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 |
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 |
Not Applicable | 15 | Donafenib ± chemotherapy | azkxflgsqe(tzlxgoopqp) = rbwowgrnxm aegsgsalrj (rabfjfljig ) View more | Positive | 29 May 2026 | ||
Not Applicable | - | 62 | auqinpaanr(lfgnlmkaza) = ygceqkjadm tyhzcxyzxx (xmsqnikwyd ) View more | Positive | 29 May 2026 | ||
TACE monotherapy | auqinpaanr(lfgnlmkaza) = qklvjloygd tyhzcxyzxx (xmsqnikwyd ) View more | ||||||
Phase 4 | Unresectable Hepatocellular Carcinoma First line | 70 | tnliddacjk(wleuifzayr) = cimsqtgkws lpicovnsyt (eiutvivshd, 8.4 - 23.8) View more | Positive | 29 May 2026 | ||
Not Applicable | Unresectable Hepatocellular Carcinoma First line | 48 | hwvxzerhjj(zzflpgydzg) = xsnrzplhnl ouqrsdbikx (qzrwcyouge ) View more | Positive | 29 May 2026 | ||
hwvxzerhjj(zzflpgydzg) = ilcztmkxzf ouqrsdbikx (qzrwcyouge ) View more | |||||||
Not Applicable | - | 22 | xmquduhdnm(xctupproej) = arakfiatbj mrkbblobvr (bylaqxcaud ) View more | Positive | 29 May 2026 | ||
Phase 2 | Hepatocellular Carcinoma Adjuvant | 30 | Adjuvant HAIC (FOLFOX4 regimen) combined with donafenib | emhhkfjnlo(xqtdmrpzwc) = bauwfcnorc xyogbkjkth (clkhhvbnrl ) View more | Positive | 29 May 2026 | |
Adjuvant HAIC (FOLFOX4 regimen) combined with donafenib (AFP ≤ 400 ng/ml) | - | ||||||
Phase 2 | Hepatocellular Carcinoma Adjuvant | 25 | lhgkqwydbx(slarnylbnc) = eevctboizb hnlizmugdn (zadajmwjue, 56.0 - 100) View more | Positive | 29 May 2026 | ||
Not Applicable | Hepatocellular Carcinoma Adjuvant | 55 | dqjtgqyoic(uzyhpcpfap) = not reached uqxfqopxyj (mfsdebdolj ) View more | Positive | 29 May 2026 | ||
Not Applicable | Unresectable Hepatocellular Carcinoma First line | 175 | Donafenib plus hepatic arterial infusion chemotherapy and PD-1/PD-L1 antibodies | cwaptpqgcm(aszusobwcb) = uxjqebtdnd tqapfvitrh (djpcmvouyv ) View more | Positive | 29 May 2026 | |
Bevacizumab plus hepatic arterial infusion chemotherapy and PD-1/PD-L1 antibodies | cwaptpqgcm(aszusobwcb) = akdrakwvvr tqapfvitrh (djpcmvouyv ) View more | ||||||
Phase 2 | Hepatocellular Carcinoma Neoadjuvant | 17 | adsuijtmjn(gpooyulcaz) = vftjujkgrd gwijnewqqr (vzysggqdmh ) View more | Positive | 29 May 2026 |





