The Indonesian Ministry of Food and Drug Safety (BPOM) has granted approval for Genexine and PT Kalbe Genexine Biologics’ (KGbio) Efepoetin alfa (GX-E4) to treat anaemia induced by chronic kidney disease (CKD).
The therapeutic drug is indicated for patients who are not receiving dialysis.
KGbio is a joint venture between PT Kalbe Farma and Genexine.
This development marks the first market approval for a treatment created by the research and development alliance between Genexine and KGbio.
The parties are jointly developing Efepoetin alfa, a long-acting erythropoietin, for the treatment of CKD patients in non-dialysis and dialysis settings.
According to data from Phase III clinical trials conducted in seven countries across Asia and Oceania, Efepoetin alfa is non-inferior to Roche’s Mircera in non-dialysis patients and demonstrated a good safety and tolerability profile.
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The treatment offered a 69.6% response rate in individuals with haemoglobin levels over 1g/dL versus 63.2% in the Mircera arm, thereby meeting the trial’s primary endpoint.
Genexine CEO Sungjune Hong stated: “Our efforts to focus on commercialisation over the past year have been successful and we now look to roll out this product in several other Asian countries and expand the indication to include dialysis patients.
“Efepoetin alfa was one of the products developed using our proprietary hyFc fusion platform and demonstrates our ability to deliver a novel long-acting EPO drug to patients suffering from CKD-induced anaemia.”
A multinational Phase III trial of the drug in dialysis patients will begin in the fourth quarter of 2023 in 11 countries in Europe and Asia.
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