Last update 23 Jan 2025

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-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
Regulation-
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Structure/Sequence

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
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
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
Metastatic human epidermal growth factor 2 positive carcinoma of breastPreclinical
UA
01 Nov 2016
Metastatic human epidermal growth factor 2 positive carcinoma of breastPreclinical
PH
01 Nov 2016
NeoplasmsDiscovery
CN
04 Mar 2021
Breast CancerDiscovery
PH
11 Nov 2016
Breast CancerDiscovery
CN
11 Nov 2016
Breast CancerDiscovery
UA
11 Nov 2016
Metastatic human epidermal growth factor 2 positive carcinoma of breastDiscovery
CN
01 Nov 2016
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
(Group A)
(jlohnqcmid) = zkkrrbfdsp cgbecnpfio (jihunbxmbb, 6.8 - NE)
Positive
27 Jun 2024
HLX22 15 mg/kg + HLX02 + XELOX
(Group B)
(jlohnqcmid) = fxlzkkyoro cgbecnpfio (jihunbxmbb, 9.9 - NE)
Phase 3
652
(HLX02+Docetaxel)
ajvipagcac(zwfjckjxyo) = ckuervxzph bzivyrorot (jstezltltl, xqovpmqpnw - progowmsbl)
-
17 May 2024
Herceptin®+docetaxel
(Herceptin®+Docetaxel)
ajvipagcac(zwfjckjxyo) = emxsrujfhg bzivyrorot (jstezltltl, cxhiwlaxvn - upsnhmnfns)
FDA_CDER
ManualManual
Not Applicable
594
Trastuzumab in combination with cisplatin and a fluoropyrimidine (FC+H)
(isncnqdpzw) = hggvuzkntk asxnxegqex (iwgsssnxhq, 11.7 - 15.7)
Positive
25 Apr 2024
Chemotherapy alone (FC)
(isncnqdpzw) = kbftsdngbp asxnxegqex (iwgsssnxhq, 9.4 - 12.5)
FDA_CDER
ManualManual
Not Applicable
222
(xsfhceakez) = szxkfyhovk bsbwczukgp (ixmklcibvl )
Positive
25 Apr 2024
FDA_CDER
ManualManual
Not Applicable
-
Trastuzumab + All Chemotherapy
(duliowchfr) = tbhhdndbkh igduyhjmej (rxmbbitvfh, 7 - 8)
Positive
25 Apr 2024
All Chemotherapy
(duliowchfr) = dyfkglwlll igduyhjmej (rxmbbitvfh, 4 - 5)
Phase 2
53
HLX22 25 mg/kg + HLX02 + XELOX
(zlkgeaoycj) = lhryiykzev mkvinrepft (ogjinikzcl, 6.8 - NE)
Positive
17 Jan 2024
HLX22 15 mg/kg + HLX02 + XELOX
(zlkgeaoycj) = ftgpetpmnm mkvinrepft (ogjinikzcl, 9.9 - NE)
Phase 1/2
2
(SBT6050 + T-DXd (6.4 mg/kg))
bkkoeyfgrv(wuvctwgxom) = dqimpcebma agnyuffmhj (vfunimxrbj, smfbwhvuby - zdslvocruf)
-
18 Aug 2022
(SBT6050 + Tucatinib + Trastuzumab)
bkkoeyfgrv(wuvctwgxom) = qutixmwrpx agnyuffmhj (vfunimxrbj, jpgagzllin - kkrgvgelak)
Phase 3
649
(kqvwlbpojr) = cvzxbbfmsi cwcfppcnrf (ynpilvysgn )
Similar
19 Jul 2022
(kqvwlbpojr) = vtjzvosohx cwcfppcnrf (ynpilvysgn )
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 )
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Regulation

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