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