IM19 Chimeric Antigen Receptor T Cell Injection

IM19 Chimeric Antigen Receptor T Cell Injection (IM19) is an autologous, CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy developed by Beijing Imunopharm Technology (formerly Beijing Immunochina Medical Science & Technology). The CAR construct consists of an FMC63-derived single-chain variable fragment (scFv) targeting CD19, a CD8α hinge and transmembrane domain, a 4-1BB (CD137) co-stimulatory domain, and a CD3ζ intracellular signaling domain. It is manufactured into a memory T-cell-enriched formulation. IM19 is primarily developed for B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL), B-cell acute lymphoblastic leukemia (B-ALL), and mantle cell lymphoma (MCL), as well as autoimmune diseases like systemic lupus erythematosus (SLE) and lupus nephritis (LN). In August 2024, Beijing Imunopharm partnered with Huadong Medicine for the commercialization of IM19 in mainland China. In November 2024, the National Medical Products Administration (NMPA) of China accepted the New Drug Application (NDA) for IM19 for the treatment of relapsed or refractory DLBCL.

Other names

IM19 CAR-T cellsIM-19 CAR-T cellsIM 19 CAR-T cellsautologous anti-CD19 CAR-T cells IM19autologous CD19-specific CAR-T cells IM19IM19嵌合抗原受体T细胞注射液