描述
Trastuzumab Deruxtecan Injection Product Specifications
Attribute | Details |
---|---|
Product Name | Trastuzumab Deruxtecan Injection (Enhertu®) |
Strength | 100?mg of ADC per vial |
Formulation | Sterile lyophilized powder for IV infusion |
Approval No. | China NMPA SJ20230005 |
Product Code | 86982561000050 |
Manufacturer | Baxter Oncology GmbH (Germany) |
Intended Use | Research use only — Not intended for clinical, diagnostic, therapeutic, |
or veterinary applications |
Mechanism of Action
Enhertu® consists of a humanized anti-HER2 monoclonal antibody linked to DXd, a potent topoisomerase I inhibitor. After HER2-mediated binding and internalization, the ADC releases DXd inside tumor cells, causing DNA damage and apoptosis. A bystander killing effect enhances potency against HER2-low and heterogeneous tumors. daiichisankyo.com+1pearceip.law+1
Research & Clinical Background
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FDA approval: December?2019 for HER2-positive metastatic breast cancer; later indications include HER2-low breast, gastric/GEJ cancer, and HER2-mutant NSCLC
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China approvals: For HER2-positive breast cancer (Feb?2023), followed by gastric cancer and HER2-mutant NSCLC
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Efficacy data: DESTINY-Breast04 showed PFS???9.9?mo vs?5.1?mo (hazard ratio?0.50); DESTINY-Breast03 demonstrated significant tumor control and CNS activity
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Toxicity profile: Common serious events include neutropenia, fatigue, nausea, anemia, thrombocytopenia, and interstitial lung disease (ILD) in ?16% of patients
Research Applications
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HER2+ / HER2-low cancer biology in vitro and in vivo
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Tumor penetration & bystander effect studies
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ADC pharmacokinetic/pharmacodynamic modeling
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Toxicity assays, especially ILD and hematologic events
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Combination therapy assessments with chemo or immunotherapy
?? Research?Use Disclaimer
This product is provided strictly for laboratory research and development use only. Not intended for clinical, diagnostic, therapeutic, veterinary, or human applications.
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