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Development Pipeline

Oncology

Development code
(Compound number)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
AF802/RG7853
(CH5424802/
RO5424802)
Non-small cell lung cancer
(NSCLC) [1st line]
#
Approved
(17/11)
US
alectinib
Alecensa®
Oral
In-house
Alecensa®
(Roche)
ALK inhibitor
Approved
(17/12)
Europe
RG7446
(MPDL3280A)
NSCLC [2nd line] Launched
(18/04)
atezolizumab
Tecentriq®
Injection
Roche
Tecentriq®
Engineered anti-PDL1 monoclonal antibody
NSCLC [1st line]
#
Filed
(18/03)
NSCLC (adjuvant)
#
Phase III
Multinational study
Small cell lung cancer
#
Phase III
Multinational study
Urothelial carcinoma
#
Phase III
Multinational study
Muscle invasive urothelial carcinoma (adjuvant)
#
Phase III
Multinational study
Renal cell carcinoma
#
Phase III
Multinational study
Renal cell carcinoma (adjuvant)
#
Phase III
Multinational study
Breast cancer
#
Phase III
Multinational study
Ovarian cancer
#
Phase III
Multinational study
Prostate cancer
#
Phase III
Multinational study
Hepatocellular carcinoma
#
Phase III
Multinational study
GA101/RG7159
(RO5072759)
Follicular lymphoma Filed
(17/08)
obinutuzumab
 
Injection
Roche
Gazyva®/
Gazyvaro® (EU)
(Nippon Shinyaku)
Glycoengineered type II anti-CD20 monoclonal antibody
RG1273
(RO4368451)
Breast cancer (adjuvant)
#
Filed
(17/10)
pertuzumab
Perjeta®
Injection
Roche
Perjeta®
HER2 dimerization inhibitory humanized monoclonal antibody
RG435
(RO4876646)
Renal cell carcinoma
#
Phase III
Multinational study
bevacizumab
Avastin®
Injection
Roche
Avastin®
Anti-VEGF (Vascular Endothelial Growth Factor) humanized monoclonal antibody
RG3502
(RO5304020)
Breast cancer (adjuvant)
#
Phase III
Multinational study
trastuzumab emtansine
Kadcyla®
Injection
Roche
Kadcyla®
Anti-HER2 antibody-tubulin polymerization inhibitor conjugate
RG7440
(GDC-0068)
Prostate cancer Phase III
Multinational study
ipatasertib

Oral
Roche/Array BioPharma AKT inhibitor
Breast cancer Phase III
Multinational study
RG7596
(RO5541077)
Diffuse large B-cell lymphoma
(DLBCL)
Phase III
Multinational study
polatuzumab vedotin
 
Injection
Roche Anti-CD79b antibody-drug conjugate
GC33/RG7686
(GC33/
RO5137382)
Hepatocellular carcinoma Phase I
Multinational study*
codrituzumab
 
Injection
In-house

(Roche)
Anti-Glypican-3 humanized monoclonal antibody
CKI27
(CKI27)
Solid tumors Phase I

Oral
In-house
 
Raf and MEK dual inhibitor
Phase I
Overseas
RG7604
(GDC-0032)
Solid tumors Phase I taselisib
 
Oral
Roche PI3K inhibitor
ERY974
(ERY974)
Solid tumors Phase I
Overseas


Injection
In-house Anti-Glypican-3/CD3 bispecific antibody
RG7421
(GDC-0973)
Solid tumors Phase I cobimetinib

Oral
Roche/Exelixis
Cotellic®
MEK inhibitor
RG7802
(RO6958688)
Solid tumors Phase I

Injection
Roche Anti-CEA/CD3 bispecific antibody
RG7828
(RO7030816)
Hematologic tumors Phase I

Injection
Roche Anti-CD20/CD3 bispecific antibody

* Multinational studies managed by Chugai

Bone and Joint Diseases

Development code
(Compound number)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
ED-71
(ED-71)
Osteoporosis Filed
(18/02)
China
eldecalcitol
Edirol®
Oral
In-house Activated vitamin D3 agent
NRD101
(NRD101)
Knee osteoarthritis
/Shoulder periarthritis
Phase III
China
purified sodium hyaluronate
Suvenyl®
Injection
In-house Sodium hyaluronate

Renal Diseases

Development code
(Compound number)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
EOS789
(EOS789)
Hyperphosphatemia Phase I

Oral
In-house
Phase I
Overseas

Autoimmune Diseases

Development code
(Compound number)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
MRA/RG1569
(RO4877533)
Systemic sclerosis
#
Phase III
Multinational study
tocilizumab
Actemra®
Injection
In-house
Actemra®/
RoActemra® (EU)
(Roche)
Humanized anti-human IL-6 receptor monoclonal antibody
SA237/RG6168
(SA237)
Neuromyelitis optica (NMO) Phase III
Multinational study*
satralizumab

Injection
In-house

(Roche)
Anti-IL-6 receptor recycling antibody
RG7845
(GDC-0853)
Rheumatoid arthritis Phase I

Oral
Roche
 
BTK inhibitor

* Multinational studies managed by Chugai

Neurology

Development code
(Compound number)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
RG1450
(RO4909832)
Alzheimer’s disease Phase III
Multinational study
gantenerumab

Injection
Roche/MorphoSys Anti-amyloid-beta human monoclonal antibody
RG7412
(RO5490245)
Alzheimer’s disease Phase III
Multinational study
crenezumab

Injection
Roche/AC Immune Anti-amyloid-beta humanized monoclonal antibody
RG6206
(BMS-986089)
Duchenne muscular dystrophy (DMD) Phase II/III
Multinational study


Injection
Roche/Bristol-Myers Squibb Anti-myostatin adnectin
RG7916
(RO7034067)
Spinal muscular atrophy (SMA) Phase II
Multinational study


Oral
Roche/PTC Therapeutics SMN2 splicing modifier
RG7935
(RO7046015)
Parkinson’s disease Phase I

Injection
Roche/Prothena Anti-α-synuclein monoclonal antibody

Others

Development code
(Compound number)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
ACE910/RG6013
(RO5534262)
Hemophilia A
(Inhibitor)
Approved
(17/11)
US
emicizumab
Hemlibra®
Injection
In-house
Hemlibra®
(Roche)
Anti-FIXa/FX bispecific antibody
Approved
(18/02)
Europe
Approved
(18/03)
Japan
Hemophilia A
(Non-inhibitor)
Phase III
Multinational study
CIM331**
(CIM331)
Pruritus in dialysis patients Phase II nemolizumab
 
Injection
In-house
 
Anti-IL-31 receptor A humanized monoclonal antibody
URC102
(URC102)
Gout Phase II
Overseas
 
 
Oral
In-house/JW Pharmaceutical

(JW Pharmaceutical)
URAT1 inhibitor
SKY59/RG6107
(RO7112689)
Paroxysmal nocturnal hemoglobinuria
(PNH)
Phase I/II
Multinational study
 
 
Injection
In-house
 
(Roche)
Anti-C5 recycling antibody
PCO371
(PCO371)
Hypoparathyroidism Phase I
Overseas
 
 
Oral
In-house PTH1 receptor agonist
RG7716
(RO6867461)
Wet age-related macular degeneration / Diabetic macular edema Phase I
 
 
Injection
Roche Anti-VEFG/Ang2 bispecific antibody
AMY109 Endometriosis Phase I
 
 
Injection
In-house
RG3637
(RO5490255)
Idiopathic pulmonary fibrosis Development
discontinued
lebrikizumab
 
Injection
Roche Anti-IL-13 humanized monoclonal antibody

** Development for atopic dermatitis: Out-licensed to Galderma (Overseas) and Maruho (Japan)

In principle, completion of first dose is regarded as the start of clinical studies in each phase.

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