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Last update 13 Sep 2025
Trastuzumab biosimilar (Hisun Pharma)
Last update 13 Sep 2025
Overview
Basic Info
Drug Type Biosimilar, Monoclonal antibody |
Synonyms Trastuzumab biosimilar, HS-022, 安瑞泽 |
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 PhaseApproved |
First Approval Date China (28 Feb 2023), |
Regulation- |
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Structure/Sequence
Sequence Code 18481L
The sequence is quoted from: *****
Sequence Code 44772H
The sequence is quoted from: *****
Related
3
Clinical Trials associated with Trastuzumab biosimilar (Hisun Pharma)CTR20180362
比较安瑞泽联合长春瑞滨与赫赛汀联合长春瑞滨治疗HER2阳性转移性乳腺癌的有效性、安全性和免疫原性的III期临床试验
[Translation] Phase III clinical trial comparing the efficacy, safety and immunogenicity of Anruiza combined with vinorelbine and Herceptin combined with vinorelbine in the treatment of HER2-positive metastatic breast cancer
NCT06107790
Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer
CTR20170021
乳腺癌受试者单次静脉输注注射用重组抗 HER2 人源化单克隆抗体（HS022） 与原研药赫赛汀®的随机、 双盲、 多中心、 平行对照的药代动力学和安全性的相似性临床试验
[Translation] A randomized, double-blind, multicenter, parallel-controlled clinical trial to compare the pharmacokinetics and safety of a single intravenous infusion of a recombinant anti-HER2 humanized monoclonal antibody (HS022) for breast cancer patients with the original drug Herceptin®
100 Clinical Results associated with Trastuzumab biosimilar (Hisun Pharma)
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100 Translational Medicine associated with Trastuzumab biosimilar (Hisun Pharma)
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100 Patents (Medical) associated with Trastuzumab biosimilar (Hisun Pharma)
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100 Deals associated with Trastuzumab biosimilar (Hisun Pharma)
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| HER2 Positive Breast Cancer | China | 28 Feb 2023 | |
| Stomach Cancer | China | 28 Feb 2023 |
Developing
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | China | 16 May 2018 |
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Clinical Result
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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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