Senlang Biotech's BCMA-Targeting CAR-T Therapy SENL103 Receives CDE IND Approval for New Indication in China

Nov 14, 2025 11:06 CST Updated 11:06

Senlang

Developer of Novel Anti-Tumor Bio-Immunotherapy Drugs

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Recently, according to the CDE official website, the IND application for SENL103 Autologous T-cell Injection by Senlangbio has been accepted by the CDE. The indication has not been disclosed.SENL103 is a CAR-T cell therapy targeting BCMA, which genetically engineers T cells to precisely target and attack the highly expressed BCMA protein in multiple myeloma cells, demonstrating potent efficacy.

Previously,The drug has received clinical approval for two indications: relapsed or refractory multiple myeloma (RRMM) and refractory generalized myasthenia gravis (rgMG).

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

The company has six cell therapy pipelines under development, three of which are in the registration phase of clinical research. The company’s CD7-targeted CAR-T product, aimed at relapsed or refractory T lymphoblastic lymphoma/leukemia, utilizes a unique "natural selection" technology platform that eliminates the need for gene editing targeting CD7. It has demonstrated good safety and efficacy in IIT (investigator-initiated trials), with relevant data published in the internationally authoritative journals *Blood* and *American Journal of Hematology*. This product is currently in Phase I registration clinical trials in China and was granted Orphan Drug Designation (ODD) by the U.S. FDA in August 2023. Globally, there are currently no approved CD7-targeted CAR-T products on the market. The company’s CD19-targeted CAR-T product for B-cell acute lymphoblastic leukemia is also currently in Phase I registration clinical trials in China.

Reference: CDE official website

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