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Donafenib: First Approval

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posted on 2021-09-08, 23:48 authored by Susan J. Keam, Sean Duggan

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. 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.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable

Additional information about this Adis Drug Review can be found here.


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.

© Springer Nature Switzerland AG 2021


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