Last update 29 Mar 2025

FAZ-053

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
FAZ 053, LAE-005, LAE005
Target
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors)
Therapeutic Areas
Originator Organization
Inactive Organization
Drug Highest PhasePhase 1/2
First Approval Date-
Regulation-
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Malignant Solid NeoplasmPhase 2
China
15 Mar 2021
Advanced Malignant Solid NeoplasmPhase 2
China
15 Mar 2021
Triple Negative Breast CancerPhase 2
China
15 Mar 2021
Triple Negative Breast CancerPhase 2
China
15 Mar 2021
Alveolar Soft Part SarcomaPhase 1
United States
20 Oct 2016
Alveolar Soft Part SarcomaPhase 1
Japan
20 Oct 2016
Alveolar Soft Part SarcomaPhase 1
Canada
20 Oct 2016
Alveolar Soft Part SarcomaPhase 1
France
20 Oct 2016
Alveolar Soft Part SarcomaPhase 1
Israel
20 Oct 2016
Alveolar Soft Part SarcomaPhase 1
Italy
20 Oct 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
22
LAE005 + AfureLAE005 100 mg + Nab-paclitaxel 125 mg/m2
gvlhiavibp(xnasdsfjbz) = gurnifxxsz gqwmwxetvo (ktbhbiudmn )
Positive
05 Apr 2024
Phase 1
61
bsorzcqrun(vempljuzhy) = bsoawgzpuk ffyvrbygyo (pvawsabhgs )
Positive
06 Nov 2018
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Clinical Trial

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Approval

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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.
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.

Regulation

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