Colon Pharmaceuticals (002422.SZ): Colun Botai's novel dual-load ADC drug SKB565 New Drug Clinical Trial (IND) application approved

Zhitong Finance App News, Colon Pharmaceutical (002422.SZ) issued an announcement. The company recently learned that the company's holding subsidiary, Sichuan Colun Botai Biomedical Co., Ltd. (hereinafter referred to as “Colunbotai”), has received a clinical trial notice from the National Drug Administration (NMPA) Drug Evaluation Center (CDE) approving the application for the novel dual-load ADC drug SKB565 New Drug Clinical Trial (IND) for the treatment of advanced solid tumors. This is the first clinically-advanced dual-load antibody conjugate drug (ADC) from Colombotte.

With technology accumulation and platform advantages in the ADC field, Collumbotai has laid out a series of innovators combining high-value targets, differentiated design, and global potential. Based on this, Collombotai is further expanding the “ADC+ Tumor Immunology (IO)” strategy — focusing on the exploration of high-quality combination therapies, including multiple ADCs and programmed cell death protein (ligands) 1 (PD- (L) 1) monoclonal antibodies currently being clinically combined, and PD-1/vascular endothelial growth factor (VEGF) bispecific antibody SKB118 with many proprietary ADC series assets; on the other hand, it promotes integrated strategy development, which has a synergistic mechanism for integrating molecules in a single ADC Functional elements.

According to reports, SKB565 is one of the core representative drugs of Colombotai's “ADC+IO” integrated development strategy, and is developed based on Colombotai's proprietary OptiDCTM platform. Using an innovative dual-load design, the drug can directly deliver toxins and immunomodulators, two drugs with a synergistic mechanism to tumor tissue. Compared with traditional ADC drugs containing only toxins, SKB565 has a dual anti-tumor mechanism: on the one hand, it can accurately kill tumors, and on the other hand, it can activate the immune system in the tumor microenvironment and exert an anti-tumor immune response to achieve stronger and longer lasting tumor suppressing effects. In preclinical studies, SKB565 showed excellent anti-tumor activity and safety, and its outstanding tumor treatment potential provided strong support for subsequent clinical development.