local hospitals aim to enhance data structuring and extraction efficiency, paving the way for more insightful clinical practices [9]

据悉，海南博鳌乐城临床真实世界数据应用试点工作6年来，相关应用实践取得突破性进展，推动乐城 先行区逐步崛起成为真实世界研究的平台高地。作为真实世界研究领域的年度盛会，博鳌国际药械真实 世界研究大会已连续举办四届，成为国际真实世界研究交流的重要平台，向世界传递出真实世界研究的 中国声音。 在全体大会上，海外权威代表分享了人工智能在药物警戒中的使用原则以及真实世界数据监管用途方面 的相关探索实践和工作进展；国家药监局药品审评中心、医疗器械技术审评中心、食品药品审核查验中 心和药品评价中心负责人分别围绕药品真实世界研究监管实践、构建真实世界证据支持医疗器械临床评 价的监管科学体系、构建科学可靠的证据体系和真实世界数据赋能药物警戒创新发展进行介绍；海南乐 城真实世界研究院执行院长陈平雁介绍了药物真实世界研究的格局。 此外，本届大会还设置了真实世界研究与药品临床评价、真实世界研究与医疗器械临床评价、真实世界 研究与中医药临床评价、真实世界研究与生物医学新技术等10个分论坛，以及真实世界研究能力提升专 题培训会和真实世界证据支持药物决策国际经验分享、真实世界数据资源与应用路演、真实世界研究青 年学者论坛3个研讨会，聚焦真 ...

第四届博鳌国际药械真实世界研究大会举行 《真实世界数据与监管科学》创刊 海南日报博鳌11月24日电(海南日报全媒体见习记者 王子豪)11月22日至23日，第四届博鳌国际药 械真实世界研究大会在琼海博鳌举办。本届大会围绕"真实世界研究助力创新药械临床评价"主题，吸引 国际组织以及国内外监管机构、知名医疗机构、顶尖科研院校、跨国药械企业等真实世界研究相关领域 的专家学者及嘉宾700余人共聚一堂，分享最新药械监管科学理念，展示先进科研成果，共同推进全球 健康事业发展。 本届大会设置了真实世界研究与药品临床评价等10个分论坛，以及真实世界研究能力提升专题培训 会和真实世界证据支持药物决策国际经验分享等3个研讨会。 会上举行了国际学术期刊《真实世界数据与监管科学》创刊仪式，旨在汇聚真实世界数据辅助监管 决策的国际前沿技术和应用案例，为监管科学提供新工具、新标准、新方法，助力乐城打造全球学术高 地。 作为真实世界研究领域的年度盛会，博鳌国际药械真实世界研究大会已连续举办4届，成为国际真 实世界研究交流的重要平台，向世界传递出真实世界研究的中国声音。 ...

Core Insights - The average approval time for imported medical devices and drugs in the Hainan Boao Lecheng International Medical Tourism Pilot Zone has been reduced to 1.6 days, facilitating faster access to international innovations for patients in China [1][2] - The Lecheng Pilot Zone has successfully introduced 523 types of international innovative medical devices and drugs, benefiting over 180,000 patients, and aims to further enhance its medical technology and drug importation efforts [2][3] Group 1 - The first global hormone replacement therapy drug for hypoparathyroidism, parathyroid hormone replacement therapy, has been successfully used by a patient in Hainan, despite not being officially launched in mainland China [2] - The Lecheng Pilot Zone's unique policies, including "licensed medical devices" and "real-world research," have enabled a significant reduction in the approval process for new medical products [2][3] - The introduction of a "zero tariff" policy for imported medical devices and drugs has further streamlined the process, reducing the average approval time from 5 working days to 1 working day [2] Group 2 - The ongoing China International Import Expo has attracted over 30 renowned domestic and international pharmaceutical and medical device companies, indicating strong interest in the Lecheng Pilot Zone [3] - The Lecheng Pilot Zone has established deep cooperative relationships with over 180 pharmaceutical and medical device companies from 20 countries and regions, including many of the top 30 global firms [3] - The management of the Lecheng Pilot Zone plans to refine the tax-exempt catalog for medical devices and drugs, aiming to create a world-class international medical tourism destination and a medical innovation platform [3]

Core Viewpoint - Ruijin Hainan Hospital is leveraging institutional innovation to establish itself as a new highland for international medical services in the Hainan Free Trade Port, aiming to connect global medical resources with local patients [3][4][5]. Group 1: Institutional Innovation and Medical Services - Ruijin Hainan Hospital is a key project approved by the Hainan provincial government, officially starting operations in December 2021 and achieving full medical process integration by March 2022 [3][4]. - The hospital has successfully implemented 186 special drug and medical device projects, benefiting over 26,800 patients, significantly reducing the economic burden on patients by negotiating lower prices for these products [5][6]. Group 2: Real-World Research and Clinical Advancements - The hospital is conducting high-quality real-world data research to accelerate the registration and market entry of international innovative drugs and devices in China, exemplified by the rapid approval of Isatuximab injection for multiple myeloma patients [6][7]. - Innovative mechanisms have been established, including a dedicated technical expansion department and a patient management platform, to enhance the accessibility of quality medical resources [6][9]. Group 3: Talent Development and Cultural Integration - The hospital is focusing on a "transfer and cultivate" approach to talent development, aiming to instill the spirit of Ruijin Hospital in Hainan while building a sustainable local talent pool [7][8]. - Collaborative initiatives with Shanghai Jiao Tong University and other institutions are being pursued to provide local talents with international learning and research opportunities [8]. Group 4: Regional Medical Ecosystem and Internationalization - Ruijin Hainan Hospital is enhancing the regional medical ecosystem through platform sharing and resource integration, collaborating with local hospitals to provide high-quality medical services [9]. - The hospital is actively pursuing international cooperation, including partnerships with Southeast Asian medical institutions and exploring international insurance models to improve service standards [9].