Investor Information

Development Status (Development Pipeline)

Development Status (Development Pipeline) (1.3MB)


Development status of OPDIVO

As of May 12, 2020

Target disease JAPAN US/EU KR/TW
Melanoma (1st) Approved Approved Approved
Melanoma (Adjuvant Therapy) Approved Approved Approved(KR)
Approved(TW)
Non-small cell lung cancer (2nd`) Approved Approved Approved
Non-small cell lung cancer (1st) Filing Filing (US)
Filing (EU)
V
Renal cell carcinoma (2nd`) Approved Approved Approved
Renal cell carcinoma (1st) Approved Approved Approved
Hodgkin lymphoma Approved Approved Approved
Head and neck cancer Approved Approved Approved
Gastric cancer Approved V Approved
Malignant pleural mesothelioma Approved V -
Colorectal canceriMSI-Hj Approved Approved (US)
U/V (EU)
Approved(TW)
Esophageal cancer Approved V Approved(KR)
V(TW)
Gastro-esophageal junction cancer
and esophageal cancer
V V V
Small cell lung cancer V Approved (US)
V (EU)
V
Hepatocellular carcinoma V Approved (US)
V (EU)
V(KR)
Approved (TW)
Glioblastoma V V -
Urothelial cancer V Approved Approved
Ovarian cancer V V V
Bladder cancer V V V
Cervix carcinoma, Uterine body cancer,
Soft tissue sarcoma
U - -
Central nervous system lymphoma,
Primary Testicular Lymphoma
U U -
Pancreatic cancer U U U
Virus positive/negative solid carcinoma T/U T/U T/U
Biliary tract cancer U - -
Multiple myeloma - V -
Diffuse large B cell lymphoma
(Non-Hodgkin lymphoma)
- U -
Follicular lymphoma (Non-Hodgkin lymphoma) - U -
Prostate cancer - U -
Pancreatic cancer,
Triple negative breast cancer
- T/U -
Blood cancer (T-cell lymphoma, Multiple myeloma, Chronic leukemia, etc. j - T -
Chronic myeloid leukemia - T -

Red: Update after May 2019

Clinical trials in combination therapy OPDIVO & other Immuno-Oncology compounds

As of May 12, 2020

Product name/ Development code (Generic name)
Pharmacological action
Cancer type Japan US/EU KR/TW
Yervoy Injection (Ipilimumab)
Anti-CTLA-4 antibody
Melanoma Approved Approved Approved
Renal cell carcinoma Approved Approved Approved
Non-small cell lung cancer Filing Filing (US)
Filing (EU)
V
Small cell lung cancer V V V
Head and neck cancer V V V
Gastric cancer V V V
Malignant pleural mesothelioma V V -
Esophageal cancer V V V
Urothelial cancer V V V
Hepatocellular carcinoma V Approved(US)
V (EU)
V
Colorectal canceriMSI-Hj Filing Approved(US)
U(EU)
Approved(TW)
Ovarian cancer - T^U -
Virus positive/negative solid carcinoma T^U T^U T^U
ONO-7701 (Linrodostat)
IDO1 inhibitor
Bladder cancer V V V
ONO-4687 (Cabiralizumab)
Anti-CSF-1R antibody
Pancreatic cancer U U U
ONO-4686
Anti-TIGIT antibody
Solid tumor T^U T^U -
ONO-7807
Anti-TIM-3 antibody
Solid tumor T^U T^U -
ONO-4482 (Relatlimab)
Anti-LAG-3 antibody
Melanoma T^U U^V -
ONO-4483 (Lirilumab)
Anti-KIR antibody
Solid tumor T T^U -
ONO-4578
PG receptor (EP4) antagonist
Solid tumor T T^U -
ONO-7475
Axl/Mer inhibitor
Solid tumor T - -
ONO-7911 (Bempegaldesleukin)
PEGylated IL-2
Solid tumor T T^U -
Melanoma - V -
Renal cell carcinoma - V -

Red: Update after May 2019

Development pipeline in Japan (Oncology, other than OPDIVO)

As of May 12, 2020

Product name/ Development code
(Generic name)
Target indication Pharmacological action
yFilingz
ONO-7643 (Anamorelin) Cancer cachexia (in all types of cancer) Ghrelin mimetic
ONO-4059 (Tirabrutinib) Primary macroglobulinemia
Lymphoplasmacytic lymphoma
BTK inhibitor
BRAFTOVI (Encorafenib) BRAF-mutant colorectal cancer BRAF inhibitor
MEKTOVI (Binimetinib) BRAF-mutant colorectal cancer MEK inhibitor
yPhaseTz
ONO-4578* Solid tumor PG receptor (EP4) antagonist
ONO-7475* Solid tumor Axl / Mer inhibitor
ONO-7913 Solid tumor Anti-CD47 mAb

Red: Update after May 2019

*Combination with Opdivo.

Development pipeline in Japan (Non-oncology)

As of May 12, 2020

Product name/ Development code
(Generic name)
Target indication Pharmacological action
yFilingz
ONO-2370 (Opicapone) Parkinson's disease Long acting COMT inhibitor
ONOACT (Landiolol hydrochloride) Tachyarrhythmia upon sepsis Short-active selective β1 blocker
ONO-5704ESI-613 Osteoarthritis Hyaluronic acid-NSAID
yPhaseVz
ORENCIA SC (Abatacept) Polymyositis/Dermatomyositis T-cell activation inhibitor
yPhaseU/Vz
ONOACT (Landiolol hydrochloride) Tachyarrhythmia in low cardiac function <Pediatric> Short-active selective β1 blocker
yPhaseUz
ONO-5704ESI-613 Enthesopathy Hyaluronic acid-NSAID
ONO-4059 (Tirabrutinib) Pemphigus BTK inhibitor
yPhaseTz
ONO-7269 Cerebral infarction FXIa inhibitor
ONO-4685 Autoimmune disease PD-1~CD3 Bispecific antibody

Red: Update after May 2019

Global development projects (Other than OPDIVO)

As of May 12, 2020

Development code
(Generic name)
Target indication Pharmacological action Area
yPhaseVz
ONO-7702 (Encorafenib) BRAF-mutant colorectal cancer BRAF inhibitor KR
BRAF-mutant melanoma KR
ONO-7703 (Binimetinib) BRAF-mutant colorectal cancer MEK inhibitor KR
BRAF-mutant melanoma KR
ONO-7912ECPI-613 (Devimistat) Pancreatic cancer Cancer metabolism inhibitor KR
Acute Myeloid Leukemia KR
yPhaseUz
ONO-4059 (Tirabrutinib) B cell lymphoma BTK inhibitor EU
Sjögrens syndrome US/EU
yPhaseT/Uz
ONO-4578* Solid tumor PG receptor (EP4) antagonist US/EU
yPhaseTz
ONO-4059 (Tirabrutinib) B cell lymphoma BTK inhibitor US
ONO-7475 Acute leukemia Axl / Mer inhibitor US
ONO-7684 Thrombosis FXIa inhibitor EU
ONO-2808 Neurodegenerative disease S1P5 receptor agonist EU

*Combination with Opdivo.