News Release：2023 | Eisai Co., Ltd.

Information in the news releases is current on the date of the announcement, but is subject to change without prior notice.

2023 Release

December 26, 2023

DEVELOPMENT OF PREDICTION MODEL FOR BRAIN AMYLOID-BETA ACCUMULATION USING WRISTBAND SENSOR
December 18, 2023

EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION IN JAPAN FOR ANTICANCER AGENT TASURGRATINIB FOR BILIARY TRACT CANCER WITH FGFR2 GENE FUSION
December 13, 2023

Eisai and Mizuho Sign Sustainability-Linked Loan Agreement
December 13, 2023

“LEQEMBI® Intravenous Infusion” (Lecanemab) for the Treatment of Alzheimer’s Disease to be Launched in Japan on December 20
December 9, 2023

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-001 Trial Evaluating LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma
November 30, 2023

EISAI’S SALES SUBSIDIARY COLLABORATES WITH MINISTRY OF PUBLIC HEALTH (MOPH) IN THAILAND
November 22, 2023

EISAI TO PRESENT LATEST DATA ON PERAMPANEL AT THE 77TH AMERICAN EPILEPSY SOCIETY (AES) ANNUAL MEETING
November 20, 2023

LEQEMBI® Wins Best New Drug And Clinical Advance Of The Year at The Scrip Awards 2023
November 16, 2023

EISAI NAMED AS “GREATEST IR IMPROVEMENT PREMIUM COMPANY” AND “BEST CONTINUAL IR EFFORTS PREMIUM COMPANY” AT THE JAPAN INVESTOR RELATIONS ASSOCIATION 30TH ANNIVERSARY COMMEMORATIVE AWARDS
October 26, 2023

EISAI PRESENTS NEW LEQEMBI® (LECANEMAB-IRMB) INVESTIGATIONAL SUBCUTANEOUS FORMULATION INTERIM STUDY RESULTS AND CLINICAL IMPROVEMENT DATA IN EARLIER STAGES OF EARLY ALZHEIMER’S DISEASE FROM ADDITIONAL ANALYSES OF CLARITY AD AT THE CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE
INVESTIGATIONAL SUBCUTANEOUS FORMULATION CLEARS 14% MORE PLAQUE THAN IV, PHARMACOKINETICS (AUC) 11% HIGHER, AND SIMILAR ARIA RATES TO IV

76% OF PATIENTS SHOWED NO DECLINE AND 60% SHOWED CLINICAL IMPROVEMENT AT 18 MONTHS IN LOW-TAU SUBPOPULATION IN ADDITIONAL ANALYSIS OF CLARITY AD

DUAL-ACTING LEQEMBI SUPPORTS BRAIN NEURON FUNCTION BY REMOVING HIGHLY TOXIC PROTEINS (PROTOFIBRILS) THAT CAN CONTINUE TO CAUSE NEURONAL INJURY AND DEATH EVEN AFTER PLAQUE REMOVAL, OFFERING EARLY AD PATIENTS THE OPPORTUNITY FOR CONTINUED BENEFIT
October 25, 2023

LEQEMBI® (LECANEMAB-IRMB) NAMED ONE OF TIME’S BEST INVENTIONS OF 2023
October 16, 2023

EISAI TO PRESENT NEW DATA FROM LEQEMBI® (LECANEMAB-IRMB) PHASE 3 CLARITY AD STUDY AND OTHER ALZHEIMER’S DISEASE PIPELINE RESEARCH AT THE CLINICAL TRIALS ON ALZHEIMER'S DISEASE (CTAD) CONFERENCE
Update on LEQEMBI Investigational Subcutaneous Formulation
October 11, 2023

EISAI TO PRESENT RESEARCH FROM ONCOLOGY PORTFOLIO AND PIPELINE AT ESMO CONGRESS 2023
October 4, 2023

Notice of Absorption-Type Merger (Simplified Merger/Short-Form Merger) of KAN Research Institute, Inc.
September 28, 2023

EISAI LAUNCHES NEW “INNOVATION” PAGE ON CORPORATE WEBSITE
September 28, 2023

TOKIO MARINE NICHIDO AND EISAI
CO-DEVELP INDUSTRY’S FIRST “DEMENTIA CARE SUPPORT INSURANCE”
September 25, 2023

“LEQEMBI® Intravenous Infusion” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan
September 22, 2023

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Two Phase 3 Trials Evaluating LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Patients With Certain Types of Metastatic Non-Small Cell Lung Cancer
September 21, 2023

RELEASE OF DEMENTIA DISEASE AWARENESS VIDEOS FOR WORLD ALZHEIMER’S DAY, SEPTEMBER 21
LIFE GOES ON 2023: TWO MEMORIES, ONE STORY
LEARNING HELPS US TO BE KIND
September 12, 2023

EISAI ESTABLISHES THEORIA TECHNOLOGIES CO., LTD., A NEW DIGITAL BUSINESS COMPANY TO BUILD A DEMENTIA ECOSYSTEM
August 25, 2023

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-010 Trial Evaluating LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Patients With Certain Types of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
August 4, 2023

EISAI LISTED FOR 22ND CONSECTUTIVE YEAR IN FTSE4GOOD INDEX SERIES, AN INDEX FOR SOCIALLY RESPONSIBLE INVESTMENT
August 1, 2023

ORGANIZATIONAL REFORM AND CHANGES OF CORPORATE OFFICERS
July 20, 2023

Eisai Presents Latest Analysis of Lecanemab’s Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer’s Association International Conference (AAIC) 2023
Further Phase 3 analysis shows benefits of lecanemab on both amyloid-beta and tau, two underlying pathological hallmarks of Alzheimer’s disease

New data on subcutaneous formulation shows promising PK /PD data modeling on efficacy and safety, representing a potential new option for administering therapy
July 12, 2023

EISAI TO PRESENT THE LATEST ALZHEIMER’S DISEASE PIPELINE AND RESEARCH, INCLUDING LECANEMAB AND ANTI-MTBR TAU ANTIBODY E2814, AT THE ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2023
July 11, 2023

CHANGES OF CORPORATE OFFICERS
July 7, 2023

FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
The first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease
The Centers for Medicare & Medicaid Services (CMS) announced broader Medicare coverage of LEQEMBI
June 30, 2023

EISAI TRANSFERS ALL FUTURE ECONOMIC RIGHTS FOR ELACESTRANT, A SELECTIVE ESTROGEN RECEPTOR DEGRADER, TO DRI HEALTHCARE
June 29, 2023

Position and Policy Regarding Reduction of the Investment Unit of the Company's Shares
June 29, 2023

NEW NEURII RESEARCH COLLABORATION BETWEEN EISAI, GATES VENTURES, HEALTH DATA RESEARCH UK, LIFEARC AND THE UNIVERSITY OF EDINBURGH TO DEVELOP DIGITAL SOLUTIONS FOR DEMENTIA IS ANNOUNCED
June 22, 2023

EISAI’S “NOUKNOW®” WILL CONTINUE TO BE UTILIZED FOR BRAIN HEALTH ASSESSMENT AS PART OF THE FY2023 DEMENTIA EXAMINATION PROJECT BY TOKYO BUNKYO CITY
ACHIEVEMENT OF OUTCOME INDICATORS IN FY2022 PAY FOR SUCCESS CONTRACT
June 10, 2023

FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Peripheral and Central Nervous System Drugs Advisory Committee voted based on data from large global confirmatory Phase 3 Clarity AD clinical trial in patients living with early Alzheimer’s disease

The PDUFA action date for traditional approval of LEQEMBI has been set for July 6, 2023, with designation of priority review

LEQEMBI received accelerated approval from the FDA for the treatment of early Alzheimer’s disease on January 6, 2023
June 8, 2023

EISAI FILES MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER’S DISEASE IN SOUTH KOREA
June 6, 2023

Notification of Ransomware Incident
June 2, 2023

EISAI TO PRESENT LATEST DATA ON LEMBOREXANT AT THE 37TH ANNUAL SLEEP 2023 MEETING
May 26, 2023

LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
After four years of follow-up, LENVIMA plus KEYTRUDA reduced the risk of death by 21% versus sunitinib in the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial
Final results will be presented at ASCO 2023 in an oral abstract session
May 25, 2023

EISAI’S INITIATIVES FOR DEVELOPING NEW MEDICINES FOR NEGLECTED TROPICAL DISEASES AND MALARIA AND COMMITMENT FOR FUNDING TO THE 3RD PHASE OF GLOBAL HEALTH INNOVATIVE TECHNOLOGY FUND ACTIVITIES
May 24, 2023

EISAI DELIVERS NEW DATA AND HIGHLIGHTS CONTINUED PROGRESS OF ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2023
May 22, 2023

EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER’S DISEASE IN GREAT BRITAIN
May 17, 2023

EISAI PUBLISHES SOCIETAL VALUE OF LECANEMAB IN JAPAN USING PHASE 3 CLARITY AD DATA IN PEER-REVIEWED NEUROLOGY AND THERAPY JOURNAL
May 16, 2023

HEALTH CANADA ACCEPTS NEW DRUG SUBMISSION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER’S DISEASE
May 15, 2023

Notification Regarding the Disposal of Treasury Stock through Third-Party Allotment in Accordance with the Revision of the Stock Compensation System (Officers’ Compensation BIP Trust)
May 15, 2023

Notification Regarding the Revision of the Compensation System for Directors and Corporate Officers and Stock Compensation System (Officers’ Compensation BIP Trust) and Additional Contribution
May 9, 2023

Notification Regarding Revision of Consolidated Financial Forecasts (IFRS) for the Fiscal Year Ended March 31, 2023
May 8, 2023

EISAI ENTERS INTO JOINT DEVELOPMENT AGREEMENT WITH BLISSBIO FOR ANTIBODY DRUG CONJUGATE BB-1701 WITH OPTION RIGHTS FOR STRATEGIC COLLABORATION
April 7, 2023

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 Trials of LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Certain Patients With Advanced Melanoma (LEAP-003) and Metastatic Colorectal Cancer (LEAP-017)
April 6, 2023

EISAI COMPLETES A MAJOR RENOVATION OF TSUKUBA RESEARCH LABORATORIES
AS A GLOBAL DRUG DISCOVERY CENTER AIMING FOR CONNECTING HUMAN AND HUMAN, AND DATA, AND THE WORLD
April 4, 2023

EISAI PUBLISHES LONG-TERM HEALTH OUTCOMES USING SIMULATION MODEL OF LECANEMAB USING PHASE 3 CLARITY AD DATA IN PEER-REVIEWED NEUROLOGY AND THERAPY JOURNAL
Treatment with Lecanemab Resulted in a Delay of 2 to 3 Years in the Mean Time to Progression to More Severe Stages of Alzheimer’s Disease, Compared with Standard of Care Alone
Subgroup Analysis Suggested that Earlier Initiation of Treatment with Lecanemab May Have a Greater Impact on Disease Progression
April 3, 2023

EISAI ENTERS INTO AGREEMENT WITH NATIONAL CANCER CENTER TO COLLABORATE ON INVESTIGATOR-INITIATED CLINICAL RESEARCH FOR ANTICANCER AGENT TAZEMETOSTAT BASED ON “PATIENT-PROPOSED HEALTHCARE SERVICES” SYSTEM
March 31, 2023

EISAI PRESENTED NEW ANALYSES OF ARIA AND QOL ON LECANEMAB IN CLARITY AD AT THE AD/PD™ 2023 ANNUAL MEETING
March 31, 2023

ADDITIONAL DETAILED ANALYSES FROM PHASE 2 STUDY 201 OF LECANEMAB PUBLISHED AS THREE PAPERS IN PEER-REVIEWED JOURNALS
March 24, 2023

EISAI TO PRESENT RESEARCH FROM ONCOLOGY PORTFOLIO AT THE SOCIETY OF GYNECOLOGIC ONCOLOGY (SGO) 2023 ANNUAL MEETING ON WOMEN’S CANCER
March 23, 2023

EISAI TO PRESENT NEW LECANEMAB DATA, INCLUDING RESEARCH EVALUATING SAFETY PROFILE, CLINICAL OUTCOMES AND QUALITY OF LIFE MEASURES, AS WELL AS OTHER IMPORTANT ALZHEIMER’S DISEASE RESEARCH, AT THE AD/PD™ 2023 ANNUAL MEETING
Presentations Explore ARIA with the Use of Antiplatelets or Anticoagulants and Isolated ARIA-H in Patients from Eisai’s Lecanemab Phase 3 Confirmatory Clarity AD Study in Early Alzheimer’s Disease
March 20, 2023

EISAI PUBLISHES SOCIETAL VALUE OF LECANEMAB USING PHASE 3 CLARITY AD DATA IN PEER-REVIEWED NEUROLOGY AND THERAPY JOURNAL
March 14, 2023

U.S. VETERANS’ HEALTH ADMINISTRATION (VHA) PROVIDES COVERAGE OF LEQEMBI™ (LECANEMAB-IRMB) TWO MONTHS AFTER LEQEMBI’S FDA ACCELERATED APPROVAL FOR VETERANS LIVING WITH EARLY STAGES OF ALZHEIMER’S DISEASE
EISAI IS PROUD TO SUPPORT U.S. VETERANS LIVING WITH EARLY STAGES OF ALZHEIMER’S DISEASE AND WILL CONTINUE TO TRANSPARENTLY SHARE OUR HIGH-QUALITY DATA WITH THE VHA
March 10, 2023

EISAI RECEIVES THE “BASIC ACHIEVEMENT GRAND PRIZE” AT THE 2023 J-WIN DIVERSITY AWARD
March 9, 2023

EISAI CERTIFIED AS A 2023 HEALTH AND PRODUCTIVITY MANAGEMENT OUTSTANDING ORGANIZATION (WHITE 500)
March 6, 2023

FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval

Priority Review accelerates FDA review time with a Prescription Drug User Fee Act (PDUFA) target action on July 6, 2023
March 2, 2023

BIOGEN JAPAN AND EISAI PROVIDE UPDATE ON CO-PROMOTION OF MULTIPLE SCLEROSIS TREATMENTS IN JAPAN
February 28, 2023

BIOLOGICS LICENSE APPLICATION FOR LECANEMAB DESIGNATED FOR PRIORITY REVIEW BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION
February 20, 2023

DISSOLUTION OF BRACCO-EISAI JOINT VENTURE
January 30, 2023

LECANEMAB RECEIVES PRIORITY REVIEW STATUS IN JAPAN
January 27, 2023

MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER’S DISEASE ACCEPTED BY EUROPEAN MEDICINES AGENCY
January 19, 2023

EISAI COMMENCES BUSINESS ACTIVITIES AT NEW PHARMA SALES SUBSIDIARY IN ISRAEL
January 18, 2023

EISAI LISTED AS A GLOBAL 100 MOST SUSTAINABLE CORPORATION FOR THE SEVENTH TIME
HIGHEST RANKED GLOBAL PHARMACEUTICAL COMPANY
January 18, 2023

EISAI AIMS TO ADVANCE GASTROINTESTINAL CANCER TREATMENT WITH RESEARCH ACROSS MULTIPLE TUMOR TYPES AT ASCO GI 2023
Highlights Include an Update from the Dose Escalation Part of a Phase 1 Study Evaluating the Novel Anticancer Agent, E7386, in Advanced Solid Tumors Including Colorectal Cancer

Research from the LEAP (LEnvatinib And Pembrolizumab) Clinical Program May Provide New Information About Treating Patients with Unresectable Hepatocellular Carcinoma
January 16, 2023

EISAI FILES MARKETING AUTHORIZATION APPLICATION FOR ANTI-AMYLOID-BETA PROTOFIBRIL ANTIBODY LECANEMAB FOR EARLY ALZHEIMER’S DISEASE IN JAPAN
January 13, 2023

EISAI LAUNCHES RENEWED SUSTAINABILITY PAGE
January 11, 2023

EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER’S DISEASE IN EUROPE
January 7, 2023

Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Submission for traditional approval follows FDA accelerated approval of LEQEMBI on the same day, and is based on data from the confirmatory Phase 3 Clarity AD clinical trial
January 7, 2023

Eisai’s Commitment to Scientific Evidence and Patient Safety
January 7, 2023

EISAI’S APPROACH TO U.S. PRICING FOR LEQEMBI™ (LECANEMAB), A TREATMENT FOR EARLY ALZHEIMER’S DISEASE, SETS FORTH OUR CONCEPT OF “SOCIETAL VALUE OF MEDICINE” IN RELATION TO “PRICE OF MEDICINE”
MAXIMIZING VALUE FOR ALL STAKEHOLDERS WHILE GIVING BACK VALUE TO SOCIETY
January 7, 2023

FDA Approves LEQEMBI™ (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer’s Disease
Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI™

Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials

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News Release：2023 | Eisai Co., Ltd.

News Release