生物技术药物的免疫原性在临床前药物安全性评价中表现为实验动物的超敏反应以及肾损伤，但其诱导免疫复合物形成的机制尚未完全明确。目前国内外主要通过检测动物体内循环态和沉积态的免疫复合物，来综合判断生物技术药物是否对动物造成免疫复合物性肾损伤。简述了临床前生物技术药物诱导免疫复合物的形成、清除、沉积、毒性反应以及检测方法的研究进展，以期为建立早期、简便、灵敏的生物技术药物免疫复合物性肾损伤的检测技术提供一定参考。

The immunogenicity of biopharmaceutical drugs is manifested as renal injuries as well as hypersensitivity reactions in experimental animals in preclinical safety evaluation of drugs. However, the mechanism of biopharmaceutical drug-induced immune complexes in experimental animals is still unclear. The immune complex-based injuries to the kidney of biopharmaceutical drugs have been mainly determined comprehensively by detecting the immune complexes of circulating and deposited states. In this paper, we briefly summarize that the formation, clearance, deposition, toxicological reactions, and detection of immune complexes induced by preclinical biopharmaceutical drugs in experimental animals, in the hope of providing some references for the establishment of early, simple, and sensitive detection methods of renal injuries caused by biopharmaceutical drug-induced immune complexes.

R965.3

江苏省新药一站式高效非临床评价公共服务平台建设项目（BM2021002）