Development Pipeline

Chugai’s development pipeline is categorized to Oncology, Immunology, Neuroscience, Hematology, Ophthalmology, and Other diseases. In addition, we disclose “Response to Requests from the MHLW Review Committee on Unapproved Drugs and Indications with High Medical Needs.”
View the status of our current development pipeline as of April 24, 2024 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 mid-size molecule drug discovery platforms. 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.
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 tumor tissue.
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 (licensed out to Roche) antibody
IV
ALPS12/RG6524
Anti-DLL3/CD3/CD137 trispecific antibody
Solid tumors ALPS12 is the first next-generation T-cell redirecting antibody applying Chugai’s proprietary Dual-Ig® technology. T-cell redirecting antibody (TRAB) is designed to guide T cells to the target cancer cells by activating and engaging T cells through its binding to CD3 on T cells. One of its challenges, however, is that it has limited antitumor killing ability against poorly T-cell infiltrated tumors. Dual-Ig® is a novel technology providing antibodies with the ability to induce CD137 signalling, a co-stimulating molecule, in addition to CD3 signalling. This property potentially results in more potent antitumor effect against poorly T-cell infiltrated tumors than conventional T-cell engagers.
In-house antibody
IV
SAIL66
Anti-CLDN6/CD3/CD137 trispecific antibody
CLDN6 positive solid tumors SAIL66 is the next-generation T-cell redirecting antibody applying Chugai’s proprietary Dual-Ig® technology. T-cell redirecting antibody (TRAB) is designed to guide T cells to the target cancer cells by activating and engaging T cells through its binding to CD3 on T cells. One of its challenges, however, is that it has limited antitumor killing ability against poorly T-cell infiltrated tumors. Dual-Ig® is a novel technology providing antibodies with the ability to induce CD137 signalling, a co-stimulating molecule, in addition to CD3 signalling. This property potentially results in more potent antitumor effect against poorly T-cell infiltrated tumors than conventional T-cell engagers.
In-house antibody
IV
ROSE12
Solid tumors ROSE12 is an antibody drug developed in-house by Chugai. It is applied to Switch Antibody technology and is expected to work selectively on tumor tissue.
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
avutometinib/VS-6766
RAF/MEK inhibitor
Recurrent LGSOC
NSCLC
mPDAC
Avutometinib 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
NSCLC
NSCLC (stage III)
Esophageal cancer
HCC
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/SC
mosunetuzumab/RG7828
Anti-CD20/CD3 bispecific antibody
Follicular lymphoma
relapsed or refractory aggressive B-cell non-Hodgkin 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
glofitamab/RG6026
Anti-CD20/CD3 bispecific antibody
Previously untreated large B-cell lymphoma 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
runimotamab/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 antibody
IV
cevostamab/RG6160
Anti-FcRH5/CD3 bispecific antibody
Relapsed or refractory multiple myeloma RG6160 is a humanized bispecific monoclonal antibody in-licensed from Roche against FcRH5/CD3 that binds to FcRH5 on myeloma cells and CD3 on T cells, and it is expected to activate cytotoxic T cell-mediated immunity and kill myeloma cells.
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
Solid tumors
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.
Roche small molecule
Oral
divarasib/RG6330
KRAS G12C inhibitor
Solid tumors RG6330 is designed as an orally available small molecule, and preclinical models showed potent and selective inhibition of the KRAS G12C protein. The combination with RG6433 will be expected synergistic anti-tumor activity.
Roche small molecule
Oral
migoprotafib/RG6433
SHP2 inhibitor
Solid tumors RG6433 is a potent, selective, and orally bioavailable small molecule SHP2 inhibitor that stabilizes SHP2 in a closed, auto-inhibited conformation. The combination with RG6330 will be expected synergistic anti-tumor activity.
Roche antibody
IV
tobemstomig/RG6139
Anti-PD-1/LAG-3 bispecific antibody
Solid tumors RG6139 is a bispecific antibody binding to PD-1 and LAG-3, which reinvigorates T cells by blocking two co-inhibitory checkpoint receptors. It preferentially targets tumor-reactive tumor infiltrating lymphocytes (TILs), and avoids immunosuppressive effects by preferential binding to effector T cells vs regulatory T cells (Tregs).

Immunology

In-house / Roche / Others Modality/
Administration
Generic name, Development Code, Mode of Action Indication Basic Information
In-house antibody
SC
DONQ52
Anti-HLA-DQ2.5/gluten peptides multispecific antibody
Celiac disease DONQ52 is a multispecific antibody against complex of HLADQ2.5/gluten peptides. DONQ52 directly inhibits gluten dependent T cell activation by neutralizing interaction of T cell receptor (TCR) and complex of HLA-DQ2.5/gluten peptides. DONQ52 covers >25 gluten derived peptides including all immunodominant gluten peptides for celiac disease. Gluten-specific blockade enables long-acting (subcutaneous injection) and high safety profile.
In-house antibody
RAY121
Autoimmune disease RAY121 is a therapeutic antibody that applies the recycling antibody® technology created by Chugai.
Roche nucleic acid
SC
RG6299
Antisense oligonucleotide targeting complement factor B mRNA
IgA nephropathy RG6299 is an ASO targeting complement factor B (CFB) mRNA. CFB is one of the molecules involved in activation of the alternative complement pathway that contributes to IgA nephropathy. After RG6299 specifically binds to CFB mRNA, synthesis of CFB is inhibited, which is expected to inhibit progression of IgA nephropathy.

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
Spinal muscular atrophy
Facioscapulohumeral muscular dystrophy (FSHD)
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 action, GYM329 is expected to improve the various conditions associated with muscle atrophy and loss of muscular strength.
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
trontinemab/RG6102
Anti-amyloid beta/TfR1 fusion protein
Alzheimer’s disease RG6102 is an anti-amyloid beta/TfR1 fusion protein 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 gene therapy
IV
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.

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
Lupus nephritis
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
(licensed out to Roche)
antibody
SC
NXT007/ RG6512
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
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.
Roche antibody
intravitreal injection
vamikibart/RG6179
Anti-IL-6 monoclonal antibody
Noninfectious uveitic macular edema RG6179 is an anti-IL-6 antibody that is administrated with IVT injection should inhibit IL-6 signaling specifically, and expected to reduce intraocular inflammation and vascular hyperfiltration improve macular edema and visual acuity with fewer progression of cataract and lower risk of increased intraocular pressure compared to steroids. RG6179 is engineered on Fc region to increase its systemic clearance and is expected that risk of systemic side-effects induction should be decreased.

Other diseases

In-house / Roche / Others Modality/
Administration
Generic name, Development Code, Mode of Action Indication Basic Information
In-house antibody
SC
AMY109
Anti-IL-8 recycling antibody
Endometriosis AMY109 is the third therapeutic antibody to apply the recycling antibody® 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
Anti-IL-31 receptor A humanized monoclonal antibody
Atopic dermatitis
Prurigo nodularis
Chronic kidney disease associated pruritus
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
orforglipron/LY3502970
Oral non-peptidic GLP-1 receptor agonist
Type 2 diabetes
Obesity
Orforglipron 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 orforglipron 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 orforglipron to Eli Lilly and Company.
In-house small molecule
IV
REVN24
Acute diseases REVN24 is a small molecule drug developed in-house by Chugai.

Response to Requests from the MHLW Review Committee on Unapproved Drugs and Indications with High Medical Needs (As of April 24, 2024)

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 Approved in June 2022
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 Approved in June 2022
CellCept Prevention of graft-versus-host disease in hematopoietic stem cell transplantation Approved in June 2021
CellCept Systemic sclerosis with interstitial lung disease (SSc-ILD) Submitted public knowledge-based sNDA filing in February 2024
CellCept Remission maintenance therapy following rituximab therapy for refractory nephrotic syndrome (frequently relapsing or steroid-dependent nephrotic syndrome) Submitted company opinion and waiting for evaluation by committee

*Transferred the marketing authorization holder of Xeloda to CHEPLAPHARM K.K. as of February 1, 2024

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