An Open, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Coagulation Factor Ⅷ-Fc Fusion Protein (FRSW107) for Injection in Pediatric Patients With Severe Hemophilia A

This study was divided into four stages: screening period, main trial period, extension period and follow-up period.
In the main trial, both groups received FRSW107 prophylactic therapy. The recommended initial dose of prophylactic administration was 50 IU/kg, the dose range was 25 to 50 IU/kg, and the recommended frequency of administration was once every three days (Q3D). The dose range could be adjusted according to the patient's response. The main trial period was prophylaxis up to ≥50 exposure days (EDs) and ≥6 months.
The investigator may adjust the dose according to the clinical efficacy of the subjects (the occurrence of bleeding and its clinical manifestations) and the concentration of FⅧ valley according to the following principles.
If necessary, the investigator may adjust the dosing interval according to the clinical efficacy of the subject (the occurrence of bleeding and its clinical manifestations) and the concentration of FⅧ. Investigators are advised to inform sponsors or their research partners when adjusting doses and dosing intervals during prophylaxis.
After participants completed prophylaxis until ≥50EDs and ≥6 months, participants' willingness and investigator evaluation were used to decide whether to enter the extended trial. All subjects entering the extended phase continued with the original prophylactic regimen until 100EDs was dosed.
During the main trial period and the extended preventive treatment period, if the subjects have breakthrough bleeding events requiring treatment, hemostatic treatment of breakthrough bleeding with investigational drugs can be performed. The researchers can refer to the treatment guidance for different degrees of bleeding in Table 6-1. Taking into account the subject's prophylactic dose, severity of bleeding, site and extent of bleeding, clinical status, and previous PK results (if any), the investigator determines the appropriate dose to administer (recommended dose range: 25 to 50 IU/kg) and dosing times until the investigator assessed significant control of bleeding episodes (e.g. reduction of pain and swelling) or return to pre-bleeding activity. If the bleeding episode stops, the subject will continue with the same dose and frequency of prophylactic medication as before the bleeding episode.

Start Date25 Dec 2026

Sponsor / Collaborator

Jiangsu Shengsi Biopharmaceutical Co., Ltd.

NCT06142552 / RecruitingPhase 3

Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Recombinant Human Coagulation Factor Ⅷ-Fc Fusion Protein (FRSW117) for Injection in Patients With Severe Hemophilia A (Adults and Adolescents)

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.

CTR20233517 / RecruitingPhase 3

评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在经治重型血友病A患者（成人及青少年）中的有效性、安全性、免疫原性和药代动力学的开放、多中心Ⅲ期临床研究

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

主要目的：评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在经治重型血友病A患者中预防治疗的有效性。评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在经治重型血友病A患者中的安全性。次要目的：评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在经治重型血友病A患者中止血治疗和手术止血治疗的有效性。评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在经治重型血友病A患者中的药代动力学（PK）特征。评价注射用培重组人凝血因子Ⅷ-Fc融合蛋白（FRSW117）在经治重型血友病A患者中的免疫原性特征。

[Translation]

Primary objectives: To evaluate the effectiveness of pegol recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW117) in the prevention and treatment of patients with severe hemophilia A. To evaluate the safety of pegol recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW117) in patients with severe hemophilia A. Secondary objectives: To evaluate the effectiveness of pegol recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW117) in hemostatic therapy and surgical hemostatic therapy in patients with severe hemophilia A. To evaluate the pharmacokinetic (PK) characteristics of pegol recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW117) in patients with severe hemophilia A. To evaluate the immunogenicity characteristics of pegol recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW117) in patients with severe hemophilia A.

Start Date27 Dec 2023

Sponsor / Collaborator

Jiangsu Shengsi Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Jiangsu Shengsi Biopharmaceutical Co., Ltd.

0 Patents (Medical) associated with Jiangsu Shengsi Biopharmaceutical Co., Ltd.

News (Medical) associated with Jiangsu Shengsi Biopharmaceutical Co., Ltd.

05 Mar 2024

·www.businesswire.com

Hemophilia B Pipeline Insight Report 2024: Comprehensive Analysis of Emerging Therapeutics - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Hemophilia B - Pipeline Insight, 2024" report has been added to ResearchAndMarkets.com's offering. Significant advances in the treatment and management of Hemophilia B are forthcoming, according to a new comprehensive research publication now available on our website. This insightful report unveils a robust and diverse therapeutic pipeline, promising enhancements in care for individuals living with this rare genetic disorder. The culmination of data provides in-depth knowledge regarding over 15 companies' endeavors and over 20 pipeline drugs spanning clinical and nonclinical development stages. Global Research Gains on Hemophilia B Therapeutics The global coverage within this report transcends geographical boundaries, providing a universal perspective on the research and development efforts aimed at combatting Hemophilia B. This disorder, stemming from a deficiency of factor IX clotting activity, often leads to bleeding episodes that can be life-altering for those afflicted. The report details each therapy’s development phase, including Phase III and late-stage products, thereby offering stakeholders a clarion view into potential forthcoming treatments. Insights into Diagnostic Processes and Treatment Regimens The report elucidates the complexity of Hemophilia B diagnosis and underscores the importance of comprehensive blood coagulation tests. Furthermore, it delves into the nuances of replacement therapy - the current cornerstone of Hemophilia B management. Prophylaxis and other advanced treatment strategies are also discussed, highlighting gene therapy as an emerging powerhouse in the realm of Hemophilia B therapeutic options. Emerging Drugs and Key Players in Hemophilia B Therapeutics BBM-H901 by Belief Biomed is currently in the limelight as it strides into Phase III trials, presenting itself as a potential gene therapy candidate. TU7710, developed by TiumBio, offers a novel approach for patients with neutralizing antibodies and is currently under Phase I investigation. Innovative Strategies for Hemophilia B Treatment Within this comprehensive report, readers will uncover the extensive range of drugs in various development stages, from preclinical discovery to Phase III trials, emphasizing the industry's dynamic approach towards eradicating the challenges associated with Hemophilia B. The document scrutinizes multiple drug profiles, bringing forth their mechanistic actions, and shines a light on critical therapeutic assessments. Discoveries Set to Transform Hemophilia B Clinical Landscape The publication underscores the unmet needs within Hemophilia B therapeutic research and how the current pipeline is poised to address these gaps. The extensive catalog of developmental activities, including collaborations, mergers, and acquisitions, suggests a sector ripe with innovation and dedication to improving patient outcomes. A selection of companies mentioned in this report includes Shanghai Vitalgen BioPharma Belief BioMed TiumBio Jiangsu Gensciences Centessa Pharmaceuticals Pfizer OPKO Health Bayer Takeda Sanofi For more information about this report visit https://www.researchandmarkets.com/r/gfbg6e About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 1Gene TherapyPhase 3

100 Deals associated with Jiangsu Shengsi Biopharmaceutical Co., Ltd.

100 Translational Medicine associated with Jiangsu Shengsi Biopharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

PEGylated Recombinant Human Coagulation Factor VIII Fc Fusion Protein (Jiangsu Gensciences) ( F8 )	Hemorrhage More	Phase 3
Recombinant Human Coagulation Factor VIIa-Fc Fusion Protein (Jiangsu Gensciences) ( tissue factor )	Hemophilia B More	Phase 2 Clinical
Pegylated recombinant human coagulation factor IX-Fc fusion protein (Gensciences) ( factor IX )	Hemophilia B More	Phase 1
SS-315	Hemophilia A More	Preclinical
Recombinant human coagulation factor VIII-Fc fusion protein (Gensciences) ( F8 )	Hemophilia A More	Pending

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