Biopharma
Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China
Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001
- By IPP Bureau
| January 07, 2026
Sichuan Kelun-Biotech Biopharmaceutical has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for SKB105 (CR-003), an internally developed integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC) aimed at treating advanced solid tumors.
In a strategic move last December, Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001.
Under the agreement, Crescent holds exclusive rights to research, develop, manufacture, and commercialize SKB105/CR-003 in the US, Europe, and all markets outside Greater China. Meanwhile, Kelun-Biotech retains exclusive rights for SKB118/CR-001 in Greater China.
“The IND application for SKB118/CR-001 has been cleared by the U.S. Food and Drug Administration (FDA), with a global Phase I/II clinical trial for the treatment of advanced solid tumors set to commence shortly,” the company confirmed.
Kelun-Biotech also said it plans to submit an IND application for SKB118/CR-001 to China’s CDE in the near future.
This dual-track strategy positions Kelun-Biotech and Crescent at the forefront of targeted oncology therapies, combining regional expertise with global development capabilities.
