Kelun-Biotech receives Investigational New Drug Approval for ITGB6-targeted ADC SKB105 from the NMPA

CAR-T Digest - August 2020

4 January 2026: Kelun-Biotech receives Investigational New Drug Approval for ITGB6-targeted ADC SKB105 from the NMPA

Kelun-Biotech has achieved a key regulatory milestone with the approval of an Investigational New Drug (IND) application for SKB105 (CR-003) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), enabling clinical development in advanced solid tumors
SKB105 is an internally developed, integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), highlighting the Company’s growing capabilities in innovative oncology biologics aimed at hard-to-treat solid malignancies
Building on this momentum, in December 2025 the Company entered a strategic collaboration with Crescent Biopharma to accelerate the global development of SKB105/CR-003 alongside SKB118 (CR-001), a PD-1 × VEGF bispecific antibody
Under the terms of the agreement, Crescent received exclusive rights to research, develop, manufacture, and commercialize SKB105/CR-003 across the United States, Europe, and all markets outside Greater China, while the Company retained exclusive rights to SKB118/CR-001 within Greater China
Looking ahead, the Company plans to submit an IND application for SKB118/CR-001 to China’s CDE in the near future, further advancing its immuno-oncology pipeline and reinforcing its long-term commitment to global cancer drug development