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pp-217

Suspension for injection

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
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;
Manufacturer #39353
Founded in 2017, this clinical-stage company pioneers Rx chemical induction approaches using an AI-augmented platform to reprogram cell fate for neurological cell therapies. Lead program NouvNeu001, targeting Parkinson's disease and Multiple System Atrophy, holds FDA Fast Track designation. Advancing innovative cell reprogramming therapies through global clinical development.

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