{"entity":{"id":"donafenib","kind":"drug","name":"Donafenib","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Donafenib","links":[{"label":"Suzhou Zelgen Biopharmaceuticals","url":"https://www.zelgen.com/en/"},{"label":"ZGDH3 (J Clin Oncol 2021)","url":"https://doi.org/10.1200/JCO.20.02672"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"indications":["hcc","thyroid"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"China","year":2021,"indication":"First-line unresectable hepatocellular carcinoma (ZGDH3)"},{"region":"China","year":2022,"indication":"Radioiodine-refractory differentiated thyroid cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/donafenib/","neighbours":{"indication":[{"id":"hcc","kind":"indication","name":"Hepatocellular carcinoma","route":"/indications/hcc/"},{"id":"thyroid","kind":"indication","name":"Thyroid cancer","route":"/indications/thyroid/"}]}}