Last update 21 Nov 2024

Trastuzumab biosimilar (Alteogen)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Herceptin biosimilar, Trastuzumab Biosimilar (Alteogen, Inc.), 曲妥珠单抗生物类似药(Alteogen, Inc.)
+ [8]
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
First Approval Date
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
HER2 Positive Breast Cancer
CN
28 Jun 2024
HER2-positive gastric cancer
CN
28 Jun 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
CN
29 Apr 2020
Breast CancerPhase 1--
Breast CancerPhase 1--
Esophageal CarcinomaPhase 1
CN
-
Esophageal CarcinomaPhase 1--
Esophageal CarcinomaPhase 1--
Stomach CancerPhase 1--
Stomach CancerPhase 1--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
473
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Positive
12 Sep 2024
原研曲妥珠单抗
(scghxqoepm) = slzjnrteqj qadbtnbflb (hwjgpvteut )
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Approval

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Regulation

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