WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that a patent for WuXiBody – a proprietary, highly flexible engineering platform that greatly enhances the developability characteristics of bispecifics – was granted by the U.S. Patent and Trademark Office. This also marks that WuXiBody has been granted patents in the US, Japan and China.

WuXiBody has been widely adopted globally since its launch in 2018. It can effectively break through the CMC barriers for the development of many bispecific antibodies with high expression yield, high stability, good solubility, and easy purification to homogeneity. Additionally, it can shorten the process by 6-18 months and significantly reduce manufacturing costs compared to many other current bispecific platforms.

The WuXiBody platform enables almost any mAb sequence pairs to be assembled into bispecific constructs that are expected to have low immunogenicity risk and a long in vivo half-life. It offers unique structural flexibility, which makes it convenient for building various formats with different combinations of valencies (1+1, 1+2, 2+2), and is also compatible with different Fc domains to meet the requirements of different target biologies.

Dr. Chris Chen, CEO of WuXi Biologics, commented, “We’re proud that our WuXiBody platform was granted the U.S. patent, further validating our global leadership in bispecific technologies and capabilities. It is a great milestone for our Discovery business, which will enable more partners to pursue different biology and therapeutic approaches via this novel bispecific antibody platform. We will continue to invest in next-generation technologies to provide new biologics solutions for our global partners and benefit patients worldwide.”

As of December 31, 2023, there are 45 out-licensed WuXiBody projects in various stages — four of which are in Phase Ⅰ clinical development. Further demonstrating the value of WuXiBody’s state-of-the-art technology, investigational New Drug (IND) applications of two WuXiBody projects are expected be approved in 2024.