Phase 1
Phase 2
Phase 3
Application
Therapeutic
area
Cardiovascular-
Metabolics
Oncology
Others
n
Prasugrel
(JP)
(CS-747 / Ischemic stroke / Anti-
platelet agent)
n
Edoxaban (ASCA
etc.)
(DU-176b / AF / oral factor Xa inhibitor)
n
Edoxaban
(ASCA etc.)
(DU-176b / VTE / oral factor Xa inhibitor)
n
Tivantinib (US/EU)
(ARQ 197 / HCC / MET inhibitor)
n
Denosumab (JP)
(AMG 162 / Breast cancer adjuvant /
Anti-RANKL antibody)
n
Nimotuzumab (JP)
(DE-766 / Gastric cancer / Anti-EGFR
antibody)
n
Vemurafenib (US/EU)
(PLX4032 / Melanoma Adjuvant / BRAF
inhibitor)
n
Quizartinib (US/EU/Asia)
(AC220 / AML-2
nd
/ FLT3-ITD inhibitor)
n
Quizartinib (US)
(AC220 / AML-1
st
/ FLT3-ITD inhibitor)
n
Pexidartinib
(US/EU)
(PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD
inhibitor)
n
Laninamivir
(US/EU)
(CS-8958 / Anti-influenza /
out-licensing with Biota)
n
Mirogabalin (US/EU)
(DS-5565 / Fibromyalgia /
α
2
δ
ligand)
n
Mirogabalin
(JP/Asia)
(DS-5565 / DPNP/
α
2
δ
ligand)
n
Mirogabalin
(JP/Asia)
(DS-5565 / PHN /
α
2
δ
ligand)
n
Denosumab (JP)
(AMG 162 / Rheumatoid arthritis /
Anti-RANKL antibody)
n
Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid
μ
–
receptor regulator)
n
CHS-0214 (JP)
(Etanercept BS / Rheumatoid
arthritis / TNF
α
inhibitor)
n
VN-0105 (JP)
(DPT-IPV /
Hib
vaccine)
n
VN-0107/MEDI3250
(JP)
(Nasal spray flu vaccine
vaccine)
n
CS-3150 (JP)
(Hypertension
・
DM
nephropathy /
MR antagonist)
n
DS-8500
(JP/US)
(Diabetes / GPR119 agonist)
n
Patritumab (US/EU)
(U3-1287 / Anti-HER3 antibody)
n
Pexidartinib (US)
(PLX3397
/ CSF-1R/KIT/FLT3-ITD
inhibitor)
n
DS-1040
(Acute ischemic stroke / TAFIa inhibitor)
n
DS-2330
(
Hyperphosphatemia
)
n
DS-9231/TS23
(Thrombosis /
α
2-PI
inactivating antibody)
n
DS-9001
(Dyslipidemia / Anti-PCSK9 Anticalin-Albumod)
n
DS-3032 (US/JP)
(MDM2
inhibitor)
n
PLX7486 (US)
(FMS / TRK inhibitor)
n
PLX8394 (US)
(BRAF inhibitor)
n
DS-6051 (US/
JP
)
(NTRK/ROS1 inhibitor)
n
PLX9486 (US)
(KIT inhibitor)
n
DS-3201 (JP)
(EZH1/2 inhibitor)
n
PLX73086 (US)
(CSF-1R
inhibitor)
n
PLX51107 (US)
(BRD4 inhibitor)
n
DS-1971
(Chronic pain)
n
DS-1501
(Osteoporosis / Anti-Siglec-15 antibody)
n
DS-7080 (US)
(AMD / Angiogenesis inhibitor)
n
DS-2969
(
Clostridium
difficile
infection
/
GyrB
inhibitor)
n
DS-5141 (JP)
(DMD / ENA
oligonucleotide)
n
VN-0102/JVC-001 (JP)
(MMR
vaccine)
n
Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid
μ
–
receptor agonist)
n
CL-108 (US)
(Acute pain / Opioid
μ
-receptor
agonist)
n
Intradermal Seasonal
Influenza Vaccine (JP)
(VN-100 / prefilled
i.d.
vaccine for
seasonal flu)
Major R&D Pipeline
n
DS-8895 (JP)
(Anti-EPHA2 antibody)
n
DS-8273 (US)
(Anti-DR5 antibody)
n
DS-5573
(JP)
(Anti-B7-H3 antibody)
n
DS-8201 (JP)
(Anti-HER2 ADC)
n
U3-1784 (EU)
(Anti-FGFR4 antibody)
n
DS-1123 (JP)
(Anti-FGFR2 antibody)
Red
:
Major changes after the FY2015
Q3
financial announcement
on January 29, 2016
As of May 2016
2
12. Major R&D Pipeline (Innovative pharmaceuticals
）
As of May 2016
◆
Launched/Approved
Generic Name
Class
Indication
Region
Status
Remarks
Edoxaban
Factor Xa inhibitor
Atrial fibrillation
（
AF
）
ASCA
etc.
Launched
S. Korea (16/2
*
)
* means Feb 2016, ditto
Approved
Taiwan (16/2)
Venous thromboembolism (VTE)
ASCA
etc.
Launched
S. Korea (16/2)
Approved
Taiwan (16/2)

The once daily oral anti coagulant (
FXa
inhibitor) discovered by Daiichi Sankyo.
Edoxaban
specifically, reversibly and directly inhibits the enzyme, Factor
Xa
, a clotting factor in the
blood. Launched in Japan in July 2011 as the prevention of venous thromboembolism (VTE) in patients with total knee
arthroplasty
, total hip
arthroplasty
and hip fracture surgery.
Additional indications for AF/VTE was approved in September 2014 and 60 mg tablet was launched in December 2014. Launched in US, Switzerland, UK, Germany, Ireland and
Netherlands in February, May, July, August, September and November 2015, respectively. Approved in South Korea in August 2015.
VN-101
Cell-culture H5N1 flu vaccine
Prevention of H5N1 influenza
JP
Approved in March 2016

This vaccine is a cell-culture H5N1 flu vaccine that has developed by Daiichi Sankyo and
Kitasato
Daiichi Sankyo Vaccine(KDSV).
KDSV was submitted a supplemental application for optimization of pediatric use.
Underline: change after FY2015 Q3 Financial Announcement in Jan 2016

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