真实世界研究

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身在乐城,链接全球前沿医疗资源
Hai Nan Ri Bao· 2025-10-14 01:57
瑞金海南医院以制度创新为引擎,助力乐城打造医疗开放新高地 身在乐城,链接全球前沿医疗资源 上海瑞金医院专家远程操控海南医院的手术机器人,为患者切除胰体尾。图为瑞金海南医院手术室现 场。海南日报全媒体记者 袁琛 摄 海南日报全媒体见习记者 王子豪 一个蓬勃生长的"医疗特区",蕴含着多大的发展潜力?一座百年传承的医学殿堂,激荡着多么澎湃的创新 活力?当二者在海南自贸港这片热土上相遇,答卷便在上海交通大学医学院附属瑞金医院海南医院(以下简称 瑞金海南医院)的创新实践中缓缓铺开。 瑞金海南医院是海南省政府批准建设的国家和省级重点项目,是乐城先行区唯一的公立医疗机构,于 2021年12月18日启动试运行,2022年3月18日实现医疗全流程贯通,2022年10月18日获批第四批国家区域医疗 中心建设项目。 "瑞金海南医院作为国家区域医疗中心建设的'先行者',深深植根于海南自贸港这片充满机遇的沃 土。"近日,上海交通大学医学院附属瑞金医院副院长,上海交通大学医学院附属瑞金医院海南医院党委书 记、院长顾志冬表示,瑞金海南医院正以制度创新为引擎,以人才建设为基石,以产业联动为蓝图,全力打 造一个立足海南、辐射全国乃至东南亚的国 ...
梅斯健康子公司中标中国某药企“痛风智管计划”大型真实世界研究项目
Zhi Tong Cai Jing· 2025-09-25 14:24
Core Viewpoint - Meis Health (02415) announced that its subsidiary, Shanghai Meis Pharmaceutical Technology Co., Ltd., has won a large real-world research project from a Chinese pharmaceutical company, focusing on the efficacy and safety of IL-1β monoclonal antibody treatment for patients with acute and intercritical gout, with a project value of approximately RMB 21 million [1] Group 1 - The project aims to systematically evaluate the effectiveness and safety of IL-1β monoclonal antibody treatment through a combination of prospective and retrospective observational studies [1] - The company leverages over a decade of experience in its internet doctor platform, utilizing big data and artificial intelligence technologies to connect doctors, patients, and medical device companies [1] - The digital solutions provided by the company aim to empower the healthcare ecosystem and improve the quality of medical services [1]
事关创新药械全生命周期价值评估,年底前11省份启动这项试点
Di Yi Cai Jing· 2025-09-23 07:53
"真实世界医保综合价值评价"将挂钩医保商保"双目录"调整 真实世界研究驱动医药创新再进一步。 23日,国家医保局发布"关于开展真实世界医保综合价值评价试点工作的通知"(以下简称"通知")。根据通知,未来三年里,我国将通过 试点探索,形成一套"以价值为导向、基于真实世界研究的医保综合价值评价体系"。2027年年底,该评价体系将进入"全国范围推广"阶 段。 目前,北京、海南、江苏等11省已被纳入试点范围。接下来,国家医保局将对试点先行地区进行动态管理,确保"有进有出"。 具体来说,在药品领域的应用场景有7个,分别为上市前研发立项参考、药品首发挂网、医保及商保创新药目录调整、集采药品疗效及价 格分析、挂网药品价格治理、药品使用分析(用法用量、联合用药、超适应症用药等)和上市后药品价值再评价。 在医用耗材领域应用场景有5个,分别为(异地就医)医用耗材医保目录调整、可单独收费目录调整、医用耗材挂网及价格治理、创新医用 耗材医保分类和集采医用耗材分组及比价系数调整。 这一基于真实世界证据的医保综合价格评价体系有望影响创新药、仿制药、医用耗材和医疗服务的定价、价格调整和多层次支付保障。根 据通知,该评价体系会在药品首发挂网 ...
片仔癀:茵胆平肝胶囊真实世界研究完成首例受试者入组
Zheng Quan Shi Bao Wang· 2025-09-17 02:41
Core Viewpoint - The company has officially launched a real-world study involving its exclusive product, Yindan Pinggan capsules, aimed at liver and gallbladder diseases, marking a significant milestone in the development of traditional Chinese medicine [1][2] Group 1: Research Overview - The real-world study is a large-scale research project involving 3,000 participants, focusing on modern diseases such as metabolic-associated fatty liver disease and alcoholic liver disease [2] - The study aims to collect clinical efficacy data in real-world treatment settings, specifically evaluating the capsules' effectiveness in reducing liver fat content, alleviating chronic cholecystitis pain, and improving liver function [2] Group 2: Strategic Implications - The successful initiation and participant enrollment in the study highlight the company's commitment to advancing traditional Chinese medicine through scientific innovation and secondary development [2] - The company plans to continue promoting evidence-based research in traditional Chinese medicine, aiming to enhance the brand strength of liver and gallbladder medications and provide new treatment strategies for liver diseases [2]
中国医疗集团重磅启动多项AI-RWS研究 领跑“AI+临床研究”新赛道
Zhi Tong Cai Jing· 2025-09-15 04:26
一、学术与研究体系 中国医疗集团(08225)发布公告,近日于上海成功举办"AI-RWS真实世界研究高峰论坛",并集中启动十 余项针对中国青少年精神障碍、老年痴呆伴行为和心理症状(BPSD)两大高发精神神经疾病的AI驱动真 实世界研究(AI-RWS)专案,标志着公司在港股"AI+临床研究"赛道战略布局迈出关键一步,进一步巩固 行业领先地位。 本次论坛汇聚40位国内儿科、青少年精神医学及老年认知障碍领域权威专家,并学习斯坦福大学、梅奥 医学中心,参照《JAMA Psychiatry》2024年最新循证指南,构建"AI智能分型—个性化治疗路径优化— 疗效与安全动态预测—复发风险早期预警"全周期闭环研究体系。该体系融合NLP、深度学习等技术, 整合多维度真实世界数据,将为两大疾病提供符合中国人群特征的高等级真实世界证据(RWE)。 - 本赛道临床研究核心:公司已获得喜恩卡微片纳米微片及喜恩美闪片的中国独家临床研究实验权利与 真实世界临床研究独家权利。 - 本赛道临床研究核心产品喜恩卡微片纳米微片,全球独家制剂享受国家医保,是治疗轻中度痴呆1级 证据A级推荐产品;采用VSMART专利技术,可解决吞咽难题、能与流食混合 ...
中国医疗集团(08225) - 自愿性公告
2025-09-15 04:01
中國醫療集團有限公司(「本公司」欣然宣佈,近日於上海成功舉辦"AI -RWS 真實世界研究 高峰論壇",並集中啟動十餘項針對中國青少年精神障礙、老年癡呆伴行為和心理症狀(BPSD) 兩大高發精神神經疾病的 AI 驅動真實世界研究(AI-RWS)專案 ,標誌著本公司在港股"AI+臨床 研究"賽道戰略佈局邁出關鍵一步,進一步鞏固行業領先地位。 一、學術與研究體系 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性或完備性亦無 發表聲明,並表明不會就本公告全部或任何部份內容或因倚賴該等內容而引致之任何損失承擔任何責任。 China Health Group Inc. 中國醫療集團有限公司 (以「萬全醫療集團」名稱在香港經營業務) (於開曼群島註冊成立之有限公司) (股份代號: 08225) 自願性公告之中國醫療集團之最新業務進展 本次論壇彙聚 40 位國內兒科、青少年精神醫學及老年認知障礙領域權威專家,並学习斯坦 福大學、梅奧醫學中心,參照《JAMA Psychiatry》2024 年最新循證指南,構建"AI 智能分型—個 性化治療路徑優化—療效與安全動態預測—復發風險早期預警"全週 ...
310个目录外药品拟角逐进入医保 面临价格博弈与“真创新”的考量
Di Yi Cai Jing· 2025-08-23 08:55
Core Points - The annual adjustment of the national basic medical insurance catalog has begun, with the National Medical Insurance Administration announcing a list of drugs that have passed preliminary review, indicating increased competition for drug inclusion in the insurance catalog this year [1][3] - A total of 310 generic drugs passed the preliminary review, significantly up from 249 in 2024, reflecting a substantial increase in the number of innovative drugs approved [1][3] - The adjustment process involves expert evaluation, negotiation, and price consultation, with a focus on balancing drug pricing and patient accessibility [1][6] Group 1: Drug Approval and Inclusion - The National Medical Insurance Administration has been adjusting the drug catalog since its establishment in 2018, with 530 drugs added through negotiations, enhancing the accessibility of innovative drugs [3] - Over 70 anti-tumor drugs have entered the insurance catalog from 2018 to 2024, addressing the needs of patients with various cancers [3] - The approval of innovative drugs has surged, with 48 first-class innovative drugs approved in 2024, more than five times the number in 2018 [3] Group 2: Pricing and Negotiation - The negotiation process for drug pricing is crucial, as it determines the reimbursement standards and affects the financial viability of innovative drugs [6][7] - The challenge lies in finding a balance between drug pricing and patient accessibility, as high prices can limit patient access while low prices may hinder the return on investment for pharmaceutical companies [6][9] - The adjustment of the insurance catalog is seen as a way to optimize the use of limited medical resources and improve the efficiency of the insurance fund [4][6] Group 3: Innovation and Evaluation - The 2025 adjustment plan emphasizes supporting true innovation and optimizing the structure of the drug catalog while ensuring fund security [8][9] - The need for a comprehensive drug value assessment system is highlighted, focusing on real-world data to evaluate the effectiveness and safety of drugs post-approval [10][12] - The integration of health technology assessments (HTA) in drug pricing negotiations is noted as a practice that could enhance transparency and fairness in the process [13]
310个目录外药品拟角逐进入医保,面临价格博弈与“真创新”的考量
Di Yi Cai Jing· 2025-08-23 08:37
Core Insights - The competition for access to the national medical insurance (NMI) directory is expected to intensify this year, with a significant increase in the number of drugs passing the preliminary review [2][4]. Group 1: NMI Directory Adjustments - The annual adjustment of the national basic medical insurance directory has commenced, with 310 drug names passing the preliminary review, up from 249 in 2024, indicating a more competitive environment for drug access [2][4]. - Since the establishment of the National Medical Insurance Administration in 2018, there have been eight rounds of adjustments to the NMI drug directory, with 530 drugs added through negotiations, enhancing the accessibility of innovative drugs [4]. - The approval of innovative drugs has surged, with the number of first-class innovative drugs approved reaching 48 in 2024, over five times that of 2018, and nearly 40 approved in the first half of this year alone [4][5]. Group 2: Pricing and Negotiation - The negotiation process for drug pricing involves expert evaluations and discussions with companies to establish mutually acceptable reimbursement standards, referred to as "soul bargaining" [7]. - The pricing of newly approved drugs is often high due to substantial R&D investments, making affordability a critical factor for patients [7][8]. - The balance between low reimbursement prices, which may hinder innovation returns, and high prices, which could strain the insurance fund, is a significant challenge in the NMI directory adjustments [7][11]. Group 3: Innovation and Evaluation - The NMI adjustments emphasize supporting true innovation and optimizing the structure of the drug directory, with a focus on filling clinical gaps and encouraging differentiated innovations [9][10]. - The establishment of a comprehensive drug value assessment system is increasingly urgent, with a need for scientific methods to guide financial decisions in the NMI [12]. - Real-world data is crucial for evaluating the effectiveness and safety of drugs post-approval, and it is essential for adjusting reimbursement standards based on actual clinical outcomes [13][14].
海南博鳌乐城加速建设国际医疗旅游目的地
Zhong Guo Xin Wen Wang· 2025-08-21 20:00
Core Insights - The introduction of the Koli Ear Nexa system has enabled 100 hearing-impaired patients in China to regain their hearing since its launch in the Boao Lecheng International Medical Tourism Pilot Zone [1] - The Lecheng Pilot Zone has established itself as a key channel for international innovative medical devices and drugs to enter the Chinese market, having introduced 504 types of urgently needed foreign medical products that are not yet available domestically [1] - The Pilot Zone has launched 31 medical tourism products across various fields, supported by favorable policies such as "zero tariff" for imported medical devices, which injects new momentum into the medical tourism industry [2] Group 1 - The Lecheng Pilot Zone has become a major hub for international innovative medical products, achieving synchronization with international standards in medical technology, equipment, and pharmaceuticals since its establishment in 2013 [1] - The zone has over 30 operational medical institutions, creating a medical industry landscape led by top public hospitals and specialized international and domestic brands [1] - The Pilot Zone's policies allow for faster access to international advanced medical devices for patients with urgent clinical needs, significantly reducing the traditional clinical verification cycle [1] Group 2 - The Boao Yiling Life Care Center has launched various medical tourism products that have gained popularity among international tourists, offering services that combine traditional Chinese medicine with cultural experiences [2] - The center has attracted patients from countries such as the United States, Russia, and Canada, providing a diverse range of health management services that integrate both Eastern and Western medical practices [2] - The Lecheng Pilot Zone is actively expanding its international market presence by hosting promotional events in countries like Indonesia and establishing connections with local travel agencies and insurance companies [3] Group 3 - Future promotional efforts will extend to Southeast Asia, Europe, America, and Australia, enhancing the zone's international outreach [3] - The Pilot Zone is also working on partnerships with overseas insurance companies to facilitate cross-border insurance payments, improving the medical service experience for international visitors [3]
乐城海南眼视光眼科医院招募眼疾患者开展真实世界研究
Hai Nan Ri Bao· 2025-08-05 01:40
Core Insights - The Hainan Eye Hospital has introduced the 0.19 fluocinolone acetonide intravitreal implant, a unique FDA-approved drug for treating diabetic macular edema (DME), leveraging the "pilot" policy of the Boao Lecheng International Medical Tourism Pilot Zone [1] - The hospital is recruiting 121 DME patients nationwide for a real-world effectiveness study, with the first patient already injected on August 1 [2] Group 1 - The 0.19 fluocinolone acetonide implant is a non-biodegradable injectable corticosteroid that provides sustained release for up to three years, specifically for DME treatment [1] - DME is a common complication of diabetes, often affecting both eyes, leading to significant treatment and economic burdens for patients [1] - The new implant aims to help DME patients manage macular edema over the long term, maintain vision, and reduce the frequency of medical visits [1]