AstraZeneca's Trispecific Antibody AZD5492 Granted New Clinical Trial Approvals in China for Systemic Lupus Erythematosus and Idiopathic Inflammatory Myopathy

Intelligent Finance APP learned on April 2 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that AstraZeneca (AZN.US)’s Class 1 new drug AZD5492 has been granted two new clinical trial implied approvals in China, intended for the treatment of systemic lupus erythematosus and idiopathic inflammatory myopathy. Public information shows that this is a CD20×TCR×CD8 trispecific antibody, a T-cell engager (TCE) guided by CD8. The product was first approved for clinical trials in China in October 2024, with indications for relapsed or refractory B-cell malignancies.

AZD5492 is an asymmetric trispecific monoclonal IgG1 antibody that contains two anti-CD20 Fab domains, one VHH domain binding to TCR, and another VHH domain binding to the CD8 co-receptor. Public data shows that due to the specific effect of anti-CD20 antibodies on B cells, they are widely developed for the treatment of B cell-related diseases, including B-cell malignancies such as non-Hodgkin lymphoma, and autoimmune diseases like systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathy.