Structure
Program Structure
Full-Stage
R&D
National Unit for Full-Stage Development of Immune Cell Gene Therapy (NDIT)
Full-Stage R&D Building an integrated development ecosystem from
discovery to clinical application.
01
Platform Technologies
Development of CAR-T, TCR-T, and TIL platform technologies
Establishment of tumor and neoantigen analysis capabilities
Establishment of tumor and neoantigen analysis capabilities
02
Preclinical & Technology Validation
Preclinical safety assessment
Mechanism-of-action analysis and evidence for clinical translation
Mechanism-of-action analysis and evidence for clinical translation
03
CMC & QC Infrastructure
Establishment of clinical-grade cell and vector manufacturing processes
Development of QC standards and quality criteria
Development of QC standards and quality criteria
04
Clinical Research Infrastructure
Clinical protocols, GMP manufacturing capabilities, and regulatory readiness
Patient enrollment, safety monitoring, and data management systems
Patient enrollment, safety monitoring, and data management systems
05
Commercialization,
Policy & Patient Access
Policy & Patient Access
Regulatory and policy collaboration for commercialization
Building the foundation for improved patient access
Building the foundation for improved patient access
06
Industry–Academia–Research–Hospital Collaboration
Establishment of institutional roles and collaborative linkages
Integrated management across research, manufacturing, and clinical application
Integrated management across research, manufacturing, and clinical application