Penpulimab: First Approval
Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sohita Dhillon is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.
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Abstract
Penpulimab (安尼可®) 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.
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