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XJ-PLT-002 is an investigational, first-in-class, induced pluripotent stem cell (iPSC)-derived, allogeneic, gene-editing-free platelet injection developed by Suzhou Xueji Biotechnology (HemaCell). It is produced using a proprietary serum-free, feeder-free, and immortalization-free directed induction and differentiation platform, ensuring high safety and purity without the risk of genomic editing or residual contaminating cells. The therapy is designed to treat rare hereditary bleeding disorders and other platelet-related deficiencies, offering a standardized, off-the-shelf alternative to donor-derived platelet transfusions. In December 2025, XJ-PLT-002 received Orphan Drug Designation (ODD) from the US FDA for the treatment of rare hereditary bleeding disorders.
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