Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-Demand Treatment

A Single-arm, Open-label, Multicenter Phase III Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-demand Treatment in Patients With Severe Hemophilia A (Adults and Adolescents) .

The indication for this product is to control bleeding in patients with hemophilia A (congenital deficiency of factor VIII).

The primary objective:

Evaluation of the efficacy of recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW107) as an on-demand treatment in previously treated patients with severe hemophilia A.

Secondary objectives:

Evaluation of the safety and immunogenicity of FRSW107 as an on-demand therapy in previously treated patients with severe hemophilia A.

Evaluate the on-demand treatment's PK profile of FRSW107 in previously treated patients with severe hemophilia A based on population pharmacokinetic (PopPK) methods ; preliminarily investigate the exposure-response (E-R) relationship of FRSW107 on-demand treatment in these patients if data permit.

Study Overview

• Status: Recruiting
• Conditions: Severe Hemophilia A
• Intervention / Treatment: Drug: FRSW107

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lijia Liu; Phone Number: + 86 1645377793; Email: lijialiu@gensciences.cn

Study Locations

• China
  • Fuyang, China
    • Not yet recruiting
    • Fuyang Hospital, Affiliated to Anhui Medical University
    • Contact: Qingyi Wang
  • Fuzhou, China
    • Not yet recruiting
    • Fujian Medical University Union Hospital
    • Contact: Meijuan Huang
  • Ganzhou, China
    • Not yet recruiting
    • Ganzhou People's Hospital
    • Contact: Jingdong Zhang
  • Guangzhou, China
    • Not yet recruiting
    • Nanfang Hospital of Southern Medical University
    • Contact: Jing Sun
  • Hefei, China
    • Not yet recruiting
    • Anhui Provincial Hospital
    • Contact: Xiaoyu Zhu
  • Huai'an, China
    • Not yet recruiting
    • Huai'an Second People's Hospital
    • Contact: Yanming Zhang
  • Jinan, China
    • Not yet recruiting
    • Jinan Central Hospital
    • Contact: Yun Chen
  • Kunming, China
    • Not yet recruiting
    • The Second Affiliated Hospital of Kunming Medical University
    • Contact: Zeping Zhou
  • Nanning, China
    • Not yet recruiting
    • The First Affiliated Hospital of Guangxi Medical University
    • Contact: Peng Cheng
  • Nantong, China
    • Not yet recruiting
    • Affiliated Hospital of Nantong University
    • Contact: Li Yang
  • Nanyang, China
    • Not yet recruiting
    • The First Affiliated Hospital of Nanyang Medical College
    • Contact: Huibing Dang
  • Qinghai, China
    • Not yet recruiting
    • Qinghai Provincial People's Hospital
    • Contact: Wenqian Li
  • Rizhao, China
    • Not yet recruiting
    • Rizhao People's Hospital
    • Contact: Jing Li
  • Shijiazhuang, China
    • Not yet recruiting
    • The Second Hospital of Hebei Medical University
    • Contact: Jingyu Zhang
  • Taiyuan, China
    • Not yet recruiting
    • The Second Hospital of Shanxi Medical University
    • Contact: Zhuanzhen Zheng
  • Tangshan, China
    • Not yet recruiting
    • North China University of Science and Technology Affiliated Hospital
    • Contact: Zhenyu Yan
  • Wenzhou, China
    • Not yet recruiting
    • Wenzhou People's Hospital
    • Contact: Miaoyong Zhu
  • Wuhan, China
    • Not yet recruiting
    • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology.
    • Contact: Huafang Wang
  • Wuxi, China
    • Not yet recruiting
    • Affiliated Hospital of Jiangnan University
    • Contact: Haiying Hua
  • Xi'an, China
    • Not yet recruiting
    • Xi'an Central Hospital
    • Contact: Yanping Song
  • Yangzhou, China
    • Not yet recruiting
    • Subei People's Hospital of Jiangsu province
    • Contact: Mei Sun
  • Zhengzhou, China
    • Not yet recruiting
    • Henan Cancer Hospital
    • Contact: Hu Zhou
  • Zhengzhou, China
    • Not yet recruiting
    • Zhengzhou People's Hospital
    • Contact: Shuxia Guo
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
      • Contact: Feng Xue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusive Criteria:

1. Males aged 12 or younger to 65 years old.
2. Patients clinically diagnosed with severe hemophilia A, i.e., those confirmed through screening or previous medical records: FⅧ Activity < 1%.
3. Previous records confirm receipt of any recombinant and/or blood-derived coagulation factor VIII products or cold precipitate products, with a treatment of ≥150 exposure days (EDs ≥150).
4. The participants have fully understood and been informed of this study, signed the informed consent form, and voluntarily enrolled in the clinical trial. The trial participants and/or their guardians are capable of cooperating with the hemostatic treatment and have the ability to complete all study procedures.

Exclusion Criteria:

1. Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins;
2. Hypersensitivity or anaphylaxis after FⅧ or IgG2 injection in the past;
3. FⅧ inhibitor positive (≥0.6 BU/mL) during the screening period, or have a history of FⅧ inhibitor positive in the past, or a family history of FⅧ inhibitor positive;
4. Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value;
5. Severe anemia at the screening stage (hemoglobin < 60 g/L);
6. Platelet count during screening period < 100×109 /L;

7. Abnormal liver function:

   .Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >3 times upper limit of normal (ULN); or Serum total bilirubin (TBIL) >1.5x ULN;

8. Patients with abnormal renal function:

   Creatinine clearance (Ccr) <50 ml/min (according to Cockcroft and Gault formula); or Serum creatinine (Cr) >1.5x ULN;

9. People with active hepatitis C, that is, hepatitis C virus (HCV) antibody positive and HCV RNA positive; Or anti-treponema pallidum specific antibody (TPHA) positive; Or positive for antibodies against the human immunodeficiency virus (HIV);
10. Patients with coagulation dysfunction other than hemophilia A;
11. Have a medical condition that may increase the risk of bleeding;
12. A history of drug or alcohol abuse;
13. Have a known mental disorder that may affect trial compliance;
14. Patients who have received transfusions of blood or blood components within 4 weeks prior to screening;
15. Participants who had participated in other clinical trials within 1 month before screening;
16. Use of any anticoagulant or antiplatelet drugs, off-label maximum dose of non-steroidal anti-inflammatory drugs (NSAID) within 7 days prior to screening; Or patients who need to be treated with anticoagulant or antiplatelet drugs or off-label maximum doses of SAID during clinical trials;
17. Severe cardiovascular and cerebrovascular disease or major thromboembolic events, such as stroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association [NYHA] grade ≥ III), and severe arrhythmias (including QTc interphase > 480 ms, corrected by Fridericia formula), uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥100 mmHg), deep vein thrombosis, etc.
18. Study patients who had used emesezumab within 6 months prior to first administration of the drug;
19. Patients who had used monoclonal antibody therapy, Fc fusion protein products (except FRSW107 and FRSW117), PEG products (except FRSW117), or intravenous immunoglobulin infusion within 3 months before the first administration of the investigational drug;
20. Study patients who underwent major surgery within 3 months prior to initial drug administration (major surgery is defined in 6.2.3 Perioperative management);
21. Study patients who have used FⅧ preparation of any standard half-life (e.g., Bycoch, Coproch, Biinidin, Renjie, NoL, Antaine, etc.) within 3 days or 5 half-lives prior to first administration of the drug (taking the elderly); Patients who have used any other extended half-life preparation FⅧ within 4 days or 5 half-lives prior to first dosing (for the elderly);
22. Study patients with fever, severe active bacterial or viral infection, and allergies within 2 weeks before the first administration of the drug;
23. Systemic immunomodulators (such as glucocorticoids [> 10 mg/ day equivalent dose of prednisone], alpha-interferon, immunoglobulin, cyclophosphamide, cyclosporin, etc.) used within 14 days prior to the first administration of the study drug or planned during the study period were allowed to be inhaled, nasal spray, or topical corticosteroids;
24. Those who had been vaccinated within 4 weeks prior to initial administration of the study drug; Or who plan to be vaccinated during PK blood collection (only for subjects in the PK subgroup);
25. Plan to have a child or sperm donation during the entire trial period and within 3 months after the last dose, or do not want to use effective physical contraception (such as condoms, diaphragms, Iuds, etc.);
26. Have other serious medical conditions that the researchers said could not benefit from them
27. Subjects deemed unsuitable by other investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: On-demand Treatment.; On-demand treatment (recommended range: 20-50 IU/kg)	Drug: FRSW107; Treatment for 6 months as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The haemostatic effective rate	The haemostatic effect of FRSW107 when used for treatment of bleeds, assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) by counting excellent and good as success and moderate and none as failure.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infusions and IU/kg of FRSW107 needed for the treatment of bleeding episodes		6 months
FVIII activity during on-demand: activity recovery rate	FVIII activity recovery rate on Day1's haemostatic therapy.	Visit1,Day1
Hemophilia Joint Health Score (HJHS 2.1) during on-demand treatment	total score and each subscale score of HJHS 2.1, as well as their changes over time.	6 month
incidence of lack of drug efficacy	Lack of drug efficacy is defined as: during on-demand treatment, hemostatic efficacy is assessed as "ineffective" or "poor/no response" following two consecutive administrations within 72 hours for the same bleeding episode. incidence of lack of drug efficacy=number of lack of drug efficacy/number of evaluated treatment*100%.	6 months
Occurrence of AEs and SAEs		6 month
Incidence rate of positive FVIII inhibitors	A positive FⅧ inhibitor is defined as a Bethesda inhibitor titer ≥ 0.6 BU/mL. Incidence rate of positive FVIII inhibitors=number of positive FⅧ inhibitors participant / total number of trial participants *100%.	6 month
Incidence rate of positive ADA, Incidence rate of positive anti-CHO antibody	Incidence rate of positive ADA=number of positive ADA participant / total number of trial participants *100% Incidence rate of positive anti-CHO antibody=number of positive anti-CHO antibody participant / total number of trial participants *100%	6 month

Collaborators and Investigators

• Sponsor: Hangzhou Gensciences Biopharmaceutical Co., Ltd.
• Investigators: Study Chair: Renchi Yang, PhD, Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Hemophilia A
• Other Study ID Numbers: SS-107-III05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No