AK2401

AK2401 is a biosimilar of pembrolizumab, a humanized IgG4/kappa monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor, developed by Anhui Anke Biotechnology. By binding to PD-1, AK2401 blocks its interaction with ligands PD-L1 and PD-L2, thereby preventing inhibitory signals in T cells and enhancing anti-tumor immune responses. In October 2026, China's National Medical Products Administration (NMPA) approved the clinical trial application (acceptance number CXSL2600850) for AK2401 to initiate clinical trials in patients with solid tumors. Preclinical and comparability studies have demonstrated high similarity to the reference product, Keytruda, in terms of protein structure, physicochemical properties, and freeze-thaw stability, alongside a favorable safety and tolerability profile.