Development Pipeline

This is the development pipeline as of July 26, 2021

1. Oncology (OPDIVO)

As of Jul 26, 2021

Product name or
Development code
(Generic name)
Mechanism Target disease Development
stage
Country/
Region
Licensor
F
i
l
i
n
g
A
p
p
r
o
v
a
l
Opdivo Intravenous Infusion
(Nivolumab)
Anti-PD-1 antibody Melanoma (2nd)
 
 
 
 
 
JP・KR・TW In-house
(Co-developed with BMS)
Melanoma (1st)
 
 
 
 
 
JP・KR・TW
Melanoma (Adjuvant therapy)
 
 
 
 
 
JP・KR・TW
Non-small cell lung cancer (2nd~)
 
 
 
 
 
JP・KR・TW
Non-small cell lung cancer (1st)
 
 
 
 
 
JP・KR・TW
Renal cell carcinoma (2nd~)
 
 
 
 
 
JP・KR・TW
Renal cell carcinoma (1st)
 
 
 
 
 
JP・KR・TW
Hodgkin’s lymphoma
 
 
 
 
 
JP・KR・TW
Hodgkin's lymphoma (Pediatric)
 
 
 
 
 
JP
Head and neck cancer
 
 
 
 
 
JP・KR・TW
Gastric cancer (3rd)
 
 
 
 
 
JP・KR・TW
Gastric cancer (1st)
 
 
 
 
 
JP
 
 
 
 
 
KR
 
 
 
 
 
TW
Malignant pleural mesothelioma (SOC refractory)
 
 
 
 
 
JP
Malignant pleural mesothelioma (1st)
 
 
 
 
 
JP・KR
Colorectal cancer (MSI-High)
 
 
 
 
 
JP・TW
Esophageal cancer (2nd)
 
 
 
 
 
JP・KR・TW
Esophageal cancer (1st)
 
 
 
 
 
JP・KR・TW
Esophageal cancer (Adjuvant)
 
 
 
 
 
JP
 
 
 
 
 
KR・TW
Urothelial cancer (2nd)
 
 
 
 
 
JP
 
 
 
 
 
KR・TW
Urothelial cancer (Adjuvant)
 
 
 
 
 
JP
 
 
 
 
 
KR・TW
Cancer of unknown primary
 
 
 
 
 
JP
Hepatocellular carcinoma (Adjuvant therapy)
 
 
 
 
 
JP・KR・TW
Hepatocellular carcinoma (2nd)
 
 
 
 
 
TW
Ovarian cancer
 
 
 
 
 
JP・KR・TW
Bladder cancer
 
 
 
 
 
JP・KR・TW
Prostate cancer
 
 
 
 
 
JP・KR・TW
Pancreatic cancer
 
 
 
 
 
JP・KR・TW
Virus positive/negative solid carcinoma
 
 
 
 
 
JP・KR・TW
Biliary tract cancer
 
 
 
 
 
JP・KR・TW

2. Oncology (Other than OPDIVO)

As of Jul 26, 2021

Product name or
Development code
(Generic name)
Mechanism Target disease Development
stage
Country/
Region
Licensor
F
i
l
i
n
g
A
p
p
r
o
v
a
l
Yervoy Injection★
(Ipilimumab)
Anti-CTLA-4 antibody Melanoma
 
 
 
 
 
JP・KR・TW BMS
Renal cell carcinoma
 
 
 
 
 
JP・KR・TW
Non-small cell lung cancer
 
 
 
 
 
JP・KR・TW
Colorectal cancer (MSI-High)
 
 
 
 
 
JP・TW
Malignant pleural mesothelioma
 
 
 
 
 
JP・KR
Gastric cancer
 
 
 
 
 
JP・KR・TW
Esophageal cancer
 
 
 
 
 
JP・KR・TW
Urothelial cancer
 
 
 
 
 
JP・KR・TW
Hepatocellular carcinoma
 
 
 
 
 
JP・KR・TW
Virus positive/negative solid carcinoma
 
 
 
 
 
JP・KR・TW
Velexbru Tablets
(Tirabrutinib Hydrochloride)
Bruton‘s tyrosine kinase (BTK) inhibitor Primary central nervous system lymphoma
 
 
 
 
 
JP In-house
 
 
 
 
 
US
Primary macroglobulinemia Lymphoplasmacytic lymphoma
 
 
 
 
 
JP
Adlumiz Tablets
(Anamorelin Hydrochloride)
Ghrelin mimetic Cancer cachexia
 
 
 
 
 
JP Helsinn
Braftovi Capsules
(Encorafenib)
BRAF inhibitor Melanoma (BRAF-mutation positive)
 
 
 
 
 
JP Pfizer
 
 
 
 
 
KR
Colorectal cancer (BRAF-mutation positive)
 
 
 
 
 
JP
 
 
 
 
 
KR
Thyroid cancer
 
 
 
 
 
JP
Mektovi Tablets
(Binimetinib)
MEK inhibitor Melanoma (BRAF-mutation positive)
 
 
 
 
 
JP Pfizer
 
 
 
 
 
KR
Colorectal cancer (BRAF-mutation positive)
 
 
 
 
 
JP
 
 
 
 
 
KR
Thyroid cancer
 
 
 
 
 
JP
Kyprolis for Intravenous Infusion
(Carfilzomib)
Proteasome inhibitor Multiple myeloma
 
 
 
 
 
JP Amgen
ONO-7701★
(Linrodostat)
IDO1 inhibitor Bladder cancer
 
 
 
 
 
JP・KR・TW BMS
ONO-7912 (Devimistat) Cancer metabolism inhibitor Pancreatic cancer
 
 
 
 
 
JP Rafael
 
 
 
 
 
KR
Acute myeloid leukemia
 
 
 
 
 
KR
ONO-4686 ★ Anti-TIGIT antibody Solid tumor
 
 
 
 
 
JP BMS
ONO-7807★ Anti-TIM-3 antibody Solid tumor
 
 
 
 
 
JP BMS
ONO-4482★ (Relatlimab) Anti-LAG-3 antibody Melanoma
 
 
 
 
 
JP BMS
ONO-7475 Axl/Mer inhibitor Solid tumor★
 
 
 
 
 
JP In-house
Non-small cell lung cancer
 
 
 
 
 
JP
Acute leukemia
 
 
 
 
 
US
ONO-4578★ PG receptor (EP4) antagonist Solid tumor・Gastric cancer
 
 
 
 
 
JP In-house
Colorectal cancer
 
 
 
 
 
JP
Pancreatic cancer
 
 
 
 
 
JP
Non-small cell lung cancer
 
 
 
 
 
JP
ONO-7911★ (Bempegaldesleukin) PEGylated IL-2 Solid tumor
 
 
 
 
 
JP BMS
ONO-7913
(Magrolimab)
Anti-CD47 antibody Solid tumor
 
 
 
 
 
JP Gilead
Myelodysplastic syndrome
 
 
 
 
 
JP
Pancreatic cancer★
 
 
 
 
 
JP
Colorectal cancer★
 
 
 
 
 
JP

★Combination with Opdivo.

3. Areas other than Oncology

As of Jul 26, 2021

Product name or
Development code
(Generic name)
Mechanism Target disease Development
stage
Country/
Region
Licensor
F
i
l
i
n
g
A
p
p
r
o
v
a
l
Coralan Tablets
(Ivabradine Hydrochloride)
HCN channel blocker Chronic heart failure
 
 
 
 
 
JP Servier
Ongentys Tablets
(Opicapone)
Long acting COMT inhibitor Parkinson’s disease
 
 
 
 
 
JP Bial
Onoact for Intravenous Infusion
(Landiolol Hydrochloride)
Short-active selective β1 blocker Tachyarrhythmia associated with sepsis
 
 
 
 
 
JP In-house
Tachyarrhythmia in low cardiac function (Pediatric)
 
 
 
 
 
JP
Orencia SC
(Abatacept )
T-cell activation inhibitor Rheumatoid arthritis (Prevention of structural damage of joints)
 
 
 
 
 
JP BMS
Polymyositis/ Dermatomyositis
 
 
 
 
 
JP
Joyclu Intra-articular Injection
(Diclofenac Etalhyaluronate Sodium)
Hyaluronic acid-NSAID Osteoarthritis (hip,knee)
 
 
 
 
 
JP Seikagaku
Enthesopathy
 
 
 
 
 
JP
Velexbru Tablets
(Tirabrutinib Hydrochloride)
Bruton's tyrosine kinase (BTK) inhibitor Pemphigus
 
 
 
 
 
JP In-house
Generalized scleroderma
 
 
 
 
 
JP
ONO-2910 Enhancement of Schwann cell differentiation Peripheral nerve disorder
 
 
 
 
 
JP In-house
ONO-4685 PD-1×CD3 bispecific antibody Autoimmune disease
 
 
 
 
 
JP In-house
ONO-2808 S1P5 receptor agonist Neurodegenerative disease
 
 
 
 
 
JP・EU In-house
ONO-7684 FXIa inhibitor Thrombosis
 
 
 
 
 
EU In-house
ONO-2909 PG receptor (DP1) antagonist Narcolepsy
 
 
 
 
 
JP In-house