Last update 21 Nov 2024

Human prothrombin complex (Guangdong Shuanglin)

Overview

Basic Info

Drug Type
Blood components
Synonyms-
Target
F10 x factor IX x factor VII x thrombin
Mechanism
F10 modulators(Coagulation factor X modulators), factor IX modulators(Coagulation factor IX modulators), factor VII modulators(Coagulation factor VII modulators)
+ [1]
Therapeutic Areas
Congenital DisordersHemic and Lymphatic DiseasesOther Diseases
Active Indication
Hemophilia B
Inactive Indication-
Originator Organization
Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.
Active Organization
Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CN (12 May 2023),
Hemophilia B
Regulation-
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Related

2
Clinical Trials associated with Human prothrombin complex (Guangdong Shuanglin)
CTR20182080 / CompletedPhase 3
验证人凝血酶原复合物治疗乙型血友病的有效性及安全性的单臂、开放、多中心临床研究
[Translation] A single-arm, open, multicenter clinical study to verify the efficacy and safety of human prothrombin complex therapy in the treatment of hemophilia B
CTR20140124 / RecruitingPhase 3
人凝血酶原复合物（PCC）治疗乙型血友病患者的安全性及疗效的多中心、开放性临床研究
[Translation] A multicenter, open-label clinical study on the safety and efficacy of human prothrombin complex (PCC) in the treatment of hemophilia B patients
100 Clinical Results associated with Human prothrombin complex (Guangdong Shuanglin)
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100 Translational Medicine associated with Human prothrombin complex (Guangdong Shuanglin)
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100 Patents (Medical) associated with Human prothrombin complex (Guangdong Shuanglin)
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100 Deals associated with Human prothrombin complex (Guangdong Shuanglin)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia B
CN
Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.
12 May 2023
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Clinical Result

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Approval

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Regulation

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