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Last update 22 May 2026
Trastuzumab/Pertuzumab/Hyaluroniase-zzxf Biosimilar(Shanghai Henlius Biotech)
Last update 22 May 2026
Overview
Basic Info
Drug Type Biosimilar, Monoclonal antibody, Enzyme |
Synonyms Trastuzumab/Pertuzumab/Hyaluroniase-zzxf Biosimilar (Shanghai Henlius Biotech, Inc.), 曲妥珠单抗/帕妥珠单抗/透明质酸酶生物类似药（上海复宏汉霖生物技术股份有限公司）, HLX-319 |
Target |
Action antagonists, modulators |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), Hyaluronic acid modulators, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 1 |
First Approval Date- |
Regulation- |
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Related
2
Clinical Trials associated with Trastuzumab/Pertuzumab/Hyaluroniase-zzxf Biosimilar(Shanghai Henlius Biotech)NCT07495930
A Randomized, Double-blind, Single Subcutaneous Administration, Parallel Control Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo® in Chinese Healthy Male Subjects.
CTR20261838
一项评估帕妥珠曲妥珠单抗皮下注射液类似物HLX319 对比EU-Phesgo®在HER2 阳性早期或局晚期乳腺癌新辅助治疗的药代动力学、疗效和安全性的随机、双盲、多中心、平行对照I 期临床研究
[Translation] A randomized, double-blind, multicenter, parallel-controlled phase I clinical trial evaluating the pharmacokinetics, efficacy, and safety of HLX319 (a subcutaneous analogue of pertuzumab and trastuzumab) versus EU-Phesgo® in neoadjuvant therapy for HER2-positive early or locally advanced breast cancer.
100 Clinical Results associated with Trastuzumab/Pertuzumab/Hyaluroniase-zzxf Biosimilar(Shanghai Henlius Biotech)
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100 Translational Medicine associated with Trastuzumab/Pertuzumab/Hyaluroniase-zzxf Biosimilar(Shanghai Henlius Biotech)
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100 Patents (Medical) associated with Trastuzumab/Pertuzumab/Hyaluroniase-zzxf Biosimilar(Shanghai Henlius Biotech)
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100 Deals associated with Trastuzumab/Pertuzumab/Hyaluroniase-zzxf Biosimilar(Shanghai Henlius Biotech)
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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 |
|---|---|---|---|---|
| HER2 Positive Breast Cancer | Phase 1 | - | 03 Jul 2026 | |
| Locally advanced breast cancer | IND Approval | China | 31 Mar 2026 |
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