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