Drug Type Biosimilar, Monoclonal antibody |
Synonyms Trastuzumab Biosimilar (Shanghai Henlius Biotech, Inc.), TRASTUZUMAB-STRF, 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 Gastroesophageal Junction Adenocarcinoma | US | 25 Apr 2024 | |
HER2-positive gastric cancer | CN | 12 Aug 2020 | |
HER2 Positive Breast Cancer | EU | 27 Jul 2020 | |
HER2 Positive Breast Cancer | IS | 27 Jul 2020 | |
HER2 Positive Breast Cancer | LI | 27 Jul 2020 | |
HER2 Positive Breast Cancer | NO | 27 Jul 2020 | |
Metastatic gastric adenocarcinoma | EU | 27 Jul 2020 | |
Metastatic gastric adenocarcinoma | IS | 27 Jul 2020 | |
Metastatic gastric adenocarcinoma | LI | 27 Jul 2020 | |
Metastatic gastric adenocarcinoma | NO | 27 Jul 2020 | |
Metastatic HER2 positive gastroesophageal junction cancer | EU | 27 Jul 2020 | |
Metastatic HER2 positive gastroesophageal junction cancer | IS | 27 Jul 2020 | |
Metastatic HER2 positive gastroesophageal junction cancer | LI | 27 Jul 2020 | |
Metastatic HER2 positive gastroesophageal junction cancer | NO | 27 Jul 2020 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | EU | 27 Jul 2020 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | IS | 27 Jul 2020 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | LI | 27 Jul 2020 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | NO | 27 Jul 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Breast Cancer | Phase 3 | CN | 11 Nov 2016 | |
Breast Cancer | Phase 3 | PH | 11 Nov 2016 | |
Breast Cancer | Phase 3 | UA | 11 Nov 2016 |
Phase 3 | 652 | gnoipdzbpk(ezkcxxdsxy) = qenjlhmstj jkowqvlmcc (aodzalfyps, itjxbmcnlt - yygxkekyxo) View more | - | 17 May 2024 | |||
Herceptin®+Docetaxel (Herceptin®+Docetaxel) | gnoipdzbpk(ezkcxxdsxy) = nmibxanpiv jkowqvlmcc (aodzalfyps, xdsrwjvlur - phugivkpfr) View more | ||||||
FDA_CDER Manual | Not Applicable | HER2 Positive Breast Cancer ERBB2 Amplification | 3,222 | khyztnurvn(hyouwtyxfi) = qenmiloipx fywekwpdbb (zuxwzxxtno ) View more | Positive | 25 Apr 2024 | |
khyztnurvn(hyouwtyxfi) = lzooqvulkg fywekwpdbb (zuxwzxxtno ) View more | |||||||
FDA_CDER Manual | Not Applicable | Metastatic breast cancer HER2 Positive | 222 | fiklmtqmgq(gbanpbwhqe) = rrijsuohnw tthhkhzcrb (niiicluxyw ) View more | Positive | 25 Apr 2024 | |
FDA_CDER Manual | Not Applicable | HER2 Positive Breast Cancer ERBB2 Amplification | HER2 Overexpression | 3,386 | Chemo → Trastuzumab (one-year trastuzumab treatment) | tdsxkfjhoj(idncduynxe) = sqhazvytwr sykimhwbrm (wyihimehax ) View more | Positive | 25 Apr 2024 |
FDA_CDER Manual | Not Applicable | Metastatic breast cancer HER2 Positive | - | Trastuzumab + All Chemotherapy | oeghayepds(kiwinkuymi) = xamtcrgtvi udewopcdwe (qnltuwrjgp, 7~8) View more | Positive | 25 Apr 2024 |
All Chemotherapy | oeghayepds(kiwinkuymi) = umgerzmgqc udewopcdwe (qnltuwrjgp, 4~5) View more | ||||||
FDA_CDER Manual | Not Applicable | Metastatic Gastric Carcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma HER2 Overexpression | ERBB2 Amplification | 594 | Trastuzumab in combination with cisplatin and a fluoropyrimidine (FC+H) | ungwwatrms(jyxrufnvvb) = gpupbamysy kmzcneizkk (lqratjhnvv, 11.7~15.7) View more | Positive | 25 Apr 2024 |
Chemotherapy alone (FC) | ungwwatrms(jyxrufnvvb) = niphlkofop kmzcneizkk (lqratjhnvv, 9.4~12.5) View more | ||||||
FDA_CDER Manual | Not Applicable | HER2 Positive Breast Cancer ERBB2 Amplification | HER2 Expression | 4,063 | gqejkzrgtt(zqlqrshuqe) = fkqyzrmwty smavngznkc (sokwfnbunt ) View more | Positive | 25 Apr 2024 | |
gqejkzrgtt(zqlqrshuqe) = vljhnzcpeg smavngznkc (sokwfnbunt ) View more | |||||||
Not Applicable | Metastatic human epidermal growth factor 2 positive carcinoma of breast First line estrogen receptor-positive | 55 | HLX02, pertuzumab, and chemotherapy | xkqowjfsvd(tztnliluab) = lbfmxhvfvy wurskxfrhc (tckrlwfecs, 16.9 - not estimated) View more | - | 15 May 2023 | |
Phase 3 | 649 | vnflnqzguq(beoxoljutq) = kbthzpclzf cabvfpckao (yyffmheeiv ) View more | Similar | 19 Jul 2022 | |||
vnflnqzguq(beoxoljutq) = sspudgijzs cabvfpckao (yyffmheeiv ) View more | |||||||
Phase 1 | 15 | Trastuzumab+Doxorubicin (Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)) | ithndfjbnw(wlgcxaysqf) = fscxsrrgcg jvhldgqqts (latszpicsq, cmbnftqcqh - uxctjebhjo) View more | - | 18 Jan 2022 | ||
Trastuzumab+Doxorubicin (Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)) | ithndfjbnw(wlgcxaysqf) = hfclydobbg jvhldgqqts (latszpicsq, ksrvfefbrb - eaoyozjefr) View more |