Delving into the Latest Updates on Factor VIII (Weiguang Biological) with Synapse

Overview

Basic Info

Drug Type

Non-recombinant coagulation factor

Synonyms-

Target

F10

Mechanism

F10 stimulants(Coagulation factor X stimulants), Coagulation factor VIII replacements

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Hemophilia A

Inactive Indication-

Originator Organization

Shenzhen Weiguang Biological Products Co., Ltd.

Active Organization

Shenzhen Weiguang Biological Products Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (27 Oct 2023),

Hemophilia A

Regulation-

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主要目的：评价人凝血因子Ⅷ在重型血友病A（先天性因子Ⅷ缺乏症）患者中单次给药后的药代动力学特征，为注册申报生产提供依据。次要目的：评价人凝血因子Ⅷ在重型血友病A（先天性因子Ⅷ缺乏症）患者中单次给药后的安全性、有效性和药效动力学。

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics of human coagulation factor VIII after a single dose in patients with severe hemophilia A (congenital factor VIII deficiency) and provide a basis for registration and production. Secondary objective: To evaluate the safety, efficacy and pharmacodynamics of human coagulation factor VIII after a single dose in patients with severe hemophilia A (congenital factor VIII deficiency).

Start Date15 Sep 2020

Sponsor / Collaborator

Shenzhen Weiguang Biological Products Co., Ltd.

CTR20182045 / CompletedPhase 3

评价人凝血因子Ⅷ治疗甲型血友病的有效性和安全性的多中心、开放性多中心、开放性、单臂Ⅲ期临床研究

[Translation] A multicenter, open-label, single-arm phase III clinical study to evaluate the efficacy and safety of human coagulation factor VIII in the treatment of hemophilia A

评价人凝血因子Ⅷ治疗甲型血友病的有效性及安全性

[Translation]

To evaluate the efficacy and safety of human coagulation factor VIII in the treatment of hemophilia A

Start Date22 Nov 2018

Sponsor / Collaborator

Shenzhen Weiguang Biological Products Co., Ltd.

100 Clinical Results associated with Factor VIII (Weiguang Biological)

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100 Translational Medicine associated with Factor VIII (Weiguang Biological)

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100 Patents (Medical) associated with Factor VIII (Weiguang Biological)

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