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]

Core Viewpoint - The National Healthcare Security Administration (NHSA) of China has announced a pilot program for a "Real-World Comprehensive Value Assessment" of healthcare, which will be linked to adjustments in both public and commercial insurance directories, aiming to establish a value-oriented assessment system based on real-world research by the end of 2027 [1][2][3]. Group 1: Pilot Program Details - Eleven provinces, including Beijing, Hainan, and Jiangsu, have been included in the pilot program, which will undergo dynamic management to ensure effective implementation [2][9]. - The assessment system is expected to influence pricing and payment guarantees for innovative drugs, generic drugs, medical consumables, and healthcare services across 21 specific scenarios [2][4]. - The NHSA will collaborate with relevant parties to address concerns regarding the evidence submitted for drug approval and its real-world clinical benefits [2][4]. Group 2: Real-World Research Significance - Real-world research (RWS) is recognized for providing evidence that complements traditional randomized controlled trials (RCTs), particularly regarding the actual efficacy and clinical benefits of drugs in practice [3][4]. - The NHSA has previously emphasized the importance of RWS in supporting the comprehensive value assessment of innovative drugs and has initiated discussions to establish a scientific methodology for RWS [3][4]. Group 3: Application Scenarios - The assessment system will be applied in seven scenarios within the pharmaceutical sector, including pre-market research, price governance, and post-market value reassessment [5][6]. - In the medical consumables sector, five application scenarios include adjustments to the insurance directory and price governance [5][6]. - The healthcare services sector will see five application scenarios, focusing on price management and dynamic adjustments [5][6]. Group 4: Implementation Phases - The pilot program will be executed in three phases: a startup phase by the end of 2023, a practical phase in 2026, and an application phase in 2027 [10][14][16]. - The startup phase will focus on establishing norms and building a talent pool in pilot regions [10][14]. - The practical phase aims to complete the construction of databases and produce preliminary evaluation results [14][15]. - The application phase will support healthcare decision-making and establish a comprehensive operational mechanism for the assessment system [16].

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]

Core Insights - China Medical Group (08225) successfully held the "AI-RWS Real World Research Summit" in Shanghai, launching over ten AI-driven real-world research projects targeting high-prevalence mental disorders among Chinese youth and behavioral and psychological symptoms in dementia, marking a significant step in the company's strategic layout in the "AI + Clinical Research" sector, further consolidating its industry-leading position [1] Academic and Research System - The forum gathered 40 authoritative experts in pediatric, adolescent psychiatry, and geriatric cognitive disorders, learning from institutions like Stanford University and Mayo Clinic, and referencing the latest evidence-based guidelines from JAMA Psychiatry 2024 to construct a comprehensive research system integrating AI smart classification, personalized treatment path optimization, dynamic efficacy and safety prediction, and early warning of relapse risk [2] Core Sector Layout and Key Products - **Youth Mental Disorders Sector**: The company initiated an AI-RWS study covering over 30 institutions in 15 cities nationwide, targeting over 10,000 patients, focusing on the treatment of over 30 million affected youth in China. The study includes the exploration of combined or sequential treatments involving new drugs such as Xixin A, Xixin E, Xixin L, Xixin A, Xixin S, and Xixin L, aiming to optimize research protocols and predict disease progression [3] - **Dementia and BPSD Sector**: The "Star Plan" aims to build the largest and longest-followed BPSD real-world database in China, planning to include 100,000 patients over five years, focusing on non-drug interventions and combination therapies, providing critical data for innovative drug registration and post-marketing safety evaluations [3] - The company has obtained exclusive clinical research rights for key products like Xienka micro-patch and Xienmei flash tablets, which are recommended for treating mild to moderate dementia [4] Commercialization Path and Future Outlook - The company employs a diversified funding model involving collaboration with research hospitals, pharmaceutical companies, government projects, and insurance co-payments, with individual projects valued from millions to billions [5] - Leveraging platforms like Hainan Boao and Hengqin, the company can reduce the duration of Phase IV clinical studies by over 30%, aligning research outcomes with national health strategies, thus benefiting from policy advantages [5] - The company aims to focus on AI-RWS research and the development of intelligent physician agents, with core layouts in the Xixin mental health brand, Xien neurological brand, and Baimin allergic reaction brand, aspiring to become a global leader in the field and accelerate the transition to AI-driven clinical research services for enhanced shareholder value [5]

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 ...

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]

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].

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]

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]

Core Insights - The introduction of the commercial insurance innovative drug directory has opened up possibilities for innovative pharmaceutical companies to access high-value and high-innovation drugs in national negotiations and multi-layered payment systems [1][2] - Real-world data (RWD) is expected to play a larger role in the pricing of new drugs and their entire lifecycle, enhancing value-based purchasing in medical insurance and innovative payment in commercial insurance [1][2] - The National Medical Insurance Administration has been actively seeking public opinions on how RWD can support the comprehensive value assessment of drugs and medical devices [1][2] Group 1: Policy Developments - The recent rapid policy advancements in the pharmaceutical industry have surprised stakeholders, particularly with the release of measures supporting high-quality development of innovative drugs [1][2] - The establishment of a comprehensive value assessment system based on RWD is a key focus in recent discussions, aiming to optimize its role in the dual directory access and post-access re-evaluation [1][2][3] Group 2: Real-World Data Application - RWD has matured as auxiliary evidence in the evaluation and approval of innovative drugs, but its application in medical insurance value purchasing is relatively new [2][3] - The need for RWD in assessing the clinical effectiveness of newly listed drugs has become critical, especially as some drugs fail to meet expected value post-market entry [2][3][10] - RWD can fill evidence gaps left by traditional clinical trials, thus reducing uncertainty in medical insurance decision-making and improving fund utilization efficiency [5][10] Group 3: Dynamic Evaluation and Pricing - The evaluation of the clinical added value of innovative drugs should be dynamic, with RWD being used to balance clinical benefits and fund affordability [5][6] - The potential for RWD to support dynamic management of the medical insurance directory and drug exit mechanisms is recognized, allowing for timely removal of low-value drugs [6][8] Group 4: Integration of Insurance Systems - The introduction of the commercial insurance innovative drug directory allows for parallel applications with the basic medical insurance directory, with over 100 drugs already applying for the innovative drug directory [7][8] - RWD is anticipated to become a crucial element in connecting the dual directories, enabling a phased approach to drug access and evaluation [8][9] Group 5: Data Quality and Governance - The quality of RWD is essential for high-quality research, with current challenges including data inconsistency and lack of standardized collection methods [11][13] - Establishing a comprehensive system for RWD collection, application, and evaluation is crucial for enhancing the negotiation process for drug pricing and ensuring proper clinical use [13][14] Group 6: Collaborative Governance - The establishment of a unified medical insurance information platform has facilitated the collection of high-quality RWD, which can support regulatory decision-making [12][14] - The recent implementation of management measures for RWD usage in Hainan province highlights the potential for RWD to inform dynamic adjustments in the medical insurance directory and improve healthcare services [14]