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R&D Pipeline R&D Pipeline antibody protein small molecule ◎ New Molecular Entity Updated since Dec. 31, 2020 Updated since Dec. 31, 2020 Nephrology As of Mar. 31, 2021 Code Name Stage [In-House or Licensed] Generic Name Mechanism of Action Indication Area Remarks Formulation PhⅠ PhⅡ PhⅢ Filed Approved KHK7580 CN [Mitsubishi Tanabe Pharma] Evocalcet Calcimimetic Secondary Hyperparathyroidism Asia product name in Japan: Orkedia Oral Diabetic Kidney Disease JP ◎RTA 402 Antioxidant Inflammation Bardoxolone Methyl [Reata] Modulator Oral Autosomal Dominant Polycystic JP Kidney Disease KW-3357 Recombinant Human [In-House] Antithrombin Gamma Preeclampsia JP Antithrombin product name in Japan:Acoalan Injection KHK7791 Hyperphosphatemia Under Tenapanor NHE3 Inhibitor JP [Ardelyx] Maintenance Dialysis Oral Oncology Code Name Stage [In-House or Licensed] Generic Name Mechanism of Action Indication Area Remarks Formulation PhⅠ PhⅡ PhⅢ Filed Approved AU CH [In-House] KW-0761 Anti-CCR4 Humanized Mycosis Fungoides and SA POTELLIGENT® Mogamulizumab Antibody Sézary Syndrome KR product name in Japan, U.S. and Injection Europe: Poteligeo CA KW ◎KHK2375 Entinostat HDAC Inhibitor Breast Cancer JP [Syndax] Oral Mobilization of Hematopoietic Stem Cells into Peripheral Blood JP for Allogeneic Blood Stem Cell KRN125 Long-Acting Transplantation [Kirin-Amgen] Pegfilgrastim Granulocyte Colony- product name in Japan:G-Lasta Injection Stimulating Factor Automated Injection Device for Decreasing the Incidence of JP Febrile Neutropenia in Patients Receiving Cancer Chemotherapy [In-House] Solid Tumor NA Combination with KW-0761 ◎KHK2455 IDO1 Inhibitor NA Oral [In-House] Urothelial carcinoma Combination with avelumab EU Indolent B-cell Non-Hodgkin's JP Lymphoma B-cell malignancies NA ◎ME-401 Zandelisib PI3Kδ Inhibitor [MEI Pharma] Oral NA EU Follicular Lymphoma Asia Oceania Immunology/Allergy Code Name Stage [In-House or Licensed] Generic Name Mechanism of Action Indication Area Remarks Formulation PhⅠ PhⅡ PhⅢ Filed Approved KHK4827 Systemic Sclerosis JP Anti-IL-17 Receptor A [Kirin-Amgen] Brodalumab Fully Human Antibody product name in Japan: Lumicef Injection Palmoplantar Pustulosis JP [In-House] JP KHK4083 Anti-OX40 Fully Human ® ◎ Atopic Dermatitis NA POTELLIGENT njection Antibody Human Antibody-Producing I EU Technology [In-House] ◎ASKP1240 Recurrence of Focal Segmental Anti-CD40 Fully Human Antibody-Producing Bleselumab Glomerulosclerosis (FSGS) in de NA Human Antibody Technology Injection novo kidney transplant recipients Jointly Developed with Astellas R&D Pipeline antibody protein small molecule ◎ New Molecular Entity Updated since Dec. 31, 2020 Updated since Dec. 31, 2020 Central Nervous System As of Mar. 31, 2021 Code Name Stage [In-House or Licensed] Generic Name Mechanism of Action Indication Area Remarks Formulation PhⅠ PhⅡ PhⅢ Filed Approved KW-6002 [In-House] Adenosine A2A Istradefylline Parkinson's Disease EU product name in Japan:Nouriast, Receptor Antagonist Oral product name in U.S.: Nourianz [In-House] KW-0761 Anti-CCR4 Humanized HTLV-1 associated myelopathy POTELLIGENT® Mogamulizumab JP Antibody (HAM) product name in Japan, U.S. and Injection Europe: Poteligeo Adenosine A2A ◎KW-6356 Receptor Parkinson's Disease JP [In-House] Oral Antagonist/Inverse Agonist KHK6640 Anti–Amyloid Beta JP ◎ Alzheimer's Disease [Immunas Pharma] Injection Peptide Antibody EU Other Code Name Stage [In-House or Licensed] Generic Name Mechanism of Action Indication Area Remarks Formulation PhⅠ PhⅡ PhⅢ Filed Approved CN BH AU X-linked Hypophosphatemia SA (XLH) SG [In-House] Human Antibody-Producing KRN23 Technology Anti-FGF23 Fully Burosumab TL Jointly Developed with Ultragenyx Human Antibody Injection MY in US and EU product name in Japan, U.S. and CN Europe: Crysvita Tumor Induced Osteomalacia EU (TIO) CA Aplastic Anemia Who Have Had PhⅡ/ an Inadequate Response to Asia Ph Conventional Therapy Ⅲ AMG531 Thrombopoietin Receptor Idiopathic (Immune) [Kirin-Amgen] Romiplostim CN Agonist Thrombocytopenic Purpura product name in Japan: Romiplate Injection Aplastic Anemia Who Were JP PhⅡ/ Previously Untreated with Asia P Immunosuppressive Therapy hⅢ KW-3357 Disseminated Intravascular Recombinant Human [In-House] Antithrombin Gamma Coagulation, Congenital EU Antithrombin product name in Japan: Acoalan Injection Antithrombin Deficiency Wet Age-Related Macular KHK4951 JP [In-House] Degeneration.
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