FRSW117 / Gensciences - LARVOL DELTA

Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (clinicaltrials.gov) - P3 | N=124 | Completed | Sponsor: Hangzhou Gensciences Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Oct 2025 | Trial primary completion date: Jan 2026 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Pharmacokinetics, Safety and Preliminary Efficacy of Multiple Doses of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW117) in Previously Treated Adult and Adolescent Subjects with Severe Hemophilia a: Results from an Open-Label, Multicenter, Phase 2 Study (ASH 2023) - P2 | "The therapy of 4 once-weekly doses of FRSW117 displayed favorable safety profile and provided about 3% mean FVIII activity on day 7 postdose with minimal accumulation. These results suggest that FRSW117 may offer extended bleeding protection with weekly dose interval and support further assessment of FRSW117 in phase 3 study."

Clinical • P2 data • PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

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. (PubMed, Haematologica) - "Not available."

Journal • P1 data • PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Jiangsu Gensciences lnc. | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2026 ➔ Sep 2026 | Trial primary completion date: Dec 2023 ➔ Jan 2026

Enrollment open • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Jiangsu Gensciences lnc.

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

Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Jiangsu Gensciences lnc.

New P3 trial • Hematological Disorders • Hemophilia • Rare Diseases

A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of a PEGylated-Recombinant Human Coagulation Factor VIII-Fc Fusion Protein in Patients With Severe Hemophilia A (ISTH 2023) - P1 | "The maximum concentration (Cmax) and area under the curve (AUC0-t) of FⅧ activity increased in a dose-dependent manner (Figure 1). The geometric mean elimination half-life of FRSW117 exceeded twice that of ADVATE® (30.928 hours vs. 13.668 hours in S1; 30.801 hours vs."

Clinical • P1 data • PK/PD data • Hematological Disorders • Hemophilia • Immunology • Rare Diseases

A PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF A PEGYLATED-RECOMBINANT HUMAN COAGULATION FACTOR VIII-FC FUSION PROTEIN WITH HALF-LIFE IN PATIENTS WITH SEVERE HEMOPHILIA A (EHA 2023) - P1 | " In this first-in-human, open label, single dose, self-controlled study, 13 males aged 12 to 65 years who had been previously treated patients with severe hemophilia A were enrolled to receive ADVATE ® followed by FRSW117. The pharmacokinetic characteristics of FRSW117 supported a potential weekly treatment interval. It also displayed favorable safety/tolerability and immunogenicity profiles. (ClinicalTrials.gov identifier: NCT04864743) Factor VIII, Pharmacokinetic, Clinical trial, Hemophilia A"

Clinical • P1 data • PK/PD data • Hematological Disorders • Hemophilia • Immunology • Rare Diseases

A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (clinicaltrials.gov) - P2 | N=15 | Completed | Sponsor: Jiangsu Gensciences lnc. | Recruiting ➔ Completed | Trial completion date: Nov 2022 ➔ Aug 2022

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

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

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

A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: Jiangsu Gensciences lnc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases