Last update 25 Mar 2025

Trastuzumab biosimilar

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
CMAB-809
Target
HER2
Action
antagonists
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Therapeutic Areas
NeoplasmsSkin and Musculoskeletal Diseases
Active Indication-
Inactive Indication
Metastatic breast cancer
Originator Organization
Taizhou Mabtech Pharmaceutical Co. Ltd.Taizhou Mabtech Pharmaceutical Co. Ltd.
Active Organization-
Inactive Organization
Taizhou Mabtech Pharmaceutical Co. Ltd.Taizhou Mabtech Pharmaceutical Co. Ltd.
Drug Highest PhasePendingPhase 1
First Approval Date-
Regulation-
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Structure/Sequence

Related

2
Clinical Trials associated with Trastuzumab biosimilar
NCT04049409
/ CompletedPhase 1
A Randomized, Double-blinded, Controlled, Single Dosing Phase I Study to Investigate The Pharmacokinetic, Safety and Immunogenicity Characteristics of CMAB809 and Herceptin in Healthy Male Subjects
CTR20190897
/ CompletedPhase 1
CMAB809与赫赛汀在健康男性志愿者的随机、双盲、平行对照、单次给药药代动力学、安全性和免疫原性的I期比对研究
[Translation] A randomized, double-blind, parallel-controlled, single-dose, phase I study comparing the pharmacokinetics, safety, and immunogenicity of CMAB809 with Herceptin in healthy male volunteers
100 Clinical Results associated with Trastuzumab biosimilar
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100 Translational Medicine associated with Trastuzumab biosimilar
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100 Patents (Medical) associated with Trastuzumab biosimilar
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100 Deals associated with Trastuzumab biosimilar
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic breast cancerPhase 1
China
Taizhou Mabtech Pharmaceutical Co. Ltd.Taizhou Mabtech Pharmaceutical Co. Ltd.
12 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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