Sichuan Kelun-Biotech Biopharmaceutical has been granted FDA IND clearance for an investigational new drug (IND) application to initiate a clinical study of its potential first-in-class ADC drug SKB518.
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 "OptiDCTM" 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.
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