According to the Zhitong Finance APP, Genrix Bio (688443.SH) announced that it has recently received the "Notice of Approval for Clinical Trials of Drugs" issued by the National Medical Products Administration. The clinical trial application for the company's investigational product GR1803 injection combined with anti-CD38 monoclonal antibody in adult patients with relapsed/refractory multiple myeloma has been approved.

GR1803 injection is a bispecific antibody drug independently developed by the company, targeting BCMA and CD3, and is classified as a Class 1 therapeutic biological product. GR1803 injection is based on a common light chain to construct a bispecific antibody molecule, whose structure is highly similar to that of normal monoclonal antibody molecules, facilitating the development of its preparation process and reducing the possibility of immunogenicity due to structural differences. GR1803 injection can simultaneously bind to the antigens BCMA and CD3, with its affinity for BCMA (10^-10 M) being two orders of magnitude higher than that for CD3 (10^-8 M). This asymmetric affinity design ensures that this bispecific antibody molecule can recruit and activate T cells to kill tumor cells while effectively reducing the non-specific activation of T cells caused by CD3 antibodies, thereby lowering the toxic side effects of GR1803 injection in vivo