Last update 11 Dec 2024

Omalizumab biosimilar (CSPC)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Omalizumab Biosimilar (Synermore Biologics (Suzhou) Co., Ltd.), Recombinant anti-IgE monoclonal antibody(CSPC Baike (Yantai) Biopharmaceutical Co. Ltd.), 奥马珠单抗生物类似药(Synermore Biologics (Suzhou) Co., Ltd.)
+ [6]
Target
Mechanism
IgE inhibitors(Immunoglobulin E inhibitors)
Inactive Indication-
Drug Highest PhaseApproved
First Approval Date
CN (26 Sep 2024),
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic Urticaria
CN
26 Sep 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AsthmaNDA/BLA
CN
-
Autoimmune DiseasesPhase 2
CN
29 Aug 2022
Autoimmune DiseasesPhase 2
EU
29 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
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08 Oct 2024
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Regulation

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