Kelun-Biotech Receives Approval for SKB118 Clinical Trials in China
Kelun-Biotech, a subsidiary of Kelun Pharmaceutical, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for its Investigational New Drug (IND) application for SKB118. SKB118 is a PD-1 x VEGF bispecific antibody designed for the treatment of advanced solid tumors. This approval allows Kelun-Biotech to proceed with clinical trials in China, marking a significant step in the global development of SKB118. The company has been collaborating with Crescent Biopharma, which granted Kelun-Biotech exclusive rights to research, develop, manufacture, and commercialize SKB118 in Greater China. Crescent Biopharma has also received regulatory clearance from the U.S. FDA for the IND application, enabling the initiation of a global Phase I/II clinical trial for SKB118.