Development Pipeline

View the status of our current development pipeline as of April 22, 2021.

Development Pipeline (all disease areas) [PDF 307KB]

Oncology

Development code Origin
Overseas name
(Collaborator)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Mode of Action
RG7596 Roche/Seattle Genetics
Polivy
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Approved
(21/03)
polatuzumab vedotin
Polivy
Injection
Anti-CD79b antibody-drug conjugate
DLBCL
#
Phase III
RG7446 Roche
Tecentriq
Non-small cell lung cancer (NSCLC)
(adjuvant)
#
Phase III atezolizumab
Tecentriq
Injection
Engineered anti-PD-L1 monoclonal antibody
NSCLC (neoadjuvant)
#
Phase III
NSCLC (stage III)
#
Phase III
(in combination with RG6058)
Urothelial carcinoma
#
Phase III
Renal cell carcinoma (adjuvant)
#
Phase III
Roche
Tecentriq
(Takeda)
Renal cell carcinoma (2nd Line)
#
Phase III
(in combination with cabozantinib)
Roche
Tecentriq
Early breast cancer
#
Phase III
Ovarian cancer
#
Phase III
(in combination with RG435)
Hepatocellular carcinoma (HCC) (adjuvant)
#
Phase III
(in combination with RG435)
HCC (intermediate stage)
#
Phase III
(in combination with RG435)
Head and neck carcinoma (adjuvant)
#
Phase III
Esophageal cancer
#
Phase III
(in combination with RG6058)
Pancreatic adenocarcinoma
#
Phase I
Morpheus platform
(in combination with RG1569 or RG6058)
RG435 Roche
Avastin
HCC (adjuvant)
#
Phase III
(in combination with RG7446)
bevacizumab
Avastin
Injection
Anti-VEGF (Vascular Endothelial Growth Factor) humanized monoclonal antibody
HCC (intermediate stage)
#
Phase III
(in combination with RG7446)
Small cell lung cancer (SCLC)
#
Phase III
(in combination with RG7446)
RG7440 Roche/Array BioPharma Breast cancer Phase III ipatasertib

Oral
AKT inhibitor
Prostate cancer Phase III
RG6264 Roche
Phesgo
Breast cancer
(Fixed-dose combination, subcutaneous injection)
Phase III trastuzumab/pertuzumab

Injection
Anti-HER2 humanized monoclonal antibody/HER2 dimerization inhibitory humanized monoclonal antibody
AF802 / RG7853 In-house
Alecensa
(Roche)
NSCLC (adjuvant)
#
Phase III alectinib
Alecensa
Oral
ALK inhibitor
RG6058 Roche SCLC Phase III
(in combination with RG7446)
tiragolumab

Injection
Anti-TIGIT human monoclonal antibody
NSCLC Phase III
(in combination with RG7446)
NSCLC (stage III) Phase III
(in combination with RG7446)
Esophageal cancer Phase III
(in combination with RG7446)
RG6171 Roche Breast cancer Phase III giredestrant

Oral
SERD (Selective Estrogen Receptor Degrader)
OBP-301 Oncolys BioPharma Esophageal cancer Phase II  
 
Injection
Oncolytic type 5 adenovirus
HCC Phase I
(in combination with RG7446 and RG435)
GC33 In-house HCC Phase I codrituzumab
 
Injection
Anti-Glypican-3 humanized monoclonal antibody
ERY974 In-house Solid tumors Phase I

Injection
Anti-Glypican-3/CD3 bispecific antibody
RG7421 Roche/Exelixis
Cotellic
Solid tumors Phase I cobimetinib

Oral
MEK inhibitor
RG7802 Roche Solid tumors Phase I cibisatamab

Injection
Anti-CEA/CD3 bispecific antibody
RG7828 Roche Hematologic tumors Phase I mosunetuzumab

Injection
Anti-CD20/CD3 bispecific antibody
RG6026 Roche Hematologic tumors Phase I glofitamab

Injection
Anti-CD20/CD3 bispecific antibody
AMY109 In-house Solid tumors Phase I

Injection
-
STA551 In-house Solid tumors Phase I

Injection
Anti-CD137 agonistic Switch antibody
SPYK04 In-house Solid tumors Phase I

Oral
-
RG6194 Roche Solid tumors Phase I

Injection
Anti-HER2/CD3 bispecific antibody

Bone and Joint Diseases

Development code Origin
Overseas name
(Collaborator)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Mode of Action
ED-71 In-house Osteoporosis Approved
(20/12)
China
eldecalcitol
Edirol
Oral
Activated vitamin D3 agent
NRD101 In-house Knee osteoarthritis
/Shoulder periarthritis
Phase III
(China)
purified sodium hyaluronate
Suvenyl
Injection
Sodium hyaluronate

Renal Diseases

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

Oral
NaPi-IIb, PiT-1, PiT-2 inhibitor

Autoimmune Diseases

Development code Origin
Overseas name
(Collaborator)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Mode of Action
RG7880 Roche Inflammatory bowel disease Phase I efmarodocokin alfa

Injection
Human IL-22 fusion protein

Neurology

Development code Origin
Overseas name
(Collaborator)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Mode of Action
SA237 / RG6168 In-house
Enspryng
(Roche)
Neuromyelitis optica spectrum disorder (NMOSD) Filed
(19/08)
EU
satralizumab
Enspryng
Injection
pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody
RG7916 Roche/PTC Therapeutics
Evrysdi
Spinal muscular atrophy (SMA) Filed
(20/10)
risdiplam

Oral
SMN2 splicing modifier
RG1450 Roche/MorphoSys Alzheimer’s disease Phase III gantenerumab

Injection
Anti-amyloid-beta human monoclonal antibody
RG6042 Roche/Ionis Pharmaceuticals Huntington’s disease Phase III tominersen

Injection
Antisense oligonucleotide targeting HTT mRNA
RG7906 Roche Schizophrenia Phase II ralmitaront

Oral
Partial TAAR1 agonist
RG7935 Roche/Prothena Parkinson’s disease Phase I prasinezumab

Injection
Anti-α-synuclein monoclonal antibody
GYM329 / RG6237 In-house

(Roche)
Neuromuscular disease Phase I

Injection
Anti-latent myostatin sweeping antibody
RG6100 Roche/AC Immune Alzheimer’s disease Phase I semorinemab

injection
Anti-tau humanized monoclonal antibody

Other diseases

Development code Origin
Overseas name
(Collaborator)
Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Mode of Action
MRA/RG1569 In-house
Actemra/RoActemra (EU)
COVID-19 pneumonia
#
Phase III*
(Japan)
tocilizumab
Actemra
Injection
Humanized anti-human IL-6 receptor monoclonal
antibody
RG7716 Roche Diabetic macular edema Phase III faricimab

Injection
Anti-VEGF/Ang2 bispecific antibody
Neovascular age related macular degeneration (nAMD) Phase III
Retinal vein occlusion Phase III
ACE910/RG6013 In-house
Hemlibra
Acquired hemophilia A
#
Phase III
(Japan)
emicizumab
Hemlibra
Injection
Anti-coagulation factor IXa/X humanized bispecific monoclonal antibody
SKY59/RG6107 In-house
 
(Roche)
Paroxysmal nocturnal hemoglobinuria
(PNH)
Phase III crovalimab
 
Injection
Anti-C5 recycling antibody
NXT007 In-house Hemophilia A Phase I/II

Injection
Anti-coagulation factor IXa/X bispecific antibody
PCO371 In-house Hypoparathyroidism Phase I  
 
Oral
PTH1 receptor agonist
AMY109 In-house Endometriosis Phase I  
 
Injection
-
RG6413/RG6412 Roche/Regeneron Pharmaceuticals COVID-19 Phase I casirivimab/imdevimab
 
Injection
SARS-CoV-2 Neutralizing antibody cocktail

In principle, completion of first dose is regarded as the start of clinical studies in each phase.
* Roche is conducting global Phase III studies of Actemra/RoActemra against COVID-19 pneumonia separately.

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