2021.

• Dec.24.2021 R & D

  ONO Receives Supplemental Approval of Opdivo® (Nivolumab) for Expanded Use for Treatment of Cancer of Unknown Primary in Japan

• Dec.22.2021 Licensing

  Ono Extends Drug Discovery Collaboration Agreement with Vanderbilt University

• Dec.16.2021 Corporate

  Notice regarding Investment to BMG, Inc.

• Dec.14.2021 Corporate

  ONO Announces the Foundation of “ONO Pharmaceutical and Dr. Honjo Honorary Research Fund”

• Dec.08.2021 Sustainability

  ONO Selected as a Highest Rating A-List Company for Both “Climate Change” and “Water Security” in CDP 2021

• Dec.01.2021 Management / Finance

  Ono Announces Status of Acquisition of Own Shares

• Nov.26.2021 Management / Finance

  Announcement on Acquisition and Retirement of Own Shares

• 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 Corporate

  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