Background
01
Addressing High
Unmet Medical Needs
in Solid Tumors
- Limited treatment response to conventional therapies, including chemotherapy, targeted agents, and immune checkpoint inhibitors
- Structural hurdles such as recurrence, metastasis, and immune evasion
- Increasing demand for novel therapeutic paradigms
02
Rising Technological Challenges in Immune Cell Gene Therapies
- CAR-T, TCR-T, and TIL therapies have emerged as a major driving force in cancer drug development worldwide
- Remarkable treatment outcomes has been proven in hematologic malignancies, but no significant breakthroughs have been made in solid tumors as of yet
- Major challenges need to be addressed in solid tumors such as tumor microenvironment (TME), immunosuppression, and poor tumor infiltration
03
Structural Gaps in Korea’s Technological, Clinical,
and Manufacturing Infrastructure
- Limited domestic capabilities in foundational technologies
- Insufficient clinical-grade CMC and quality control infrastructure
- Segmented pipeline development process: discovery-manufacturing-clinical application
- Lack of multi-institutional collaboration system slowing development timelines
04
Need for a Full-Stage Integrated Development Platform
- Successful clinical translation requires a seamless pathway connecting basic research, preclinical development, manufacturing, clinical application, and regulatory alignment
- A national platform is essential to simultaneously establish regulatory, manufacturing, and clinical infrastructure.
05
National R&D Initiative for
Full-Stage Development of Immune Cell Gene Therapy
- Bridging gaps across technology, clinical applications, and regulatory systems
- Government-led development of immune cell therapies in solid tumors
- Securing global competitiveness in next-generation therapeutics