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B023 (also known as B023 cell injection) is an allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapy developed by SPH Biotherapeutics, a subsidiary of Shanghai Pharmaceuticals. It consists of non-genetically modified iNKT cells expanded from healthy donor peripheral blood. iNKT cells are a unique lineage of T lymphocytes that express a semi-invariant T-cell receptor (TCR) composed of Vα24-Jα18 and Vβ11 chains. These cells recognize lipid antigens presented by the non-polymorphic MHC class I-like molecule CD1d on tumor cells. Upon activation, B023 exerts dual antitumor functions: direct CD1d-mediated cytotoxicity against tumor cells and rapid secretion of immunomodulatory cytokines (such as IFN-γ and IL-4) to activate other innate and adaptive immune cells. Because CD1d is non-polymorphic across the human population, B023 can be administered allogeneically without inducing graft-versus-host disease (GvHD). It is being developed for the treatment of locally advanced or metastatic solid tumors, including non-small cell lung cancer, gastric cancer, and triple-negative breast cancer.
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