Research & Development

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Pipeline

As of June 30, 2018  PDF file:New window opensKyowa Hakko Kirin R&D Pipeline(199KB)

Since March 31, 2018

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Modalities:
Therapeutic Area:

Code Name
Generic name

Therapeutic
Area

Indication

Phase
123F/A

Region

KHK4827 Brodalumab

Psoriasis

F/A

Approved in TW

Therapeutic Area :
Region : Approved in TW
Formulation : Injection
Mechanism of Action : Anti-IL-17 Receptor A Fully Human Antibody
In-House or Licensed : Kirin-Amgen

KRN1493 Cinacalcet Hydrochloride

Secondary
Hyperparathyroidism

F/A

Approved in BN

Therapeutic Area :
Region : Approved in BN
Formulation : Oral
Mechanism of Action : Calcium Receptor Agonist
In-House or Licensed : Shire-NPS

KRN23 Burosumab

X-linked
Hypophosphatemia (XLH)

F/A

Approved in US

Therapeutic Area :
Region : Approved in US
Formulation : Injection
Mechanism of Action : Anti-FGF23 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology
Jointly Developed with Ultragenyx in US and EU

KHK4827 Brodalumab

Psoriasis

F/A

Filed in TH, SG, MY and HK

Therapeutic Area :
Region : Filed in TH, SG, MY and HK
Formulation : Injection
Mechanism of Action : Anti-IL-17 Receptor A Fully Human Antibody
In-House or Licensed : Kirin-Amgen

KRN23 Burosumab

X-linked
Hypophosphatemia (XLH)

F/A

Filed in CA

Therapeutic Area :
Region : Filed in CA
Formulation : Injection
Mechanism of Action : Anti-FGF23 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology
Jointly Developed with Ultragenyx in US and EU

KRN321 Darbepoetin Alfa

Renal Anemia (on Dialysis)

F/A

NDA in preparation in CN

Therapeutic Area :
Region : NDA in preparation in CN
Formulation : Injection
Mechanism of Action : Long-Acting Erythropoiesis Stimulating Agent
In-House or Licensed : Kirin-Amgen

KRN321 Darbepoetin Alfa

Renal Anemia

F/A

Filed in ID

Therapeutic Area :
Region : Filed in ID
Formulation : Injection
Mechanism of Action : Long-Acting Erythropoiesis Stimulating Agent
In-House or Licensed : Kirin-Amgen

KW-0761 Mogamulizumab

Cutaneous T-cell
Lymphoma

F/A

Filed in US, EU, and JP

Therapeutic Area :
Region : Filed in US, EU, and JP
Formulation : Injection
Mechanism of Action : Anti-CCR4 Humanized Antibody
In-House or Licensed : In-House
Remarks : POTELLIGENT®
Additional Indication, Dosage and Administration (Japan)

KW-6002 Istradefylline

Parkinson's Disease

F/A

NDA in preparation in US

Therapeutic Area :
Region : NDA in preparation in US
Formulation : Oral
Mechanism of Action : Adenosine A2A Receptor Antagonist
In-House or Licensed : In-House

AMG531 Romiplostim

Idiopathic (Immune) Thrombocytopenic Purpura

3

CN

Therapeutic Area :
Region : CN
Formulation : Injection
Mechanism of Action : Thrombopoietin Receptor Agonist
In-House or Licensed : Kirin-Amgen

AMG531 Romiplostim

Aplastic Anemia

3

JP and KR

Therapeutic Area :
Region : JP and KR
Formulation : Injection
Mechanism of Action : Thrombopoietin Receptor Agonist
In-House or Licensed : Kirin-Amgen

KHK4563 Benralizumab

Chronic Obstructive Pulmonary Disease (COPD)

3

JP

Therapeutic Area :
Region : JP
Formulation : Injection
Mechanism of Action : Anti-IL-5 Receptor Humanized Antibody
In-House or Licensed : In-House
Remarks : Jointly Developed with AstraZeneca/MedImmune in JP and KR
POTELLIGENT®

KHK4827 Brodalumab

Psoriasis

3

KR

Therapeutic Area :
Region : KR
Formulation : Injection
Mechanism of Action : Anti-IL-17 Receptor A Fully Human Antibody
In-House or Licensed : Kirin-Amgen

KHK4827 Brodalumab

Axial Spondyloarthritis(axSpA)

3

JP, KR, TW

Therapeutic Area :
Region : JP, KR, TW
Formulation : Injection
Mechanism of Action : Anti-IL-17 Receptor A Fully Human Antibody
In-House or Licensed : Kirin-Amgen

KHK7580 Evocalcet

Hypercalcemia In Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism

3

JP

Therapeutic Area :
Region : JP
Formulation : Oral
Mechanism of Action : Calcium Receptor Agonist
In-House or Licensed : Mitsubishi Tanabe Pharma

KRN23 Burosumab

X-linked Hypophosphatemia (XLH) in adult patients

3

US, CA, EU, JP and KR

Therapeutic Area :
Region : US, CA, EU, JP and KR
Formulation : Injection
Mechanism of Action : Anti-FGF23 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology
Jointly Developed with Ultragenyx in US and EU

KRN23 Burosumab

X-linked Hypophosphatemia (XLH) in pediatric patients

3

US, CA, EU, AU, JP, KR

Therapeutic Area :
Region : US, CA, EU, AU, JP, KR
Formulation : Injection
Mechanism of Action : Anti-FGF23 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology
Jointly Developed with Ultragenyx in US and EU

KW-0761 Mogamulizumab

HTLV-1 associated
myelopathy(HAM)

3

JP

Therapeutic Area :
Region : JP
Formulation : Injection
Mechanism of Action : Anti-CCR4 Humanized Antibody
In-House or Licensed : In-House
Remarks : POTELLIGENT®

RTA 402 Bardoxolone Methyl

Diabetic Kidney Disease

3

JP

Therapeutic Area :
Region : JP
Formulation : Oral
Mechanism of Action : Antioxidant Inflammation Modulator
In-House or Licensed : Reata
Project Type : New Molecular Entity

ASKP1240 Bleselumab

Recurrence of Focal Segmental Glomerulosclerosis (FSGS) in de novo kidney transplant
recipients

2

US

Therapeutic Area :
Region : US
Formulation : Injection
Mechanism of Action : Anti-CD40 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology
Jointly Developed with Astellas

KHK2375 Entinostat

Breast Cancer

2

JP

Therapeutic Area :
Region : JP
Formulation : Oral
Mechanism of Action : HDAC Inhibitor
In-House or Licensed : Syndax
Project Type : New Molecular Entity

Ulcerative Colitis

2

US, EU, and others

Therapeutic Area :
Region : US, EU, and others
Formulation : Injection
Mechanism of Action : Anti-OX40 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : POTELLIGENT®
Human Antibody-Producing Mouse

KHK4563 Benralizumab

Eosinophilic Chronic Rhinosinusitis (ECRS)

2

JP

Therapeutic Area :
Region : JP
Formulation : Injection
Mechanism of Action : Anti-IL-5 Receptor Humanized Antibody
In-House or Licensed : In-House
Remarks : POTELLIGENT®

KRN23 Burosumab

Tumor Induced Osteomalacia(TIO) / Epidermal Nevus Syndrome (ENS)

2

US

Therapeutic Area :
Region : US
Formulation : Injection
Mechanism of Action : Anti-FGF23 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology
Jointly Developed with Ultragenyx in US and EU

KRN23 Burosumab

Tumor Induced Osteomalacia(TIO) / Epidermal Nevus Syndrome (ENS)

2

JP and KR

Therapeutic Area :
Region : JP and KR
Formulation : Injection
Mechanism of Action : Anti-FGF23 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology

KW-0761 Mogamulizumab

Adult T-cell
Leukemia/Lymphoma

2

US, EU and others

Therapeutic Area :
Region : US, EU and others
Formulation : Injection
Mechanism of Action : Anti-CCR4 Humanized Antibody
In-House or Licensed : In-House
Remarks : POTELLIGENT®

Parkinson's Disease

2

JP

Therapeutic Area :
Region : JP
Formulation : Oral
Mechanism of Action : Adenosine A2A Receptor Antagonist
In-House or Licensed : In-House
Project Type : New Molecular Entity

Solid Tumor

1

US

Therapeutic Area :
Region : US
Formulation : Oral
Mechanism of Action : IDO 1 Inhibitor
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Combination with KW-0761

Cancer

1

UK

Therapeutic Area :
Region : UK
Formulation : Injection
Mechanism of Action : Anti-CD123 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : POTELLIGENT®
Human Antibody-Producing Technology

Ulcerative Colitis

1

JP

Therapeutic Area :
Region : JP
Formulation : Injection
Mechanism of Action : Anti-OX40 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : POTELLIGENT®
Human Antibody-Producing
Technology

Atopic Dermatitis

1

JP

Therapeutic Area :
Region : JP
Formulation : Injection
Mechanism of Action : Anti-OX40 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : POTELLIGENT®
Human Antibody-Producing
Technology

KHK4827 Brodalumab

Autoimmune Disease

1

JP

Therapeutic Area :
Region : JP
Formulation : Injection
Mechanism of Action : Anti-IL-17 Receptor A Fully Human Antibody
In-House or Licensed : Kirin-Amgen

Alzheimer's Disease

1

JP

Therapeutic Area :
Region : JP
Formulation : Injection
Mechanism of Action : Anti-Amyloid Beta Peptide Antibody
In-House or Licensed : Immunas Pharma
Project Type : New Molecular Entity

Alzheimer's Disease

1

EU

Therapeutic Area :
Region : EU
Formulation : Injection
Mechanism of Action : Anti-Amyloid Beta Peptide Antibody
In-House or Licensed : Immunas Pharma
Project Type : New Molecular Entity

KW-0761 Mogamulizumab

Solid Tumor

1

US

Therapeutic Area :
Region : US
Formulation : Injection
Mechanism of Action : Anti-CCR4 Humanized Antibody
In-House or Licensed : In-House
Remarks : Combination with Nivolumab
(Jointly Developed with Bristol-Myers Squibb)
POTELLIGENT®

KW-0761 Mogamulizumab

Solid Tumor

1

JP

Therapeutic Area :
Region : JP
Formulation : Injection
Mechanism of Action : Anti-CCR4 Humanized Antibody
In-House or Licensed : In-House
Remarks : Combination with Nivolumab
(Jointly Developed with Ono Pharmaceutical)
POTELLIGENT®

KW-3357 Antithrombin Gamma

Disseminated
Intravascular Coagulation,
Congenital Antithrombin
Deficiency

1

EU

Therapeutic Area :
Region : EU
Formulation : Injection
Mechanism of Action : Recombinant Human Antithrombin
In-House or Licensed : In-House

New / Advanced

Code Name
Generic name

Therapeutic Area

Indication

Phase
123F/A

Region

KHK4827 Brodalumab

Psoriasis

F/A

Approved in TW

Therapeutic Area :
Region : Approved in TW
Formulation : Injection
Mechanism of Action : Anti-IL-17 Receptor A Fully Human Antibody
In-House or Licensed : Kirin-Amgen

KRN1493 Cinacalcet Hydrochloride

Secondary
Hyperparathyroidism

F/A

Approved in BN

Therapeutic Area :
Region : Approved in BN
Formulation : Oral
Mechanism of Action : Calcium Receptor Agonist
In-House or Licensed : Shire-NPS

KRN23 Burosumab

X-linked
Hypophosphatemia (XLH)

F/A

Approved in US

Therapeutic Area :
Region : Approved in US
Formulation : Injection
Mechanism of Action : Anti-FGF23 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology
Jointly Developed with Ultragenyx in US and EU

KHK4827 Brodalumab

Psoriasis

F/A

Filed in HK

Therapeutic Area :
Region : Filed in HK
Formulation : Injection
Mechanism of Action : Anti-IL-17 Receptor A Fully Human Antibody
In-House or Licensed : Kirin-Amgen

KRN23 Burosumab

X-linked
Hypophosphatemia (XLH)

F/A

Filed in CA

Therapeutic Area :
Region : Filed in CA
Formulation : Injection
Mechanism of Action : Anti-FGF23 Fully Human Antibody
In-House or Licensed : In-House
Project Type : New Molecular Entity
Remarks : Human Antibody-Producing Technology
Jointly Developed with Ultragenyx in US and EU

RTA 402 Bardoxolone Methyl

Diabetic Kidney Disease

3

JP

Therapeutic Area :
Region : JP
Formulation : Oral
Mechanism of Action : Antioxidant Inflammation Modulator
In-House or Licensed : Reata
Project Type : New Molecular Entity

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