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            Lead Product(s): Canagliflozin

            Therapeutic Area: Nephrology Product Name: Canaglu

            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 26, 2021

            Details:

            Tai Tien Pharmaceuticals has obtained the regulatory approval of CANAGLU® (CANAGLU)(INN: canagliflozin; Japan names: CANAGLU® Tablets 100mg) for a treatment agent for diabetic nephropathy in Taiwan FDA.

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            Lead Product(s): Sucroferric Oxyhydroxide

            Therapeutic Area: Nephrology Product Name: Velphoro

            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 15, 2021

            Details:

            Clinical Kidney Journal published results from a real-world setting study, the VELREAL multicenter study, which showed a 20% decrease in serum phosphorus in addition to reduced parathyroid hormone level using Vifor Pharma’s Velphoro in CKD patients on dialysis.

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            Lead Product(s): Sevelamer Carbonate

            Therapeutic Area: Nephrology Product Name: Undisclosed

            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, 2021

            Details:

            Sevelamer Carbonate Tablets, 800 mg, are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.

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            Lead Product(s): Metolazone

            Therapeutic Area: Nephrology Product Name: Undisclosed

            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 December 03, 2020

            Details:

            The approved ANDA is therapeutically equivalent to the reference listed drug product, Zaroxolyn Tablets 2.5 mg, 5 mg, and 1 O mg, of Lannett Company. Metolazone Tablets are indicated for the treatment of salt and water retention caused by heart failure or kidney disease.

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            Lead Product(s): Sodium Zirconium Cyclosilicate

            Therapeutic Area: Nephrology Product Name: Lokelma

            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 November 24, 2020

            Details:

            The approval by the NMPA was based on data from the Phase IIIb DIALIZE trial. The trial showed sustained potassium control pre-dialysis for more patients receiving Lokelma, compared with placebo.

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            Lead Product(s): Patiromer

            Therapeutic Area: Nephrology Product Name: Veltassa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Fresenius Kabi AG

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration November 19, 2020

            Details:

            Fresenius Kabi will have the exclusive right to distribute and sell Veltassa® across China. By bringing Veltassa® to China, VFMCRP and Fresenius Kabi will deliver a treatment that will enable patients to remain on RAASi therapy by managing their chronic hyperkalemia.

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            Lead Product(s): Alfacalcidol

            Therapeutic Area: Nephrology Product Name: One-Alpha

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Cheplapharm Arzneimittel Gmbh

            Deal Size: $357.0 million Upfront Cash: Undisclosed

            Deal Type: Divestment August 31, 2020

            Details:

            The divested portfolio comprises four products within bone disorders/nephrology, dermatology and gynecology: One-Alpha©, Locoid©, Pimafucin©, and Zineryt©.

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            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 August 26, 2020

            Details:

            Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO™.

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            Lead Product(s): Canagliflozin

            Therapeutic Area: Nephrology Product Name: Invokana

            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 July 03, 2020

            Details:

            The EC approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which achieved pre-specified efficacy criterion.

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            Lead Product(s): Canagliflozin

            Therapeutic Area: Nephrology Product Name: Invokana

            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 July 02, 2020

            Details:

            The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on the achievement of a pre-specified efficacy criterion.

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