Donafenib: First Approval

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.