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Research Report
JYB-1904 (RPT-904): A Strategic Analysis of a Second-Generation Anti-IgE Monoclonal Antibody
1.0 Executive Summary
1.1 Overview
JYB-1904 is a next-generation, recombinant humanized anti-immunoglobulin E (IgE) monoclonal antibody of the IgG1 subtype, currently in Phase II clinical development. It has been strategically engineered as a "biobetter" to omalizumab (Xolair®), the first-in-class and commercially successful anti-IgE therapy approved for multiple allergic diseases.[1] The core value proposition of JYB-1904 is centered on overcoming the known limitations of omalizumab by incorporating specific molecular enhancements. These modifications are designed to deliver a superior pharmacokinetic and pharmacodynamic profile, characterized by a significantly extended serum half-life, which enables less frequent subcutaneous dosing, and enhanced potency in neutralizing free IgE.[1] This profile positions JYB-1904 to offer improved patient convenience, adherence, and potentially enhanced clinical efficacy, addressing key unmet needs in the management of IgE-mediated conditions.
1.2 Key Findings
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/09/10 | Phase 1 | Completed | |||
2021/03/26 | Phase 1 | Completed | |||
2014/10/31 | Phase 1 | Completed |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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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
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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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