CAR-T manufacturing expansion: South Korea’s first homegrown CAR T

South Korea’s MFDS approved Curocell’s anbalcabtagene-autoleucel (Limcato) as the first homegrown CAR T-cell therapy for patients with advanced diffuse large B-cell lymphoma. The approval marks a regulatory milestone for domestic cell therapy manufacturing and clinical delivery. Limcato targets a specific patient population with limited options after conventional approaches, and the approval underscores the maturation of the local cell therapy ecosystem. The decision also adds a new commercial-grade CAR T option within Korea’s growing hematology pipeline. For global sponsors, the MFDS decision signals continued regulatory readiness for locally developed cell therapies and may influence future study designs and capacity planning.