Development Pipeline

Chugai’s development pipeline is categorized to Oncology, Autoimmune Diseases, Neurology, and Other diseases.
View the status of our current development pipeline as of Apr 25, 2022 in a PDF format.

Basic Information on Development Pipeline*
*Exclude products that have already obtained regulatory approval

Oncology

In-house / Roche / Others Modality/
Administration
Generic name, Development Code, Mode of Action Indication Basic Information
In-house mid-size molecule
Oral
LUNA18
RAS inhibitor
Solid tumors LUNA18, the first project in mid-size molecule drug project, is an orally administrable cyclic peptide molecule created by Chugai’s unique APOLLO* platform. It inhibits protein-protein interaction between RAS and GEF to retain RAS in an inactive state. LUNA18 exhibits growth inhibitory activity against tumor cells with various RAS alterations (mutations or amplifications) and can be expected to have anti-tumor effects against cancers with RAS alterations where there are no therapeutic drugs yet.
  • *APOLLO: Artificial, Peptidic, Orally available, Limitlessly Localizable Omicron
In-house antibody
IV
codrituzumab/GC33
Anti-Glypican-3 humanized monoclonal antibody
HCC GC33, a humanized monoclonal antibody created by Chugai, targets glypican-3 (GPC3), which is specifically expressed in hepatocellular carcinoma.
In-house antibody
IV
ERY974
Anti-Glypican-3/CD3 bispecific antibody
Solid tumors ERY974 is the first T-cell redirecting antibody (TRAB) developed by Chugai. TRAB is a bispecific antibody that creates a short bridge between CD3 on T cells and tumor antigen on tumor cells to activate T cells in a tumor antigen-dependent manner, and is expected to demonstrate strong cytotoxicity against tumor cells.
In-house antibody
IV
STA551
Anti-CD137 agonistic Switch antibody
Solid tumors STA551, a “switch antibody,” is the first application of switch antibody technology, which was developed by Chugai. Switch antibodies bind to the target antigen only where there is a high concentration of a certain “switch” molecule, which is concentrated specifically at the diseased site. STA551 binds to CD137 and activates T cells in the presence of the switch molecule ATP, but not in the absence of ATP. It therefore promises to act selectively on tumors.
In-house
(licensed out to Roche)
antibody
IV
SOF10/RG6440
Anti-latent TGF-β1 monoclonal antibody
Solid tumors SOF10, a monoclonal antibody created by Chugai, binds to latent TGF-β1 and inhibit the activation. By changing the immunosuppressive tumor microenvironment, such as developing fibrosis of tumor tissue, an anti-tumor effect is expected against cancers where anti-cancer drugs do not respond.
In-house small molecule
Oral
SPYK04
Solid tumors SPYK04 is a small molecule drug developed in-house by Chugai.
In-house
(licensed out to 3rd party)
small molecule
Oral
CKI27
RAF/MEK inhibitor
Ovarian cancer
NSCLC
CKI27 is an oral RAF/MEK inhibitor developed in-house by Chugai.
In January 2020, Chugai granted Verastem Oncology an exclusive worldwide license to manufacture, develop and commercialize CKI27.
Roche antibody
IV
tiragolumab/RG6058
Anti-TIGIT human monoclonal antibody
SCLC
NSCLC
NSCLC (stage III)
Esophageal cancer
RG6058 is an anti-TIGIT monoclonal antibody in-licensed from Roche. TIGIT is an immune checkpoint expressed on the surface of NK cells and T cells that binds to poliovirus receptors (PVR) expressed on tumor cell surfaces. This binding is thought to allow the cancer cells to evade attack by immune cells. RG6058 restores and maintains the immune response of NK cells and T cells by blocking the binding of TIGIT to PVR, and is thus expected to demonstrate efficacy against cancer cells.
Roche antibody
IV
mosunetuzumab/RG7828
Anti-CD20/CD3 bispecific antibody
Follicular lymphoma RG7828 is a bispecific antibody in-licensed from Roche. It is expected to activate T cells and attack tumor cells by crosslinking CD3 on T cells to CD20 on B cells.
Roche antibody
IV
cibisatamab/RG7802
Anti-CEA/CD3 bispecific antibody
Solid tumors RG7802, a bispecific antibody in-licensed from Roche, is expected to activate T cells and attack tumor cells by crosslinking CD3 on T-cells to carcinoembryonic antigen (CEA) on tumor cells.
Roche antibody
IV
glofitamab/RG6026
Anti-CD20/CD3 bispecific antibody
Hematologic tumors RG6026 is a bispecific antibody in-licensed from Roche. By cross-linking CD3 on T cells with CD20 on B cells, it is expected to cause T-cell activation and proliferation and attack on the target B cells through cytokine release, resulting in antitumor effect.
Roche antibody
IV
RG6194
Anti-HER2/CD3 bispecific antibody
Solid tumors RG6194, an anti-HER2/CD3 bispecific antibody in-licensed from Roche, is expected to act against HER2-expressing cancer cells by inducing and activating T cells.
Roche small molecule
Oral
ipatasertib/RG7440
AKT inhibitor
Prostate cancer RG7440 is an AKT inhibitor in-licensed from Roche.
Roche small molecule
Oral
giredestrant/RG6171
Selective Estrogen Receptor Degrader (SERD)
Breast cancer
Breast cancer (adjuvant)
RG6171 is a selective estrogen receptor degrader (SERD) in-licensed from Roche. It is expected to exert a stronger anti-estrogen effect by promoting the degradation of ER as well as competitively inhibiting estrogen receptor binding.
Roche small molecule
Oral
pralsetinib/RG6396
RET inhibitor
NSCLC RG6396 is a RET inhibitor designed to selectively target rearranged during transfection (RET) alterations, including fusions and mutations, regardless of the tissue of origin.
Roche small molecule
Oral
cobimetinib/ RG7421
MEK inhibitor
Solid tumors RG7421 is an MEK inhibitor in-licensed from Roche.

Immunology

In-house / Roche / Others Modality/
Administration
Generic name, Development Code, Mode of Action Indication Basic Information
Roche non-antibody protein
IV
efmarodocokin alfa/RG7880
Human IL-22 fusion protein
Inflammatory bowel disease RG7880 is a human IL-22 fusion protein in-licensed from Roche. It is expected to demonstrate efficacy in treating inflammatory bowel disease by directly promoting the regenerative and protective functions of IL-22 in epithelial tissue.

Neuroscience

In-house / Roche / Others Modality/
Administration
Generic name, Development Code, Mode of Action Indication Basic Information
In-house
(licensed out to Roche)
antibody
SC
GYM329/RG6237
Anti-latent myostatin sweeping antibody
Neuromuscular disease GYM329, created by Chugai, is a next-generation antibody that applies Chugai’s proprietary antibody engineering technologies, including its recycling antibody and sweeping antibody technologies. Latent myostatin is an inactive form that is mainly secreted from muscle cells, and is activated by BMP-1 and other protein degrading enzymes. Activated myostatin inhibits muscle growth and hypertrophy, and by inhibiting myostatin, GYM329 is expected to improve the various conditions associated with muscle atrophy and loss of muscular strength.
Roche antibody
SC
gantenerumab/RG1450
Anti-amyloid-beta human monoclonal antibody
Alzheimer’s disease RG1450 targets aggregate amyloid beta, with a high binding affinity to plaques in particular. It is expected to reduce cognitive deterioration by removing amyloid beta in the brain.
Roche antibody
IV
prasinezumab/RG7935
Anti-α-synuclein monoclonal antibody
Parkinson’s disease RG7935 is a monoclonal antibody that targets α-synuclein. It slows the expansion of nerve cell death by inhibiting the cell-to-cell propagation of aggregated forms of neurotoxic α-synuclein, and is expected to reduce and delay progression of the disease.
Roche antibody
IV
semorinemab/RG6100
Anti-tau humanized monoclonal antibody
Alzheimer’s disease RG6100 binds to tau proteins found in the extracellular space of the brain, and is expected to slow the deterioration of cognitive functions in Alzheimer’s disease by halting the propagation of tau via neurons.
Roche antibody
IV
RG6102
Anti-amyloid beta/TfR1 fusion protein
Alzheimer’s disease RG6102 is gantenerumab (RG1450) with a novel transferrin receptor (TfR1) binding Ab moiety to achieve efficient transport over the BBB and target Aβ engagement in the brain. It is potential for superior Aβ clearance in brain to delay progression of Alzheimer’s disease.
Roche nucleic acid
IV
tominersen/RG6042
Antisense oligonucleotide targeting HTT mRNA
Huntington’s disease RG6042 is an ASO targeting human HTT mRNA, which is believed to be the cause of Huntington’s disease. It has the potential to delay or slow disease progression in people with Huntington’s disease by binding specifically to HTT mRNA, after which synthesis of the HTT protein is inhibited.
Roche
(development under 3rd party)
gene therapy
Intramuscular injection
RG6356/SRP-9001
Micro-dystrophin gene therapy
Duchenne muscular dystrophy (DMD) RG6356 is an investigational gene transfer therapy developed for targeted muscle expression of micro-dystrophin, a shortened, functional dystrophin protein, that addresses the genetic cause of DMD. Sarepta manages the global study including Japan.
Roche small molecule
Oral
ralmitaront /RG7906
Partial TAAR1 agonist
Schizophrenia RG7906 has the novel pharmacological action of working as a partial agonist of trace amino-associated receptor Type 1 (TAAR1).

Hematology

In-house / Roche / Others Modality/
Administration
Generic name, Development Code, Mode of Action Indication Basic Information
In-house
(licensed out to Roche)
antibody
SC
crovalimab (SKY59)/RG6107
Anti-C5 recycling antibody
Paroxysmal nocturnal hemoglobinuria (PNH)
Atypical hemolytic uremic syndrome
(aHUS)Chronic sickle cell disease
SKY59 is a recycling antibody discovered by Chugai that inhibits the C5 complement component. The onset of a number of diseases is reported to be caused by complement activation. SKY59 is expected to inhibit cleavage of C5 to C5a and C5b, thus suppressing complement activation and improving disease conditions. In PNH, SKY59 may have a suppressive effect on hemolysis by preventing the destruction of red blood cells. Application of multiple Chugai proprietary antibody engineering technologies resulted in a prolonged half-life, and the antibody is being developed as a subcutaneous self-injection.
In-house antibody
SC
NXT007
Anti-coagulation factor IXa/X bispecific antibody
Hemophilia A NXT007, created by Chugai, is a bispecific antibody that stimulates blood coagulation using the same mode of action as Hemlibra. It is applied with Chugai’s antibody engineering technologies FAST-Ig, which enhances large-scale production of the bispecific antibody and ACT-Fc, which is expected to improve antibody pharmacokinetics. NXT007 is expected to achieve the levels of hemostasis found in healthy adults and children, and is being developed to improve convenience, including the administration device.

Ophthalmology

In-house / Roche / Others Modality/
Administration
Generic name, Development Code, Mode of Action Indication Basic Information
Roche antibody faricimab/ RG7716
Anti-VEGF/Ang2 bispecific antibody
Diabetic macular edema Neovascular age related macular degeneration (nAMD)
Retinal vein occlusion
RG7716, which Chugai in-licensed from Roche, is the first bispecific antibody for ophthalmology diseases. It selectively binds to vascular endothelial growth factor A (VEGF-A), a key mediator of angiogenesis and vascular permeability, and angiopoietin-2 (Ang-2, an antagonist of Ang-1, which contributes to the stability of mature vessels), a destabilizer of chorioretinal vessels and inducer of vascular permeability. By simultaneously neutralizing intraocular VEGF-A and Ang-2 in wAMD and DME patients, RG7716 is expected to demonstrate better treatment outcomes and a more sustained effect than the anti-VEGF drugs that are the current standard of care.
Roche antibody
injection via implant
ranibizumab (Port Delivery System)/ RG6321 Neovascular
Age-related macular degeneration (nAMD)
Diabetic macular edema
“RG6321” is Port Delivery System with ranibizumab. Ranibizumab is a Fab fragment of a recombinant humanized monoclonal antibody against vascular endothelial growth factor A (VEGF-A), and is already sold and supplied worldwide as Lucentis® for intravitreal administration. This product is expected to maintain visual acuity without frequent dosing by the long-term and sustained release of ranibizumab from ocular implant with the highest formulation concentration.

Other diseases

In-house / Roche / Others Modality/
Administration
Generic name, Development Code, Mode of Action Indication Basic Information
In-house antibody
SC
AMY109
Endometriosis AMY109 is the third therapeutic antibody to apply the recycling antibody engineering technology created by Chugai. Its approach differs from hormone therapy, which is the standard treatment for endometriosis, and its anti-inflammatory action is expected to provide new value to patients.
In-house
(licensed out to 3rd party)
antibody
SC
nemolizumab/CIM331
Anti-IL-31 receptor A humanized monoclonal antibody
Atopic dermatitis
Prurigo nodularis
CIM331 (nemolizumab) is an anti-IL-31 receptor A humanized monoclonal antibody originating from Chugai. The drug is expected to improve itching and skin inflammation in atopic dermatitis by blocking IL-31, a proinflammatory cytokine, from binding to its receptor.
In July 2016, Chugai entered into a global license agreement granting Galderma S.A. of Switzerland exclusive rights for the development and marketing of nemolizumab worldwide, with the exception of Japan and Taiwan. In September 2016, Chugai entered into a license agreement granting Maruho Co., Ltd., the rights for the development and marketing of nemolizumab in the skin disease area for the Japanese market. In March 2022, Maruho received regulatory approval for nemolizumab in the treatment of itching associated with atopic dermatitis (only when existing treatment is insufficiently effective) in Japan. (Product name: Mitchga)
In-house
(licensed out to 3rd party)
small molecule
Oral
OWL833
Oral non-peptidic GLP-1 receptor agonist
Type 2 diabetes
Obesity
OWL833 is an oral non-peptidic GLP-1 receptor agonist created by Chugai. GLP-1 agonists have potent hypoglycemic action and induce weight loss, but convenience for patients has been an issue because they are conventionally administered in a subcutaneous injection. Because OWL833 is orally bioavailable, it is easier for patients to take, and is thus expected to contribute to the treatment of diabetes, including through improvement of drug adherence.
In September 2018, Chugai licensed the worldwide development and commercialization rights for OWL833 to Eli Lilly and Company.

Response to Requests from the MHLW Review Committee on Unapproved Drugs and Indications with High Medical Needs (As of April 25, 2022)

Development
Request
Product Indication Development Status
First
development
request
Xeloda Advanced or recurrent gastric cancer Approved in February 2011
Tarceva Advanced or recurrent pancreatic cancer Approved in July 2011
Avastin Advanced or recurrent breast cancer Approved in September 2011
CellCept Pediatric renal transplant Approved in September 2011
Herceptin Q3W dosage metastatic breast cancer overexpressing HER2 Approved in November 2011
Neoadjuvant breast cancer overexpressing HER2
Kytril Gastrointestinal symptoms associated with radiotherapy Approved in December 2011
Pulmozyme Improvement of pulmonary function in patients with cystic fibrosis Approved in March 2012
Bactramin Treatment and prevention of pneumocystis pneumonia Approved in August 2012
Avastin Ovarian cancer Approved in November 2013
Second
development
request
Avastin Recurrent glioblastoma Approved in June 2013 (Malignant glioma)
Herceptin Q1W dosage postoperative adjuvant breast cancer overexpressing
HER2
Approved in June 2013
CellCept Lupus nephritis Approved in May 2016
Third development request Tamiflu Additional dosage for neonates and infants younger than 12 months Approved in March 2017
Xeloda Adjuvant chemotherapy in rectal cancer Approved in August 2016
Avastin Additional Q2W dosage and administration for ovarian cancer Evaluated by the Review Committee in December 2021 as eligible for public knowledge-based application; application approved February 4, 2022, by the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council
Fourth development request Copegus Improvement of viraemia associated with genotype 3 chronic hepatitis C or compensated cirrhosis related to hepatitis C when administered in combination with sofosbuvir Approved in March 2017
Xeloda Neuroendocrine tumor Submitted company opinion and waiting for evaluation by committee
Avastin Cerebral edema induced by radiation necrosis Submitted company opinion and waiting for evaluation by committee
Neutrogin Combination therapy with chemotherapy including fludarabine for relapsed/refractory acute myeloid leukemia Evaluated by the Review Committee in December 2021 as eligible for public knowledge-based application; application approved February 4, 2022, by the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council
CellCept Prevention of graft-versus-host disease in hematopoietic stem cell transplantation Approved in June 2021
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