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近年来,随着我国生物制药自主创新能力的提高,越来越多的创新型抗体药物申请注册临床试验。按照其技术特点,可分为全新序列抗体(改良型抗体或新靶点抗体)、双特异性抗体(或复方抗体)、抗体偶联物等三类。与生物类似药不同,创新型抗体的开发具有“创试性”、“阶段性”和“渐进性”等显著特点。与之相适应,其药学评价内容与技术要求也区别于生物类似药。本文总结了近年来国内外创新型抗体的发展趋势与申报现状,对代表品种的技术特点进行分析。并结合新药审评实践,着重就创新型抗体药学评价的关注点、一般考虑与评价要点展开探讨,以期促进此类药物由研发顺利转入早期临床试验阶段。
In recent years, with the improvement of China’s bio-pharmaceutical independent innovation capability, more and more innovative antibody drugs are applied for registration of clinical trials. According to its technical characteristics, it can be divided into three types: new sequence antibody (modified antibody or new target antibody), bispecific antibody (or compound antibody) and antibody conjugate. Unlike bio-analogs, the development of innovative antibodies has such notable features as “tentative”, “stage” and “progressive”. Correspondingly, the contents and technical requirements of its pharmaceutical evaluation are also different from the biological analogues. This article summarizes the development trends and application status of innovative antibodies at home and abroad in recent years, and analyzes the technical characteristics of the representative varieties. Combined with the review of new drug practice, focused on the innovative antibody antibody evaluation concerns, the general considerations and evaluation points to explore in order to promote the smooth development of such drugs into the early clinical trial phase.