Sichuan Kelun-Biotech’s SKB518 receives FDA clearance for clinical trials

CAR-T Digest - August 2020

21 Apr 2025: Sichuan Kelun-Biotech’s SKB518 receives FDA clearance for clinical trials

Kelun-Biotech has received IND clearance from the U.S. FDA to begin clinical trials for its novel antibody-drug conjugate (ADC) SKB518
SKB518 is positioned as a potential first-in-class innovative ADC therapy targeting certain advanced solid tumors
This clearance allows Kelun-Biotech to initiate clinical studies in the United States
The company had already begun a Phase 1 clinical trial for SKB518 in China following approval from China’s National Medical Products Administration in June 2024
The FDA approval marks a significant step in Kelun-Biotech’s global clinical development strategy for SKB518