FRSW107 / Gensciences - LARVOL DELTA

Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A (clinicaltrials.gov) - P3 | N=76 | Not yet recruiting | Sponsor: Jiangsu Gensciences lnc. | Trial completion date: Apr 2025 ➔ Dec 2026 | Initiation date: May 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial initiation date • Trial primary completion date • Hematological Disorders • Hemophilia • Pediatrics • Rare Diseases

A Novel Extended half-life factor VIII Fc fusion protein FRSW107 for severe hemophilia A: A multicentre, open-label, single-arm, phase 3 study and its open-label extension (ISTH 2024) - "Eighty-three patients received prophylaxis and 36 received on-demand treatment; 101 entered the extension period. FRSW107 had a mean elimination half-life of 20.1±4.7 h and a mean incremental recovery of 2.1±0.5 IU/dL/IU/kg. By exposure day 100, 53 (63.9%) patients in the prophylaxis group had zero bleed."

Clinical • P3 data • Hematological Disorders • Hemophilia • Rare Diseases

Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A (clinicaltrials.gov) - P3 | N=76 | Not yet recruiting | Sponsor: Jiangsu Gensciences lnc. | Initiation date: Nov 2023 ➔ May 2024

Trial initiation date • Hematological Disorders • Hemophilia • Pediatrics • Rare Diseases

Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A (clinicaltrials.gov) - P3 | N=76 | Not yet recruiting | Sponsor: Jiangsu Gensciences lnc.

New P3 trial • Hematological Disorders • Hemophilia • Pediatrics • Rare Diseases

Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A (clinicaltrials.gov) - P3 | N=101 | Completed | Sponsor: Zhengzhou Gensciences Inc | Recruiting ➔ Completed

Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A. (clinicaltrials.gov) - P3 | N=119 | Completed | Sponsor: Zhengzhou Gensciences Inc | Active, not recruiting ➔ Completed

Trial completion • Hematological Disorders • Hemophilia • Rare Diseases • CD4

A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Jiangsu Gensciences lnc. | Active, not recruiting ➔ Completed | N=28 ➔ 13

Enrollment change • Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: Jiangsu Gensciences lnc. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2022 ➔ Jun 2023

Enrollment closed • Trial completion date • Hematological Disorders • Hemophilia • Rare Diseases

Pharmacokinetics, Efficacy and Safety Evaluation of FRSW107 in Previously Treated Hemophilia a Patients: A Multicentre, Open-Label, Non-Randomized Phase III Study (ASH 2022) - P3 | "The data indicate that FRSW 107 was safe and effective for prophylaxis and treatment of bleeding episodes in previously treated adolescent and adult HA patients."

Clinical • P3 data • PK/PD data • Cardiovascular • Hematological Disorders • Hemophilia • Rare Diseases

A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Jiangsu Gensciences lnc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases

A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Jiangsu Gensciences lnc.

New P1 trial • Hematological Disorders • Hemophilia • Rare Diseases

Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A (clinicaltrials.gov) - P3; N=120; Recruiting; Sponsor: Zhengzhou Gensciences Inc

New P3 trial • Hematological Disorders • Hemophilia • Rare Diseases

An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A. (clinicaltrials.gov) - P3; N=100; Active, not recruiting; Sponsor: Zhengzhou Gensciences Inc; Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Disorders • Hemophilia • Rare Diseases • CD4

An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A. (clinicaltrials.gov) - P3; N=100; Recruiting; Sponsor: Zhengzhou Gensciences Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases

[VIRTUAL] Extended Half-Life of the Double-Chain Recombinant Factor VIII-Fc Fusion Protein (FRSW107) in Previous Treated Hemophilia A Patients (ISTH 2020) - P1 | " PTPs (12 to 60 years old) with FVIII: C＜2% and without history of FVIII inhibitors were enrolled and received a single dose injection of rFVIII (Advate) at either 25 or 65 IU/kg followed by an equal dose of FRSW107. In this phase I clinical study, FRSW107 shows no safety issues and is well tolerated in PTPs. The half- life of FRSW 107 is significantly extended compared with conventional rFVIII. The PK and pharmacodynamics of FRSW107 will be further determined in future phase III clinical trial."

Clinical • Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases

An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A. (clinicaltrials.gov) - P3; N=100; Not yet recruiting; Sponsor: Zhengzhou Gensciences Inc

Clinical • New P3 trial • Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases