2020.

• Dec.25.2020 R & D

  Bristol Myers Squibb Announces Update on Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme(115 KB)

• Dec.21.2020 Products

  Launch of Parsabiv® Intravenous Injection Syringe for Dialysis, a Calcimimetic Agent in Japan(168 KB)

• Dec.17.2020 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for First-Line Treatment of Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer in South Korea(238 KB)

• Dec.15.2020 Licensing

  ONO Enters into Exclusive License Agreement with Chordia Therapeutics on CTX-177, a MALT1 Inhibitor, and its Related Compounds(131 KB)

• Dec.10.2020 R & D

  ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand the Use for Treatment of Unresectable Advanced or Recurrent Gastric Cancer in Japan(144 KB)

• Dec.09.2020 Sustainability

  ONO Selected as an “A List Company” for Climate Change in CDP 2020 for the Third Consecutive Year(212 KB)

• Nov.30.2020 R & D

  Forxiga approved in Japan for the treatment of chronic heart failure(316 KB)

• Nov.27.2020 R & D

  Combination Therapy concerning Opdivo and Yervoy Approved in Japan for First–Line Treatment of Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer(204 KB)

• Nov.27.2020 R & D

  ONO Receives Approval 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(194 KB)

• Nov.27.2020 R & D

  New Treatment Regimen Available for KYPROLIS® for Intravenous Injection, a Proteasome Inhibitor, in Combination with Darzalex® plus Dexamethasone for Treatment of Relapsed or Refractory Multiple Myeloma in Japan(136 KB)

• Nov.26.2020 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(111 KB)

• Nov.17.2020 Sustainability

  ONO Selected for the First Time for DJSI World Index and DJSI Asia Pacific Index(204 KB)

• Nov.09.2020 R & D

  FOIPAN® Tablets, a Protease Enzyme Inhibitor, Started Clinical Study in Patients with Novel Coronavirus Infection (COVID-19)(99 KB)

• Nov.09.2020 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer(114 KB)

• Nov.09.2020 Licensing

  ONO and Bristol Myers Squibb Enter Patent License Agreement with Roche(129 KB)

• Oct.29.2020 Management / Finance

  Announcement on Financial Results for FY2020 2Q

• Oct.27.2020 R & D

  Ono and Takeda Submit Supplemental Application for Opdivo® (Nivolumab) and CABOMETYX® (Cabozantinib) Combination Therapy in Japan to Expand the Use for Treatment of Unresectable or Metastatic Renal Cell Carcinoma(127 KB)

• Oct.27.2020 R & D

  ONO and BMSKK Submit Supplemental Applications for Opdivo and Yervoy in Combination Treatment to Expand the Use for First-line Treatment of Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma in Japan(189 KB)

• Oct.20.2020 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Applications for OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Advanced Renal Cell Carcinoma(116 KB)

• Oct.19.2020 R & D

  Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(113 KB)

• Oct.13.2020 Licensing

  Ono Enters into License Agreement on Cenobamate, an Antiepileptic Drug with SK Biopharmaceuticals(156 KB)

• Oct.08.2020 R & D

  Opdivo (nivolumab) Plus Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial(115 KB)

• Oct.05.2020 R & D

  Bristol Myers Squibb Announces Update on CheckMate -915 Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus Opdivo in Resected High-Risk Melanoma Patients(138 KB)

• Oct.05.2020 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma(114 KB)

• Sep.25.2020 R & D

  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(135 KB)

• Sep.25.2020 R & D

  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(219 KB)

• Sep.23.2020 R & D

  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(136 KB)

• Sep.23.2020 R & D

  Opdivo (nivolumab) Demonstrated Superior Disease-Free Survival in Patients with Resected Esophageal or Gastroesophageal Junction Cancer Compared to Placebo in the Adjuvant Setting(113 KB)

• Sep.23.2020 R & D

  Opdivo (nivolumab) Plus Chemotherapy Demonstrated Significant Overall and Progression-Free Survival Benefits Versus Chemotherapy in First-Line Treatment of Gastric and Esophageal Cancers(143 KB)

• Sep.23.2020 R & D

  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(114 KB)

• Sep.22.2020 R & D

  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(190 KB)

• Sep.22.2020 R & D

  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(140 KB)

• Sep.18.2020 R & D

  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(117 KB)

• Sep.16.2020 R & D

  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(115 KB)

• Aug.26.2020 Products

  Launch of Ongentys® Tablets 25mg, a Peripheral COMT Inhibitor in Japan(173 KB)

• Aug.24.2020 R & D

  FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen with DARZALEX® (daratumumab) and Dexamethasone in Both Once- and Twice-Weekly Dosing Regimens(136 KB)

• Aug.21.2020 R & D

  ONO Receives a Supplemental Approval in Japan for Velexbru® Tablet 80mg, a BTK Inhibitor, for Additional Indication of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma(166 KB)

• Aug.12.2020 R & D

  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(143 KB)

• Aug.12.2020 R & D

  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(160 KB)

• Aug.11.2020 R & D

  Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma(115 KB)

• Aug.03.2020 R & D

  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(188 KB)

• Jul.31.2020 Management / Finance

  Announcement on Financial Results for FY2020 1Q

• Jul.30.2020 R & D

  Development of Therapeutic Drugs for Novel Coronavirus Infection (COVID-19)(102 KB)

• Jul.15.2020 Sustainability

  ONO Selected for “MSCI Japan ESG Select Leaders Index” for the 2nd consecutive year(137 KB)

• Jul.14.2020 Sustainability

  Support for Relief Efforts to the Disaster Caused by Heavy Rain in July 2020(96 KB)

• Jul.06.2020 Corporate

  Notice regarding Filing an Appeal for a Lawsuit against the Company(112 KB)

• Jul.03.2020 Management / Finance

  Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights)(102 KB)

• Jun.29.2020 R & D

  ONO Recieves Manufacturing and Marketing Approval in Japan for Parsabiv® Intravenous Injection Syringe for Dialysis, a Calcimimetic Agent(129 KB)

• Jun.29.2020 R & D

  A Short-Acting Selective β₁ Blocker, Onoact® for Intravenous Infusion 50mg/150mg Approved for Additional Indication of Tachyarrhythmia Associated with Sepsis in Japan(186 KB)

• Jun.29.2020 R & D

  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(151 KB)

• Jun.18.2020 Management / Finance

  Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)(222 KB)

• Jun.11.2020 R & D

  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(148 KB)

• Jun.11.2020 R & D

  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(115 KB)

• Jun.05.2020 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Additional Indication of Unresectable Advanced or Recurrent Squamous Cell Carcinoma of Esophageal Cancer in Taiwan(187 KB)

• Jun.05.2020 R & D

  FOIPAN® Tablets, a Protease Enzyme Inhibitor, ONO Has Started Clinical Studies for Novel Coronavirus Infection (COVID-19)(100 KB)

• Jun.05.2020 Sustainability

  ONO Joins RE100, an International Initiative Aiming to Use 100% Renewable Energy at its Business Operations(357 KB)

• May.27.2020 R & D

  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(130 KB)

• May.20.2020 Products

  Launch of Velexbru® Tablet 80mg, a Bruton’s Tyrosine Kinase Inhibitor in Japan(216 KB)

• May.18.2020 R & D

  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%(153 KB)

• May.14.2020 R & D

  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(115 KB)

• May.14.2020 R & D

  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%(149 KB)

• May.14.2020 R & D

  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(113 KB)

• May.12.2020 Management / Finance

  Announcement on Financial Results for FY2019

• May.12.2020 Corporate

  Ono establishes a specified subsidiary and a local subsidiary in the US(117 KB)

• Apr.21.2020 R & D

  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(113 KB)

• Apr.21.2020 R & D

  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(183 KB)

• Apr.13.2020 R & D

  U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAF^V600E-mutant Metastatic Colorectal Cancer (CRC) after Prior Therapy(140 KB)

• Apr.13.2020 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Additional Indication of Unresectable Advanced or Recurrent Squamous Cell Carcinoma of Esophageal cancer in South Korea(139 KB)

• Apr.09.2020 R & D

  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(113 KB)

• Apr.08.2020 Corporate

  Announcement on Election of Provisional Audit & Supervisory Board Member (Temporary Acting Audit & Supervisory Board Member)(132 KB)

• Apr.06.2020 Corporate

  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(117 KB)

• Mar.30.2020 Licensing

  ONO Enters into a New Research and Option Agreement with Numab(123 KB)

• Mar.26.2020 R & D

  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(201 KB)

• Mar.25.2020 R & D

  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(129 KB)

• Mar.12.2020 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib(115 KB)

• Mar.05.2020 Licensing

  ONO and Nichi-Iko Enter into Licensing Agreement and Technical Collaboration for Limaprost Alfadex Tablets(94 KB)

• Mar.04.2020 R & D

  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(112 KB)

• Mar.03.2020 Sustainability

  ONO First Selected as a "2020 Health & Productivity Stock"(368 KB)

• Feb.27.2020 R & D

  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(196 KB)

• Feb.21.2020 R & D

  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(148 KB)

• Feb.21.2020 R & D

  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(174 KB)

• Feb.17.2020 R & D

  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(115 KB)

• Feb.17.2020 R & D

  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(113 KB)

• Feb.03.2020 R & D

  Bristol-Myers Squibb Withdraws European Application of Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer(136 KB)

• Jan.31.2020 Management / Finance

  Announcement on Financial Results for FY2019 3Q

• Jan.24.2020 R & D

  ONO Announces Result from Phase III Clinical Study Evaluating Opdivo® (Nivolumab) in Patients with Platinum-Refractory Advanced or Recurrent Ovarian Cancer(111 KB)

• Jan.20.2020 Sustainability

  ONO Selected as a "Climate Change A List" Company in CDP 2019 for Two Consecutive Years(210 KB)

• Jan.16.2020 R & D

  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(113 KB)

• Jan.06.2020 R & D

  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(202 KB)