News Releases

2020

R&D
Sep.25.2020
Opdivo and Yervoy Combination Therapy Approved in Japan to Expand Use for the Treatment of Microsatellite Instability High (MSI-High) Colorectal Cancer, and Opdivo for Additional Dosage and Administration in Monotherapy Dosing Regimen (224KB)
R&D
Sep.25.2020
Opdivo (nivolumab) Significantly Improves Disease Free-Survival vs. Placebo as Adjuvant Therapy for Patients with High-Risk, Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial (138KB)
R&D
Sep.23.2020
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemotherapy as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer (117KB)
R&D
Sep.23.2020
Opdivo (nivolumab) Plus Chemotherapy Demonstrated Significant Overall and Progression-Free Survival Benefits Versus Chemotherapy in First-Line Treatment of Gastric and Esophageal Cancers (147KB)
R&D
Sep.23.2020
Opdivo (nivolumab) Demonstrated Superior Disease-Free Survival in Patients with Resected Esophageal or Gastroesophageal Junction Cancer Compared to Placebo in the Adjuvant Setting (116KB)
R&D
Sep.23.2020
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial (140KB)
R&D
Sep.22.2020
Phase II / III (ATTRACTION-4) Study Result Evaluating Opdivo in Combination with Chemotherapy in Patients with Unresectable Advanced or Recurrent Gastric Cancer Who are Previously Untreated with the First-line Therapy Presented at ESMO 2020 (143KB)
R&D
Sep.22.2020
Phase III Study Result Evaluating Opdivo in Combination with Bevacizumab and Chemotherapy in Chemotherapy-naïve Patients with Stage IIIB/IV or Recurrent Non-squamous Non-small Cell Lung Cancer Unsuitable for Radical Radiation Presented at ESMO 2020 (194KB)
R&D
Sep.18.2020
Four-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (120KB)
R&D
Sep.16.2020
European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma (118KB)
Products
Aug.26.2020
Launch of Ongentys® Tablets 25mg, a Peripheral COMT Inhibitor in Japan (177KB)
R&D
Aug.24.2020
FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen with DARZALEX® (daratumumab) and Dexamethasone in Both Once- and Twice-Weekly Dosing Regimens (139KB)
R&D
Aug.21.2020
ONO Receives a Supplemental Approval in Japan for Velexbru® Tablet 80mg, a BTK Inhibitor, for Additional Indication of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma (170KB)
R&D
Aug.12.2020
CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival (164KB)
R&D
Aug.12.2020
CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers (147KB)
R&D
Aug.11.2020
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma (118KB)
R&D
Aug.03.2020
Opdivo in Combination with Bevacizumab and Chemotherapy Demonstrates a Significant Improvement of Progression-Free Survival in Chemotherapy-naïve Patients with Stage IIIB/IV or Recurrent Non-squamous Non-small Cell Lung Cancer Unsuitable for Radical Radiation in Phase III Clinical Study (193KB)
Management / Finance
Jul.31.2020
Announcement on Financial Results for FY2020 1Q
R&D
Jul.30.2020
Development of Therapeutic Drugs for Novel Coronavirus Infection (COVID-19) (104KB)
CSR
Jul.15.2020
ONO Selected for “MSCI Japan ESG Select Leaders Index” for the 2nd consecutive year (141KB)
CSR
Jul.14.2020
Support for Relief Efforts to the Disaster Caused by Heavy Rain in July 2020 (98.7KB)
Corporate
Jul.06.2020
Notice regarding Filing an Appeal for a Lawsuit against the Company (115KB)
Management / Finance
Jul.03.2020
Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights) (105KB)
R&D
Jun.29.2020
Ono Receives a Manufacturing and Marketing Approval in Japan of "Ongentys® Tablets 25mg", a Peripheral COMT Inhibitor for the Improvement of Parkinson's Disease Patients with Motor Fluctuations (151KB)
R&D
Jun.29.2020
A Short-Acting Selective β1 Blocker, Onoact® for Intravenous Infusion 50mg/150mg Approved for Additional Indication of Tachyarrhythmia Associated with Sepsis in Japan (187KB)
R&D
Jun.29.2020
ONO Recieves Manufacturing and Marketing Approval in Japan for Parsabiv® Intravenous Injection Syringe for Dialysis, a Calcimimetic Agent (129KB)
Management / Finance
Jun.18.2020
Notice Concerning Issuance of Stock Options (Stock Acquisition Rights) (227KB)
R&D
Jun.11.2020
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy (118KB)
R&D
Jun.11.2020
Ono and Seikagaku Announce the Results from a Phase III Clinical Study in Japan of ONO-5704/SI-613 in Patients with Knee Osteoarthritis Presented at an Academic Conference (152KB)
R&D
Jun.05.2020
FOIPAN® Tablets, a Protease Enzyme Inhibitor, ONO Has Started Clinical Studies for Novel Coronavirus Infection (COVID-19) (102KB)
CSR
Jun.05.2020
ONO Joins RE100, an International Initiative Aiming to Use 100% Renewable Energy at its Business Operations (365KB)
R&D
Jun.05.2020
Opdivo® (Nivolumab) Intravenous Infusion Approved for Additional Indication of Unresectable Advanced or Recurrent Squamous Cell Carcinoma of Esophageal Cancer in Taiwan (192KB)
R&D
May.27.2020
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (134KB)
Products
May.20.2020
Launch of Velexbru® Tablet 80mg, a Bruton’s Tyrosine Kinase Inhibitor in Japan (221KB)
R&D
May.18.2020
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1% (157KB)
R&D
May.14.2020
Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Limited Chemotherapy Significantly Improves Overall Survival vs. Chemotherapy Alone for Patients with First-Line Metastatic Non-Small Cell Lung Cancer in CheckMate -9LA Study (116KB)
R&D
May.14.2020
Three-Year Data from CheckMate -227 Confirm Durable, Long-Term Survival Benefit for Opdivo (nivolumab) Plus Yervoy (ipilimumab) vs. Chemotherapy in Metastatic First-Line Non-Small Cell Lung Cancer Patients with PD-L1 ≥1% (153KB)
R&D
May.14.2020
ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand the Use for Treatment of Previously Untreated Unresectable Advanced or Recurrent Gastric Cancer in Japan (118KB)
Management / Finance
May.12.2020
Ono establishes a specified subsidiary and a local subsidiary in the US (120KB)
Management / Finance
May.12.2020
Announcement on Financial Results for FY2019
R&D
Apr.21.2020
Ono and Takeda Announce Results from Phase 3 CheckMate -9ER Study for Opdivo® (Nivolumab) and CABOMETYX® (Cabozantinib) Combination Therapy in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (188KB)
R&D
Apr.21.2020
Bristol Myers Squibb Announces Positive Topline Result from Pivotal Phase 3 Trial Evaluating Opdivo® (nivolumab) plus Yervoy® (ipilimumab) vs. Chemotherapy in Previously Untreated Malignant Pleural Mesothelioma (116KB)
R&D
Apr.13.2020
Opdivo® (Nivolumab) Intravenous Infusion Approved for Additional Indication of Unresectable Advanced or Recurrent Squamous Cell Carcinoma of Esophageal cancer in South Korea (142KB)
R&D
Apr.13.2020
U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-mutant Metastatic Colorectal Cancer (CRC) after Prior Therapy (144KB)
R&D
Apr.09.2020
Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer (116KB)
Corporate
Apr.08.2020
Announcement on Election of Provisional Audit & Supervisory Board Member (Temporary Acting Audit & Supervisory Board Member) (135KB)
Corporate
Apr.06.2020
Announcement on Candidates of Members of the Board of Directors, Members of Audit & Supervisory Board and Corporate Officers, and Resignation of Audit & Supervisory Board Member (115KB)
Licensing
Mar.30.2020
ONO Enters into a New Research and Option Agreement with Numab (126KB)
R&D
Mar.26.2020
ONO and BMSKK Submit Supplemental Application for Opdivo plus Yervoy in Combination Treatment with Chemotherapy in Japan to Expand the Use for First-Line Treatment of Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer (206KB)
R&D
Mar.25.2020
ONO Receives a Manufacturing and Marketing Approval for Velexbru® Tablet 80mg, a BTK inhibitor, for Treatment of Recurrent or Refractory Primary Central Nervous System Lymphoma in Japan (132KB)
R&D
Mar.12.2020
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib (117KB)
Licensing
Mar.05.2020
ONO and Nichi-Iko Enter into Licensing Agreement and Technical Collaboration for Limaprost Alfadex Tablets (95.7KB)
R&D
Mar.04.2020
ONO Submits Supplemental Application of BRAFTOVI® Capsule, a BRAF Inhibitor and MEKTOVI® Tablet, a MEK Inhibitor for Additional Indication of Unresectable, Advanced or Recurrent BRAF-Mutant Colorectal Cancer in Japan (115KB)
CSR
Mar.03.2020
ONO First Selected as a "2020 Health & Productivity Stock" (377KB)
R&D
Feb.27.2020
ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand the Use for Treatment of Unresectable Advanced or Recurrent Non-small Cell Lung Cancer, in Combination Treatment with Chemotherapy in Japan (200KB)
R&D
Feb.21.2020
ONO Receives Approval of Opdivo® (Nivolumab) for Additional Indications of Unresectable Advanced or Recurrent Esophageal Cancer, and MSI-High Unresectable Advanced or Recurrent Colorectal Cancer in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval (178KB)
R&D
Feb.21.2020
BMSKK and ONO Receive Approval of Orencia® for I.V. Infusion,
Orencia® Syringe for S.C. Injection and Orencia® Auto-injector for S.C. Injection,
a Selective T-cell Co-Stimulation Modulator in Japan, to Include the Description of Prevention of Structural Damage of Joints in Current Indication of Rheumatoid Arthritis (152KB)
R&D
Feb.17.2020
Updated CheckMate -025 Results Show 26% of Patients Treated with Opdivo are Alive at Five Years in Patients with Previously Treated Advanced or Metastatic Renal Cell Carcinoma (116KB)
R&D
Feb.17.2020
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 42-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (118KB)
R&D
Feb.03.2020
Bristol-Myers Squibb Withdraws European Application of Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (139KB)
Management / Finance
Jan.31.2020
Announcement on Financial Results for FY2019 3Q
R&D
Jan.24.2020
ONO Announces Result from Phase III Clinical Study Evaluating Opdivo® (Nivolumab) in Patients with Platinum-Refractory Advanced or Recurrent Ovarian Cancer (113KB)
CSR
Jan.20.2020
ONO Selected as a "Climate Change A List" Company in CDP 2019 for Two Consecutive Years (215KB)
R&D
Jan.16.2020
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in First-Line Non-Small Cell Lung Cancer (116KB)
R&D
Jan.06.2020
Ono and Seikagaku Submit a New Drug Application for Manufacturing and Marketing Approval for ONO-5704/SI-613 for the Treatment of Osteoarthritis in Japan (207KB)