FZ-AD005

FZ-AD005 is a novel antibody-drug conjugate (ADC) targeting delta-like ligand 3 (DLL3), which is overexpressed in small cell lung cancer (SCLC) and other neuroendocrine tumors. The drug consists of a recombinant anti-DLL3 monoclonal antibody (FZ-A038) linked via a valine–alanine dipeptide linker to the cytotoxic payload DXd, a DNA topoisomerase I inhibitor. Fc-silencing technology has been incorporated to minimize off-target toxicity mediated by Fcγ receptors. Preclinical studies have demonstrated that FZ-AD005 binds specifically to DLL3-positive tumor cells, undergoes efficient internalization, releases its cytotoxic payload intracellularly, and exhibits potent antitumor activity with bystander killing effects in both cell line-derived and patient-derived xenograft models. The drug has shown favorable pharmacokinetics and safety profiles in animal studies. Developed by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, it is currently being evaluated for advanced solid tumors including SCLC, large cell neuroendocrine carcinoma, and prostate cancer[2][3][5][6][7].