Clinical trial application for new drug targeting integrin β6 ADC approved

January 5, 2026  Source: drugdu 43

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Kelun Pharmaceutical (002422.SZ) announced that its subsidiary, Kelun Biotech , has received approval from the Center for Drug Evaluation of the National Medical Products Administration of China for its clinical trial application for SKB105 (also known as CR-003), an antibody-drug conjugate targeting integrin β6 (ITGB6) , for the treatment of advanced solid tumors."/In addition, in December 2025, Kelun Biotech and Crescent Biopharma entered into a strategic collaboration on SKB105/CR-003 and SKB118 (PD-1 x VEGF bispecific antibody, also known as CR-001). Kelun Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside Greater China. Crescent granted Kelun Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China. Kelun Biotech plans to submit an IND application for SKB118/CR-001 in the near future.

SKB105 is a differentiated ADC targeting ITGB6, using a topoisomerase 1 inhibitor as its payload. ITGB6 is highly expressed in a variety of solid tumors but lowly or absent in most normal tissues, thus offering the potential to reduce systemic toxicity and off-target risks. In its drug design, SKB105 employs proprietary Kthiol® irreversible conjugation technology, linking a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting ITGB6 to a stable and clinically validated cleavable linker. This aims to enhance drug stability and tumor-specific payload delivery while reducing adverse reactions. Preclinical studies have shown that SKB105 exhibits favorable properties in terms of efficacy, safety, and pharmacokinetics (PK).

https://mp.weixin.qq.com/s/dskJODkCDTVjSbvcqp7dbw

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