FDA022-BB05

FDA022-BB05 is an investigational antibody-drug conjugate (ADC) developed by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical. It targets the human epidermal growth factor receptor 2 (HER2/ERBB2) and is designed for the treatment of advanced or metastatic solid tumors, including breast cancer, esophageal cancer, gastrointestinal cancer, and other HER2-expressing malignancies[1][3][4]. The ADC consists of a trastuzumab-based monoclonal antibody (FDA022) linked to a cytotoxic payload (DXd) via a novel double self-immolative Val-Ala linker platform ("BB05 Platform"), which enhances stability and enables effective delivery to tumor cells[2][6]. Preclinical studies have demonstrated that FDA022-BB05 exhibits enhanced stability, cathepsin B sensitivity, increased bystander killing effect, reduced cell proliferation in tumor models, and favorable safety profiles with broad therapeutic index in both HER2-positive and -negative xenografts[6][2]. The drug is currently being evaluated in phase 1 and phase 2 clinical trials for various advanced solid tumors[1][4].

Other names

FDA022 antibody drug conjugate for injectionFDA-022 antibody drug conjugate for injectionFDA 022 antibody drug conjugate for injection