Development Pipeline

View the status of our current development pipeline as of October 24, 2019.

Development Pipeline (all disease areas) [PDF 348KB]

Oncology

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin Overseas name
(Collaborator)
Mode of Action
RG6268 Solid tumors [NTRK fusion-positive] Launched
(19/09)
entrectinib
Rozlytrek
Oral
Roche / Nerviano Medical Sciences ROS1/TRK inhibitor
Non-small cell lung cancer (NSCLC)
#
Filed
(19/03)
RG7446 Small cell lung cancer
#
Approved
(19/08)
atezolizumab
Tecentriq
Injection
Roche
Tecentriq
Engineered anti-PD-L1 monoclonal antibody
Breast cancer
#
Approved
(19/09)
NSCLC (adjuvant)
#
Phase III
NSCLC (neoadjuvant)
#
Phase III
Urothelial carcinoma
#
Phase III
Muscle invasive urothelial carcinoma (adjuvant) # Phase III
Renal cell carcinoma
#
Phase III
Renal cell carcinoma (adjuvant)
#
Phase III
Early breast cancer
#
Phase III
Ovarian cancer
#
Phase III
Hepatocellular carcinoma
#
Phase III
Head and neck carcinoma (adjuvant)
#
Phase III
Prostate cancer
#
Development discontinued
RG435 Renal cell carcinoma
#
Phase III bevacizumab
Avastin
Injection
Roche
Avastin
Anti-VEGF (Vascular Endothelial Growth Factor) humanized monoclonal antibody
Hepatocellular carcinoma
#
Phase III
RG3502 Breast cancer (adjuvant)
#
Filed
(19/08)
trastuzumab emtansine
Kadcyla
Injection
Roche
Kadcyla
Anti-HER2 antibody-tubulin polymerization inhibitor conjugate
RG7440 Prostate cancer Phase III ipatasertib

Oral
Roche/Array BioPharma AKT inhibitor
Breast cancer Phase III
RG7596 Diffuse large B-cell lymphoma
(DLBCL)
Phase III polatuzumab vedotin

Injection
Roche Anti-CD79b antibody-drug conjugate
RG6264 Breast cancer
(Fixed-dose combination, subcutaneous injection)
Phase III trastuzumab/pertuzumab
Herceptin / Perjeta
Injection
Roche
Herceptin / Perjeta
Anti-HER2 humanized monoclonal antibody/ HER2 dimerization inhibitory humanized monoclonal antibody
AF802 / RG7853 NSCLC (adjuvant)
#
Phase III alectinib
Alecensa
Oral
In-house
Alecensa
(Roche)
ALK inhibitor
GC33 Hepatocellular carcinoma Phase I codrituzumab
 
Injection
In-house Anti-Glypican-3 humanized monoclonal antibody
CKI27 Solid tumors Phase I

Oral
In-house Raf and MEK dual inhibitor
ERY974 Solid tumors Phase I

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

Oral
Roche/Exelixis
Cotellic
MEK inhibitor
RG7802 Solid tumors Phase I cibisatamab

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

Injection
Roche Anti-CD20/CD3 bispecific antibody

Bone and Joint Diseases

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

Renal Diseases

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

Oral
In-house -

Autoimmune Diseases

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
RG7845 Rheumatoid arthritis Phase I fenebrutinib

Oral
Roche BTK inhibitor
RG7880 Inflammatory bowel disease Phase I

Injection
Roche Human IL-22 fusion protein

Neurology

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

Injection
Roche/MorphoSys Anti-amyloid-beta human monoclonal antibody
SA237 / RG6168 Neuromyelitis optica spectrum disorder (NMOSD) Filed
US
satralizumab

Injection
In-house

(Roche)
Anti-IL-6 receptor recycling antibody
Filed
(19/08)
EU
Phase III
Japan
RG6042 Huntington’s disease Phase III

Injection
Roche/Ionis Pharmaceuticals Antisense oligonucleotide targeting HTTmRNA
RG6206 Duchenne muscular dystrophy (DMD) Phase II/III

Injection
Roche/Bristol-Myers Squibb Anti-myostatin adnectin
RG7916 Spinal muscular atrophy (SMA) Phase II/III risdiplam

Oral
Roche/PTC Therapeutics SMN2 splicing modifier
RG7935 Parkinson’s disease Phase I prasinezumab

Injection
Roche/Prothena Anti-α-synuclein monoclonal antibody
GYM329 / RG6237 Neuromuscular disease Phase I

Injection
In-house

(Roche)
Anti-latent myostatin sweeping antibody
RG7906 Psychiatric disorders Phase I

Oral
Roche

RG6100 Alzheimer’s disease Phase I

injection
Roche/AC Immune Anti-tau humanized monoclonal antibody
RG7314 Autism spectrum disorder Phase I balovaptan

Oral
Roche Vasopressin 1a receptor antagonist

Other diseases

Development code Indication
# Additional
indication
Stage
(Date)
Generic name
Product name
Dosage form
Origin
Overseas name
(Collaborator)
Mode of Action
RG7716 Diabetic macular edema Phase III faricimab

Injection
Roche Anti-VEGF/Ang2 bispecific antibody
Wet age-related macular degeneration Phase III
CIM331* Pruritus in dialysis patients Phase II nemolizumab
 
Injection
In-house
 
Anti-IL-31 receptor A humanized monoclonal antibody
SKY59/RG6107 Paroxysmal nocturnal hemoglobinuria
(PNH)
Phase I/II crovalimab
 
Injection
In-house
 
(Roche)
Anti-C5 recycling antibody
PCO371 Hypoparathyroidism Phase I  
 
Oral
In-house PTH1 receptor agonist
AMY109 Endometriosis Phase I  
 
Injection
In-house -
NXT007 Hemophilia A Phase I

Injection
In-house Anti-FIXa/FX bispecific 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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