The board of directors of CSPC Pharmaceutical Group Limited announced that the first mRNA-Lipid Nanoparticles (LNP)-based Chimeric Antigen Receptor (CAR)-T Cell Injection (SYS6020) (the "Product"), developed by the Group, has obtained approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China. The Product is the world's first mRNA-LNP-based cell therapy product approved for clinical trials. By expressing a CAR that can specifically recognise the BCMA antigens, it can then target and kill BCMA-positive cells in patient's body to achieve therapeutic purposes.

Compared to conventional CAR-T products, the Product has the advantage of high cell viability, high CAR-positive percentage, no risk of tumorigenicity due to genomic integration, and minimal side effects such as cytokine release syndrome (CRS). Preclinical studies have demonstrated that the Product can significantly kill BCMA antigen-positive myeloma cells and has a good safety and efficacy profile. The indication for this clinical trial approval is multiple myeloma (MM).

In addition, the Product has the potential to be used for the treatment of autoimmune diseases such as systemic lupus erythematosus (SLE) and myasthenia gravis (MG), providing a promising clinical development value. The clinical trial approval obtained for the Product marks the first significant achievement of the Group in the field of cell therapy, which lays a solid foundation for the development of other cell therapy products, such as in vivo-generated CAR-T.