pp-230 Solution for injection
Dossier type
CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
Japan
Comments
Indication: Chronic Arterial Occlusive Disease (with lower limb ulcers) / Clinical stage: Phase 2 (late-stage in US; marketed in Japan as world-first HGF therapy) / Modality: Gene therapy - plasmid DNA encoding hepatocyte growth factor / Mechanism & Target: HGF expression to promote angiogenesis / Route & form: Intramuscular injection / Differentiation: World-first approved HGF gene therapy (Japan 2019); novel mechanism
Manufacturer #39437
| Pioneer in plasmid DNA gene therapy for vascular and ischemic conditions. Holds regulatory approval for gene therapy in its domestic market and pursues international expansion. Advances late-stage clinical programs targeting severe peripheral vascular disease. |
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