创新单抗药物申报临床阶段药学研究关注点

General Chemistry Manufacture and Control (CMC) issues during Investigational New Drug(IND) application of innovative monoclonal antibody products

近年来,创新单抗药物成为研发与申报的热点,与生物类似药不同,其药学研究和开发思路具有阶段性和渐进性的特点。自国家药品监督管理局发布《新药Ⅰ期临床试验申请技术指南》(2018年第16号)以来,随着国内创新单抗药物研发的推进,在创新单抗临床准入技术要求方面形成共识需要监管部门和工业界进行不断的研究和探讨。为了提高创新单抗药物的研发与审评效率,规范申报资料要求,加快推进创新药物进入临床,笔者结合当前创新单抗药物申报临床前沟通交流的药学共性问题,以及审评实践中临床准入安全性问题的关注点和基本考虑,提出以下建议供业界借鉴和探讨。

In recent years, innovative monoclonal antibody products have become the focus of drug research and registration. Compared to biosimilar antibodies, the Chemistry Manufacture and Control(CMC) research and development(R&D) of innovative antibodies follow the clinical staged-appropriate principle. The National Medical Products Administration issued the "Guideline of Investigational New Drug Application"(No. 17, 2018), along with development of domestic innovative antibodies, agreement on key CMC issues with regards to the admittance of clinical trails need deep discussion between industry and regulatory authority. In order to effectively improve drug development and assessment, standardize the technical requirements of submitted dossier and accelerate the entrance of innovative drugs into clinical trials, based on the common questions raised by the pre-IND meeting as well as general CMC safe issues with regard to principles and considerations summarized in drug evaluation practice, the following considerations and recommendations are proposed and discussed in this paper.