国家医疗保障局开展真实世界医保综合价值评价试点工作 这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 9月23日，国家医疗保障局办公室发布《关于开展真实世界医保综合价值评价试点工作的通知》。通知 提出，试点先行地区要在国家医保局统一部署下，按照"顶层设计、实践验证、决策应用"的工作思路， 通过在评价规范标准、技术方法、应用场景的实践探索以及相关数据、人才支撑体系拓展建设，到2027 年底，推进十个选题的研究落地，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，并在全国范围推广。 21点评：这是一场涉及理念、技术和制度的系统性变革。通过构建科学的评价体系、优化数据治理、深 化三医联动等，试点将推动医保从"被动支付"向"主动购买价值"转型，提高医保基金使用效率，赋能医 药行业高质量发展。 药械审批 恒瑞医药：阿得贝利单抗注射液新适应症上市许可申请获国家药监局受理 9月23日，恒瑞医药(600276.SH)公告称，公司子公司上海盛迪医药有限公司收到国家药监局下发的《受 理通知书》，公司阿得贝利单抗注射液新适应症的药品上市许可申请获国家药监局受理。 ...

自2017年成立以来，该集团已建立由11款候选药物组成的管线，包括核心产品TY-9591、七款临床阶段 产品及三款临床前阶段或早期临床开发阶段产品。公司目前正在准备TY-9591附条件上市NDA申请，将 其用于表皮生长因子受体(EGFR)突变肺癌脑转移的一线治疗，以及正在中国进行TY-9591单药治疗的注 册性III期临床试验，将其用于EGFR L858R突变的局部晚期(IIIb至IV期)或转移性NSCLC的一线治疗。 公司将始终聚焦市场需求，深耕自研前沿产品的研发创新。依托人工智能模型的技术赋能，公司将深化 内部团队与国外顶尖团队的协同合作，高效推进新分子的开发。同时，在依托内部团队的基础上，积极 联动外部AI药物发现平台，力求在药物研发领域实现更多突破性进展，以此持续提升研发效率与核心 价值，为业务的升级和发展注入新的动力，最终助力公司实现可持续发展的长远目标。"新建固体制剂 工厂项目"是公司的产业化项目，新增片剂生产线及胶囊剂生产线。项目建成后，公司年产能可达到1.5 亿片剂或胶囊，同时满足临床药品及TY-9591产品部分商业化的生产任务。一期项目已于2024年6月30 日完成土建竣工验收，预计2026 ...

Core Viewpoint - The State Council of China has approved the "Open Innovation Development Plan for the Entire Biopharmaceutical Industry Chain in the China (Jiangsu) Pilot Free Trade Zone," aiming to enhance the biopharmaceutical sector's innovation and competitiveness on a global scale [2][5]. Group 1: Implementation Guidelines - The implementation of the plan should be guided by Xi Jinping's thoughts on socialism with Chinese characteristics for a new era, emphasizing high-quality development and a new development pattern [5]. - Jiangsu Provincial Government is tasked with formulating a special plan to ensure the objectives of the proposal are met, including risk prevention and regulatory collaboration [5]. Group 2: Strategic Importance - The biopharmaceutical industry is identified as a strategic emerging industry crucial for national security and public welfare [6]. - The plan emphasizes the integration of domestic and international resources, focusing on collaboration with research teams and innovation talents to enhance the industry [6]. Group 3: Innovation and Development - The government aims to build a robust platform for technology transfer and innovation, supporting the entire chain from basic research to industrial application [6]. - There is a focus on enhancing the service mechanisms for innovative drugs and medical devices, ensuring a supportive environment for high-quality development in the biopharmaceutical sector [6].

Group 1 - The core viewpoint of the article highlights the significant stock increase of JingTai Holdings (02228) by over 6% following the announcement of a collaboration with South Korea's Dong-A ST to develop innovative therapies for immune and inflammatory diseases using AI and robotics [1] - JingTai Technology anticipates a substantial increase in comprehensive revenue for the first half of the year, expecting no less than 500 million RMB, representing an annual increase of approximately 387% [1] - The company expects to turn a profit with a net income of no less than 50 million RMB, marking its first half-year profitability [1] Group 2 - The collaboration will leverage JingTai's AI and robotics-driven drug development platform to identify targets and design first-in-class or best-in-class drug candidates [1] - The financial performance improvement is primarily attributed to the partnership with DoveTree, which has significantly contributed to revenue growth through AI-based drug discovery solutions [1]

Core Viewpoint - JingTai Holdings (02228) has seen a significant stock price increase of over 8%, currently trading at HKD 8.06, with a transaction volume of HKD 819 million. The company anticipates a substantial improvement in its financial performance for the mid-2025 period, projecting a consolidated revenue of no less than RMB 500 million, representing an increase of at least approximately 387% year-on-year. This marks the company's first half-year profit [1]. Financial Performance Expectations - The company expects to turn from a loss to a profit, with a projected net profit of no less than RMB 50 million for the mid-2025 period. Adjusted net profit (non-IFRS measure) is expected to be no less than RMB 120 million [1]. - The anticipated improvement in financial performance is primarily attributed to the collaboration with DoveTree Medicines LLC and its affiliates, leveraging an end-to-end AI drug discovery platform and comprehensive "AI + Robotics" technology [1]. Revenue Contributions - The collaboration with DoveTree has led to significant revenue growth, with the company receiving an initial payment of USD 51 million, which has been recognized as revenue for the mid-2025 period and has made a substantial contribution to the company's earnings during the reporting period [1]. - According to the terms of the agreement with DoveTree, the company is entitled to receive further payments, which will be recognized as revenue in batches in the future [1].

Core Viewpoint - Shuyou Shen is gaining market attention as an innovative drug development and commercialization company, focusing on clinical value and advancing its pipeline projects through strategic partnerships and external capital infusion [1][2]. Group 1: Company Strategy and Developments - The establishment of the subsidiary Beijietai in Wuxi is aimed at leveraging the favorable business environment and support for biopharmaceutical innovation [1][2]. - Shuyou Shen has received a total of 200 million yuan from the Jin Yi Yuan Li Fund for capital increase and equity transfer, indicating strong external investment interest [1]. - The company is committed to a strategy of innovation-driven development, focusing on differentiated competition and advancing drug commercialization [1][2]. Group 2: R&D Focus and Pipeline - Shuyou Shen is concentrating resources on clinical-stage projects with clear commercialization potential, particularly in areas such as neurological diseases, respiratory and critical care, infectious diseases, and autoimmune diseases [4]. - The company has multiple projects in clinical trials, with STSA-1002 and BDB-001 nearing completion of Phase II trials, and BDB-001 recognized as a breakthrough therapy by the National Medical Products Administration in 2023 [4]. - The company is also exploring the application of artificial intelligence in drug development to enhance efficiency and reduce costs [5][6]. Group 3: Market Position and Product Offerings - Shuyou Shen's main marketed products include innovative biopharmaceuticals such as Su Tai Sheng (injection of mouse nerve growth factor) and Shuyai Qing (compound polyethylene glycol electrolyte solution) [6]. - The company is actively iterating on its existing products, with new formulations launched since 2022 to improve patient compliance and accessibility [6].

Industry Overview - The Chinese life sciences industry is undergoing rapid transformation driven by policy relaxation, technological innovation, and the emergence of domestic companies [10][20] - The government has eased foreign investment restrictions in gene and cell therapy, allowing wholly foreign-owned hospitals in major cities [11][21] - Local governments in cities like Beijing, Shanghai, and Shenzhen are implementing targeted subsidies and fast-track approval processes to support biotechnology development [11][26] Innovation and Company Growth - Chinese life sciences companies are shifting from generic drug production to innovative therapies, with firms like CanSino Biologics and BeiGene leading in CAR-T cell therapy and artificial intelligence-assisted research [12][29] - These companies are attracting international investment and licensing agreements, enhancing China's position in the global life sciences arena [12][39] Real Estate Development and Regional Hubs - Innovation hubs such as Suzhou BioBay and Shanghai Zhangjiang Hi-Tech Park provide comprehensive support, including shared laboratories and venture capital access [13][34] - Emerging second-tier cities like Chengdu and Ningbo are expanding growth corridors in the life sciences sector [13][33] Owner Perspective - Evolving Real Estate Models - Real estate developers are adapting to industry-specific needs through light-asset models and flexible leasing arrangements [15][45] - While first-tier cities face saturation, demand remains robust in central and western regions, with a focus on sustainability and compliance [15][45] Tenant Perspective - Growth, Innovation, and Challenges - Life sciences tenants are navigating regulatory reforms and increased compliance requirements while localizing production and R&D [16][46] - There is a strong demand for GMP-certified laboratories and modular production facilities, with tenants prioritizing location advantages and sustainability certifications [16][46] Future Outlook - High-Value Growth and Real Estate Evolution - Future growth opportunities lie in AI-driven drug development, personalized medicine, and advanced therapies [17][20] - The life sciences real estate sector is transitioning from generic parks to specialized, digitally-enabled facilities with high compliance and flexibility [17][20]

Core Viewpoint - The company, Yinos, is a leading contract research organization (CRO) in the non-clinical safety evaluation sector, providing comprehensive research services that align with both domestic and international standards, and has recently passed a GLP inspection by the FDA, enhancing its international service capabilities [25][26]. Company Overview - Yinos specializes in non-clinical research services for biopharmaceuticals, being one of the earliest companies in China to obtain GLP certifications from NMPA, OECD, and FDA, thus aligning with international standards [3][4]. - The company has a modern facility of nearly 60,000 square meters and a research team of over 1,000, with locations in Shanghai, Nantong, Shenzhen, Huangshan, and San Francisco [4]. - As of December 31, 2024, Yinos has served over 900 pharmaceutical companies and research institutions, contributing to numerous successful drug development cases [4][18]. Financial Performance - In the reporting period, Yinos achieved a revenue of RMB 1,141.67 million, representing a year-on-year growth of 9.94%, while the net profit attributable to shareholders decreased by 24% to RMB 147.78 million [23]. - The proposed profit distribution plan includes a cash dividend of RMB 3.2 per 10 shares, totaling RMB 45.11 million, which accounts for 30.53% of the net profit for the year [1]. Industry Context - The global CRO market is projected to grow at a compound annual growth rate (CAGR) of 9.0% from 2023 to 2026, with the market size expected to exceed USD 147.7 billion by 2030 [11]. - In China, the CRO service market is estimated to reach RMB 848.2 billion in 2023, with a projected CAGR of 9.9% from 2023 to 2026 [12]. - The industry is supported by government policies aimed at enhancing drug research and development capabilities, which is expected to drive long-term growth in the CRO sector [13][14]. Technological Advancements - Yinos is investing in artificial intelligence (AI) applications in non-clinical research, aiming to enhance efficiency and reduce costs in drug development processes [19]. - The company is also exploring organoid technology for drug screening and toxicity testing, which is gaining traction in the pharmaceutical research field [19][20]. Strategic Positioning - Yinos has established strong partnerships with leading pharmaceutical companies, positioning itself as a strategic partner in the innovative drug development process [18][21]. - The company is expanding its international presence, having established a subsidiary in the United States to enhance its global market share [22].

Core Viewpoint - The focus of institutional investors on Yipinhong's innovative drug AR882 highlights its potential in the gout treatment market, with significant clinical trial progress and FDA fast track designation [1][2][3]. Group 1: Clinical Trial Progress - Yipinhong's AR882 has received FDA fast track designation for treating visible tophi in gout patients, indicating a potential gap in the oral medication market for this condition [2]. - The Phase III clinical trials for AR882 have commenced, with the first patient enrolled on March 4, 2025, and the global REDUCE2 trial completing patient enrollment shortly thereafter [2]. - The REDUCE1 trial, parallel to REDUCE2, also began patient enrollment on March 17, 2025, focusing on the drug's efficacy in lowering serum uric acid levels [2]. Group 2: Competitive Landscape - Current treatments for hyperuricemia and gout are limited, with existing drugs primarily focused on disease prevention and pain management, while AR882 aims to provide a more effective solution [3]. - Yipinhong asserts that AR882's clinical data shows it can not only lower serum uric acid but also dissolve gout tophi, setting it apart from competitors that only demonstrate uric acid reduction [3]. Group 3: Drug Development and Safety - AR882's molecular design aims to reduce liver toxicity and enhance efficacy, with a prolonged action time of up to 24 hours, addressing safety concerns associated with existing treatments [4]. - The company is optimistic about AR882's market potential, given its unique clinical data and the significant demand in the gout treatment market [4]. Group 4: Research and Development Pipeline - Yipinhong has a total of 71 projects in development, including 15 innovative drug projects, with AR882 and another drug, APH01727, currently in clinical trials [5]. - The company is building a smart manufacturing base compliant with FDA and EU standards, integrating advanced automation and information management systems to support global drug manufacturing needs [5]. Group 5: Subsidiary Developments - Yipinhong's subsidiary, Fendi Pharmaceutical, is focused on developing targeted protein degradation agents for cancer and viral infections, utilizing advanced technologies to enhance drug discovery [6]. - Another subsidiary, Alpha Molecular, is leveraging AI and original biocomputing for drug research targeting GPCRs, with several self-developed pipelines nearing clinical application [6].