Core Viewpoint - The OTC2025 forum focuses on the advanced applications of organoids and 3D cell culture, discussing topics such as disease modeling, drug screening, AI-driven organ-on-chip technologies, and quality control in organoid cultivation [1][4]. Group 1: Forum Overview - The forum will take place on July 24-25 in Shanghai, featuring over 50 speakers and more than 800 attendees [1]. - Organized by Shanghai Aoshun Pharmaceutical, Shanghai Bai'ao Tai Pharmaceutical Technology, and Yao Jingtong Bio, with support from various academic and medical institutions [1]. Group 2: Agenda Highlights - The main sessions include discussions on tumor organoid drug sensitivity testing, bone organoids, and AI applications in drug screening [4][5]. - Specific topics include retinal organoid technology, high-throughput analysis of tumor organoids, and the application of organoids in disease modeling and drug screening [5][6][7]. Group 3: Key Participants - Notable speakers include experts from prestigious institutions such as Peking University, Macau University, and various research institutes [5][6][7]. - The forum will also feature discussions on the integration of AI in analyzing large-scale organoid data for personalized drug screening [52]. Group 4: Industry Trends - The forum emphasizes the importance of developing automated cultivation systems to enhance organoid production efficiency and reduce costs [54]. - There is a focus on combining 3D bioprinting and microfluidic technologies to improve the complexity and functionality of organoids [54].

Core Viewpoint - The article discusses the strategic investment by XtalPi in Xellar Biosystems, focusing on the integration of AI and organ-on-a-chip technology to enhance drug development and safety evaluation processes, aiming to replace traditional animal testing methods with more efficient and reliable alternatives [1][2][5]. Group 1: Investment and Collaboration - Xellar Biosystems has completed a multi-million yuan strategic financing round led by XtalPi, with continued support from existing investors TianTu Investment and Yayi Capital [1]. - The investment will accelerate the development of Xellar's "3D-Wet-AI" closed-loop system, which integrates organ-on-a-chip technology, wet lab capabilities, and AI algorithms [1][2]. - XtalPi, a leader in AI drug and new materials research, will collaborate with Xellar to address industry challenges such as high-quality biological data generation and AI-assisted toxicology predictions [2][6]. Group 2: Technological Advancements - Xellar's EPIC™ platform combines microfluidic chip technology, disease modeling, and generative AI algorithms, enabling rapid construction of complex microenvironments and high-throughput experiments [4]. - The integration of AI with organ-on-a-chip technology is seen as a transformative approach in life sciences, potentially revolutionizing drug development processes [5][9]. - The collaboration aims to create a seamless connection between in vitro complex models and AI molecular generation and screening algorithms, enhancing drug development efficiency and success rates [2][6]. Group 3: Regulatory Environment - Global regulatory bodies are accelerating the adoption of alternatives to animal testing, with the FDA modernizing its standards to include non-animal methods for new drug IND submissions [3][4]. - Xellar is actively participating in standard validation alongside regulatory agencies, providing predictive analysis services for drug safety and efficacy [4][5]. Group 4: Market Position and Future Outlook - Xellar is positioned as a key player in the AI and organ-on-a-chip space, with a strong foundation in cell biology and disease modeling, which enhances its competitive edge [6][8]. - The partnership with XtalPi is expected to strengthen Xellar's capabilities in automation and intelligent modeling, paving the way for innovative solutions in non-animal testing and precision efficacy prediction [9].

Core Insights - Xellar Biosystems, a technology platform focused on "AI + organ-on-a-chip" integration, has completed a new round of strategic financing amounting to tens of millions of yuan, led by XtalPi, a global leader in AI drug and new materials research [1] - The funding will accelerate the development of its "3D-Wet-AI" closed-loop system, which integrates organ-on-a-chip technology, wet lab capabilities, and AI algorithms, while also expanding international collaborations and commercial applications [1][2] - Xellar Biosystems aims to redefine drug development, safety evaluation, and precision medicine processes through its self-developed high-throughput organ-on-a-chip and AI model platform [1][4] Investment and Collaboration - The strategic investment from XtalPi will facilitate deep collaboration on high-quality biological data generation, complex disease modeling, AI-assisted toxicology predictions, and drug efficacy extrapolation [2] - The partnership aims to integrate organ-on-a-chip technology with automation, creating a seamless connection between in vitro complex models and AI molecular generation and screening algorithms [2][5] - This collaboration is expected to enhance drug development efficiency and success rates by providing clinically relevant research data [2][3] Regulatory Landscape - Global regulatory bodies are accelerating the transition away from animal testing, with the FDA Modernization Act 2.0 allowing non-animal methods for new drug IND submissions [3] - The FDA is launching multiple multi-center validation projects from 2023 to 2025 to incorporate organ-on-a-chip and human cell models into mainstream toxicology and efficacy evaluation standards [3] - Xellar Biosystems is actively participating in standard validation with regulatory agencies, providing safety and efficacy analysis services to pharmaceutical companies and research institutions [3] Technological Advancements - Xellar's EPIC platform combines microfluidic chip technology, disease modeling, high-throughput experimental systems, and generative AI algorithms, enabling rapid construction of complex microenvironments and multi-dimensional imaging [4] - The platform has been utilized in early drug toxicity prediction, functional food and skincare product screening, and personalized treatment response simulation [4] - The integration of AI and organ-on-a-chip technology is seen as a transformative shift in life sciences, enhancing the entire research and development logic [4][5] Market Position and Future Outlook - Xellar Biosystems is positioned as a key player in the AI + organ-on-a-chip sector, with strong technical execution and industry sensitivity demonstrated over the past two years [5][6] - The collaboration with XtalPi is viewed as a significant step in reinforcing Xellar's leading position in the AI + organ-on-a-chip integration path [5] - The focus on high-quality physiological data generation and deep coupling with AI models is expected to drive innovation in biomedicine, enhancing decision-making across regulatory, industrial, and consumer scenarios [6]

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]