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Find Clinical Drug Pipeline Developments & Deals by Kyowa Kirin

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            Lead Product(s): Burosumab

            Therapeutic Area: Genetic Disease Product Name: Crysvita

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 05, 2020

            Details:

            CRYSVITA, created by Kyowa Kirin, is a recombinant fully human monoclonal IgG1 antibody against the FGF23. More people in Europe are now eligible for treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of XLH.

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            Lead Product(s): Zandelisib

            Therapeutic Area: Oncology Product Name: ME-401

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: MEI Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 02, 2020

            Details:

            Phase 2, multicenter, open-label, single-arm clinical study is conducted by Kyowa Kirin to evaluate zandelisib as monotherapy for treatment of Japanese patients with relapsed or refractory iNHL with at least two prior systemic therapies.

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            Lead Product(s): Tivozanib

            Therapeutic Area: Immunology Product Name: Fotivda

            Highest Development Status: IND Enabling Product Type: Small molecule

            Recipient: Aveo Oncology

            Deal Size: $433.5 million Upfront Cash: $25.0 million

            Deal Type: Agreement August 05, 2020

            Details:

            The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an investigational new drug (IND) application for tivozanib in a non-oncology indication being developed by Kyowa Kirin.

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            Lead Product(s): Burosumab

            Therapeutic Area: Genetic Disease Product Name: Crysvita

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 24, 2020

            Details:

            The European Commission has already granted a conditional marketing authorisation for CRYSVITA for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons.

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            Lead Product(s): Tenapanor

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 08, 2020

            Details:

            Tenapanor’s effect of decreasing pill burden of phosphate binders , which is the outcome of a phase 2 study of tenapanor for hemodialysis patients with hyperphosphatemia in Japan, was presented in a poster session virtually at ERA-EDTA 2020 Anual Meeting.

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            Lead Product(s): ME-401

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Recipient: MEI Pharma

            Deal Size: $682.5 million Upfront Cash: $100.0 million

            Deal Type: Licensing Agreement April 14, 2020

            Details:

            MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S., with MEI booking all revenue from U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

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            Lead Product(s): Mesalamine

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: Zeria Pharmaceutical

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement February 03, 2020

            Details:

            Kyowa Kirin will finish its commercialization activity for ASACOL on March 31, 2020, and Zeria will obtain the full rights of the commercialization activities for ASACOL from April 1, 2020.