Last update 20 Mar 2025

Human immunoglobulin(pH4)(Xinjiang Deyuan Biological Engineering Co.,Ltd.)

Overview

Basic Info

Drug Type
Immunoglobulin
Synonyms-
Target-
Action
modulators
Mechanism
Immunomodulators
Therapeutic Areas
Immune System DiseasesCongenital DisordersOther Diseases
Active Indication
Autoimmune DiseasesPrimary Immunodeficiency DiseasesSecondary immunodeficiencies
Inactive Indication
Purpura, Thrombocytopenic, Idiopathic
Originator Organization
Xinjiang Deyuan Biology Engineering Co. Ltd.
Active Organization
Xinjiang Deyuan Biology Engineering Co. Ltd.
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
China (16 Jul 2020),
Autoimmune DiseasesPrimary Immunodeficiency DiseasesSecondary immunodeficiencies
Regulation-
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Related

1
Clinical Trials associated with Human immunoglobulin(pH4)(Xinjiang Deyuan Biological Engineering Co.,Ltd.)
CTR20160321
/ CompletedPhase 3
静注人免疫球蛋白（pH4）治疗原发免疫性血小板减少症随机、单盲、阳性药平行对照、多中心临床试验
[Translation] A randomized, single-blind, positive-drug parallel-controlled, multicenter clinical trial of intravenous human immunoglobulin (pH4) in the treatment of primary immune thrombocytopenia
100 Clinical Results associated with Human immunoglobulin(pH4)(Xinjiang Deyuan Biological Engineering Co.,Ltd.)
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100 Translational Medicine associated with Human immunoglobulin(pH4)(Xinjiang Deyuan Biological Engineering Co.,Ltd.)
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100 Patents (Medical) associated with Human immunoglobulin(pH4)(Xinjiang Deyuan Biological Engineering Co.,Ltd.)
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100 Deals associated with Human immunoglobulin(pH4)(Xinjiang Deyuan Biological Engineering Co.,Ltd.)
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Autoimmune Diseases
China
Xinjiang Deyuan Biology Engineering Co. Ltd.
16 Jul 2020
Primary Immunodeficiency Diseases
China
Xinjiang Deyuan Biology Engineering Co. Ltd.
16 Jul 2020
Secondary immunodeficiencies
China
Xinjiang Deyuan Biology Engineering Co. Ltd.
16 Jul 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Purpura, Thrombocytopenic, IdiopathicDiscovery
China
Xinjiang Deyuan Biology Engineering Co. Ltd.
07 Jan 2016
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Clinical Result

Indication
Phase
Evaluation
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Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date

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Approval

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Biosimilar

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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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