HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma - LARVOL DELTA

Efficacy, safety, and dose selection of efepoetin alfa in anemic patients on maintenance dialysis: a phase 2, randomized, multicenter, active-controlled trial. (PubMed, Kidney Res Clin Pract) - "Over 12 weeks, HD patients received intravenous efepoetin alfa (5 or 8 µg/kg once weekly [Q1W], 8 µg/kg every 2 weeks [Q2W]) or darbepoetin alfa (30 µg Q1W). PD patients received subcutaneous efepoetin alfa (5 or 8 µg/kg Q2W) or methoxy polyethylene glycol-epoetin beta (0.6 µg/kg Q2W)...Exploratory DCR analysis supported 4 µg/kg Q2W efepoetin alfa as the phase 3 starting dose. Efepoetin alfa demonstrated dose-dependent erythropoietic efficacy and an acceptable safety profile in dialysis patients, supporting dose-range characterization and phase 3 starting dose selection."

Journal • P2 data • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Site-specific enrichment of highly sialylated N-glycans in an erythropoietin-hybrid Fc fusion protein. (PubMed, Eur J Pharm Biopharm) - "Erythropoietin-hybrid Fc fusion protein (EPO-hyFc), comprising an EPO domain fused to a hybrid IgD-IgG4 Fc, is a next-generation erythropoiesis-stimulating agent with an approximately two-fold longer serum half-life than darbepoetin alfa, a clinically established long-acting EPO formulation...The average number of sialic acids per N-glycan was 2.2, and the sialic acid-capping ratio was 90.9%, indicating extensive terminal sialylation across the EPO sites. These results provide the first site-specific characterization of N-glycosylation in EPO-hyFc and offer structural and quantitative insights for optimizing its stability, pharmacokinetics, and therapeutic efficacy."

Journal

A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (clinicaltrials.gov) - P3 | N=429 | Recruiting | Sponsor: Genexine, Inc. | Trial completion date: Sep 2027 ➔ Mar 2028 | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

EFFICACY OF LONG-ACTING ERYTHROPOIESIS STIMULATING AGENTS (ESAS) IN ANEMIC CHRONIC KIDNEY DISEASE PATIENTS WITH DIABETES MELLITUS: A SUBGROUP ANALYSIS OF A PHASE 3 NON-INFERIORITY TRIAL (ISN-WCN 2026) - P3 | "Efepoetin alfa, a novel long-acting erythropoietin (EPO)-hybrid Fc fusion protein, was previously shown to be non-inferior to methoxy polyethylene glycol-epoetin beta (mPEG-epoetin beta) for the treatment of anemia in CKD in a pivotal phase 3 trial. Timothy Widjaja is a full-time employee of PT Kalbe Genexine Biologics, which is the developer and manufacturer of Efepoetin alfa. The phase 3 clinical trial mentioned in this abstract was funded by PT Kalbe Genexine Biologics.I did not use generative AI and AI-assisted technologies in the writing process."

Clinical • Head-to-Head • P3 data • Chronic Kidney Disease • Diabetes • Hematological Disorders • Metabolic Disorders • Nephrology • Renal Disease

GX-E4-HV-003: Clinical Trial of Efepoetin Alfa in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Genexine, Inc. | Recruiting ➔ Completed | Trial completion date: Oct 2025 ➔ Mar 2025

Trial completion • Trial completion date

Non-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial. (PubMed, Nephrology (Carlton)) - "Efepoetin alfa demonstrated non-inferiority to methoxy polyethylene glycol-epoetin beta in correcting anaemia and maintaining haemoglobin (Hb) levels among stage 3 and 4 CKD patients. Moreover, the safety profile of efepoetin alfa was comparable to methoxy polyethylene glycol-epoetin beta."

Biomarker • Clinical • Head-to-Head • Journal • P3 data • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

GX-E4-HV-003: Clinical Trial of Efepoetin Alfa in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Genexine, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (clinicaltrials.gov) - P3 | N=429 | Recruiting | Sponsor: Genexine, Inc. | Trial completion date: Apr 2027 ➔ Sep 2027 | Trial primary completion date: Jun 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Clinical Trial of Efepoetin Alfa in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Genexine, Inc.

New P1 trial

A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (clinicaltrials.gov) - P3 | N=429 | Recruiting | Sponsor: Genexine, Inc.

New P3 trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient (clinicaltrials.gov) - P3 | N=391 | Completed | Sponsor: PT Kalbe Genexine Biologics | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jun 2023

Trial completion • Trial completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

OPEN LABEL, NON-INFERIORITY, RANDOMIZED, ACTIVE-CONTROLLED, PHASE III CLINICAL STUDY OF EPOETIN ALFA VERSUS METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA FOR TREATMENT OF ANAEMIA IN CKD NON-DIALYSIS PATIENT (ISN-WCN 2023) - "We report here the interim results of a randomized multinational study that compared Efepoetin Alfa with Methoxy Polyethylene Glycol-Epoetin Beta for the correction of anaemia in non-dialysis CKD patients. A total of 322 adverse events (AE) in 99 patients (69.7%) in Epoetin Alfa group and 264 AE in 91 patients (64.5%) in Methoxy Polyethylene Glycol-Epoetin Beta group. Conclusions Based on this study, the interim data indicates that the Epoetin Alfa and Methoxy Polyethylene Glycol-Epoetin Beta have comparable efficacy and safety profiles for anaemia in CKD-non-dialysis patients."

Clinical • Head-to-Head • P3 data • Anemia • Hematological Disorders

A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient (clinicaltrials.gov) - P3 | N=391 | Active, not recruiting | Sponsor: PT Kalbe Genexine Biologics | Unknown status ➔ Active, not recruiting | Trial completion date: Jun 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2021 ➔ Jul 2023

Enrollment closed • Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects (clinicaltrials.gov) - P1; N=10; Not yet recruiting; Sponsor: Genexine, Inc.

New P1 trial • Biosimilar