By Fineline Cube 
Shanghai Pharmaceuticals Holding Co., Ltd’s (SPH, HKG: 2607, SHA: 601607) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its B019 injection, a treatment for refractory systemic lupus erythematosus (SLE). This marks a significant milestone in the development of this innovative therapy.
B019 Mechanism and Innovation
B019 is a category of autologous T cells with chimeric antigen receptors (CARs) targeting both CD19 and CD22. It enables the expression of two independent CARs on T cells, which can bind to the CD19 or CD22 proteins on B lymphocytes without interfering with each other. This dual-targeting approach enhances the therapeutic potential of the treatment.
Previous Approvals and Development
B019 injection had previously received NMPA approval to conduct clinical trials for two indications: relapsed or refractory acute B-lymphoblastic leukemia and relapsed or refractory B-cell non-Hodgkin’s lymphoma. This new approval expands the potential applications of B019 to include SLE, further underscoring its broad therapeutic potential.