Core Insights - The gathering of over 40 executives from 15 multinational pharmaceutical companies in the Greater Bay Area (GBA) highlights the region's growing importance in the biopharmaceutical industry [1][3] - The event serves as a platform for dialogue between government and industry leaders to explore the GBA's advantages and future potential in biopharmaceutical development [1][3] Group 1: Investment and Development - Multinational pharmaceutical companies are increasingly establishing production bases and regional headquarters in the GBA, signaling strong confidence in the region's biopharmaceutical industry [3][4] - The GBA has been recognized for its favorable business environment, with Guangdong province leading in foreign investment and being rated as having the best business environment in China [4][6] Group 2: Market Potential and Resources - Guangdong's healthcare market is vast, with a basic medical insurance enrollment of 112 million people by the end of 2024, and it leads the nation in the scale of pharmaceutical circulation and the number of top-tier hospitals [4][9] - The integration of the Guangdong-Hong Kong-Macao markets is unlocking significant potential in the biopharmaceutical sector, with a focus on translating advantages into patient benefits [6][12] Group 3: Regulatory and Collaborative Framework - The "Hong Kong-Macao Drug and Medical Device Access" initiative has facilitated the approval of 149 drug and medical device varieties, enhancing patient access to innovative treatments [7][8] - The establishment of a provincial commercial health insurance platform aims to alleviate patient financial burdens, further promoting the use of innovative drugs [8][9] Group 4: Innovation and Research - The GBA is becoming a key innovation hub, with one-third of global biopharmaceutical research pipelines originating from China, and many multinational companies are shifting early-stage research to the region [9][11] - The region has seen a significant increase in the approval of innovative drugs and medical devices, with a 667% increase in first-class innovative drugs approved during the 14th Five-Year Plan compared to the previous period [9][10] Group 5: Future Directions and Challenges - The collaboration between Guangdong and Hong Kong is crucial for enhancing the accessibility of innovative drugs, with a focus on real-world data and joint research initiatives [12][16] - Challenges such as cross-border regulation, data flow, and talent mobility need to be addressed to optimize the biopharmaceutical industry's collaborative efforts in the GBA [16][17]

"我们还打造了真实世界研究的'乐城模板'，全力推动生物医学新技术和特医食品的临床落地。"顾志冬 说，2025年，开出了全国首张特医食品的处方，填补了国内的空白。今后，瑞金海南医院将紧紧依靠海 南自贸港建设的独特背景，将乐城先行先试的政策和瑞金的文化积淀深度融合，聚焦百姓所急、百姓所 盼、百姓所需，充分满足人民大众对于优质医疗资源多层次、多方面的需求。 顾志冬表示，瑞金海南医院是博鳌乐城国际医疗旅游先行区唯一的公立医疗机构，在"十四五"期间，瑞 金海南医院充分利用乐城的先行先试政策，着力推进将上海瑞金医院的技术、人才、管理、品牌平移到 瑞金海南医院。推动实现了乐城"医疗装备、技术、药品"与国际三同步，落地了212项最新的药械，涵 盖了神经脑科学、肿瘤、罕见病等数十个专业领域，其中147个项目是全国首落，已经为来自全国各地 超过4万名患者实现了服务，解决了"大病不出国"的问题。 ...

转自：前瞻产业研究院 以下数据及分析来自于前瞻产业研究院医药研发外包(CRO)研究小组发布的《中国医药研发外包（CRO） 行业市场前瞻与投资战略规划分析报告》。 行业主要上市公司：目前国内CRO行业主要的上市公司有药明康德(603259.SH)、康龙化成(300759.SZ)、泰 格医药(300347.SZ)、凯莱英(002821.SZ)、昭衍新药(603127.SH)、九洲药业(603456.SH)、皓元医药 (688131.SH)、博腾股份(300363.SZ)、成都先导(688222.SH)、药石科技(300725.SZ)等。 1、"十五"到"十五五"：中国CRO行业政策聚焦 作为支撑医药创新的战略新兴产业，CRO是我国从医药大国迈向医药强国的关键力量。从"十五"到"十五 五"，我国从生物医药行业逐步聚焦到CRO专项领域，持续完善政策体系。"十五"将生物医药置于重要位 置，强调结构调整;"十一五"列为重点发展领域，支持产业集群;"十二五"提升至战略地位，明确支持CRO等 专业服务;"十三五"纳入战略性新兴产业，出台专项政策;"十四五"定位为生物医药高质量发展的"关键基础 设施";"十五五"则从单纯鼓励创 ...

首先帮助严把评价入口关。为了使发起方提出的评价方案，能够反映研究目的、科学规范，特别是反映临床的实际需求，医保部门需要可信评价点医疗机构 派出专业人员，协助各级医保部门，对发起方提交的评价方案提前把关，夯实方案规范性的源头基础。 其次是帮助把握检查关，确保数据的真实性。对于有关方面反映的可能存在的评价中的缺陷和不足，医保部门会邀请可信评价参与检查，及时核对流程和原 始数据，希望可信评价点积极参与。同时，也希望协助做好同行评价，守牢评价的质量，能够立足专业领域扎实开展工作。以严谨的态度，客观的公正的出 具可信评价报告，确保评价结果的真实性，经得起时间和行业的检验，共同守护评价体系的科学性和公信力。 第三方面，医保部门也希望各可信评价点健全信息共享机制，赋能医保评价工作提质增效。 丁一磊表示，医保部门将统筹指导各可信评价点，按时归集信息，定期形成工作动态，梳理创新的思路、成熟的流程、典型的案例以及问题的应对方法，形 成可复制可参考的经验储备库。 21世纪经济报道记者 贺佳雯 北京报道 近日，真实世界医保综合价值评价中，79家医院纳入国家可信评价点网络。 真实世界研究如何可信，成为备受公众关注的核心。作为真实世界医 ...

智通财经APP讯，欧康维视生物-B(01477)发布公告，本集团产品OT-703(ILUVIEN，氟轻松玻璃体植入 剂)(是一款可注射的、非生物降解的氟轻松玻璃体植入剂，用于治疗糖尿病性黄斑水肿(DME))最近已完 成于中华人民共和国海南省博鰲乐城国际医疗旅游先行区进行的真实世界研究合共195例患者的入组。 OT-703(即190微克氟轻松玻璃体内植入剂(0.19毫克))是一款可注射的、非生物降解的氟轻松玻璃体植入 剂，通过于眼部连续缓释最多36个月的微量非专有皮质类固醇醋酸氟轻松(FAc)治疗DME。其已获得美 国食品药品监督管理局(FDA) 的监管批准，并以商号"ILUVIEN"上市。OT-703是FDA批准的唯一一款缓 释长达3年的治疗DME的皮质类固醇眼内植入剂。于2021年4月，本公司与Alimera Sciences, Inc. (Alimera)订立一份独家许可协议，据此，本公司自Alimera获得 ILUVIEN在大中华区、韩国及东南亚11 个国家的独家开发及商业化许可权利。于2023年12月，OT-703获得香港药剂业及毒药管理局的批准， 可根据香港法例第 138章《药剂业及毒药条例》在香港 ...

Core Viewpoint - The National Healthcare Security Administration (NHSA) has signed agreements with 79 hospitals to initiate a pilot program for real-world comprehensive value assessment of medical insurance, aiming to evaluate the effectiveness, safety, and economic value of pharmaceutical products post-market [1] Group 1: Real-World Research and Evaluation - Real-world research refers to the assessment of the effectiveness, safety, and economic value of medical products based on data generated from daily clinical practices [1] - The NHSA acknowledges that while a dynamic adjustment mechanism for the medical insurance catalog is in place, challenges remain in decision-making due to the idealized conditions of pre-market clinical trials [1][6] - The evaluation will incorporate patient experiences and satisfaction, addressing the discrepancies between clinical trial populations and the broader patient population [3] Group 2: Data Collection and Analysis - Comprehensive data collection will include patient demographics, treatment plans, clinical outcomes, and adverse effects of medications [5] - Real-world data can reveal complexities and uncertainties, such as the actual incidence of side effects that may differ from clinical trial results [8] - The use of real-world data will enable clearer insights into which medications genuinely improve patient quality of life and which medical services offer better cost-effectiveness [8] Group 3: Implications for Healthcare Funding - The real-world comprehensive value assessment is expected to enhance the efficiency of healthcare fund allocation, allowing for the identification and exclusion of high-cost, low-efficacy drugs [10] - This approach aims to create a more patient-centered healthcare system by prioritizing innovative technologies and services that meet actual patient needs [10]

Core Insights - The establishment of the National Credible Evaluation Point Network for Real-World Medical Insurance Comprehensive Value Assessment aims to scientifically evaluate the actual value of pharmaceutical products using real clinical data [1][2] - The initiative involves 79 leading medical institutions and is intended to support key decisions in medical insurance, including drug negotiations and pricing [1] - The network will provide objective evidence for the adjustment of the medical insurance catalog, ensuring that the benefits and cost-effectiveness of negotiated drugs are in line with initial expectations [1] Group 1 - The Real-World Research focuses on evaluating the effectiveness, safety, and economic value of pharmaceutical products based on data generated from daily clinical practices [1] - The National Healthcare Security Administration (NHSA) emphasizes the importance of real-world research as a foundational work for medical insurance decision-making [1] - The NHSA plans to conduct evaluations every two years for negotiated drugs to ensure their benefits align with expectations [1] Group 2 - The NHSA aims for each credible evaluation point to participate in at least one real-world comprehensive value assessment of a drug, consumable, or medical service by 2026 [2] - The initiative is expected to generate demonstrable results that can withstand scrutiny and be applied in practical scenarios [2]

Core Insights - The year 2025 marks significant advancements in China's healthcare security system, showcasing resilience and a focus on people's health amidst modernization efforts [1] Group 1: Multi-layered Medical Security System - The "1+3+N" framework emphasizes a multi-layered medical security system, including a unified medical insurance information platform, basic medical insurance, major illness insurance, and support for commercial health insurance [2] - Reimbursement rates for inpatient expenses under employee and resident medical insurance have reached approximately 80% and 70%, respectively, with improvements in outpatient services [2] Group 2: Dual Drug Catalogs - The introduction of the "dual catalog" system for basic medical insurance and commercial health insurance marks a significant step in defining the boundaries of coverage, facilitating access to innovative drugs [3] - In 2025, the basic medical insurance catalog added 114 new drugs, with 50 being innovative drugs, achieving a negotiation success rate of 88% [3] Group 3: Provincial Coordination - The push for provincial coordination in basic medical insurance aims to enhance fairness and sustainability, with 20 provinces already advancing this initiative [5] - The focus is on optimizing fund management and ensuring uniform policy implementation across regions [5] Group 4: Anti-Competition Measures - The "anti-involution" strategy aims to stabilize drug pricing and maintain quality by preventing irrational price competition in the pharmaceutical industry [6][7] - Mechanisms have been introduced to ensure fair pricing and enhance clinical selection in drug procurement [7] Group 5: Real-World Research - Real-world research (RWS) has been established as a key tool for evaluating the comprehensive value of drugs and medical technologies, aiming to support sustainable fund management [8] - The National Medical Insurance Administration is developing a nationwide evaluation system to integrate real-world data into decision-making processes [8] Group 6: Long-term Care Professionals - The introduction of long-term care professionals aims to strengthen the workforce for long-term care services, with over 3,500 candidates participating in certification exams across multiple provinces [10] - The long-term care insurance system has expanded to cover nearly 300 million people, benefiting over 3.3 million individuals with disabilities [10] Group 7: Maternity Insurance System - The maternity insurance system aims for "no out-of-pocket" expenses for childbirth within policy coverage, with 2.55 billion people enrolled in the program [11] - Efforts are underway to include more demographics, such as flexible workers and migrant workers, into the maternity insurance coverage [11] Group 8: Drug Traceability Codes - The implementation of drug traceability codes has led to the collection of 39.885 billion codes, enhancing consumer protection and combating counterfeit drugs [13] - By July 2025, all medical institutions will be required to implement full traceability for drug sales [13] Group 9: Three-Settlement Reform - The "three-settlement" reform aims to streamline payment processes in the healthcare sector, significantly reducing the payment cycle for pharmaceutical companies [14] - The initiative includes immediate, direct, and synchronized settlements to enhance service efficiency for patients [14] Group 10: Medical Service Pricing Guidelines - The establishment of national medical service pricing guidelines aims to standardize pricing across provinces, addressing discrepancies and improving service quality [16] - The National Medical Insurance Administration has issued 36 batches of guidelines, with plans to complete 40 by 2026 [16]

Core Viewpoint - The year 2025 marks significant advancements in China's medical insurance system, showcasing resilience and a focus on people's health through various reforms and initiatives [1][20]. Group 1: "1+3+N" Multi-layered Medical Security System - The National Healthcare Security Administration emphasizes the establishment of a "1+3+N" multi-layered medical security system, which includes a unified national medical insurance information platform, three levels of basic medical insurance, and support for commercial health insurance and other forms of assistance [2][21]. - The reimbursement rates for inpatient expenses under employee and resident medical insurance have reached approximately 80% and 70%, respectively, while the level of serious illness insurance has increased by 10 to 15 percentage points [2][21]. Group 2: Dual Directory System - The introduction of the "dual directory" system, which includes the National Basic Medical Insurance and Commercial Health Insurance Innovation Drug Directories, represents a significant step in defining the boundaries of basic and commercial insurance [3][23]. - In 2025, the basic medical insurance directory added 114 new drugs, with 50 being innovative drugs of significant clinical value, achieving a historic high [3][23]. Group 3: Provincial Coordination - The push for provincial coordination of basic medical insurance aims to enhance fairness and sustainability within the system, with 20 provinces already advancing this initiative [5][24]. - The National Healthcare Security Administration has mandated the optimization of fund management and the establishment of provincial adjustment funds to support this coordination [5][24]. Group 4: Anti-Overcompetition - The eleventh round of centralized drug procurement has shifted towards a focus on quality and sustainability, with the concept of "anti-overcompetition" introduced to prevent irrational price competition [6][24]. - Mechanisms have been implemented to ensure rational pricing and to enhance clinical choice, allowing medical institutions to report quantities based on specific brands [6][26]. Group 5: Real-World Research - Real-world research (RWS) has been established as a key tool for evaluating the comprehensive value of drugs and medical technologies, aiming to support sustainable fund management and high-quality industry development [7][25]. - The National Healthcare Security Administration is planning to integrate real-world evaluation results into the entire chain of medical insurance payment and management [7][27]. Group 6: Long-term Care Workers - Long-term care workers have been introduced as a new profession to support long-term care services, with over 3,500 candidates participating in skill assessments across 28 provinces [10][29]. - The long-term care insurance system has covered nearly 300 million people, benefiting over 3.3 million individuals with disabilities [10][30]. Group 7: Maternity Insurance System - The maternity insurance system aims to achieve "no out-of-pocket" expenses for childbirth within policy coverage, with 2.55 billion people enrolled in maternity insurance during the 14th Five-Year Plan [11][30]. - The plan includes expanding coverage to flexible workers and improving prenatal care expense coverage [11][12]. Group 8: Drug Traceability Codes - The implementation of drug traceability codes has led to the collection of 39.885 billion codes, enhancing consumer protection and combating drug return issues [14][32]. - By July 2025, all medical institutions will be required to implement full traceability code collection [14][32]. Group 9: Three Settlement Reforms - The "three settlements" reform (instant, direct, and synchronized settlements) aims to reshape the payment ecosystem in the healthcare sector, with significant progress made in instant settlements covering 593,600 medical institutions [15][33]. - Direct settlements are designed to expedite payments to enterprises, reducing the average payment cycle from 180 days to under 30 days [15][33]. Group 10: Medical Service Pricing Guidelines - The National Healthcare Security Administration is working on standardizing medical service pricing across provinces to enhance transparency and service quality [18][35]. - By 2026, the administration aims to complete the compilation of 40 pricing guidelines to unify medical service pricing projects nationwide [18][35].

Core Insights - The company has rebranded from "圣方医药研发" to "太美智研医药," positioning itself as an "AI-driven pharmaceutical research solution provider" to contribute to the innovation in the pharmaceutical industry [2] Group 1: Strategic Developments - The company is actively involved in the TALENTop Phase III study for hepatocellular carcinoma, led by Professor Fan Jia from Fudan University, with results set to be globally unveiled at the 2025 ESMO conference [4] - The company has established a clinical endpoint evaluation alliance, CMAC, which received the "Best Annual Project Award" from CMAC Club, enhancing its industry influence [17] Group 2: Professional Support and Safety Management - The company provided independent and professional adjudication support for a key Phase III registration project of a well-known pharmaceutical company [5] - It offered drug safety risk management services for Tian Shili's clinical trial of a drug for cerebral infarction, aiding in the approval of the core indication [5] Group 3: Data Science and Innovation - The company provided Data Monitoring Committee (DMC) services for the global Phase III clinical trial of a pioneering dual-antibody ADC drug, accelerating the development of innovative therapies [11] - Collaboration with Stanford University resulted in a publication in the New England Journal of Statistics, focusing on considerations for single-arm trials to support accelerated approval of oncology drugs [11] Group 4: Publications and Knowledge Sharing - The company organized the translation and publication of "Cardiovascular Safety Assessment of Drugs: Innovative Methods and Regulatory Trends," introducing authoritative international findings [13] - It contributed to the writing of "Real-World Evidence in Drug Development: From RWD to RWE," providing industry-standard references [22] Group 5: Patient Recruitment and Market Expansion - The intelligent subject recruitment system developed for Nocare received the "2025 IDC Digital Native Enterprise Special Award" [19] - The company assisted Lepu Biopharma in obtaining approval for the world's first EGFR ADC drug, MRG003 [21] Group 6: Future Outlook - The company is set to embark on a new journey in pharmaceutical innovation in 2026, aiming to build a new brilliance in the health industry [30]