China NMPA Nods IASO Bio's IND Application For IASO-782

IASO Biotechnology (IASO Bio) has disclosed that the National Medical Products Administration (NMPA) has granted approval for the investigational new drug (IND) application for IASO-782 Injection, a fully human monoclonal antibody targeting human CD19, for treating systemic lupus erythematosus (SLE).

Before obtaining this authorization, the IASO-782 Injection was granted IND approval in China and the US for treating immune thrombocytopenic purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The recent approval for the use of IASO-782 Injection in treating SLE broadens the therapeutic range of the drug, showcasing IASO Bio's continued innovation in biopharmaceuticals and understanding of patient requirements.

Dr. Jie Chen, chief medical officer of IASO Bio, stated: "Autoimmune diseases are the strategic focus for IASO Bio. Since last year, IASO-782 Injection has successfully received approval for three INDs in China and the US respectively The CAR T therapy Equecabtagene Autoleucel Injection has also received NMPA IND approval for the treatment of neuromyelitis optica spectrum disorder and refractory generalized myasthenia gravis. Cabaletta Bio, one of IASO Bio's partners, licensed IASO’s CD19 binder and developed CD19-targeting CAR-T to treat autoimmune diseases. It has received IND approval from the US Food and Drug Administration for the treatment of four autoimmune indications, including SLE. IASO Bio will continue to collaborate with our peers to further promote innovation and development in the treatment of autoimmune diseases, so as to bring significant clinical benefits to patients through innovative therapies."