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Last update 08 May 2025
Trastuzumab biosimilar
Last update 08 May 2025
Overview
Basic Info
Drug Type Biosimilar, Monoclonal antibody |
Synonyms |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
License Organization |
Drug Highest PhasePendingPhase 1 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 18481L
The sequence is quoted from: *****
Sequence Code 44772H
The sequence is quoted from: *****
Related
2
Clinical Trials associated with Trastuzumab biosimilarNCT04049409
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
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. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Metastatic breast cancer | Phase 1 | China | 12 Jun 2019 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Not Applicable | 193 | (mhjqtsknac) = dljpsbsqrj jahucwlyjs (mauuwlwluj ) | Positive | 12 May 2023 | |||
Referent Trastuzumab | (mhjqtsknac) = byaabisxpx jahucwlyjs (mauuwlwluj ) | ||||||
Not Applicable | HER2 Positive Breast Cancer Neoadjuvant | - | mdymmkytvh(rojewxcbmj) = bjbvcbjcqz mhpqewkqtw (obduprelwd ) | - | 03 Dec 2022 | ||
mdymmkytvh(rojewxcbmj) = llgtffyzsl mhpqewkqtw (obduprelwd ) | |||||||
Not Applicable | HER2 Positive Breast Cancer Neoadjuvant | 39 | (swayagyrxg) = fgymqcmknh wupuueuhvj (vtjqugfuxm ) | Positive | 26 May 2019 |
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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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Regulation
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