Development Pipeline
View the status of our current development pipeline as of October 22, 2020.
Oncology
| Development code | Indication
# Additional indication |
Stage
(Date) |
Generic name
Product name Dosage form |
Origin Overseas name
(Collaborator) |
Mode of Action |
|---|---|---|---|---|---|
| RG7446 | Hepatocellular carcinoma # |
Approved (20/09) |
atezolizumab
Tecentriq Injection |
Roche
Tecentriq |
Engineered anti-PD-L1 monoclonal antibody |
| NSCLC (adjuvant)
# |
Phase III | ||||
| NSCLC (neoadjuvant)
# |
Phase III | ||||
| NSCLC (stage III)
# |
Phase III
(in combination with RG6058) |
||||
| Urothelial carcinoma
# |
Phase III | ||||
| Renal cell carcinoma (adjuvant)
# |
Phase III | ||||
| Renal cell carcinoma (2nd Line) # |
Phase III
(in combination with cabozantinib) |
Roche
Tecentriq (Takeda) |
|||
| Early breast cancer
# |
Phase III | Roche
Tecentriq |
|||
| Ovarian cancer
# |
Phase III | ||||
| Hepatocellular carcinoma (adjuvant)
# |
Phase III | ||||
| Head and neck carcinoma (adjuvant)
# |
Phase III | ||||
| Esophageal cancer
# |
Phase III
(in combination with RG6058) |
||||
| RG3502 | Breast cancer (adjuvant)
# |
Approved (20/08) |
trastuzumab emtansine
Kadcyla Injection |
Roche
Kadcyla |
Anti-HER2 antibody-tubulin polymerization inhibitor conjugate |
| RG435 | Hepatocellular carcinoma
# |
Approved (20/09) (in combination with RG7446) |
bevacizumab
Avastin Injection |
Roche
Avastin |
Anti-VEGF (Vascular Endothelial Growth Factor) humanized monoclonal antibody |
| Hepatocellular carcinoma (adjuvant)
# |
Phase III (in combination with RG7446) |
||||
| Small cell lung cancer (SCLC)
# |
Phase III (in combination with RG7446) |
||||
| RG7596 | Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) | Filed (20/06) |
polatuzumab vedotin
Injection |
Roche/Seattle Genetics Polivy |
Anti-CD79b antibody-drug conjugate |
| Diffuse large B-cell lymphoma (DLBCL) |
Phase III | ||||
| RG7440 | Prostate cancer | Phase III | ipatasertib
Oral |
Roche/Array BioPharma | AKT inhibitor |
| Breast cancer | Phase III | ||||
| RG6264 | Breast cancer
(Fixed-dose combination, subcutaneous injection) |
Phase III | trastuzumab/pertuzumab
Herceptin/Perjeta Injection |
Roche
Phesgo |
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 |
| RG6058 | SCLC | Phase III
(in combination with RG7446) |
tiragolumab
Injection |
Roche | 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 | Breast cancer | Phase III | Oral |
Roche | SERD (Selective Estrogen Receptor Degrader) |
| OBP-301 | Esophageal cancer | Phase II |
Injection |
Oncolys BioPharma | Oncolytic type 5 adenovirus |
| GC33 | Hepatocellular carcinoma | Phase I | codrituzumab
Injection |
In-house | Anti-Glypican-3 humanized monoclonal antibody |
| 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 |
| RG6026 | Hematologic tumors | Phase I | glofitamab Injection |
Roche | Anti-CD20/CD3 bispecific antibody |
| RG7461 | Solid tumors | Phase I | Injection |
Roche | Anti-FAP humanized antibody-engineered IL-2 variant fusion protein |
| AMY109 | Solid tumors | Phase I | Injection |
In-house | - |
| STA551 | Solid tumors | Phase I | Injection |
In-house | Anti-CD137 agonistic Switch antibody |
| SPYK04 | Solid tumors | Phase I | Oral |
In-house | - |
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 |
|---|---|---|---|---|---|
| SA237 / RG6168 | Neuromyelitis optica spectrum disorder (NMOSD) | Launched (20/08) Japan |
satralizumab
Enspryng Injection |
In-house
Enspryng (Roche) |
pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody |
|
Approved (20/08) US |
|||||
|
Filed (19/08) EU |
|||||
| RG7916 | Spinal muscular atrophy (SMA) | Filed
(20/10) |
risdiplam
Oral |
Roche/PTC Therapeutics
Evrysdi |
SMN2 splicing modifier |
| RG1450 | Alzheimer’s disease | Phase III | gantenerumab
Injection |
Roche/MorphoSys | Anti-amyloid-beta human monoclonal antibody |
| RG6042 | Huntington’s disease | Phase III | tominersen
Injection |
Roche/Ionis Pharmaceuticals | Antisense oligonucleotide targeting HTT mRNA |
| RG7906 | Schizophrenia | Phase II | ralmitaront
Oral |
Roche | Partial TAAR1 agonist |
| 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 |
| RG6100 | Alzheimer’s disease | Phase I | semorinemab
injection |
Roche/AC Immune | Anti-tau humanized monoclonal antibody |
Other diseases
| Development code | Indication
# Additional indication |
Stage
(Date) |
Generic name
Product name Dosage form |
Origin
Overseas name (Collaborator) |
Mode of Action |
|---|---|---|---|---|---|
| MRA/RG1569 | COVID-19 pneumonia # |
Phase III* Japan |
tocilizumab
Actemra Injection |
In-house
Actemra/RoActemra (EU) |
Humanized anti-human IL-6 receptor monoclonal antibody |
| RG7716 | Diabetic macular edema | Phase III | faricimab
Injection |
Roche | Anti-VEGF/Ang2 bispecific antibody |
| Neovascular age related macular degeneration (nAMD) | Phase III | ||||
| ACE910/RG6013 | Acquired hemophilia A # |
Phase III Japan |
emicizumab
Hemlibra Injection |
In-house
Hemlibra |
Anti-coagulation factor IXa/X humanized bispecific monoclonal antibody |
| SKY59/RG6107 | Paroxysmal nocturnal hemoglobinuria (PNH) |
Phase III | crovalimab
Injection |
In-house
(Roche) |
Anti-C5 recycling antibody |
| NXT007 | Hemophilia A | Phase I/II |
Injection |
In-house | Anti-coagulation factor IXa/X bispecific antibody |
| PCO371 | Hypoparathyroidism | Phase I |
Oral |
In-house | PTH1 receptor agonist |
| AMY109 | Endometriosis | Phase I |
Injection |
In-house | - |
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.
