Drug Type Biosimilar, Monoclonal antibody |
Synonyms Trastuzumab biosimilar (Hanwha Biologics), 曲妥珠单抗生物类似药(Hanwha Biologics), 曲妥珠单抗生物类似药(Prestige BioPharma Ltd.) + [4] |
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 |
Regulation- |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 Positive Breast Cancer | EU | 19 Sep 2024 | |
HER2 Positive Breast Cancer | IS | 19 Sep 2024 | |
HER2 Positive Breast Cancer | LI | 19 Sep 2024 | |
HER2 Positive Breast Cancer | NO | 19 Sep 2024 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | EU | 19 Sep 2024 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | IS | 19 Sep 2024 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | LI | 19 Sep 2024 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | NO | 19 Sep 2024 | |
HER2 Positive Stomach Adenocarcinoma | EU | 19 Sep 2024 | |
HER2 Positive Stomach Adenocarcinoma | IS | 19 Sep 2024 | |
HER2 Positive Stomach Adenocarcinoma | LI | 19 Sep 2024 | |
HER2 Positive Stomach Adenocarcinoma | NO | 19 Sep 2024 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | EU | 19 Sep 2024 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | IS | 19 Sep 2024 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | LI | 19 Sep 2024 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | NO | 19 Sep 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Stomach Cancer | NDA/BLA | CA | 01 Aug 2021 |
Phase 3 | HER2 Positive Breast Cancer Neoadjuvant | 502 | (iohnjdscri) = During the posttreatment follow-up period, adverse events were reported for 64 (27.4%) and 72 (29.8%) patients in the HD201 and the reference trastuzumab groups, respectively vbuqheiwxo (wkkwqfteur ) View more | Positive | 31 Jan 2023 | ||
Referent trastuzumab | |||||||
Phase 3 | 474 | gbmmqdlrdm(uirewkxmur) = mgniokdyga ohrpjctkeg (qlunyjeyrc ) View more | Similar | 03 Dec 2022 | |||
gbmmqdlrdm(uirewkxmur) = yfnsmypknb ohrpjctkeg (qlunyjeyrc ) View more | |||||||
Phase 3 | 502 | pxsfmaheod(vdyoncdtxk) = nuzfopagfm xdmlyjrrmo (cmjwhafczk ) View more | Similar | 03 Mar 2022 | |||
pxsfmaheod(vdyoncdtxk) = arqoyriubl xdmlyjrrmo (cmjwhafczk ) View more | |||||||
Phase 1 | - | 105 | zampfcimvp(kbeeqclgpg) = were within 80%-125% for the comparisons of HD201 to EU-Herceptin or US-Herceptin and EU-Herceptin to US-Herceptin cxryspagwa (xnsnazdzmx ) | Positive | 01 Aug 2021 | ||
Herceptin |