随着分子生物学技术的进步和抗体基因结构的阐明，以小分子抗体为基础并经基因工程改建从而用于研究和临床诊治的大量基因工程抗体片段应运而生。其中，可将生物学活性效应桥连于治疗靶标的双特异性抗体、同时增强抗体效能及细胞毒靶向性的免疫结合物、以独特的单域结构在生物技术和临床医学等方面倍受青睐的纳米抗体，以及在细胞内特定部位表达的细胞内抗体是近年来研究最活跃的几个领域。凭借免疫原性弱、组织渗透性强、低毒性及制备简便等优势，基因工程抗体片段较之单克隆抗体受到了更广泛的关注与认可。尽管大多数处于临床开发的抗体片段的安全性和有效性还有待确定，但基因工程抗体片段的研发必将大大提高人类疾病尤其是肿瘤的诊治水平。

With the advances in molecular biology and the clarification of antibody genetic structure, a variety of smallmolecule antibody basedand genetic manipulatedgenetic engineering antibody fragments have emerged and been widely used in scientific research, clinical diagnosis and therapy. Among which, bispecific antibody with combined biological activity and therapeutic targeting activity, immunoconjugate with enhanced function and targeting cytotoxicity, nanobody with special single domain structure which is widely applied in biological technology and clinical research, and intrabody with special intracellular expression are the most active fields in antibody fragment research. Genetic engineering antibody fragments have received extensive attention and approval over fulllength monoclonal antibodies owing to their desirable characteristics, such as weak immunogenicity, strong tissue permeability, minimal toxicity and simple preparation. although the safety and efficiency of most antibody fragments in clinical research still need to be further identified, development of scientific research on genetic engineering antibody fragments, will inevitably improve diagnosis and therapy of human diseases.

国家自然科学基金资助项目（No. 30872750）