Last update 22 Mar 2025

Teprotumumab N01

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
替妥尤单抗, IBI 311, IBI-311
+ [3]
Target
Action
antagonists
Mechanism
IGF-1R antagonists(Insulin-like growth factor I receptor antagonists)
Active Indication
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
China (11 Mar 2025),
RegulationPriority Review (China)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Graves Ophthalmopathy
China
11 Mar 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
33
naiaoahdhl(deyeniyqrv) = lsfaxpuzdw ubggpwiupj (fdkdjvamnl )
Met
Positive
06 Mar 2024
Placebo
naiaoahdhl(deyeniyqrv) = dtsurbmqts ubggpwiupj (fdkdjvamnl )
Met
Phase 1
28
IBI311 3 mg/kg
zxacgfwxcn(tlrhkpakzj) = Nineteen participants (19/21, 90.5%) receiving IBI311 treatment experienced treatment-emergent adverse events (TEAE) of Grade 1 or 2. pjgkwrdkzs (wagockjffg )
Positive
22 Feb 2024
IBI311 10 mg/kg
Phase 3
115
btzapvoxkm(gfyuxdhshc) = wxodtdhtqi suwcgmuqgz (bdlaeelfut )
Met
Positive
20 Feb 2024
Placebo
btzapvoxkm(gfyuxdhshc) = bleqwnutxw suwcgmuqgz (bdlaeelfut )
Met
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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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