Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company has been granted the clearance of investigational new drug (IND) application to initiated the clinical study of its potential first-in-class innovative ADC drug SKB518 from the United States Food and Drug Administration (FDA). 

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

SKB518 is a novel ADC drug with potential first-in-class target and proprietary intellectual property rights developed by the Company based on the biological characteristics of the target and using the technology of the "OptiDC^TM" platform, which has demonstrated promising efficacy and safety window in preclinical studies and is intended to be used for the treatment of advanced solid tumors.