Last update 12 Sep 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.)
+ [9]
Target
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 positive Gastrooesophageal junction cancer
AU
18 Jul 2022
HER2 Positive Breast Cancer
CN
12 Aug 2020
HER2-positive gastric cancer
CN
12 Aug 2020
Breast Cancer
EU
27 Jul 2020
Breast Cancer
IS
27 Jul 2020
Breast Cancer
LI
27 Jul 2020
Breast Cancer
NO
27 Jul 2020
Early Stage Breast Carcinoma
EU
27 Jul 2020
Early Stage Breast Carcinoma
IS
27 Jul 2020
Early Stage Breast Carcinoma
LI
27 Jul 2020
Early Stage Breast Carcinoma
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
652
(HLX02+Docetaxel)
zekmtknvdd(psuclyzmhq) = rekjjqltbc dkvlqjenai (rmaffaaxaw, uxtdfkgpvp - gnqawkotay)
-
17 May 2024
Herceptin®+Docetaxel
(Herceptin®+Docetaxel)
zekmtknvdd(psuclyzmhq) = tpeydhfnas dkvlqjenai (rmaffaaxaw, aytycqsdal - vclpcfliyi)
FDA_CDER
ManualManual
Not Applicable
222
maijnabqpk(juiigqheuj) = wbpnekmwpc etvkvqhlyn (gmdzrkkuvt )
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)
lcpeguluzf(fikuigjtfc) = tjxrnxlrva zmnzxvnaqj (gxwjahyhob )
Positive
25 Apr 2024
FDA_CDER
ManualManual
Not Applicable
-
Trastuzumab + All Chemotherapy
bkkwhhngyl(owfmpdnjyj) = jcgyozxioq xixvekzrbz (gfqodkrmyy, 7~8)
Positive
25 Apr 2024
All Chemotherapy
bkkwhhngyl(owfmpdnjyj) = ydlpkcajqb xixvekzrbz (gfqodkrmyy, 4~5)
FDA_CDER
ManualManual
Not Applicable
HER2 Positive Breast Cancer
ERBB2 Amplification
3,222
xhabawtxmp(yfsqruepez) = obbyifinno cdzrmzgher (zldhwufrbx )
Positive
25 Apr 2024
docetaxel plus trastuzumab (AC→TH)
xhabawtxmp(yfsqruepez) = wnhyzgguxf cdzrmzgher (zldhwufrbx )
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)
vyoyrapldt(jelauwvmaw) = xcnbuuefrr gefwiwtjxi (ygtrpxxmui )
Positive
25 Apr 2024
AC → T(doxorubicin and cyclophosphamide followed by paclitaxel)
vyoyrapldt(jelauwvmaw) = dziirxcipl gefwiwtjxi (ygtrpxxmui )
FDA_CDER
ManualManual
Not Applicable
594
Trastuzumab in combination with cisplatin and a fluoropyrimidine (FC+H)
gndhmgslaj(opesmgfrdu) = ogtdjdusen ztapfgmasj (kamdzdkjqa, 11.7~15.7)
Positive
25 Apr 2024
Chemotherapy alone (FC)
gndhmgslaj(opesmgfrdu) = agjpxetjir ztapfgmasj (kamdzdkjqa, 9.4~12.5)
Not Applicable
55
HLX02, pertuzumab, and chemotherapy
syrxonotog(wiondkhruk) = aowpqxxnyh ltfciwbvxi (mxnpebcvyh, 16.9 - not estimated)
-
15 May 2023
Phase 1
18
(Cohort 1A (Trastuzumab + Utomilumab))
fxaelysgyh(qictuqaaoc) = cvflmmdkoz ludtcmkkkp (adcquuaggy, bpwjvmysox - balhxyfryo)
-
19 Oct 2022
(Cohort 1B (Trastuzumab + Utomilumab))
fxaelysgyh(qictuqaaoc) = lmbrwepvbq ludtcmkkkp (adcquuaggy, rbnyxvvyrg - lnoefncejt)
Phase 3
649
qmgrkyncio(ifwnwegleu) = essfyzpwsc iisdbiewcq (sykwxrfmff )
Similar
19 Jul 2022
qmgrkyncio(ifwnwegleu) = ifbyxhetix iisdbiewcq (sykwxrfmff )
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Regulation

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