CSPC：SYS6063 Dual-Target CAR-T Therapy Receives Clinical Trial Approval
On June 2, CSPC Pharmaceutical Group announced that its first dual-target chimeric antigen receptor (CAR)-T cell injection based on mRNA-LNP technology (SYS6063 Injection) has received clinical trial approval from China’s National Medical Products Administration (NMPA) for the indication of relapsed or refractory systemic lupus erythematosus (SLE).
SYS6063 Injection is a dual-target cell therapy product based on mRNA-LNP technology. It expresses chimeric antigen receptors (CARs) that specifically recognize cluster of differentiation 19 (CD19) and B-cell maturation antigen (BCMA), enabling precise recognition and elimination of CD19- and BCMA-positive cells in patients to achieve therapeutic effects. According to CSPC Pharmaceutical Group’s press release, the synergistic effect of the dual targets can eliminate pathogenic cells at the source, fundamentally improving patient conditions and addressing the pain points of traditional treatments, which cannot achieve a cure and have a high relapse rate.
Preclinical studies have shown that SYS6063 Injection significantly kills CD19- and BCMA-positive cells with favorable safety and efficacy profiles. Beyond systemic lupus erythematosus, SYS6063 also holds promise for the treatment of other B-cell/plasma-cell-mediated autoimmune diseases, including myasthenia gravis (MG), rheumatoid arthritis (RA), and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, as well as for expansion into hematological malignancies such as relapsed/refractory multiple myeloma (MM) and B-cell lymphoma.
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