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Product Pipeline

Feb 06. 2019

<Domestic>

Stage Code No.
(Generic name)
Therapeutic field Indications Origin Development
NDA filing NS-73
(defibrotide)
hematologic malignancies veno-occlusive disease (treatment) Licensed - in from
Jazz Pharmaceuticals plc
Nippon Shinyaku
Phase III NS-73
(defibrotide)
hematologic malignancies veno-occlusive disease (prevention) Licensed - in from
Jazz Pharmaceuticals plc
Co - developed with
Jazz Pharmaceuticals plc
Phase III NS-304
(selexipag)
intractable disease・orphan disease chronic thromboembolic pulmonary
hypertension
Nippon Shinyaku Co - developed with
Actelion Pharmaceuticals Japan Ltd.
Preparation for
Phase III
NS-32 gynecology iron deficiency anemia Licensed - in from
Pharmacosmos A/S
Nippon Shinyaku
Phase II NS-304
(selexipag)
cardiovascular arteriosclerosis obliterans Nippon Shinyaku Nippon Shinyaku
Phase II NS-304
(selexipag)
orthopedics lumbar spinal stenosis Nippon Shinyaku Nippon Shinyaku
Phase II NS-580 gynecology endometriosis Nippon Shinyaku Nippon Shinyaku
Phase II NS-17
(azacitidine)
hematologic malignancies acute myeloid leukemia Licensed - in from
Celgene Corporation
Nippon Shinyaku
Phase I/II NS-065/NCNP-01
(viltolarsen)
intractable disease・orphan disease Duchenne muscular dystrophy Co - development:
National Center of Neurology and Psychiatry
Nippon Shinyaku
Preparation for development NS-917 hematologic malignancies relapsed/refractory acute myeloid leukemia Licensed - in from
Delta-Fly Pharma, Inc.
Nippon Shinyaku
Preparation for development NS-87 hematologic malignancies secondary acute myeloid leukemia Licensed - in from
Jazz Pharmaceuticals plc
Nippon Shinyaku

<Overseas>

Stage Code No.
(Generic name)
Therapeutic field Indications Origin Development
China
NDA filing
NM441
(prulifloxacin)
anti-infection bacterial infections Nippon Shinyaku Licensed - out to
Lee's Pharmaceutical Holdings Limited
Rolling submission for NDA NS-065/NCNP-01
(viltolarsen)
intractable disease・orphan disease Duchenne muscular dystrophy Co - development:
National Center of Neurology and Psychiatry
Nippon Shinyaku
Phase I/II NS-018 hematologic malignancies myelofibrosis Nippon Shinyaku Nippon Shinyaku
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