Amgen's Bispecific Antibody AMG 570 Receives IND Approval in China for Systemic Lupus Erythematosus

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that AMG 570, a Class 1 innovative drug from Amgen, has received implicit approval for clinical trials, with plans to develop it for the treatment of systemic lupus erythematosus (SLE). Public information indicates that AMG 570 is a bispecific antibody targeting BAFF and ICOSL, currently in Phase 2 clinical studies globally.

Source: CDE Official Website

Systemic lupus erythematosus is a chronic systemic autoimmune disease characterized by multisystem involvement. Its pathogenesis is complex, encompassing the proliferation and activation of autoreactive T cells and B cells, the production of various pathogenic autoantibodies, and abnormalities in cytokine secretion and receptor expression.

ICOS (also known as CD278) is an immune checkpoint expressed on activated T cells and functions as a co-stimulatory receptor. ICOS is primarily expressed on activated T cells, while its ligand, ICOSL, is mainly expressed on B cells and antigen-presenting cells. By binding to ICOSL, ICOS induces cell proliferation, survival, and differentiation, and modulates various T cell functions. Studies have shown that ICOS expression levels on T cells are elevated in patients with autoimmune diseases such as systemic lupus erythematosus.

BAFF (B cell-activating factor), also known as BLyS (B lymphocyte stimulator), supports B cell survival by binding to the BAFF receptor (BAFFR) expressed on B cells. BAFF is a type II transmembrane protein primarily expressed by monocytes and dendritic cells. It is released through proteolytic cleavage and exerts its effects in the periphery. Studies have shown that overexpression of BAFF is a significant contributor to various B lymphocyte-associated autoimmune diseases, including systemic lupus erythematosus.

AMG 570 is a bispecific antibody developed by Amgen that simultaneously targets BAFF and ICOSL, intended for the treatment of systemic lupus erythematosus and other diseases.

Note: The original text has been abridged.

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