Core Insights - The traditional reliance on animal testing in drug development is being challenged by advancements in organoids, organ-on-a-chip technology, and AI simulations, marking a new era in life sciences and pharmaceutical research [1][3] - The FDA has mandated the gradual elimination of mandatory animal testing for monoclonal antibodies and has incorporated organoids and organ-on-a-chip solutions into its regulatory framework [1] - The first fully automated AI organoid system in Asia was showcased at a forum in Shanghai, highlighting the city's potential to leverage this "black technology" for biomedicine [1][4] Organoid and Organ-on-a-Chip Technology - Organoids mimic the structure and function of real organs, such as brain and intestinal organoids, and have been recognized as a top technology by Science magazine in 2013 [2] - Organ-on-a-chip technology combines organoids with microfluidic chips to simulate physiological environments, with over 60 companies globally involved in this sector, projected to reach a market size of $620 million by 2029 [2] Market Growth and Applications - The organoid industry is expected to maintain a compound annual growth rate (CAGR) of over 20% in the coming years, enhancing drug screening efficiency and reducing costs and risks in drug development [3] - Personalized medicine is a significant development direction for organoids, allowing for the creation of patient-specific organoids to simulate disease states for tailored treatment plans [3] Technological Advancements - The newly introduced AI organoid system can automate the entire biological process, significantly improving the efficiency of stem cell and organoid growth, and addressing challenges in clinical applications [4][5] - This system aims to overcome the "valley of death" in biomedicine by providing high-fidelity models that retain tumor microenvironments and generating predictive models for drug efficacy [4] Strategic Initiatives in Shanghai - Shanghai is positioning itself as a leader in the organoid innovation ecosystem, having supported various projects since 2021 focused on drug screening and personalized medicine [6] - The city has established a framework for integrating cutting-edge technologies like AI and organoids into clinical research, with policies that encourage innovation [6][7] - Shanghai's unique advantages include rich clinical resources, a robust AI infrastructure, and pioneering regulatory frameworks that facilitate clinical validation of organoid technologies [7]

FDA提出了一个宏大的计划，路径还不清晰。 "这一项目预计在2026年第一季度完成双盲药物的验证工作。"耀速科技科学事务总监叶森对第一财经表示。 他说的是美国食品药品监督管理局（FDA）启动一项面向药物性肝损伤预测的验证项目。该项目测试非动物方 法在药物性肝损伤预测中的应用。在研药物进行人体试验之前，要进行动物试验以检测毒性。每年超过千万只 的猴子、小白鼠和兔子等动物参与各类毒性试验。 美国是全球最大的医药市场，FDA的指挥棒影响着全球药企的研发方向。FDA正在试图做的事情，就是通过类 器官、器官芯片以及AI模型等方式，在更准确更高效的基础上，使得人类不必再需要猴子试毒。 替代猴子 今年三月份，美国FDA找到耀速科技，双方签订合作协议，由后者参与实施一项跨平台的药物验证工作。除了 耀速科技，还有其他八家肝脏微生理系统平台机构参与了FDA的项目。 这一项目中，耀速科技提供自研的高仿生肝脏芯片，还参与SOP（标准作业流程）执行与数据比对机制的标准 化共建，接入AI辅助分析流程，用于提升毒性判断的分辨率与一致性。 人体服药的时候，几乎所有药物都会对肝脏造成负担；药企不管开发哪一种药物，都会面临药物性肝损伤的风 险。 ...

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 establishment of a regulatory science framework tailored to traditional Chinese medicine (TCM) is essential to address the unique characteristics of TCM and improve drug evaluation standards [1][2][3]. Group 1: Challenges in Current Drug Evaluation - The existing drug evaluation system, largely based on Western methodologies, fails to capture the multi-component and multi-target nature of TCM [1]. - A significant concern is the low efficacy of target-based drug discovery, with only 9.4% of small molecule drugs developed based on target theory [2]. - The complexity of TCM's metabolic processes and mechanisms has led to a lack of industry acceptance for existing regulatory tools and standards [3]. Group 2: Regulatory Science Development - The National Medical Products Administration (NMPA) has initiated research into regulatory science for TCM, emphasizing the need for new tools, standards, and methods [2][3]. - Cross-disciplinary collaboration is essential for developing a comprehensive regulatory framework, integrating expertise from various fields such as informatics and engineering [3]. Group 3: Technological Advancements - The adoption of advanced technologies, including AI and organ-on-a-chip models, is recognized as a means to enhance the regulatory process and reduce drug development costs [4][5]. - The application of cutting-edge technologies in TCM research and development is crucial for modernizing and internationalizing the entire drug development process [5].