# Donafenib

Source: https://nuclide.cc/drugs/donafenib/  
Nuclide record `donafenib` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

Donafenib is a Chinese redesign of sorafenib that lived longer than the original in a head-to-head liver cancer trial and is approved in China as a first-line option.

## Summary

Zelgen's donafenib was approved by the NMPA in June 2021 for first-line unresectable hepatocellular carcinoma on the ZGDH3 trial (668 patients: median overall survival 12.1 versus 10.3 months with sorafenib, hazard ratio 0.83; Journal of Clinical Oncology 2021), the first drug to beat sorafenib on survival in this setting. Radioiodine-refractory differentiated thyroid cancer followed in 2022. A modest gain, but a first for a Chinese company and a model of incremental chemistry (deuteration) turned into an approval.

## Fields

- Kind: Agent
- Status: approved
- Last checked: 2026-09-10
- Tags: china
- Brand: Zepsun
- Code: CM4307
- Modality: Small-molecule multi-kinase inhibitor (deuterated sorafenib)
- Mechanism: Deuterium-substituted analogue of sorafenib inhibiting RAF kinases and VEGFR/PDGFR; deuteration slows metabolism and raises exposure.
- Approvals: China 2021: First-line unresectable hepatocellular carcinoma (ZGDH3); China 2022: Radioiodine-refractory differentiated thyroid cancer

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Donafenib
- Suzhou Zelgen Biopharmaceuticals: https://www.zelgen.com/en/
- ZGDH3 (J Clin Oncol 2021): https://doi.org/10.1200/JCO.20.02672
- NMPA (National Medical Products Administration): https://www.nmpa.gov.cn

## Connected records

- indications: [Hepatocellular carcinoma](https://nuclide.cc/indications/hcc/), [Thyroid cancer](https://nuclide.cc/indications/thyroid/)

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