Overview
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Indication
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Associated Conditions
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Research Report
JSKN-003: A Comprehensive Clinical and Scientific Dossier
Executive Summary
JSKN-003 is an investigational, next-generation antibody-drug conjugate (ADC) engineered to target the human epidermal growth factor receptor 2 (HER2). Developed by Alphamab Oncology, it represents a significant evolution in ADC technology, integrating multiple proprietary innovations to enhance efficacy and broaden the therapeutic window.[1] The core structure of JSKN-003 is built upon KN026, a biparatopic antibody that uniquely binds to two distinct epitopes on the HER2 receptor. This antibody is site-specifically conjugated to a potent topoisomerase I inhibitor payload using a proprietary glycan-specific platform, resulting in a highly stable and homogenous therapeutic agent with a powerful bystander effect.[1]
The clinical development program for JSKN-003 has yielded compelling data across multiple heavily pretreated solid tumor indications, most notably in platinum-resistant ovarian cancer (PROC) and HER2-positive breast cancer. In a pooled analysis of patients with PROC, JSKN-003 demonstrated a transformative objective response rate (ORR) of 64.4% and a median progression-free survival (PFS) of 7.1 months, far exceeding historical benchmarks for standard-of-care chemotherapy.[3] A landmark finding from these studies is the drug's profound activity in patients with HER2-negative (immunohistochemistry [IHC] 0) tumors, challenging the conventional biomarker-driven paradigm for HER2-targeted agents and suggesting a potential HER2-agnostic role in this setting.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/31 | Phase 2 | Not yet recruiting | Shanghai JMT-Bio Inc. | ||
2025/02/26 | Phase 3 | Recruiting | Shanghai JMT-Bio Inc. | ||
2024/12/30 | Phase 3 | Not yet recruiting | |||
2023/10/12 | Phase 3 | Recruiting | |||
2023/02/27 | Phase 1 | Active, not recruiting | |||
2022/10/17 | Phase 2 | Recruiting | |||
2022/08/10 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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