企业界方面，参展商包括华润、国控、广药等大型医药企业，百济神州、康方、一品红等创新型企业， 以及电信、联通、移动等通信企业。 相关附件 广州市人民政府主办，广州市卫生健康委员会、广州市协作办公室负责筹办的"2025广州医疗与健康产 业博览会"（以下简称医博会）将在8月22日至24日在中国进出口商品交易会展馆B区举办。 本次医博会展览面积高达3万平方米，共设置3个展馆、18个展区，基因编辑、细胞治疗、类器官、器官 芯片、核药、3D 打印、生物制造、合成生物学等一系列前沿技术成果在此汇聚，覆盖研发、转化、生 产、临床应用、第三方服务、金融支持等全产业链环节。 今年，医博会的影响力辐射更为广泛，安徽、四川、福建、重庆、新疆等地卫生健康行政部门纷纷组团 参会。在科研领域，广州实验室、高校科技成果转化中心等顶尖科研机构，以及50余家本地三甲医院受 邀参展。 ...

与市场观点不同，市场顾虑FDA新政影响及海外业务增长潜力，但该行认为：新政以单抗领域为切入点 进行尝试且国内尚未跟进。中短期看，动物实验3-5年内仍为全球药物安评领域的绝对主流方法；长期 看，新方法学(AI、类器官等)应用前景仍待观察，需结合其过渡期内的对比结果及远期技术成熟度综合 考量。该行看好动物实验与新方法学协同演进推动行业整体发展，并看好公司通过新方法学的积极布局 进一步提升综合能力。 华泰证券发布研报称，昭衍新药在历经18-22年的业绩高增，23-25年的订单量价承压调整后，利空逐渐 出清，26年起有望凭借国内复苏(BD出海热潮、IND数量上升)+海外离岸外包双轮驱动进入新一轮增长 通道。报告指出，实验猴价格是安评行业供需关系和周期性的风向标，国内目前位于8-10万元/只，企 稳后略有上升，供需端处于紧平衡状态。该行认为，伴随后续供需缺口拉大，猴价或逐渐进入新一轮上 升周期(22年时高达15-20万元/只)。 智通财经APP获悉，昭衍新药(06127)尾盘涨超9%，截至发稿，涨9.23%，报24.62港元，成交额3.91亿港 元。 ...

Core Viewpoint - The FDA has initiated a significant project aimed at validating non-animal methods for predicting drug-induced liver injury, with completion expected in Q1 2026 [1][3]. Group 1: FDA's Initiative - The FDA is collaborating with multiple organizations, including YaoSu Technology, to implement a cross-platform drug validation project using organ-on-a-chip technology [3][4]. - The project aims to enhance the accuracy and efficiency of toxicity assessments, reducing reliance on animal testing [4][6]. - The FDA's recent policy updates encourage the use of organ chips and AI modeling in early drug development stages, signaling a shift in research funding priorities [3][10]. Group 2: Cost and Time Efficiency - Utilizing organ-on-a-chip technology can significantly reduce the time required for toxicity testing, with some tests potentially completed in two weeks compared to several months for traditional animal testing [5][6]. - The cost of animal testing is substantial, with a mouse costing around 100 yuan and a monkey potentially costing up to 100,000 yuan, making non-animal methods financially attractive [4][6]. Group 3: Accuracy of Testing Methods - Current animal models have a liver injury prediction accuracy of only 50% to 65%, which is marginally better than random chance [6][9]. - Organ-on-a-chip technology could improve prediction accuracy to between 80% and 90%, leading to significant cost savings in drug development [6][9]. Group 4: Challenges and Future Directions - There are still significant technical and regulatory hurdles to fully replace animal testing, with a complete transition unlikely within the next decade [8][10]. - The FDA's goal is not to eliminate animal testing entirely but to shift the focus towards in vitro models, using animals only when necessary [9][11]. - The development of multi-organ chips that can simulate human physiology remains a long-term objective, requiring further research and standardization [9][10].

Summary of Preclinical CRO Industry Conference Call Industry Overview - The preclinical CRO industry is experiencing a decline in demand and increased competition since the second half of 2023, leading to a price war. The overall industry is expected to remain sluggish in 2024, with only slight growth anticipated in 2025, recovering slowly [1][2] - Large pharmaceutical companies now account for 70% of orders, while biotechnology companies have seen their share drop to 30% [5] Key Trends and Insights - There has been a slight increase in domestic project demand, but foreign orders remain scarce. Expanding into international markets, particularly in monkey resources, could enhance profit margins [1][6] - The fastest-growing drug types are concentrated in ADC, bispecific antibodies, and small nucleic acids, while orders for cell and gene therapies have decreased significantly [7][8] - The average cost of monkeys in China is currently around 80,000 yuan, expected to rise to approximately 100,000 yuan in the second half of the year due to reduced supply. However, this price increase is seen as temporary, with potential declines anticipated by 2026 as import channels open [11][12] Pricing and Competition - The preclinical CRO industry entered a price war in the second half of 2023, with prices dropping by 20% in the first half of 2023 and reaching a 50% decline by the end of the year. Prices stabilized at around 40-50% of original levels in 2024 [3][28] - Some leading companies, such as WuXi AppTec, have begun raising prices for animal testing to maintain profit margins, indicating a potential recovery trend [9][10] Market Dynamics - The competitive landscape remains intense, with approximately 70 companies holding GLP certification, but only about 20 capable of handling projects. Market orders are primarily concentrated among a few top-tier companies [16] - Companies are optimizing non-core segments and downsizing to improve efficiency, a trend expected to continue into 2026 [17] Regulatory and Cost Factors - Rising tariffs have increased the cost of testing reagents by less than 10%, primarily affecting project scheduling rather than pricing. Companies are seeking domestic alternatives to mitigate cost pressures [18][19] - The improvement in the domestic investment environment is expected to reflect in order volumes by the second or third quarter of the following year [22] Future Outlook - The industry is actively exploring alternatives to animal testing, such as organoids and organ-on-chip technologies, although complete replacement of animal testing is not yet feasible [23][24] - The opening of import channels for monkeys could lead to a decrease in domestic prices, contingent on government policy [13][14] Conclusion - The preclinical CRO industry is navigating a challenging landscape characterized by declining demand, price competition, and evolving regulatory requirements. Companies are adapting by optimizing operations and exploring new technologies to remain competitive in the long term [2][23]

Core Viewpoint - The article discusses a groundbreaking study that successfully developed highly vascularized lung and gut organoids using human induced pluripotent stem cells (iPSCs), addressing the limitations of traditional organoid models that lack functional vascular networks and organ-specific characteristics [2][11]. Group 1: Research Background - The study was published in the journal Cell on June 30, 2025, by teams from Cincinnati Children's Hospital and UCLA, marking a significant advancement in organoid research [1]. - Prior to this research, organoids generally lacked organ-specific vascular networks, particularly in endoderm-derived organs like the lung and gut, which limited their application in disease modeling and therapeutic contexts [1][2]. Group 2: Methodology and Findings - The research established an in vitro vascularized organoid platform that accurately replicates the co-development of mesoderm and endoderm lineages, enabling efficient differentiation of endoderm-derived cells into organotypic endothelial and mesenchymal cell populations [11]. - The new method requires fewer factors for organoid development: only one inhibitor (Noggin) for lung organoids and three activators (CHIR99021, FGF4, and VEGFA) for gut organoids, allowing for spontaneous formation of vascular networks [13]. - The resulting vascularized organoids exhibited enhanced cellular diversity, improved three-dimensional structure, and physiological functions, such as tight barriers in lung organoids for gas exchange and high permeability in gut organoids for nutrient absorption [13]. Group 3: Implications for Disease Modeling - The vascularized organoids can be utilized to study abnormal intercellular interactions in various disease contexts, such as ACDMPV, a congenital lung disease caused by FOXF1 gene mutations [14]. - By differentiating patient-derived iPSCs with FOXF1 mutations into vascularized lung organoids, the study successfully replicated primary endothelial defects and secondary epithelial abnormalities associated with the disease [14]. - This platform allows for the simultaneous modeling of multi-organ interactions in diseases, providing insights into complex conditions that traditional models could not address [14][15].

撰文丨王聪 编辑丨王多鱼 排版丨水成文 近年来，研究人员创造了各种类器官以模拟人体器官的功能，然而，一直难以构建出能够增殖且功能完备的 肝脏类器官 。这是因为，在实验室条件下， 肝脏中 的主要细胞肝细胞会发生 胆管化生，转变为胆管细胞样细胞，以平衡细胞功能和增殖之间的能量消耗，这导致肝细胞的功能最多只能维持 1-2 周。 2025 年 4 月 16 日， 庆应义塾大学医学院 佐藤俊朗 教授团队在国际顶尖学术期刊 Nature 上发表了题为 ： Generation of human adult hepatocyte organoids with metabolic functions 的研究论文。 该研究从直接取自人类患者的冷冻保存的成人肝细胞中培养出了 具有代谢功能的成人肝细胞类器官 。研究团队使用 参与炎症反应的信号蛋白 抑瘤素M （ Oncostatin-M，OSM ） 进行处理，使得肝细胞类器官的增殖量达到了百万倍，这与之前研究中的肝细胞几乎不生长的情况形成了鲜明对比。这些肝细胞类器官 持续生长了三个月，并且在半年内仍保持分化能力。这些肝细胞类器官为肝脏疾病的建模和治疗提供了新平台。 在这项最新研究中 ...