Last update 14 Dec 2024

Human Coagulation Factor IX (Shandong Taibang)

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms-
Target
F10
Mechanism
F10 stimulants(Coagulation factor X stimulants), Blood coagulation pathway activation
Therapeutic Areas
Congenital DisordersHemic and Lymphatic DiseasesOther Diseases
Active Indication
Hemophilia B
Inactive Indication-
Originator Organization
Shandong Taibang Biological Products Co. Ltd.Shandong Taibang Biological Products Co. Ltd.
Active Organization
Shandong Taibang Biological Products Co. Ltd.Shandong Taibang Biological Products Co. Ltd.
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CN (08 Jul 2020),
Hemophilia B
RegulationPriority Review (CN)
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Related

2
Clinical Trials associated with Human Coagulation Factor IX (Shandong Taibang)
CTR20231335 / CompletedPhase 4
评价人凝血因子Ⅸ在中重型血友病B（因子Ⅸ缺乏症）患者中单次给药后的安全性和药代动力学特征的单臂、开放、单中心临床试验
[Translation] A single-arm, open-label, single-center clinical trial to evaluate the safety and pharmacokinetic characteristics of human coagulation factor IX after a single dose in patients with moderate to severe hemophilia B (factor IX deficiency)
CTR20170472 / CompletedPhase 3
验证人凝血因子Ⅸ治疗乙型血友病的有效性及安全性的单臂、开放性、多中心临床研究
[Translation] A single-arm, open-label, multicenter clinical study to verify the efficacy and safety of human coagulation factor IX in the treatment of hemophilia B
100 Clinical Results associated with Human Coagulation Factor IX (Shandong Taibang)
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100 Translational Medicine associated with Human Coagulation Factor IX (Shandong Taibang)
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100 Patents (Medical) associated with Human Coagulation Factor IX (Shandong Taibang)
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100 Deals associated with Human Coagulation Factor IX (Shandong Taibang)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia B
CN
Shandong Taibang Biological Products Co. Ltd.Shandong Taibang Biological Products Co. Ltd.
08 Jul 2020
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Clinical Result

Indication
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Evaluation
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Regulation

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