pp-217 Suspension for injection

Indication: Parkinson's disease — dopaminergic neuron replacement therapy Clinical stage: Phase 2 Modality: Biological (allogeneic iPSC-derived dopaminergic progenitor cell therapy — NBE) Mechanism / Target: Off-the-shelf allogeneic cells derived from induced pluripotent stem cells (iPSCs) chemically induced to dopaminergic progenitor phenotype using Hanmi proprietary ""AI + Chemical Induction"" protocol; stereotactic bilateral putamen implantation; engrafts and differentiates to replace dopaminergic neurons lost in substantia nigra; immune tolerance achieved without long-term immunosuppression (immunosuppressants discontinued after 6 months) Route / form: Stereotactic intracerebral injection (bilateral putamen implantation, single procedure) Differentiation: First allogeneic iPSC-derived cell therapy globally to hold both FDA Fast Track Designation (FTD) and RMAT — groundbreaking regulatory milestone; no immunosuppression required after 6 months;