近日， 北京尔瑞鑫悦科技有限公司 （以下简称"尔瑞鑫悦"）宣布完成新一轮 近亿元 A轮战略融资 。 本轮融资由 国中资本 领投， 成都思佰益基金 参与投资。此次融资为公司近四年来的第四轮增资，资 金将主要用于产能布局、平台技术升级及外泌体相关产品的临床与商业化推进。 在体外诊断与精准医疗持续向 "更早期、更微量、更无创" 方向演进的背景下，外泌体作为重要的信息 载体，其在复杂疾病诊断中的应用价值正在逐步被验证。尔瑞鑫悦本轮融资，反映出资本市场对外泌体 从科研工具走向临床产品阶段的持续关注。 # 围绕外泌体构建的平台型技术路径 从产业逻辑来看 ，外泌体的商业化难点并不只在于发现新的生物学意义，更在于如何在复杂样本中实现 稳定、可重复的提取与检测，这也是行业长期面临的工程化与标准化挑战。 在诊断应用方面， 尔瑞鑫悦已围绕神经系统疾病开展产品布局。公司基于脑源性外泌体靶向富集技术， 开发了用于检测血浆神经元外泌体中 α-突触核蛋白的体外诊断试剂盒，并已完成注册审批。该类产品 尝试通过外周血实现对中枢神经系统相关标志物的检测，切入帕金森病等神经退行性疾病的早期辅助诊 断场景。 从行业视角看， 这一方向代表着外泌体技术 ...

Core Insights - The forum focused on the latest developments in exosome technology and the progress of local cell technology companies in achieving international compliance for related raw materials [1][3][5] Group 1: Event Overview - The forum, themed "Exploring Cell Messengers Leading the Future of Regeneration," was held in Xi'an and co-hosted by the Xi'an Science and Technology Association and the Xi'an High-tech Zone Management Committee [1][3] - It attracted participation from academic experts, government representatives, clinical researchers, and industry professionals, highlighting the application potential of exosomes in regenerative medicine and disease diagnosis [3][5] Group 2: Key Presentations - Renowned scientist Academician Pei Duanqing provided insights into the development trends, scientific value, and future prospects of exosome technology, emphasizing its potential in regenerative medicine, disease diagnosis, and new drug development [5] - He noted that the standardization and industrialization of exosomes are essential directions for the future [5] Group 3: Industry Developments - The forum announced that local company Medcell Biotechnology's exosome raw materials have received FDA DMF (Drug Master File) registration and have been included in the International Cosmetic Ingredient (INCI) list [5] - This FDA DMF registration indicates that the raw materials meet pharmaceutical-grade regulatory standards, facilitating their application in innovative drug development, while inclusion in the INCI list opens opportunities in the cosmetics sector [5] Group 4: Collaborative Efforts - A ceremony for "Building an Innovative Ecosystem for the Exosome Industry" was held, showcasing the collective commitment of academicians, university representatives, and business leaders to advance exosome technology from laboratory research to industrial application [7] - Collaborating institutions include Shaanxi Normal University and Northwestern Polytechnical University, contributing to the promotion of industry-academia-research cooperation in the biopharmaceutical frontier [7]

Core Insights - The 28th Beijing-Taipei Technology Forum focused on "Innovation-Driven Integrated Development: Jointly Building a New Ecosystem for the Biotechnology Industry" and gathered representatives from both regions to discuss trends and collaboration opportunities in the biopharmaceutical sector [1][2] Group 1: Policy and Regulatory Framework - The Deputy Director of Beijing's Drug Administration highlighted the "Measures to Support the High-Quality Development of Innovative Pharmaceuticals in Beijing (2025)", emphasizing policies related to clinical trials, approval processes, production, circulation, clinical application, and investment support [1] - The administration aims to enhance innovation services, expedite review processes, and improve inspection efficiency to promote high-quality development in the pharmaceutical and health industry [1] Group 2: Industry Trends and Innovations - Discussions included topics such as natural drug development, ADC innovation technology, cell and gene therapy, AI-assisted pathology diagnosis, and exosome technology [1] - Companies like Tianjin Biotechnology Group and Yuyuan Pharmaceutical shared insights on their innovative products, including the first approved natural new drug for diabetic foot ulcers and advancements in ADC technology [1][2] - The Chinese innovative pharmaceutical industry is transitioning from a "follower" to a key global innovator, with ongoing improvements needed in original innovation capabilities and global competitiveness [1] Group 3: Industry Growth and Economic Impact - The Beijing Economic and Technological Development Zone hosts over 5,000 companies in the biotechnology and health sector, with projected industrial output value of 81.3 billion yuan in 2024 and a 16.6% year-on-year revenue growth in the technology service sector [2] - The establishment of the International Pharmaceutical Innovation Park (BioPark) has attracted major international companies like AstraZeneca, Eli Lilly, Pfizer, and Bayer, with all six centers of the National Medical Products Administration now located there [2]

Core Insights - The article discusses the emergence of exosomes in the skincare industry, highlighting their potential to revolutionize traditional skincare methods through advanced biotechnological applications [1][7]. Group 1: What are Exosomes? - Exosomes are nano-sized vesicles (30-150 nanometers) released by cells, serving as key carriers for intercellular communication [2]. - They transport bioactive substances, including proteins, nucleic acids, and lipids, facilitating the regulation of recipient cell functions [3]. Group 2: Mechanism of Action - Exosomes operate through two primary mechanisms: 1. They provide an efficient delivery system that can penetrate the skin barrier, allowing active ingredients to reach deeper skin layers [4]. 2. They possess messenger functions that can significantly influence cell behavior, promoting collagen production and reducing inflammation [5][6]. Group 3: Application in Cosmetics - The use of exosomes in cosmetics presents several advantages: - High efficiency due to their nano-scale and targeted delivery, potentially requiring lower concentrations than traditional ingredients [8]. - Multifunctionality, allowing a single ingredient to address multiple skin concerns, thus simplifying formulations [8]. - High biocompatibility, particularly with plant-derived exosomes, which reduces the risk of allergic reactions [8]. - However, challenges exist, including high technical barriers for extraction and purification, and variability in safety based on the source of exosomes [9].

Core Insights - Company has successfully registered its exosome raw materials with the FDA under the Type II Drug Master File (DMF), marking a significant achievement in meeting international standards for exosome technology [1] - The exosome technology is recognized for its low immunogenicity, strong penetration capabilities, and potential for targeted modification, making it applicable in various fields including drug delivery, regenerative medicine, and consumer markets such as aesthetics and anti-aging [1][2] - The successful DMF registration indicates that the company has passed rigorous international reviews regarding production processes, quality control, and safety data, which is a testament to its R&D capabilities and will facilitate market entry in high-end segments and other overseas markets [1] Company Developments - The exosome project is based on the K'Exosome delivery technology platform, which enables the large-scale and standardized manufacturing of clinical-grade exosomes, along with efficient loading of proteins/small nucleic acids and precise targeting capabilities [2] - The global market for exosome diagnostics, therapeutics, and research tools reached $227.5 million in 2023 and is projected to grow to $1.3 billion by 2028, reflecting a compound annual growth rate (CAGR) of approximately 42.2% [2] - The company is committed to an "innovation + internationalization" strategy, with significant progress in its overseas business and ongoing efforts to advance "R&D internationalization," positioning itself to penetrate the European, American, and emerging markets effectively [2]