2025 年 12 月 10 日 ，浙江大学药学院、金华研究院和先进药物递释系统全国重点实验室 顾臻 教授、 俞 计成 教授团队联合中国医科大学附属第一医院 刘福囝 教授团队 （ 浙江大学 博士后 徐妍 为论文第一作者 ） ，在国际大奖学术期刊 Cell 上 发表了题为： Sensitized mast cells for targeted drug delivery and augmented cancer immunotherapy 的研究论文。 该研究报道了一个基于 工程化肥大细胞 的靶向治疗平台， 让这些平时在过敏反应中扮演重要角色的细 胞，化身为对抗癌症的"快递员"，在动物模型上验证了利用 肿瘤相关抗原 作为" 过敏原 "，驱动装载抗肿 瘤药物的肥大细胞可在体内主动聚集至肿瘤部位，诱发"过敏反应"并释放药物 。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 有些人一吃海鲜会起荨麻疹，一到花粉季节就喷嚏打不停，这些常见反应都源自人体最快、最强烈的防御 机制之一 —— 过敏反应 。 而现在，浙江大学的研究团队将这种强大的免疫反应重新定向，不再对抗花粉或食物，而是用来 对抗癌症 。 灵感来自过敏反应：肥大细胞的 ...

Group 1: Industry Overview - The biopharmaceutical industry is a strategic emerging industry crucial to national security and public health, currently facing challenges in translating basic research into clinical applications [1] - Clinical trials are identified as a core driver for upgrading the biopharmaceutical industry, with significant room for improvement in resource integration and efficiency [1][2] - The number of IND applications for new drugs has been increasing, reaching 1,241 in 2023, a 31.7% year-on-year growth, marking a five-year high [3] Group 2: Clinical Trial Development - Clinical trials are essential for validating and commercializing research outcomes, serving as a key step for companies and hospitals to enhance their clinical research capabilities [2] - The number of new drug clinical trials in China has nearly doubled from 2018-2020 (2,758 trials) to 2021-2023 (5,216 trials), with antibody-drug conjugates and bispecific antibodies showing significant growth in trial numbers [3][4] - In 2023, China registered 270 clinical trials, surpassing the United States' 222 trials during the same period, indicating a recovery in clinical trial activity [4] Group 3: Quality Control and Regulatory Framework - The quality of clinical trials is emphasized as a critical factor, with ongoing improvements in quality management systems and regulatory standards being necessary for high-quality development [5][6] - The implementation of ICH E6 (R3) from January 2025 is expected to reshape clinical trial design and execution processes, significantly impacting industry quality systems [10] - A comprehensive quality control system is recommended to ensure data integrity and participant safety throughout the clinical trial lifecycle [6][11] Group 4: Digital Transformation in Clinical Trials - The clinical trial industry is entering a digital era, with the integration of new technologies such as artificial intelligence and digital solutions to enhance efficiency and quality [7][8] - Nearly 80% of recent studies have utilized electronic clinical outcome assessments (eCOA), indicating a shift towards more digitalized and automated clinical trials [7] - The use of electronic data capture (EDC) systems is highlighted as a core entry point for data management, improving accuracy and processing efficiency [13]