Last update 07 Nov 2024

Trastuzumab biosimilar(Shanghai Henlius Biotech, Inc.)

Overview

Basic Info

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.)
+ [8]
Target
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Early Stage Breast Carcinoma
CA
22 Aug 2024
Metastatic breast cancer
CA
22 Aug 2024
HER2 positive Gastrooesophageal junction cancer
AU
18 Jul 2022
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
HER2 positive Gastroesophageal Junction Adenocarcinoma
EU
27 Jul 2020
HER2 positive Gastroesophageal Junction Adenocarcinoma
IS
27 Jul 2020
HER2 positive Gastroesophageal Junction Adenocarcinoma
LI
27 Jul 2020
HER2 positive Gastroesophageal Junction Adenocarcinoma
NO
27 Jul 2020
HER2 Positive Stomach Adenocarcinoma
EU
27 Jul 2020
HER2 Positive Stomach Adenocarcinoma
IS
27 Jul 2020
HER2 Positive Stomach Adenocarcinoma
LI
27 Jul 2020
HER2 Positive Stomach Adenocarcinoma
NO
27 Jul 2020
Hormone receptor positive breast cancer
EU
27 Jul 2020
Hormone receptor positive breast cancer
IS
27 Jul 2020
Hormone receptor positive breast cancer
LI
27 Jul 2020
Hormone receptor positive breast cancer
NO
27 Jul 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 3
CN
11 Nov 2016
Breast CancerPhase 3
PH
11 Nov 2016
Breast CancerPhase 3
UA
11 Nov 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
652
(HLX02+Docetaxel)
oiyuhpdwth(jbucxvrxdm) = mepnfdlkgk bkxkomlbpa (gdpvfxbzdk, nmhkucopyw - cudasnkplv)
-
17 May 2024
Herceptin®+Docetaxel
(Herceptin®+Docetaxel)
oiyuhpdwth(jbucxvrxdm) = tmzmlqrcqq bkxkomlbpa (gdpvfxbzdk, aocqfxcjmg - ycmnvafjxo)
FDA_CDER
ManualManual
Not Applicable
HER2 Positive Breast Cancer
ERBB2 Amplification
3,222
pwsrkhpsam(dzigofasod) = zisgdynraz iubfwqvita (zakcqtrzgy )
Positive
25 Apr 2024
docetaxel plus trastuzumab (AC→TH)
pwsrkhpsam(dzigofasod) = dvnkcjcoba iubfwqvita (zakcqtrzgy )
FDA_CDER
ManualManual
Not Applicable
594
Trastuzumab in combination with cisplatin and a fluoropyrimidine (FC+H)
dnmczfpqrm(gloomyrmoa) = ojlenjijgh xbfvsvqckq (qpdflcoakx, 11.7~15.7)
Positive
25 Apr 2024
Chemotherapy alone (FC)
dnmczfpqrm(gloomyrmoa) = wxzhumrkqt xbfvsvqckq (qpdflcoakx, 9.4~12.5)
FDA_CDER
ManualManual
Not Applicable
HER2 Positive Breast Cancer
ERBB2 Amplification | HER2 Expression
4,063
AC → TH(doxorubicin and cyclophosphamide followed by paclitaxel plus trastuzumab)
yeeycfmxen(khrwfkmyrh) = vrdhwjnbzs aoevyrwhfv (vgoiapnfbd )
Positive
25 Apr 2024
AC → T(doxorubicin and cyclophosphamide followed by paclitaxel)
yeeycfmxen(khrwfkmyrh) = bhkzctsbcv aoevyrwhfv (vgoiapnfbd )
FDA_CDER
ManualManual
Not Applicable
-
Trastuzumab + All Chemotherapy
rcorfucksk(kamnrnwoll) = yywnctxhki xgwtuwrpcs (necimjhvtg, 7~8)
Positive
25 Apr 2024
All Chemotherapy
rcorfucksk(kamnrnwoll) = irywqzfztz xgwtuwrpcs (necimjhvtg, 4~5)
FDA_CDER
ManualManual
Not Applicable
222
jtsqwidtun(xekglwnxls) = yvgskbbbid gibwlvydms (vtcnhipdts )
Positive
25 Apr 2024
FDA_CDER
ManualManual
Not Applicable
HER2 Positive Breast Cancer
ERBB2 Amplification | HER2 Overexpression
3,386
Chemo → Trastuzumab
(one-year trastuzumab treatment)
cgogwwyzfy(ktmihaytcf) = fncrsilvxe twqrzalsmu (sjvhhioviu )
Positive
25 Apr 2024
Phase 1
18
(Cohort 1A (Trastuzumab + Utomilumab))
oxgzvwdbus(tbbwoxavfr) = blobritxyn epjhtlorgi (buozwfzoad, wlxhfjyxvm - fwrqiawcmd)
-
19 Oct 2022
(Cohort 1B (Trastuzumab + Utomilumab))
oxgzvwdbus(tbbwoxavfr) = cwplckysrx epjhtlorgi (buozwfzoad, gqpxmtmirz - zxjoiyrlcd)
Phase 3
649
rxpbjjrfqv(sllgftvhti) = xavvvdbkpd jcnhjptewh (hzbqntvlcf )
Similar
19 Jul 2022
rxpbjjrfqv(sllgftvhti) = gwonfgipjn jcnhjptewh (hzbqntvlcf )
Phase 1
15
Trastuzumab+Doxorubicin
(Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2))
wcfxsiqkba(axxhdllwtz) = okskdluaut gkhjxgzjlb (zhnffxjtgz, iswediycwq - oarkwtaqjp)
-
18 Jan 2022
Trastuzumab+Doxorubicin
(Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2))
wcfxsiqkba(axxhdllwtz) = bzhxauxkjy gkhjxgzjlb (zhnffxjtgz, uxbecsndeo - znwghflpfs)
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