Home Senlang Bio's BCMA-Targeted CAR-T Therapy SENL103 Granted Clinical Approval for Autoimmune Disease Treatment

Senlang Bio's BCMA-Targeted CAR-T Therapy SENL103 Granted Clinical Approval for Autoimmune Disease Treatment

Aug 06, 2025 15:52 CST Updated 15:52
Senlang

Developer of Novel Anti-Tumor Bio-Immunotherapy Drugs

2025Year8Month5DaySenlangbio's SENL103 Autologous T-cell Injection Granted Clinical Trial Approval for Refractory Generalized Myasthenia Gravis (rgMG)

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SENL103 Autologous T-cell Injection is aCAR-T cell therapy drugs targeting BCMA can "precisely target" tumors through genetically engineered T cells, specifically acting on the highly expressed BCMA in multiple myeloma cells., thereby exerting the therapeutic effect. Previously,The approved clinical indication is relapsed or refractory multiple myeloma (RRMM).

Autoimmune DiseaseIt is a class of diseases in which the immune system generates an immune response against the body's own tissues, where autoantibodies or autoreactive lymphocytes attack normal cells, leading to damage of one’s own tissues, such as systemic lupus erythematosus, type 1 diabetes, and myasthenia gravis. Most of these diseases are incurable and require lifelong treatment.The ideal treatment is to eliminate pathogenic autoreactive cells while preserving protective immunity.
B lymphocytes/plasma cells are one of the most important effector cells in autoimmune diseases. Previous chimeric antigen receptor (CAR) T-cell therapy has achieved significant efficacy in the treatment of acute B lymphoblastic leukemia (B-ALL), B-cell non-Hodgkin lymphoma (B-NHL), and multiple myeloma (MM) by specifically targeting and killing B lymphocytes, suggestingThe Great Potential of CAR-T Cell Therapy in the Treatment of Autoimmune Diseases.

Senlangbio is a high-tech enterprise specializing in the research, production, and commercialization of cell therapy products. The company is committed to advancing the clinical application of cell therapy through leading technologies and innovative solutions, benefiting a wide range of patients.

Since its establishment in 2016, the company has been continuously growing and developing. It now owns a 14,000㎡ R&D and production base built in accordance with international standards, and has established a one-stopCell therapy drug research and development and industrialization platform, nanobody development and screening platform, mastering core technologies such as large-scale plasmid preparation, lentiviral vector preparation, and primary immune cell preparation, successfully establishing the full CAR-T industry chain in China.Senlangbio's CD7-targeted CAR-T product, developed for relapsed or refractory T-lymphoblastic lymphoma/leukemia, utilizes a unique "natural selection" technology platform. It does not require gene editing for CD7 and has demonstrated good safety and efficacy in IIT (Investigator-Initiated Trials).Relevant data have been published in the international authoritative journals *Blood* and *American Journal of Hematology*. This product is currently in Phase I clinical trials in China, and in August 2023, it was granted Orphan Drug Designation (ODD) by the U.S. FDA. Globally, no CD7-targeted CAR-T therapy has been approved for marketing yet. The company’s CD19-targeted CAR-T product for B-cell acute lymphoblastic leukemia is currently undergoing clinical trial research in China.

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