IASO Biotechnology, a Chinese biotech firm, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to commence trials of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), for the treatment of non-renal systemic lupus erythematosus (SLE) and systemic lupus nephritis (LN).
Fucaso is co-developed by IASO and Innovent Biologics, Inc. (HKG: 1801), a Chinese pharmaceutical company. The duo achieved a milestone on June 30, 2023, with the National Medical Products Administration (NMPA) of China granting market approval for Fucaso in treating relapsed and/or refractory multiple myeloma (r/r MM) in patients who had received at least three prior lines of treatment. In a strategic move in July 2024, the partnership terms were revised, with IASO acquiring all rights to Fucaso, including intellectual property, from Innovent. Concurrently, Innovent redirected the proceeds to secure an 18% equity stake in IASO. Prior to this, the drug had also received clinical trial approvals for multiple sclerosis and general myasthenia gravis.- Flcube.com
