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Donafenib: First Approval

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Abstract

Donafenib (Zepsun®, 泽普生®), a deuterium derivative of sorafenib, is an oral small molecule multikinase inhibitor of multiple receptor kinases, including vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and Raf kinases. Donafenib is being developed by Suzhou Zelgen Biopharmaceuticals Co., Ltd. (Zelgen) for the treatment of various cancers, including hepatocellular carcinoma, colorectal cancer and thyroid cancer. In June 2021, donafenib received its first approval in China for the treatment of patients with unresectable hepatocellular carcinoma who have not previously received systemic treatment. This article summarizes the milestones in the development of donafenib leading to this first approval for use in unresectable hepatocellular carcinoma.

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Authors and Affiliations

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

    Susan J. Keam & Sean Duggan

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  1. Susan J. Keam
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  2. Sean Duggan
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Correspondence to Susan J. Keam.

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The preparation of this review was not supported by any external funding.

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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. Susan Keam and Sean Duggan are salaried employees 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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Keam, S.J., Duggan, S. Donafenib: First Approval. Drugs 81, 1915–1920 (2021). https://doi.org/10.1007/s40265-021-01603-0

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