Drug Type Biosimilar, Monoclonal antibody |
Synonyms Herceptin biosimilar, Trastuzumab Biosimilar (Alteogen, Inc.), 曲妥珠单抗生物类似药(Alteogen, Inc.) + [8] |
Target |
Mechanism HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (28 Jun 2024), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 Positive Breast Cancer | CN | 28 Jun 2024 | |
HER2-positive gastric cancer | CN | 28 Jun 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | CN | 29 Apr 2020 | |
Breast Cancer | Phase 1 | - | - | |
Breast Cancer | Phase 1 | - | - | |
Esophageal Carcinoma | Phase 1 | CN | - | |
Esophageal Carcinoma | Phase 1 | - | - | |
Esophageal Carcinoma | Phase 1 | - | - | |
Stomach Cancer | Phase 1 | - | - | |
Stomach Cancer | Phase 1 | - | - |
NCT05629949 (NEWS) Manual | Phase 3 | HER2 Positive Breast Cancer First line | 473 | (scghxqoepm) = svtcrdwund qadbtnbflb (hwjgpvteut ) View more | Positive | 12 Sep 2024 | |
原研曲妥珠单抗 | (scghxqoepm) = slzjnrteqj qadbtnbflb (hwjgpvteut ) View more |