近期，FDA宣布将逐步取消在单抗疗法等 药物研发中的动物实验强制要求。 文 ｜ 胡香赟 封面来源 ｜ Pixabay 36氪获悉，耀速科技（Xellar Biosystems）近期已完成新一轮数千万元战略融资。本轮融资由晶泰科技领投，老股东天图投资与 雅亿资本持续加码，募集资金将用于加速其器官芯片、湿实验室与AI算法"3D-Wet-AI"闭环体系建设，拓展国际合作与多场景商 业化落地。 耀速科技于2021年底成立，专注于通过开发高通量器官芯片和AI模型平台，辅助临床研发、安全性评价等新药研发的核心流程。 36氪此前曾对其进行报道。 值得一提的是，近期，针对类器官及器官芯片类企业的一大利好在于，美国FDA正式宣布计划逐步取消在单抗疗法等药物研发中 对动物实验的强制性要求。这是自此前《FDA现代化法案2.0》（2022年）之后，类器官及器官芯片领域的又一里程碑式进展。 拯救"猴哥"、拥抱AI，作为一项可能"颠覆"传统新药研发方式的技术革命，类器官及器官芯片类企业终于要迎来自己的"春天"了 吗？ 市场对此的反馈并不一致。虽有反对者认为，这是"不负责任的举措"，可能会导致生物制药业陷入混乱局面。但支持的声音更为 普遍 ...

Core Insights - Xellar Biosystems has recently completed a strategic financing round of several tens of millions, led by Jingtai Technology, with existing investors TianTu Investment and Yayi Capital increasing their stakes [1] - The funds will be used to accelerate the construction of the "3D-Wet-AI" closed-loop system and expand international cooperation and commercialization [1] - The FDA's recent announcement to gradually eliminate mandatory animal testing for monoclonal antibody therapies represents a significant milestone for organoid and organ-on-chip companies [1] Company Overview - Founded at the end of 2021, Xellar Biosystems focuses on developing high-throughput organ chips and AI model platforms to assist in core processes of new drug development, including clinical research and safety evaluation [1][2] - The company has participated in the OASIS Consortium, which supports the development of next-generation clinical drug toxicity prediction tools [2] - Xellar's EPIC™ technology platform integrates microfluidic chip technology, disease organ modeling, high-throughput experimental systems, and generative AI algorithms to enhance drug development processes [2] Market and Industry Trends - Major pharmaceutical companies are increasingly interested in organoid and organ-on-chip technologies to reduce drug screening costs and improve predictive accuracy through AI [2] - The combination of AI and organ chips is seen as a potential revolution in traditional drug development methods, with the industry anticipating a positive shift following the FDA's new policies [1][3] - There are mixed market reactions, with some viewing the FDA's decision as irresponsible, while others see it as a concrete step towards integrating organoid technology with AI [1] Investor Perspectives - The CEO of Xellar, Dr. Xie Xin, emphasizes that the integration of AI and organ chips is not just a technological upgrade but a reconstruction of the entire research logic [3] - Jingtai Technology's chairman, Dr. Wen Shuhao, views Xellar as a strategic partner in the AI and organ chip space, aiming to create a sustainable, iterative new drug development system [3][4] - TianTu Investment highlights Xellar as a key technology platform company, noting its rapid iteration in chip design and organ modeling, as well as its collaboration with international pharmaceutical companies [3][4]