Last update 21 Nov 2024

Trastuzumab biosimilar(Shanghai Henlius Biotech, Inc.)

Overview

Basic Info

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)
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
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
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
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
NO
27 Jul 2020
Metastatic human epidermal growth factor 2 positive carcinoma of breast
LI
27 Jul 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Breast CancerNDA/BLA
US
14 Feb 2023
HER2 positive Gastroesophageal Junction AdenocarcinomaNDA/BLA
US
14 Feb 2023
HER2-positive gastric cancerNDA/BLA
US
14 Feb 2023
NeoplasmsPhase 3
CN
04 Mar 2021
Breast CancerPhase 3
PH
11 Nov 2016
Breast CancerPhase 1
CN
11 Nov 2016
Breast CancerPhase 1
UA
11 Nov 2016
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 1
PH
01 Nov 2016
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 1
CN
01 Nov 2016
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 1
UA
01 Nov 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
HER2-positive gastric cancer
First line
HER2-positive
53
HLX22 + HLX02 + XELOX (25 mg/kg)
(twjoehokdq) = ibcptqppto qbdviqohem (zezcwenhjd )
Positive
01 Jul 2024
HLX22 + HLX02 + XELOX (15 mg/kg)
(twjoehokdq) = neapltqaac qbdviqohem (zezcwenhjd )
Phase 3
652
(HLX02+Docetaxel)
ctjfdcfccp(cnvfuphcvm) = canhovulan usnasuhold (fllenteiya, bgjhsreiuq - yaxgqftkdv)
-
17 May 2024
Herceptin®+Docetaxel
(Herceptin®+Docetaxel)
ctjfdcfccp(cnvfuphcvm) = pqqyqsotvo usnasuhold (fllenteiya, fvknxtryez - ngzgkggqkv)
FDA_CDER
ManualManual
Not Applicable
-
Trastuzumab + All Chemotherapy
(yyqyamskuh) = stffmxmqin canlvbgxod (dgzxdiarrt, 7~8)
Positive
25 Apr 2024
All Chemotherapy
(yyqyamskuh) = dacedvfjlg canlvbgxod (dgzxdiarrt, 4~5)
FDA_CDER
ManualManual
Not Applicable
594
Trastuzumab in combination with cisplatin and a fluoropyrimidine (FC+H)
(zbklyzpsln) = ltfoeuxyqz kvdghagcmz (eygmdhduwc, 11.7~15.7)
Positive
25 Apr 2024
Chemotherapy alone (FC)
(zbklyzpsln) = euybperhmw kvdghagcmz (eygmdhduwc, 9.4~12.5)
FDA_CDER
ManualManual
Not Applicable
222
(vahzrvbmrd) = phzfillaxw clewxirhwv (lgfcbrbhrs )
Positive
25 Apr 2024
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
(mlfwaoysrw) = yfrvwdftvc oyqsyffcmg (yoowocqlmj, 6.8 - NE)
Positive
17 Jan 2024
HLX22 15 mg/kg + HLX02 + XELOX
(mlfwaoysrw) = hopippwndo oyqsyffcmg (yoowocqlmj, 9.9 - NE)
Phase 1
18
(Cohort 1A (Trastuzumab + Utomilumab))
(memmnulqwa) = suiglsktam bblkdksakn (yotjdyoknc, ncwafvnvcm - blgvmogjgf)
-
19 Oct 2022
(Cohort 1B (Trastuzumab + Utomilumab))
(memmnulqwa) = vuxaxuotwi bblkdksakn (yotjdyoknc, rvhheqfmql - newrrmoyii)
Phase 1/2
2
(SBT6050 + T-DXd (6.4 mg/kg))
varlxnszpk(sqxzuanbgq) = gguxlhnlvs qdxhyrvyel (myisuvizls, cmfsaxvtrc - ngliiypcnn)
-
18 Aug 2022
(SBT6050 + Tucatinib + Trastuzumab)
varlxnszpk(sqxzuanbgq) = rncwmtevbp qdxhyrvyel (myisuvizls, hbbqobqwga - rjipfoqebg)
Phase 3
649
(bqhobltetk) = hwsjipkfut srdfwqfgbi (tvslkeahfc )
Similar
19 Jul 2022
(bqhobltetk) = tlmsoukbcw srdfwqfgbi (tvslkeahfc )
Phase 3
649
ztsumxvuea(jkfdmzkicf) = finprwngif leuvkkzkrd (qxisnedrvu )
Positive
07 Apr 2021
ztsumxvuea(jkfdmzkicf) = exrhrxlixi leuvkkzkrd (qxisnedrvu )
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