CSBio CSBio

X
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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"},{"orgOrder":0,"company":"Milla Pharmaceuticals","sponsor":"Woodward Pharma Services","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"A.forall Announces Launch of a Generic Version of Sodium Acetate Injection 4 mEq\/mL","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Milla Pharmaceuticals"},{"orgOrder":0,"company":"Travere Therapeutics","sponsor":"Renalys Pharma","pharmaFlowCategory":"D","amount":"$120.0 million","upfrontCash":"Undisclosed","newsHeadline":"Travere Therapeutics Announces Licensing Agreement with 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Applicable","upfrontCash":"Not Applicable","newsHeadline":"\u200b\u200bBoehringer's Jardiance Now Gets CDSCO Nod for Chronic Kidney Disease","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Boehringer Ingelheim GmbH"}]

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            Jardiance (empagliflozin) is an oral inhibitor of sodium-glucose co-transporter 2 (SGLT2) inhibitor, which is indicated for the treatment of chronic kidney disease.

            Lead Product(s): Empagliflozin

            Therapeutic Area: Nephrology Product Name: Jardiance

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 14, 2024

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            Under the agreement, Renalys will bring Filspari (sparsentan), a dual endothelin angiotensin receptor antagonist for the treatment of IgA nephropathy, to patients in Japan and other countries in Asia.

            Lead Product(s): Sparsentan

            Therapeutic Area: Nephrology Product Name: Filspari

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Renalys Pharma

            Deal Size: $120.0 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement January 25, 2024

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            Filspari (sparsentan) is a once-daily oral medication is designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II). It isapproved for the treatment of IgA Nephropathy.

            Lead Product(s): Sparsentan

            Therapeutic Area: Nephrology Product Name: Filspari

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 25, 2024

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            Sodium Acetate-generic Injection 4 mEq/mL is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake.

            Lead Product(s): Sodium Acetate

            Therapeutic Area: Nephrology Product Name: Sodium Acetate-Generic

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Woodward Pharma Services

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 09, 2024

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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.

            Lead Product(s): Budesonide

            Therapeutic Area: Nephrology Product Name: Nefecon

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2023

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            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.

            Lead Product(s): Efepoetin Alfa

            Therapeutic Area: Nephrology Product Name: Efesa

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Kalbe Genexine Biologics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 23, 2023

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            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.

            Lead Product(s): Potassium Citrate,Potassium hydrogen carbonate

            Therapeutic Area: Nephrology Product Name: Sibnayal

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Advicenne

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership October 18, 2023

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            Details:

            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.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: SLR Capital Partners

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing October 17, 2023

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            Details:

            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.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 17, 2023

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            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.

            Lead Product(s): Vadadustat

            Therapeutic Area: Nephrology Product Name: Vafseo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 28, 2023

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