Development of bispecific antibodies in China: overview and prospects

ABSTRACT A bispecific antibody (bsAb) can simultaneously bind two different epitopes or antigens, allowing for multiple mechanistic functions with synergistic effects. BsAbs have attracted significant scientific attentions and efforts towards their development as drugs for cancers. There are 21 bsAbs currently undergoing clinical trials in China. Here, we review their platform technologies, expression and production, and biological activities and bioassay of these bsAbs, and summarize their structural formats and mechanisms of actions. T-cell redirection and checkpoint inhibition are two main mechanisms of the bsAbs that we discuss in detail. Furthermore, we provide our perspective on the future of bsAb development in China, including CD3-bsAbs for solid tumors and related cytokine release syndromes, expression and chemistry, manufacturing and controls, clinical development, and immunogenicity.