China-based biopharmaceutical company IASO Biotherapeutics announced Monday that the US Food and Drug Administration (FDA) has approved the investigational new drug (IND) application for its fully human anti-BCMA chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel,Eque-cel) intended for the treatment of Non-renal Systemic Lupus Erythematosus (SLE) and Lupus Nephritis(LN).

This is the fifth IND approval obtained for Eque-cel for autoimmune diseases in China and the United States.

To date, Eque-cel has received three IND approvals from the US FDA for autoimmune indications, including the treatment of Myasthenia Gravis (MG), Multiple Sclerosis (MS), and SLE/LN. It has also received two IND approvals from the National Medical Products Administration (NMPA) for autoimmune indications Neuromyelitis Optica Spectrum Disorder (NMOSD) and MG in China. It has also received marketing approval by the NMPA for the treatment of patients with relapsed and/or refractory Multiple Myeloma (R/RMM) who received less than or equal to three lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent.

Yongke Zhang, M.D., IASO Bio chief scientific officer, said, 'We are delighted that the IND for the two new indications--SLE and LN--has been approved by the US FDA, further highlighting Eque-cel's potential as a product for autoimmune diseases. Clinical trial data from China have demonstrated Eque-cel's significant efficacy and safety in treating relapsed/refractory autoantibody-mediated neurological diseases. We believe it holds similar promise for other autoimmune diseases, such as SLE and LN, where autoantibodies play key pathogenic roles. We are eager to accelerate this innovative therapy to benefit more patients with autoimmune diseases in China and globally.'