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2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Ardelyx"},{"orgOrder":0,"company":"Genexine","sponsor":"Kalbe Genexine Biologics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine and KGbio Received the First Market Approval for Novel Long-acting Erythropoietin, Efepoetin Alfa, from The Indonesian Food and Drug Authority (BPOM)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Genexine"},{"orgOrder":0,"company":"Everest Medicines","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Everest Medicines Announces New Drug Application Approval by the Pharmaceutical Administration Bureau of Macau for Nefecon\u00ae for the Treatment of Primary IgA Nephropathy","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Everest Medicines"}]
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Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary IgA nephropathy.
Efesa (efepoetin alfa) is a bio-better drug for CKD-induced anemia, developed based on hyFc®, Genexine's proprietary long-acting platform technology, which is investigated for the treatment of chronic kidney disease induced anemia in non-dialysis patients.
Under the partnership, Avanzanite gains commercialization and distribution rights into three additional European countries, for Sibnayal (potassium citrate and potassium bicarbonate), the first approved medicinal product in Europe for distal Renal Tubular Acidosis.
The financing will support the commercialization of company's two FDA approved products, Ibsrela (tenapanor), for irritable bowel syndrome with constipation, and Xphozah (tenapanor), indicated to reduce serum phosphorus in adults with chronic kidney disease.
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease on dialysis.
Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to treat anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Vadadustat is currently approved for use in 35 countries.
Phozevel (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the NHE3, indicated for the treatment improvement of hyperphosphatemia in adult patients with CKD on dialysis.
Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with IgAN. It is being investigated for focal segmental glomerulosclerosis.
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