CSBio CSBio

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Applicable","newsHeadline":"Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Delta-Fly Pharma","sponsor":"Nippon Shinyaku","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phase 3 Study of DFP-10917 in the R\/R AML Patients Shall Be Done with the 1st Interim Analysis for NDA Approval.","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Delta-Fly Pharma"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Hutchmed","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Takeda Pharmaceutical"},{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LENVIMA\u00ae (lenvatinib) Plus KEYTRUDA\u00ae (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas Submits New Drug Application for Zolbetuximab in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Hutchmed","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda and Hutchmed Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Takeda Pharmaceutical"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Accepts Astellas\u2019 Marketing Authorization Application for Zolbetuximab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"China\u2019s National Medical Products Administration Accepts Astellas\u2019 Biologics License Application for Zolbetuximab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Eisai","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-010 Trial Evaluating LENVIMA\u00ae (lenvatinib) Plus KEYTRUDA\u00ae (pembrolizumab) in Patients With Certain Types of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Validates Type II Variation for Astellas' XTANDI\u00ae (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"China\u2019s National Medical Products Administration Accepts New Drug Application for XTANDI\u00ae (enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Daiichi Sankyo","sponsor":"AstraZeneca","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Datopotamab Deruxtecan Demonstrated Statistically Significant and Clinically Meaningful Progression-Free Survival Benefit in Patients With HR-Positive, HER2-Low or Negative Breast Cancer in Tropion-Breast01 Phase III Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Daiichi Sankyo"},{"orgOrder":0,"company":"Eisai","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Two Phase 3 Trials Evaluating LENVIMA\u00ae (lenvatinib) Plus KEYTRUDA\u00ae (pembrolizumab) in Patients With Certain Types of Metastatic Non-Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Daiichi Sankyo","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"$22,000.0 million","upfrontCash":"$5,500.0 million","newsHeadline":"Daiichi Sankyo and Merck Announce Global Development and Commercialization Collaboration for Three Daiichi Sankyo DXd ADCs","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Daiichi Sankyo"},{"orgOrder":0,"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tecentriq plus Chemotherapy and Avastin Reduced the Risk of Disease Worsening or Death in Phase III study in People with Extensive-stage Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Chugai Pharmaceutical"},{"orgOrder":0,"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chugai Files for Additional Indication of Alecensa for Postoperative Adjuvant Therapy for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Chugai Pharmaceutical"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Validates Type II Variation Application for PADCEV\u00ae (enfortumab vedotin) with KEYTRUDA\u00ae (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Daiichi Sankyo","sponsor":"AstraZeneca","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Daiichi Sankyo"}]

Find Oncology Drugs in Phase III Clinical Development in JAPAN

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            DS-1062a (datopotamab deruxtecan) is an investigational TOP1 & TROP2 directed ADC comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, which is being evaluated for the treatment of advanced nonsquamous non-small cell lung cancer.

            Lead Product(s): Datopotamab Deruxtecan

            Therapeutic Area: Oncology Product Name: DS-1062a

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: AstraZeneca

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 19, 2024

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            Padcev (enfortumab vedotin-ejfv) is a nectin-4 inhibitor ADC Keytruda (pembrolizumab) is a USFDA approved, PD-1 inhibitor, approved product which is being evaluated in phase 3 clinical trials for the adjuvant therapy in patients with renal cell carcinoma (RCC) following nephrectomy.Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

            Lead Product(s): Enfortumab Vedotin-ejfv,Pembrolizumab

            Therapeutic Area: Oncology Product Name: Padcev

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 26, 2024

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            IMAB362 (zolbetuximab) is a chimeric IgG1 monoclonal antibody that binds to claudin 18.2 (CLDN18.2). It is being evaluated in phase 3 studies for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

            Lead Product(s): Zolbetuximab,Oxaliplatin,Capecitabine

            Therapeutic Area: Oncology Product Name: IMAB362

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 08, 2024

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            Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is under phase 3 clinical trials for postoperative adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.

            Lead Product(s): Alectinib Hydrochloride

            Therapeutic Area: Oncology Product Name: Alecensa

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2023

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            Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) and platinum-based chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), met its primary endpoint of progression-free survival (PFS).

            Lead Product(s): Atezolizumab,Bevacizumab

            Therapeutic Area: Oncology Product Name: Tecentriq

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 24, 2023

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            Under the collaboration, the companies will jointly develop and potentially commercialize Daiichi’s first-in-class DXd ADC candidates, patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), worldwide, except in Japan.

            Lead Product(s): Patritumab Deruxtecan

            Therapeutic Area: Oncology Product Name: HER3-DXd

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Merck & Co

            Deal Size: $22,000.0 million Upfront Cash: $5,500.0 million

            Deal Type: Collaboration October 19, 2023

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            Dato-DXd (datopotamab deruxtecan) is an investigational TROP2 directed ADC comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, which is investigated for the treatment of HR)-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer.

            Lead Product(s): Datopotamab Deruxtecan

            Therapeutic Area: Oncology Product Name: Dato-DXd

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: AstraZeneca

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2023

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            LENVIMA (lenvatinib) capsule is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the VEGF receptors and is being evaluated in combination with pembrolizumab in patients with Metastatic Non-Small Cell Lung Cancer.

            Lead Product(s): Lenvatinib,Pembrolizumab

            Therapeutic Area: Oncology Product Name: Lenvima

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Merck & Co

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2023

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            Xtandi (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. It decreased proliferation, tumor volume and induced cell death of prostate cancer cells.

            Lead Product(s): Enzalutamide

            Therapeutic Area: Oncology Product Name: Xtandi

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 19, 2023

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            Xtandi® (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. It decreased proliferation, tumor volume and induced cell death of prostate cancer cells.

            Lead Product(s): Enzalutamide,Leuprolide Acetate

            Therapeutic Area: Oncology Product Name: Xtandi

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 12, 2023

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