Phase 1
Phase 2
Phase 3
Application
Therapeutic
area
Cardiovascular-
Metabolics
Oncology
Others
Edoxaban (JP)
(DU-176b / AF / FXa inhibitor)
Prasugrel (JP)
(CS-747 / Ischemic stroke / Anti-
platelet agent)
Esaxerenone (JP)
(CS-3150 / Hypertension /
MR antagonist)
Edoxaban (ASCA etc.)
(DU-176b / AF / FXa inhibitor)
Edoxaban (ASCA etc.)
(DU-176b / VTE / FXa inhibitor)
Denosumab (JP)
(AMG 162 / Breast cancer adjuvant /
Anti-RANKL antibody)
Nimotuzumab (JP)
(DE-766 / Gastric cancer / Anti-EGFR
antibody)
Vemurafenib (US/EU)
(PLX4032 / Melanoma Adjuvant / BRAF
inhibitor)
Quizartinib (US/EU/Asia)
(AC220 / AML-2
nd
/ FLT3-ITD inhibitor)
Quizartinib (US/EU/Asia)
(AC220 / AML-1
st
/ FLT3-ITD inhibitor)
Pexidartinib (US/EU)
(PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD
inhibitor)
Laninamivir (US/EU)
(CS-8958 / Anti-influenza /
out-licensing with Biota)
Mirogabalin (US/EU)
(DS-5565 / Fibromyalgia /
α
2
δ
ligand)
Mirogabalin (JP/Asia)
(DS-5565 / DPNP/
α
2
δ
ligand)
Mirogabalin (JP/Asia)
(DS-5565 / PHN /
α
2
δ
ligand)
CHS-0214 (JP)
(Etanercept BS / Rheumatoid
arthritis / TNF
α
inhibitor)
VN-0105 (JP)
(DPT-IPV / Hib vaccine)
Laninamivir (JP)
(CS-8958 / Anti-influenza / nebulizer)
Esaxerenone (JP)
(CS-3150 / DM nephropathy / MR
antagonist)
Patritumab (EU)
(U3-1287 / Anti-HER3 antibody)
Pexidartinib (US)
(PLX3397 / Glioblastoma /
CSF-1R/KIT/FLT3-ITD
inhibitor)
DS-1647 (JP)
(Glioblastoma / G47
Δ
virus)
Quizartinib (JP)
(AC220 / AML-2
nd
/ FLT3-ITD
inhibitor)
DS-1040
(Acute ischemic stroke / TAFIa inhibitor)
DS-2330
(Hyperphosphatemia)
DS-9231/TS23
(Thrombosis /
α
2-PI inactivating antibody)
DS-3032 (US/JP)
(MDM2 inhibitor)
PLX7486 (US)
(FMS / TRK inhibitor)
PLX8394 (US)
(BRAF inhibitor)
DS-6051 (US/JP)
(NTRK/ROS1 inhibitor)
PLX9486 (US)
(KIT inhibitor)
DS-3201 (JP/
US
)
(EZH1/2 inhibitor)
PLX73086 (US)
(CSF-1R inhibitor)
PLX51107 (US)
(BRD4 inhibitor)
DS-1971
(Chronic pain)
DS-1501 (US)
(Osteoporosis / Anti-Siglec-15 antibody)
DS-7080 (US)
(AMD / Angiogenesis inhibitor)
DS-2969 (US)
(
Clostridium difficile
infection
/GyrB inhibitor)
DS-5141 (JP)
(DMD / ENA oligonucleotide)
VN-0102/JVC-001 (JP)
(MMR vaccine)
Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid
μ
–
receptor agonist)
CL-108 (US)
(Acute pain / Opioid
μ
-receptor
agonist)
Intradermal Seasonal
Influenza Vaccine (JP)
(VN-100 / prefilled i.d. vaccine for
seasonal flu)
VN-0107/MEDI3250 (JP)
(Nasal spray flu vaccine)
Denosumab (JP)
(AMG 162 / Rheumatoid arthritis /
Anti-RANKL antibody)
Major R&D Pipeline
DS-8273 (US)
(Anti-DR5 antibody)
DS-8201 (JP/US)
(anti-HER2 ADC
）
DS-1123 (JP)
(Anti-FGFR2 antibody)
U3-1402 (JP)
(Anti-HER3 ADC)
DS-1001 (JP)
（
IDH1m inhibitor
）
As of May 2017
Red: Major changes after the FY2016 Q3 financial announcement on Ja
nuary 31, 2017
12. Major R&D Pipeline (Innovative pharmaceuticals
）
◆
Oncology (Late-stage
pipeline products)
Generic Name/Project Code Number
(Brand Name)
Class
Target indication
Region Stage
Dosage
Form
Partner
Target FY for
approval/launch
Anti-RANKL antibody
Breast cancer adjuvant
JP
P3 Injection
Amgen
2020
BRAF inhibitor
Melanoma adjuvant
US/EU
P3
Oral
–
–
US/EU/Asia P3
2018
US/EU/Asia P3
2021-
JP
P2
2018-
Tenosynovial Giant Cell Tumor (TGCT)
US/EU
P3
2019
Solid tumors
Asia
P1
–
Glioblastoma
US
P2
–
c-KIT Melanoma
Asia
P1/2
–
Melanoma, Solid tumors
US
P1/2
Merck & Co., Inc.
–
Anti-EGFR antibody
Gastric cancer
JP
P3 Injection InnoClMAb Pte Ltd
2
020
Anti-HER3 antibody
Head & neck cancer
EU
P2 Injection
–
–
Oncolytic HSV-1
Glioblastoma
JP
P2 Injection
ActiVec Inc.
–
Underline: change after FY2016 Q3 Financial Announcement in Jan
uary 2017
Denosumab/AMG 162
Ranmark (JP)
Additional indication
The fully human monoclonal antibody to target RANK Ligand, an e
ssential mediator of osteoclast formation.
Vemurafenib/PLX4032
Zelboraf
Additional indication. Licensee Roche is conducting the
study. Submission in 2017 is planned.
The molecular-targe
ted agent to inhibit BRAF V600E mutation.
Nimotuzumab/DE-766
Patritumab/U3-1287
Pexidartinib/PLX3397
CSF-1R/KIT/FLT3-ITD inhibitor
Oral
–
Quizartinib/AC220
DS-1647(G47
)
Granted SAKIGAKE designation from MHLW
Investigator Initiated Study is on-going
The third generation oncolytic herpes simplex virus type 1(HSV-
1), genetically-engineered to restrict virus replication to tum
or cells. This oncolytic virus therapy is expected equal or be
tter safety and better efficacy profile compare to
existing oncolytic virus.
As of May 2017
The humanized monoclonal antibody to target Epidermal Growth Fa
ctor Receptor(EGFR). This antibody is expected to be a best in
class EGFR, safety against the skin toxicity and the efficacy c
omparable to the other antibodies.
The fully human monoclonal antibody to target HER3, one of the
Epidermal Growth Factor Receptor (EGFR) family of proteins. HER
3 is overexpressed in many tumors of epithelial origin and HER
2/HER3 dimers and EGFR/HER3
dimers are expected more potent to induce tumor cell proliferat
ion than homodimers of HER2 or EGFR.
Including pigmented villonodular synovitis
Including TGCT
Combination with pembrolizumab in collaboration with Merck
The molecular-targeted agent to inhibit CSF-1R, KIT and FLT3-IT
D. This agent is expected to reduce tumor cell proliferation an
d expansion of metastases.
Remarks
FLT3-ITD inhibitor
Acute myeloid leukemia
Oral
–
Relapsed and refractory AML patients
Newly diagnosed AML patients
Relapsed and refractory AML patients
Kinase inhibitor against a receptor-type tyrosine kinase, FLT3.
Therapeutic effect for patients with acute myeloid leukemia ha
rboring FLT3-ITD mutation is expected.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!