China-based Sichuan Kelun-Biotech Biopharmaceutical Co Ltd announced on Monday that the company has been granted investigational new drug (IND) clearance to initiate the clinical study of its potential first-in-class innovative antibody drug conjugate (ADC), SKB518, from the US Food and Drug Administration (FDA).

In June 2024, the company received a clinical trial notice approving the IND application for SKB518 for advanced solid tumours from Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The Phase 1 clinical trial for SKB518 is ongoing in China.

Developed by Kelun-Biotech, SKB518 is a novel ADC drug with potential first-in-class target and proprietary intellectual property rights based on the biological characteristics of the target and using the technology of the OptiDCTM platform. It has demonstrated promising efficacy and safety in preclinical studies and is intended to be used for the treatment of advanced solid tumours.