AbbVie's BTK Inhibitor ABBV-105 Receives Chinese Clinical Approval for Systemic Lupus Erythematosus in Combination with Upadacitinib

On December 12, the CDE website showed that AbbVie's ABBV-105 combined with Upadacitinib for the treatment of moderate to severe active systemic lupus erythematosus received implicit clinical approval.

ABBV-105 is a BTK inhibitor. Overexpression of BTK leads to abnormal activation of the BCR signaling pathway, resulting in B-cell dysfunction, altered immune tolerance, and transformation into autoreactive B cells that secrete large amounts of autoantibodies, thereby inducing autoimmune diseases. In recent years, an increasing number of BTK inhibitors for systemic lupus erythematosus have entered clinical development, including Biogen’s BIIB068, Nuocheng Jianhua’s orelabrutinib, Roche’s fenebrutinib, and Merck’s evobrutinib.

Upadacitinib, a JAK1 inhibitor marketed under the brand name Rinvoq, received FDA approval on August 15 this year for the treatment of patients with moderate to severe rheumatoid arthritis. AbbVie has initiated multiple clinical trials in China for this drug, targeting indications including ulcerative colitis, atopic dermatitis, and rheumatoid arthritis.