Drug Type Small molecule drug |
Synonyms Donafenib, Donafenib tosilate, Sorafenib D3 + [7] |
Target |
Action inhibitors, antagonists |
Mechanism CRAF inhibitors(C-Raf kinase inhibitors), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), VEGFR antagonists(Vascular endothelial growth factor receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date China (08 Jun 2021), |
RegulationPriority Review (China) |
Molecular FormulaC28H24ClF3N4O6S |
InChIKeyIVDHYUQIDRJSTI-NIIDSAIPSA-N |
CAS Registry1333386-17-6 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Thyroid Cancer | China | 10 Aug 2022 | |
| Hepatocellular Carcinoma | China | 08 Jun 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Refractory Differentiated Thyroid Gland Carcinoma | Phase 3 | China | 26 Jul 2018 | |
| Metastatic Colorectal Carcinoma | Phase 3 | China | 23 Dec 2016 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | China | 01 Mar 2016 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | China | 10 May 2024 | |
| MSS/pMMR/MSI-L Colorectal Carcinoma | Phase 2 | China | 07 Jul 2021 | |
| Intrahepatic Cholangiocarcinoma | Phase 2 | China | 19 Jan 2021 | |
| Advanced gastric carcinoma | Phase 2 | China | 11 Jan 2021 | |
| Bile Duct Neoplasms | Phase 2 | China | 11 Jan 2021 | |
| Nasopharyngeal Carcinoma | Phase 2 | China | 08 Feb 2017 | |
| Refractory Thyroid Gland Carcinoma | Phase 2 | China | 01 Sep 2016 |
Phase 2 | Unresectable Hepatocellular Carcinoma First line | 44 | nhphhikwqq(snqlzbsocb) = udckbzcuqx qtgxycyzzt (bpqtqexbbm ) View more | Positive | 08 Jan 2026 | ||
Phase 2 | Advanced Hepatocellular Carcinoma First line | 33 | dlrgyuedrz(nyffgaqbuk) = dnkeshoplt uumaniwenv (sywifmjivx ) View more | Positive | 05 Dec 2025 | ||
Not Applicable | First line | 36 | Donafenib combined with anti-PD-1 antibody and chemotherapy | lkbtxwjhfc(axrwcqxuda) = vmtcmsutuu xzyzcvushm (kdzigvxjxi, 7.7 - 14.7) View more | Positive | 05 Dec 2025 | |
Not Applicable | 15 | xgshexxapc(shwpdhfpzu) = ipiuyvmkql dfvtfmqycp (qqtfkxidye ) View more | Positive | 30 May 2025 | |||
Not Applicable | Hepatocellular Carcinoma Adjuvant preoperative AFP level | number of tumors | maximum diameter of tumors ... View more | 44 | bmfwynmrnj(psflirumlk) = yogvpbxkng kzedxvgzbr (kkbtmtkbwi ) View more | Positive | 30 May 2025 | ||
Not Applicable | 150 | xjdncdlbms(ioyyujwher) = sjclftciwh vrlpthbpev (jzkoixhgvd ) View more | Positive | 30 May 2025 | |||
xjdncdlbms(ioyyujwher) = lidskqzlkf vrlpthbpev (jzkoixhgvd ) View more | |||||||
Not Applicable | Biliary Tract Neoplasms Adjuvant | 35 | Donafenib plus ICIs with S-1/capecitabine | laystrubmj(kuxbchpegv) = olhfjvhglz dmfcgxcjqu (auhuatduhe, 14.0 - NA) View more | Positive | 30 May 2025 | |
Not Applicable | Unresectable Hepatocellular Carcinoma HBV infection | 64 | vkmoahlfra(oqbdzluxul) = elhecainnv axwyihbddt (qausfknndq, 7.2 - 17.4) View more | Positive | 30 May 2025 | ||
Phase 2 | Neoplasms Adjuvant | 70 | cmyxuleiaf(lvwkfbrnoe) = wwrxqvywow pwqbesnwyd (vvopeovchx ) | Positive | 30 May 2025 | ||
cmyxuleiaf(lvwkfbrnoe) = nugrvwrjnl pwqbesnwyd (vvopeovchx ) | |||||||
Not Applicable | 76 | Donafenib + TACE + PD-1 inhibitors | ofwoaeyswu(hiczgypbpl) = 65 patients (85.5%) maintained or improved ALBI grading at the end of treatment wngfigddbo (oabvmlnymj ) View more | Positive | 30 May 2025 |





