Penpulimab: First Approval

Abstract

Penpulimab (^®) is a humanised anti-programmed cell death 1 (PD-1) monoclonal antibody developed by Akeso Biopharma, in collaboration with Chia Tai Tianqing (a subsidiary of SinoBiopharm), for the treatment of various cancers, including Hodgkin's lymphoma, nasopharyngeal cancer, non-small cell lung cancer (NSCLC) and solid tumours. Penpulimab is an immunoglobulin G1 monoclonal antibody engineered to completely eliminate Fcγ receptor binding and Fc-mediated effector functions that can compromise anti-tumour activity. In August 2021, penpulimab received its first approval in China for the treatment of adult patients with relapsed or refractory classic Hodgkin's lymphoma who have undergone at least second-line chemotherapy. Penpulimab is under regulatory review for nasopharyngeal cancer and NSCLC in China. Clinical studies of penpulimab are underway for various cancers in China and Australia. This article summarizes the milestones in the development of penpulimab leading to this first approval for relapsed or refractory classic Hodgkin's lymphoma.