IASO Biotechnology, a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted tacit approval for its Investigational New Drug (IND) application for IASO-782. The company’s injectable drug candidate is slated for clinical trials in China to evaluate its efficacy in treating systemic lupus erythematosus (SLE), an autoimmune disease.
IASO-782 is a fully human monoclonal antibody designed to target human CD19 with enhanced antibody-dependent cellular cytotoxicity (ADCC) function through specific Fc mutations, while preserving other critical Fc functions such as antibody-dependent cellular phagocytosis (ADCP), complement-dependent cytotoxicity (CDC), and FcRn binding. This targeted approach enables the depletion of CD19+ B cells, plasmablast cells, and certain plasma cells, which can significantly reduce or eliminate the auto-reactive antibodies they produce. The drug candidate has previously received IND approvals in both China and the US for the treatment of various autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).- Flcube.com
