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 |
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 | |
| Colorectal Cancer | Phase 3 | China | 23 Dec 2016 | |
| 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 | |
| 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 | Hepatocellular Carcinoma Adjuvant tumor diameter ≥5 cm | tumor number ≥2 | microvascular invasion ... View more | 47 | jsweagjdwg(fcwbmctywp) = hctpnzhmsh alwecbdjez (bfqgrezusy ) View more | Positive | 30 May 2025 | ||
Not Applicable | Hepatocellular Carcinoma First line HBV | serum a-fetoprotein levels ≥400 ng/mL | tumor thrombus ... View more | 30 | Donafenib + Anti-PD-1 Antibody + TACE | edojlxwayu(nrvmykbckp) = vbovrzcopr knpxdmqupe (whaipscybm ) View more | Positive | 30 May 2025 | |
Not Applicable | Unresectable Hepatocellular Carcinoma HBV infection | 64 | hiqzvxngss(sqqmkcysrk) = xzjrtbjdjb emtrjmeqgy (tixoiaghjb, 7.2 - 17.4) View more | Positive | 30 May 2025 | ||
Phase 2 | Neoplasms Adjuvant | 70 | cgjuefofvf(bpscpqlkwm) = qepqyfgtip xqbjagjfib (mhmfywncas ) | Positive | 30 May 2025 | ||
cgjuefofvf(bpscpqlkwm) = oeqgrrtfgh xqbjagjfib (mhmfywncas ) | |||||||
Not Applicable | Hepatocellular Carcinoma Adjuvant preoperative AFP level | number of tumors | maximum diameter of tumors ... View more | 40 | ncwbhdpvgl(bpozfztisu) = yenaovgcdt pgdrxoffsk (yoyaepuqep ) View more | Positive | 30 May 2025 | ||
Not Applicable | 40 | Donafenib + PD-(L)1 + TACE | dokjbhnsdb(xekjmwpxqi) = zfhlurqsin pazcnekyuh (syxnkfinoj ) View more | Positive | 30 May 2025 | ||
Not Applicable | 76 | Donafenib + TACE + PD-1 inhibitors | oqlfnzgjhe(safkvaaxdb) = 65 patients (85.5%) maintained or improved ALBI grading at the end of treatment cwzlszoolh (kkmocxfaws ) View more | Positive | 30 May 2025 | ||
Not Applicable | 15 | zchtznwzhk(qlkzfwgncf) = puadesiglq sjjutbxmnu (nqtjjyhvyx ) View more | Positive | 30 May 2025 | |||
Not Applicable | Biliary Tract Neoplasms Adjuvant | 35 | Donafenib plus ICIs with S-1/capecitabine | jduaeyccoa(gkqjskhjqr) = mjavlzornf cadyejcitv (ckqjgmtijj, 14.0 - NA) View more | Positive | 30 May 2025 | |
Not Applicable | Hepatocellular Carcinoma Adjuvant preoperative AFP level | number of tumors | maximum diameter of tumors ... View more | 44 | khzxiucnaq(pfulwlltav) = egoeligwbh quamfpddbw (ntmvtmcrux ) View more | Positive | 30 May 2025 |





