IASO Bio Gets NMPA Approval for IASO-782 IND for Systemic Lupus Erythematosus

IASO Biotechnology (IASO Bio), a biopharmaceutical company focused on innovative cell therapy and antibody products, has received approval from the National Medical Products Administration (NMPA) for an investigational new drug (IND) application for IASO-782 Injection. This fully human monoclonal antibody targets human CD19 and will now be used to treat systemic lupus erythematosus (SLE).

Previously, IASO-782 Injection had obtained IND approval in both China and the U.S. for treating immune thrombocytopenic purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The new approval for SLE broadens the therapeutic applications of IASO-782, showcasing IASO Bio's innovative prowess in the biopharmaceutical industry and its deep understanding of patient needs.

Dr. Jie Chen, Chief Medical Officer of IASO Bio, emphasized the company's strategic focus on autoimmune diseases. Since the previous year, IASO-782 Injection has achieved approval for three INDs across China and the U.S. Furthermore, the company’s CAR T therapy, Equecabtagene Autoleucel Injection, has received NMPA IND approval for treating neuromyelitis optica spectrum disorder and refractory generalized myasthenia gravis. IASO Bio collaborates with partners like Cabaletta Bio, which has licensed IASO's CD19 binder and developed CD19-targeting CAR-T therapies for autoimmune diseases, receiving IND approval from the U.S. FDA for four autoimmune indications, including SLE. Dr. Chen reiterated the company’s commitment to innovation and collaboration to deliver significant clinical benefits through advanced therapies.

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease involving multiple systems and organs. It is characterized by autoimmune responses and B lymphocyte abnormalities, resulting in periods of exacerbation and remission if untreated, leading to irreversible organ damage. According to Frost & Sullivan, there were around 8.049 million SLE patients globally in 2023, with approximately 1.048 million in China. The disease affects females disproportionately more than males, with a prevalence ratio of about 1:10-12.

IASO-782 Injection is a fully human monoclonal antibody designed to target human CD19. The antibody features Fc mutations that enhance antibody-dependent cellular cytotoxicity (ADCC) while maintaining other Fc functions like antibody-dependent cellular phagocytosis (ADCP). The B cell surface antigen CD19 is present throughout B cell development and in some plasma cells. Autoimmune diseases like ITP and AIHA are often mediated by auto-reactive antibodies from pathogenic B and plasma cells. IASO-782 effectively depletes CD19+ B cells, plasmablasts, and some plasma cells, reducing or eliminating auto-reactive antibodies. Being a fully human antibody, IASO-782 likely has low immunogenicity and is less prone to induce anti-drug antibodies after repeated use, making it advantageous for long-term treatment of autoimmune diseases.

IASO Biotechnology is a biopharmaceutical company dedicated to discovering and developing novel cell therapies and biologics for oncology and autoimmune diseases. The company has comprehensive capabilities across the entire drug development spectrum, from early discovery to clinical development, regulatory approval, and commercial production. IASO Bio's pipeline includes over ten novel products, such as Equecabtagene Autoleucel, a fully human BCMA CAR-T injection, which has received New Drug Application (NDA) approval from China's NMPA and U.S. FDA IND approval for treating relapsed/refractory multiple myeloma (R/RMM). Backed by a strong management team and innovative product pipeline, IASO Bio aims to provide transformative, curative, and affordable therapies to meet unmet medical needs both in China and globally.

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