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Sugemalimab: First Approval

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Abstract

Sugemalimab (Cejemly® in China) is a fully human, full length, anti-programmed death ligand 1 (PD-L1) immunoglobulin G4 (IgG4) monoclonal antibody (mAb) that is being developed by CStone Pharmaceuticals for the treatment of advanced solid tumours and lymphoma. In December 2021, sugemalimab was approved in China for the first-line treatment of epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK) negative metastatic non-small cell lung cancer (NSCLC) administered in combination with pemetrexed and carboplatin for non-squamous NSCLC and in combination with paclitaxel and carboplatin for squamous NSCLC. Sugemalimab is under regulatory review as consolidation treatment in patients with stage III NSCLC in China. Clinical studies assessing sugemalimab for the treatment of several other cancers, including liver cancer, gastric cancer, oesophageal cancer, Hodgkin lymphoma and extranodal natural killer/T cell lymphoma are underway in China, the US and Australia. This article summarizes the milestones in the development of sugemalimab leading to this first approval for the first-line treatment of EGFR gene mutation and ALK-negative metastatic NSCLC.

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Change history

  • 10 April 2022

    Digital Features update

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Authors and Affiliations

  1. Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand

    Sohita Dhillon & Sean Duggan

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  1. Sohita Dhillon
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  2. Sean Duggan
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Corresponding author

Correspondence to Sohita Dhillon.

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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 Sean Duggan is a salaried employee of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Dhillon, S., Duggan, S. Sugemalimab: First Approval. Drugs 82, 593–599 (2022). https://doi.org/10.1007/s40265-022-01693-4

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  • DOI: https://doi.org/10.1007/s40265-022-01693-4

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