Delving into the Latest Updates on PEGylated Recombinant Human Coagulation Factor VIII Fc Fusion Protein (Jiangsu Gensciences) with Synapse

To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.
To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.
Secondary purpose:
To evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein for injection (FRSW117) in hemostasis and surgical hemostasis in patients with severe hemophilia A.
To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.
To evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.

Start Date27 Dec 2023

Sponsor / Collaborator

Jiangsu Shengsi Biopharmaceutical Co., Ltd.

CTR20220283

/ CompletedPhase 2

在重型血友病A患者（成人和青少年）中评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）多次给药的药代动力学、安全性和初步疗效的开放、多中心、II期临床研究

[Translation] An open, multicenter, phase II clinical study to evaluate the pharmacokinetics, safety, and preliminary efficacy of multiple doses of recombinant human coagulation factor VIII-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A (adults and adolescents)

主要目的：评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在重型血友病A患者中多次给药的药代动力学（PK）特征。评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在重型血友病A患者中多次给药的安全性和免疫原性。次要目的：评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在重型血友病A患者中的初步疗效。

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor VIII-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A after multiple administration. To evaluate the safety and immunogenicity of recombinant human coagulation factor VIII-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A after multiple administration. Secondary objective: To evaluate the preliminary efficacy of recombinant human coagulation factor VIII-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A.

Start Date14 Apr 2022

Sponsor / Collaborator

Jiangsu Shengsi Biopharmaceutical Co., Ltd.

NCT05265286

/ CompletedPhase 2

A Phase II, Multicentre, Open-label Study to Evaluate the Pharmacokinetic, Safety and Preliminary Efficacy of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Subjects With Severe Hemophilia A

Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.

Start Date14 Apr 2022

Sponsor / Collaborator

Jiangsu Shengsi Biopharmaceutical Co., Ltd.

100 Clinical Results associated with PEGylated Recombinant Human Coagulation Factor VIII Fc Fusion Protein (Jiangsu Gensciences)

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100 Translational Medicine associated with PEGylated Recombinant Human Coagulation Factor VIII Fc Fusion Protein (Jiangsu Gensciences)

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100 Patents (Medical) associated with PEGylated Recombinant Human Coagulation Factor VIII Fc Fusion Protein (Jiangsu Gensciences)

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Literatures (Medical) associated with PEGylated Recombinant Human Coagulation Factor VIII Fc Fusion Protein (Jiangsu Gensciences)

HAEMATOLOGICA

First-in-human pharmacokinetic, safety, and preliminary efficacy of single- and multiple-dose FRSW117, a novel PEGylated recombinant factor VIII-Fc fusion protein with an extended half-life, in patients with severe hemophilia A

Article

Author: Hua, Haiying ; Cao, Yu ; Xu, Chongyuan ; Feng, Xianqi ; Chen, Yun ; Yang, Renchi ; Liu, Ping ; Wen, Qing ; Guo, Shuxia ; Sun, Jing ; Chen, Weizhi ; Xue, Feng

Not available.

100 Deals associated with PEGylated Recombinant Human Coagulation Factor VIII Fc Fusion Protein (Jiangsu Gensciences)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 3	China	Jiangsu Shengsi Biopharmaceutical Co., Ltd.	27 Dec 2023
Hemorrhage	Phase 3	China	Jiangsu Shengsi Biopharmaceutical Co., Ltd.	27 Dec 2023

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Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2023	Phase 2	Hemophilia A	15	FRSW117 40IU/kg	rmxvyqufjo(xtvymwdmlb) = uwobapeopm ypzzkrkkgz (qovtbqwtbi ) View more	-	10 Dec 2023
				FRSW117 50IU/kg	rmxvyqufjo(xtvymwdmlb) = bjcootrcfo ypzzkrkkgz (qovtbqwtbi ) View more
NCT04864743 (EHA2023)	Phase 1	Hemophilia A	13	FRSW117 at 25 IU/kg	jbskbytgei(ntbllwzhdi) = eqzbazmbao vqzfygpwig (rsckujptud )	-	08 Jun 2023
				FRSW117 at 50 IU/kg	jbskbytgei(ntbllwzhdi) = qsfvrkgwla vqzfygpwig (rsckujptud )

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Biosimilar

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