Drug Type Biosimilar, Monoclonal antibody |
Synonyms TRASTUZUMAB-STRF, Trastuzumab Biosimilar (Shanghai Henlius Biotech, Inc.), 曲妥珠单抗生物类似药(Shanghai Henlius Biotech, Inc.) + [9] |
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- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 Positive Breast Cancer | NO | 27 Jul 2020 | |
HER2 Positive Breast Cancer | IS | 27 Jul 2020 | |
HER2 Positive Breast Cancer | EU | 27 Jul 2020 | |
HER2 Positive Breast Cancer | LI | 27 Jul 2020 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | NO | 27 Jul 2020 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | LI | 27 Jul 2020 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | EU | 27 Jul 2020 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | IS | 27 Jul 2020 | |
HER2 Positive Stomach Adenocarcinoma | IS | 27 Jul 2020 | |
HER2 Positive Stomach Adenocarcinoma | LI | 27 Jul 2020 | |
HER2 Positive Stomach Adenocarcinoma | EU | 27 Jul 2020 | |
HER2 Positive Stomach Adenocarcinoma | NO | 27 Jul 2020 | |
Hormone receptor positive breast cancer | LI | 27 Jul 2020 | |
Hormone receptor positive breast cancer | NO | 27 Jul 2020 | |
Hormone receptor positive breast cancer | IS | 27 Jul 2020 | |
Hormone receptor positive breast cancer | EU | 27 Jul 2020 | |
Metastatic Gastric Carcinoma | IS | 27 Jul 2020 | |
Metastatic Gastric Carcinoma | EU | 27 Jul 2020 | |
Metastatic Gastric Carcinoma | LI | 27 Jul 2020 | |
Metastatic Gastric Carcinoma | NO | 27 Jul 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 Positive Breast Cancer | NDA/BLA | US | 14 Feb 2023 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | NDA/BLA | US | 14 Feb 2023 | |
HER2-positive gastric cancer | NDA/BLA | US | 14 Feb 2023 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Preclinical | UA | 01 Nov 2016 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Preclinical | PH | 01 Nov 2016 | |
Neoplasms | Discovery | CN | 04 Mar 2021 | |
Breast Cancer | Discovery | PH | 11 Nov 2016 | |
Breast Cancer | Discovery | CN | 11 Nov 2016 | |
Breast Cancer | Discovery | UA | 11 Nov 2016 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Discovery | CN | 01 Nov 2016 |
Phase 2 | 53 | (jlohnqcmid) = zkkrrbfdsp cgbecnpfio (jihunbxmbb, 6.8 - NE) View more | Positive | 27 Jun 2024 | |||
(jlohnqcmid) = fxlzkkyoro cgbecnpfio (jihunbxmbb, 9.9 - NE) View more | |||||||
Phase 3 | 652 | ajvipagcac(zwfjckjxyo) = ckuervxzph bzivyrorot (jstezltltl, xqovpmqpnw - progowmsbl) View more | - | 17 May 2024 | |||
Herceptin®+docetaxel (Herceptin®+Docetaxel) | ajvipagcac(zwfjckjxyo) = emxsrujfhg bzivyrorot (jstezltltl, cxhiwlaxvn - upsnhmnfns) View more | ||||||
FDA_CDER Manual | Not Applicable | 594 | Trastuzumab in combination with cisplatin and a fluoropyrimidine (FC+H) | (isncnqdpzw) = hggvuzkntk asxnxegqex (iwgsssnxhq, 11.7 - 15.7) View more | Positive | 25 Apr 2024 | |
Chemotherapy alone (FC) | (isncnqdpzw) = kbftsdngbp asxnxegqex (iwgsssnxhq, 9.4 - 12.5) View more | ||||||
FDA_CDER Manual | Not Applicable | 222 | (xsfhceakez) = szxkfyhovk bsbwczukgp (ixmklcibvl ) View more | Positive | 25 Apr 2024 | ||
FDA_CDER Manual | Not Applicable | - | Trastuzumab + All Chemotherapy | (duliowchfr) = tbhhdndbkh igduyhjmej (rxmbbitvfh, 7 - 8) View more | Positive | 25 Apr 2024 | |
All Chemotherapy | (duliowchfr) = dyfkglwlll igduyhjmej (rxmbbitvfh, 4 - 5) View more | ||||||
Phase 2 | 53 | (zlkgeaoycj) = lhryiykzev mkvinrepft (ogjinikzcl, 6.8 - NE) View more | Positive | 17 Jan 2024 | |||
(zlkgeaoycj) = ftgpetpmnm mkvinrepft (ogjinikzcl, 9.9 - NE) View more | |||||||
Phase 1/2 | 2 | (SBT6050 + T-DXd (6.4 mg/kg)) | bkkoeyfgrv(wuvctwgxom) = dqimpcebma agnyuffmhj (vfunimxrbj, smfbwhvuby - zdslvocruf) View more | - | 18 Aug 2022 | ||
(SBT6050 + Tucatinib + Trastuzumab) | bkkoeyfgrv(wuvctwgxom) = qutixmwrpx agnyuffmhj (vfunimxrbj, jpgagzllin - kkrgvgelak) View more | ||||||
Phase 3 | 649 | (kqvwlbpojr) = cvzxbbfmsi cwcfppcnrf (ynpilvysgn ) View more | Similar | 19 Jul 2022 | |||
(kqvwlbpojr) = vtjzvosohx cwcfppcnrf (ynpilvysgn ) View more | |||||||
Phase 1 | - | 123 | (nudzsywlsa): GLSMR = 0.95 (90% CI, 0.891 - 1.013) | - | 01 Mar 2021 | ||
CN-trastuzumab | |||||||
Phase 3 | 649 | nfeyitipyn(fmwmogjjie) = dzcagfdwea phbnjxiyvc (ixuratwwss ) | Positive | 19 Sep 2020 | |||
EU-TZB | nfeyitipyn(fmwmogjjie) = lnxqfgbzov phbnjxiyvc (ixuratwwss ) |