Colunbotai Biotech (06990): SKB565 new drug clinical trial application approved by the State Drug Administration

Zhitongcaijing · 3d ago

According to the Zhitong Finance App, Colun Botai Biotech (06990) announced that the company has received a clinical trial notice from the National Drug Administration (NMPA) Drug Evaluation Center (CDE) approving the application for the clinical trial (IND) of the novel dual-loaded ADC drug SKB565 for the treatment of advanced solid tumors. This is the company's first dual-load antibody conjugate drug (ADC) to enter the clinical phase.

With technology accumulation and platform advantages in the ADC field, the company has laid out a series of innovators combining high-value targets, differentiated design, and global potential. Based on this, the company is further expanding the “ADC+ tumor immunology (IO)” strategy - on the one hand, focusing on the exploration of high-quality combination therapies, including various ADCs and programmed cell death protein (ligands) 1 (PD- (L) 1) monoclonal antibodies, and the PD-1 vascular endothelial growth factor (VEGF) bispecific antibody SKB118 with the company's many proprietary ADC series assets; on the other hand, it promotes integrated strategy development to integrate functional elements with a synergistic mechanism in a single ADC molecule.