Bioray Laboratories has received investigational new drug (IND) clearance from its China homeland's National Medical Products Administration (NMPA) for BRL-303, a novel allogeneic UCAR-T therapy targeting CD19 for the treatment of moderate-to-severe refractory systemic lupus erythematosus (SLE). BRL-303 is the first allogeneic, off-the-shelf CAR-T product globally to have demonstrated efficacy in an investigator-initiated trial for an autoimmune disease. Developed on Bioray's proprietary TyUCell platform, the therapy uses multiple gene edits to avoid graft-versus-host disease and host rejection while targeting pathogenic B-cells to restore immune balance.

The approval marks a significant expansion of Bioray's universal cell therapy technology from haematological cancers into complex autoimmune conditions. Pre-clinical and early clinical data have shown the therapy's potential for deep and durable remission. As a readily available product, BRL-303 bypasses the need for individualised manufacturing, potentially lowering costs and reducing treatment wait times compared to autologous CAR-T. Bioray plans to initiate a multi-centre clinical trial (CT) in China to further evaluate the therapy.

According to PharmCube's NextBiopharm® database, BRL-303 coexists with over 80 other CAR-T projects in SLE, including 67 in clinical development and 3 approved. Click here to request a free trial for NextBiopharm®.