26 July 2024 | Friday | News
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IASO Biotechnology ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, hereby announces that the investigational new drug (IND) application for IASO-782 Injection, a fully human monoclonal antibody targeting human CD19, has been approved by the National Medical Products Administration (NMPA) for the treatment of a new indication — systemic lupus erythematosus (SLE).
Prior to this approval, the IASO-782 Injection has received IND approval in both China and the U.S. for the treatment of immune thrombocytopenic purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The latest approval for the indication of SLE further expands the therapeutic scope of the IASO-782 Injection, once again demonstrated IASO Bio's innovative capabilities in the biopharmaceutical field and its profound understanding of patient needs.
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 U.S 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."
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