Kelun Pharmaceutical's SKB518 clinical trial approved by FDA

Sichuan Kelun Pharmaceutical (SZSE:002422) announced that its subsidiary, Kelun Biotech, has received approval from the U.S. Food and Drug Administration (FDA) to initiate clinical trials for its innovative antibody-drug conjugate (ADC) drug, SKB518. This follows the NMPA's (National Medical Products Administration) CDE (Center for Drug Evaluation) approval in June 2024 for SKB518's IND application for advanced solid tumors, with Phase 1 clinical trials already underway in China. SKB518, developed using Kelun Biotech's OptiDC™ platform, targets unique biological characteristics and exhibits promising preclinical efficacy and safety, intended for treating advanced solid tumors. The company cautions that drug development is lengthy and success is not guaranteed, advising investors to exercise caution and be aware of investment risks.