R&D Pipeline

R&D Pipeline(In-House)

As of November 2017

Development
Stage
Product name/
Development Code
(Generic name)
Development Classification Expected indications
Category
Approved RECTABUL®
AJG511
(Budesonide)
In-licensed /
Co-development with EA Pharma (Japan)

Ulcerative colitis
- A locally-active steroid -
- Rectal foam product -

NDA

KRP-114V
(Vibegron)
In-licensed /
Co-development with KYORIN Pharmaceutical (Japan)

Overactive bladder
- Beta 3 adrenergic receptor agonist -

NDA P-TOL®
(Sucroferric Oxyhydroxide)
In-licensed /
Vifor-Fresenius Medical Care Renal Pharma (Switzerland)

Hyperphosphatemia in hemodialysis patients
- Phosphate binder -
- Additional dosage form: Granule -

Phase III KPS-0373
(Rovatirelin)
In-licensed /
Shionogi (Japan)

Spinocerebellar ataxia
- Product mimetic of TRH action -

AJM300
(Carotegrast Methyl)
In-licensed /
Co-development with EA Pharma (Japan)

Ulcerative colitis
- Alpha 4 integrin antagonist -

JR-131 In-licensed /
Co-development with JCR Pharmaceuticals (Japan)

Renal anemia
- Increase the red blood cell (RBC) count -
-A biosimilar "darbepoetin alfa" -

Phase II KLH-2109 Kissei

Endometriosis
- GnRH antagonist -

MR13A9
(Difelikefalin)
In-licensed /
Co-development with Maruishi Pharmaceutical (Japan)

Uremic pruritus in dialysis patients
- Kappa opioid receptor agonist-

Phase I / II YS110 In-licensed /
Y's AC, University of Tokyo, AMED (Japan)

Malignant mesothelioma
- Humanized anti-CD26 monoclonal antibody -

Phase I KDT-3594 Kissei

Parkinson's disease
- Dopamine receptor stimulation -

CCX168
(Avacopan)
In-licensed /
Vifor-Fresenius Medical Care Renal Pharma (Switzerland)

ANCA (anti-neutrophil cytoplasmic auto-antibody)-associated vasculitis
- A selective inhibitor of the Complement C5a Receptor -





R&D Pipeline(Out-Licensing)

As of November 2017

Development Stage Development Code /
Generic name
Development Company Territory Expected indications
Category
NDA Mitiglinide Eisai(Japan) ASEAN *1 Type 2 diabetes mellitus
Silodosin Eisai(Japan) ASEAN, India, SriLanka *2 Dysuria associated with benign prostatic hyperplasia
Phase III KLH-2109 ObsEva SA (Switzerland) Worldwide, excluding some countries in Asia such as Japan

Uterine fibroids
- GnRH antagonist -

Phase II Bedoradrine MediciNova(U.S.) Worldwide, except for Japan

Acute exacerbation of asthma /
Preterm labor

KLH-2109 ObsEva SA (Switzerland) Worldwide, excluding some countries in Asia such as Japan

Endometriosis
- GnRH antagonist -

Phase I Bedoradrine MediciNova(U.S.) Worldwide, except for Japan COPD


*1: Launched in Thailand, the Philippines, Cambodia, Myanmar ; NDA in 2 countries
*2: Launched in Thailand, India, Indonesia, the Philippines, Cambodia ; Approved in Myanmar ; NDA in 3 ASEAN countries