2021.

• Nov.26.2021 Corporate

  Announcement on Acquisition and Retirement of Own Shares
  (Acquisition of Own Shares pursuant to the Provisions of Paragraph 2, Article 165 of the Companies Act and Retirement of Own Shares pursuant to the Provisions of Article 178 of the Companies Act)

• Nov.25.2021 R & D

  ONO Receives Approval of Opdivo® (nivolumab) for Expanded Use for Two Indications in Japan
  － First-line Treatment of Unresectable Advanced or Recurrent Gastric Cancer in Combination with Chemotherapy
  － Adjuvant Treatment of Esophageal Cancer

• Nov.18.2021 Sustainability

  ONO Introduces Carbon Neutral City Gas

• Nov.16.2021 Sustainability

  ONO Selected for the DJSI World Index and DJSI Asia Pacific Index for the Second Consecutive Year

• Nov.12.2021 Corporate

  ONO Announces the Settlement of Litigation Raised by Dr. Honjo

• Nov.09.2021 R & D

  Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Event-Free Survival in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

• Nov.08.2021 R & D

  Velexbru® Tablet 80 mg, a BTK inhibitor, Approved in South Korea for Treatment of Recurrent or Refractory B-cell Primary Central Nervous System Lymphoma

• Nov.01.2021 Corporate

  Notice on the Selection to Apply to New Market Segment “Prime Market” on the Tokyo Stock Exchange

• Nov.01.2021 Management / Finance

  Announcement on Financial Results for FY2021 2Q

• Oct.29.2021 R & D

  Rafael Pharmaceuticals Provides Update on Pivotal Phase 3 Clinical Trial in Patients with Metastatic Pancreatic Cancer and Interim Analysis of Pivotal Phase 3 Clinical Trial in Patients with Relapsed or Refractory Acute Myeloid Leukemia

• Oct.28.2021 R & D

  ONO Submits an Application of ONOACT® for Intravenous Infusion 50mg/150mg, a Short-Acting Selective β₁ Blocker, in Japan for Additional Indication of Tachyarrhythmia in Pediatric Patients with Low Cardiac Function for a Partial Change in Approved Items of Manufacturing and Marketing Approval

• Oct.22.2021 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) + Chemotherapy for Patients with HER2 Negative, Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma whose Tumors Express PD-L1 with CPS ≥ 5

• Oct.20.2021 R & D

  Opdivo® Intravenous Infusion Approved for the Treatment of Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma in Combination with Chemotherapy in Taiwan

• Oct.19.2021 Corporate

  Notice on Decision of Recipients of the "Osamu Hayaishi Memorial Scholarship for Study Abroad" of the FY2022 Japanese Biochemical Society

• Oct.04.2021 R & D

  European Medicines Agency Validates Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as First-Line Treatment for Patients with Unresectable or Metastatic Melanoma

• Oct.01.2021 Sustainability

  Ono Starts Innovation Talent Development Program

• Sep.28.2021 R & D

  U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

• Sep.27.2021 R & D

  ONO Receives Approval of Opdivo® (nivolumab) for Dosage and Administration for Treatment of Pediatric Patients with Recurrent or Refractory Classical Hodgkin Lymphoma in Japan

• Sep.21.2021 R & D

  Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) + Chemotherapy for Patients with HER2-Negative Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma whose Tumors Express PD-L1 with CPS ≥ 5

• Sep.21.2021 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma

• Sep.17.2021 R & D

  Five-Year Data from CheckMate -214 Show Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Longest Median Overall Survival Currently Reported in Phase 3 Trial of Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

• Sep.14.2021 R & D

  Applications Submitted for Combination Therapy of Opdivo + Yervoy and Opdivo + Chemotherapy for First-line Treatment of Unresectable Advanced or Recurrent Esophageal Cancer in Japan

• Sep.14.2021 R & D

  Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Durable Overall Survival at Three Years Compared to Chemotherapy in First-Line Unresectable Malignant Pleural Mesothelioma in Phase 3 CheckMate -743 Trial

• Sep.08.2021 R & D

  Opdivo® Received an Approval to Expand its Use for First-Line Treatment of Unresectable Malignant Pleural Mesothelioma in Combination with Yervoy® in Taiwan

• Aug.26.2021 R & D

  Forxiga Approved in Japan for the Treatment of Chronic Kidney Disease in Patients with and without Type-2 Diabetes
  Approval marks a significant progress in the treatment of patients suffering from chronic kidney disease in Japan

• Aug.25.2021 R & D

  Ono and Takeda Receive an Approval for Opdivo® (nivolumab) and CABOMETYX® (cabozantinib) Combination Therapy in Japan for Treatment of Unresectable or Metastatic Renal Cell Carcinoma

• Aug.23.2021 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma

• Aug.20.2021 R & D

  BRAFTOVI® Capsule, a BRAF Inhibitor, Approved in South Korea for Treatment of Advanced or Recurrent BRAF^V600E-Mutant Colorectal Cancer

• Aug.19.2021 R & D

  EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

• Aug.10.2021 Sustainability

  ONO Continuously Selected as a Constituent of ESG Investment Indices Provided by MSCI, FTSE Russell, etc.

• Aug.10.2021 Licensing

  Ono Enters into Drug Discovery Collaboration Agreement with MiraBiologics To Discover and Create Biopharmaceuticals

• Aug.06.2021 Corporate

  (Update) Notice on Investigation Results by the Investigation Committee and Future Measures

• Aug.04.2021 Licensing

  Ono Enters into Research Collaboration Agreement with Healx Limited

• Aug.02.2021 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy

• Jul.30.2021 Management / Finance

  Announcement on Financial Results for FY2021 1Q

• Jul.19.2021 R & D

  Phase 2 Clinical Study Initiated for Velexbru (tirabrutinib), a BTK Inhibitor, in Patients with Primary Central Nervous System Lymphoma in the US

• Jul.19.2021 R & D

  Bristol Myers Squibb Provides Update on CheckMate -651 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus EXTREME Regimen as First-Line Treatment for Squamous Cell Carcinoma of the Head and Neck

• Jul.02.2021 Management / Finance

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

• Jul.02.2021 Corporate

  Notice on Suspicious Emails Disguised as Our Company

• Jun.30.2021 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy

• Jun.29.2021 R & D

  Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy

• Jun.29.2021 Corporate

  Judgment against our employees

• Jun.21.2021 R & D

  Revision of Package Insert of Opdivo relating to Additional Combination Therapy with Bevacizumab and Chemotherapy in Unresectable, Advanced or Recurrent Non-small Cell Lung Cancer

• Jun.17.2021 Management / Finance

  Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)

• Jun.14.2021 R & D

  Opdivo® Intravenous Infusion Approved for Two Expanded Indications as First-Line Treatment of “Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma” and “Malignant Pleural Mesothelioma” in South Korea

• Jun.11.2021 R & D

  Phase III Study Result of FOIPAN® Tablets, a Protease Enzyme Inhibitor, in Japan in Patients with Novel Coronavirus Infection (COVID-19)

• Jun.04.2021 R & D

  Bristol Myers Squibb Presents Data from CheckMate -648 Showing Opdivo plus Chemotherapy and Opdivo plus Yervoy Significantly Improved Overall Survival Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

• Jun.03.2021 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma

• May.27.2021 R & D

  Opdivo and Yervoy Combination Therapy Approved in Japan for First-line Treatment of Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma

• May.24.2021 R & D

  Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy

• May.21.2021 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy

• May.20.2021 R & D

  Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy Demonstrates Durable Overall Survival vs. Chemotherapy at Two Years in First-Line Non-Small Cell Lung Cancer in Phase 3 CheckMate -9LA Trial

• May.20.2021 R & D

  Four-Year Data from Phase 3 CheckMate -227 Trial Show Durable, Long-Term Survival with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Non-Small Cell Lung Cancer with PD-L1 Expression ≥1%

• May.20.2021 R & D

  Bristol Myers Squibb Announces LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination Significantly Improves Progression-Free Survival vs. Opdivo (nivolumab) in Patients with Previously Untreated Metastatic or Unresectable Melanoma

• May.20.2021 R & D

  Six-and-a-Half-Year Outcomes for Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Continue to Demonstrate Durable Long-Term Survival Benefits in Patients with Advanced Melanoma

• May.19.2021 Products

  Ono and Seikagaku Announce the Launch of JOYCLU® 30mg Intra-articular Injection, a Joint Function Improvement Agent, in Japan

• May.13.2021 Management / Finance

  Revisions of Consolidated Financial Forecasts

• May.11.2021 Corporate

  Announcement on Partial Changes of Members of the Board of Directors, Audit & Supervisory Board Members and Corporate Officers

• May.11.2021 Management / Finance

  Announcement on Financial Results for FY2020

• May.06.2021 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Muscle-Invasive Urothelial Carcinoma

• Apr.28.2021 Management / Finance

  ONO Announces Revision (Dividend Increase) to its Dividend Forecast for the Fiscal Year Ending March 2021

• Apr.27.2021 Corporate

  Announcement of New Office Establishment of U.S. Subsidiary (ONO PHARMA USA, INC.)

• Apr.26.2021 R & D

  Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma

• Apr.21.2021 Products

  Launch of Adlumiz® (anamorelin), a Ghrelin Receptor Agonist in Japan
  - Provides a New Treatment Option to Patients with Cancer Cachexia in Malignant Tumors -

• Apr.19.2021 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status

• Apr.15.2021 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

• Apr.14.2021 R & D

  ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand the Use for Cancer of Unknown Primary in Japan

• Apr.12.2021 R & D

  Neoadjuvant Opdivo® (nivolumab) Plus Chemotherapy Significantly Improves Pathologic Complete Response in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

• Apr.09.2021 R & D

  Bristol Myers Squibb Announces Opdivo (nivolumab) plus Chemotherapy and Opdivo plus Yervoy (ipilimumab) Demonstrate Superior Survival Benefit Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

• Apr.05.2021 Corporate

  Announcement on Changes of Members of the Board of Directors, Audit & Supervisory Board Members and Corporate Officers

• Mar.31.2021 R & D

  ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand its Use as Adjuvant Therapy of Resected Urothelial Cancer in Japan

• Mar.30.2021 R & D

  European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Muscle-Invasive Urothelial Carcinoma

• Mar.29.2021 Sustainability

  ONO Received “Osaka Governor's Award” of the
  Osaka Stop Global Warming Awards for FY2020

• Mar.26.2021 R & D

  Bristol Myers Squibb Announces RELATIVITY-047, a Trial Evaluating Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab) in Patients with Previously Untreated Metastatic or Unresectable Melanoma Meets Primary Endpoint of Progression-Free Survival

• Mar.26.2021 R & D

  ONO Joins the University of California Drug Discovery Consortium

• Mar.23.2021 R & D

  Ono and Seikagaku Announce a Manufacturing and Marketing Approval in Japan for JOYCLU® 30mg Intra-articular Injection, a Joint Function Improvement Agent, for the Indication of Osteoarthritis (Knee Joint and Hip Joint)

• Mar.01.2021 Licensing

  ONO Entered License Agreement with PeptiDream Inc. on Automated Peptide Discovery Platform System (PDPS) Platform

• Mar.01.2021 R & D

  Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

• Feb.26.2021 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for First–Line Treatment of Advanced or Recurrent Non-Small Cell Lung Cancer in Combination Therapy in Taiwan

• Feb.26.2021 R & D

  ONO Entered Sponsorship Agreements with LabCentral and MBC BioLabs

• Feb.18.2021 R & D

  ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand the Use for Adjuvant Therapy of Resected Esophageal Cancer in Japan

• Feb.17.2021 Corporate

  Statement concerning Prosecution of Employees

• Feb.09.2021 R & D

  Adjuvant Treatment with Opdivo (nivolumab) Demonstrates Statistically Significant and Clinically Meaningful Improvement in Disease-Free Survival in Patients with Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial

• Feb.09.2021 R & D

  OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma in the Phase 3 CheckMate -9ER Trial

• Feb.02.2021 Licensing

  ONO enters into License Agreement with Ribon Therapeutics for the Development and Commercialization of RBN-2397, a PARP7 Inhibitor, in Japan, South Korea, Taiwan and ASEAN Countries

• Feb.01.2021 Management / Finance

  Announcement on Financial Results for FY2020 3Q

• Feb.01.2021 Corporate

  Notice concerning the Establishment of Ono Pharma Healthcare Co., Ltd.

• Feb.01.2021 Products

  ONO Announces Transfer of the Manufacturing and Marketing Approval Authorization for Kinedak Tablets to Alfresa Pharma Corporation

• Jan.29.2021 Corporate

  Statement concerning Arrest of Employees

• Jan.28.2021 R & D

  ONO Submits Supplemental Application for Approval of Opdivo® (Nivolumab) to Expand the Use for Treatment of Pediatric Patients with Recurrent or Refractory Classical Hodgkin Lymphoma in Japan

• Jan.25.2021 R & D

  U.S. Food and Drug Administration Approves OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma

• Jan.22.2021 R & D

  ONO Receives a Manufacturing and Marketing Approval of Adlumiz® (Anamorelin), a Ghrelin Receptor Agonist for the Treatment of Cancer Cachexia in Japan

• Jan.21.2021 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer

• Jan.21.2021 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) Combined with Chemotherapy as First-Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma

• Jan.12.2021 Corporate

  Notice on the Adopter of the "Osamu Hayaishi Memorial Scholarship for Study Abroad" of the FY2021 Japanese Biochemical Society

• Jan.07.2021 R & D

  European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) as Adjuvant Treatment for Resected Esophageal or Gastroesophageal Junction Cancer Following Chemoradiotherapy

• Jan.07.2021 R & D

  European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) Combined with Chemotherapy as First-Line reatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma

• Jan.05.2021 Corporate

  Notice on renewal of Ono’s official corporate website