news – page 4 – eisai china lnc.-pg电子app

feng yanhui, president of eisai china, visited sinopharm holding henan co., ltd for business research, accompanied by li yunlong, vp of eisai china, zhao jianjun, director of north china access department, and xia ruiying, manger of north china access department in eisai china. chen zhanyu, vice president of sinopharm holding and chairman of sinopharm holding henan, zhang zhaohui, general manager of sinopharm holding henan, xu hai, deputy general manager of sinopharm holding global procurement and supply chain service center , li jie, assistant general manager of sinopharm holding henan, and yang fan, director of supply chain business development department of sinopharm holding received feng yanhui and her delegation.

the two sides conducted a business seminar in the company’s conference room. li jie briefly introduced the development of sinopharm holding henan and the cooperation between sinopharm holding henan and eisai china. leaders from both sides had an in-depth discussion on the cooperation in medical, retail and other business modes, and pointed out the direction for the future cooperation between the two sides.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into a joint development agreement with bliss biopharmaceutical (hangzhou) co., ltd. (headquarters: zhejiang province, china, “blissbio”), for bb-1701, an antibody-drug conjugate (adc) with option rights for a strategic collaboration.

bb-1701 is an adc that is composed of eisai’s in-house developed anticancer agent eribulin, and anti-her2 antibody using a linker, and is expected to have anti-tumor effects on breast, lung and other solid tumors that express her2. the linker-payload, which uses eribulin as a payload, is a proprietary technology platform developed by eisai’s u.s. research base exton site, and eisai is investigating the possibilities of using this platform to link to various antibodies. under a license agreement signed by the two companies in 2018, eisai has granted blissbio global exclusive development rights for several adcs to use eribulin as the payload. based on the status of the phase i/ii clinical trials of bb-1701 currently being conducted by blissbio, the both companies have decided to co-develop this drug.

under the terms of the joint development agreement, eisai will make upfront and development milestone payments to blissbio, conduct a phase ii clinical trial in breast cancer, and obtain option rights to develop and commercialize bb-1701 globally, excluding greater china (china, hong kong, macau, taiwan). if eisai exercises the option rights, an additional upfront payment will be made to blissbio, as well as development and regulatory milestone payments, sales milestone payments and a certain amount of royalties on sales revenue of bb-1701 after the launch. if all development, regulatory and sales milestones are achieved, up to a total of $2 billion usd will be paid.

“bb-1701 is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “our collaboration with blissbio will accelerate the development of bb-1701 with the goal of bringing a new treatment option to patients globally.”

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eisai co., ltd.
81-(0)3-3817-5120

the “national kickoff meeting of lecturer group on gastrointestinal mucosa ” was grandly held on april 14th at the inner mongolia building in beijing, accompanied by the 2023 beijing union medical college international digestive disease forum.

professor li jingnan, head of the gastrointestinal hormone and mucosal barrier group of division of gastroenterology in the chinese society of medical sciences, said in his speech at the conference that, eisai china and the group had worked closely together to promote academic development in the field of gi mucosa, and thanked eisai china for its strong support to the group, and that the establishment of the lecturer group would assist the group in raising doctors’ awareness of gi mucosa protection.

more than 20 mucosa-related experts from different provinces and cities were announced as lecturers for this “kick-off meeting”, including professor li jingnan from peking union medical college hospital, professor wang xiaozhong from union hospital of fujian medical university, professor wang jiangbin from china-japan friendship hospital of jilin university, professor dong weiguo from people’s hospital of wuhan university, professor wang liangjing from the second hospital of zhejiang university medical college, professor wang fangyu from the general hospital of the eastern war zone of the chinese people’s liberation army, professor zeng zhirong from the first hospital of sun yat-sen university, professor miao yinglei from the first affiliated hospital of kunming medical university, professor jiang haixing from the first affiliated hospital of guangxi medical university, and professor jiang haixing from the first hospital of huazhong university of science and technology, professor jiang haixing from the first affiliated hospital of guangxi medical university, professor lin rong from union hospital of tongji medical college of huazhong university of science and technology, professor zhang kaiguang from the first affiliated hospital of china university of science and technology, professor zuo xiuli from qilu hospital of shandong university, professor wu hao from west china hospital of sichuan university, professor liu caifang from people’s hospital of hebei province, professor zhang chuan from tong ren hospital of beijing, professor xu guifang from gulou hospital of nanjing university school of medicine.

during the meeting, the experts discussed the work plan of gastrointestinal mucosa related work in 2023. in particular, it should be noted that the case directions and criteria for the collection of cases related to gi mucosal injury were clarified, including the collection of cases of drug-derived gi injury, small bowel mucosal injury, ulcers, colonic mucosal lesions, etc. selected cases are planned to be published in the chinese journal of gastroenterology supplement, which is the result of a win-win collaboration between eisai and the group.

the establishment of the gi mucosa lecturer group and the conduct of lecture tours will provide high-quality academic content for doctors and raise their awareness of gi mucosa protection, benefiting a wider range of digestive patients.

as a global drug discovery center aiming for connecting human and human, and data, and the world

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) today announced the completion of a major renovation of its tsukuba research laboratories (ibaraki, japan), which is a part of strategic investment to execute eisai’s medium-term business plan “eway future & beyond”.

eisai implements research and development activities under the dhbl (deep human biology learning) drug discovery and development system in our efforts to create new drugs based on innovative and efficient next-generation drug discovery concepts. for this purpose, we recognize diseases as disease continuum to redefine their concepts through comprehensive analysis on genomic, pathophysiological and clinical information associated with underlying causes of disease in order to enhance our understanding on human biology by acquiring data leading to next drug discovery with information, such as biomarkers and imaging data from patients on our drugs. tsukuba research laboratories is positioned as a core facility in the dhbl drug discovery and development system. this renovation seeks to accelerate knowledge circulation by connecting each researcher with patients, other members within the laboratories, other research sites across the world, and external researchers based on our key concept “human connected laboratories: laboratories connecting human and human, and data, and the world.” total investment on this major renovation was 8.5 billion yen.

main idea of this major renovation

[designs to enhancing connection with patients]

in the eisai group, all employees around the world use 1% of their total business hours to interact with patients (socialization) to understand their thoughts and feelings. accordingly, we have been working on the initiatives (hhc activities) to lead value creation for patients. to enhance the opportunities for closer interaction with people outside the company, such as further socialization with patients, at tsukuba research laboratories, a traffic line from the front gate through the main building lobby to the courtyard is placed as interactive zone to enable various communications.

[realizing connections between researchers and data driven drug discovery]

in favor of generating natural communication between researchers across different therapeutic areas on a daily basis, workspaces for biology researchers and data scientists are allocated on the same floor, and likewise workspaces for chemistry and pharmacokinetics/analytical researchers are placed on nearby floors to foster new connections and knowledge exchange. further creative solutions are implemented in laboratories, including collective arrangement of structural openings and devices. these designs facilitate data driven drug discovery through knowledge exchange.

[knowledge circulation generated from links between buildings]

corridors linking multiple buildings embodying the concept of knowledge circulation are placed. a traffic line named “knowledge corridor” enables people to move all around the laboratory, with which research efficiency and convenience are considerably improved.

[meeting rooms value connection with the world]

each meeting room is equipped with an it environment that allows smooth communication with overseas offices, as well as systems able to deal with hybrid meeting which dominantly accepted in recent days.

eisai will accelerate the drug discovery activities under the dhbl drug discovery system in order to fulfill unmet medical needs, and in our efforts to further contribute to improve the benefits of patients and the people in the daily living domain.

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

[notes to editors]

1. outline of tsukuba research laboratories

location: 5-1-3 tokodai, tsukuba, ibaraki

groundbreaking of the renovation: december 2019

completion of the renovation: february 2023 (opening ceremony: 6 april 2023)

site area: 86,845.05 m²

building area: 65,110.78 m²

total investment on the renovation: 8.5 billion yen

an interactive zone for researchers and people outside company

a traffic line named “knowledge corridor”

a workplace for data scientists

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the presentation of two abstracts at the society of gynecologic oncology (sgo) 2023 annual meeting on women’s cancer (#sgomtg), which is taking place in-person in tampa, florida and virtually from march 25-28.

notable research to be featured in the scientific plenary ix: the best of the rest session includes a presentation of real-world outcomes and healthcare resource utilization in patients with recurrent or advanced endometrial carcinoma who were rechallenged with platinum chemotherapy in europe (abstract: #17). also to be presented are data from the leap (lenvatinib and pembrolizumab) clinical program analyzing tumor-response from the lenvatinib (lenvima^®) plus pembrolizumab (keytruda^®) arm of the pivotal phase 3 study 309/keynote-775 trial in patients with advanced endometrial carcinoma following at-least one prior platinum-based regimen in any setting (; abstract: #518).

“we look forward to sharing our data at this year’s sgo annual meeting, particularly a new study that will be presented in an oral scientific plenary session featuring real-world outcomes in patients with recurrent or advanced endometrial cancer who were rechallenged with platinum chemotherapy,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “we believe this research is important to the healthcare providers and patients we aim to serve because it is essential to understand treatment dynamics and related outcomes in clinical practice. as a human health care company, we remain steadfast in our commitment to advance the science of cancer medicine through the generation of real-world evidence.”

in march 2018, eisai and merck & co., inc., rahway, nj, usa (known as msd outside of the united states and canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with merck’s anti-pd-1 therapy pembrolizumab. to date, more than 10 trials have been initiated under the leap clinical program, which is evaluating the combination across multiple tumor types.

this release discusses investigational compounds and investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational compounds or investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

the full list of eisai presentations is included below. full abstracts will be posted the day of scheduled presentations.

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the company will present the latest findings on lecanemab (generic name, u.s. brand name: leqembi™), eisai’s anti-amyloid beta (aβ) protofibril* antibody for the treatment of alzheimer’s disease (ad), at the 2023 international conference on alzheimer’s and parkinson’s diseases and related neurological disorders (ad/pd™) from march 28-april 1 in gothenburg, sweden and virtually. eisai will present new findings from the company’s large, global phase iii confirmatory study of lecanemab, clarity ad, including research into the management and monitoring of amyloid-related imaging abnormalities (aria) and health-related quality of life (hrqol) measures. eisai will also host a symposium, titled “patient clinical care pathway in alzheimer’s disease: dialogue amongst experts,” which will address the evolving landscape in ad. the lecanemab data and additional research findings from eisai’s ad portfolio will be featured in 11 presentations, including seven oral and four poster presentations.

“our latest research examines the real-world outcomes based on lecanemab’s impact on clinical results and safety, including its effect on health-related quality of life. through our ongoing research, we hope to help simplify the patient journey and improve the lives of those living with alzheimer’s disease,” said michael irizarry, m.d., deputy chief clinical officer and senior vice president of clinical research at eisai inc. “in addition to lecanemab, eisai is presenting on several other key issues that will shape the future of alzheimer’s disease and brain health, including the next generation of clinical care and diagnostic pathways, exploration of unique populations affected by the disease, and accelerating drug development. we look forward to sharing our latest findings, including new insights from eisai’s clarity ad trial of lecanemab, with the scientific community at ad/pd 2023.”

key eisai lecanemab and ad presentations

two presentations related to aria in the clarity ad trial will be presented during an oral session on thursday, march 30:
– an analysis evaluating the use of antiplatelet and anticoagulant drugs in patients who experienced aria.
– an analysis of isolated aria-h events in the clarity ad trial.
research evaluating caregiver burden and hrqol across multiple scales using clarity ad data will be presented during an oral session on thursday, march 30.
research studying the characterization of aβ protofibrils and the unique binding properties and mechanisms of aβ clearance of lecanemab on friday, march 31.
designing the next generation clinical care and diagnostic pathway for alzheimer’s disease: a presentation focused on a new pathway which interweaves clinical, biological and digital assessments to guide an individualized ad patient journey on friday, march 31.

eisai symposium – patient clinical care pathway in ad: dialogue amongst experts

eisai is sponsoring a symposium featuring three prominent clinical experts in the field of ad, dr. alireza atri, dr. sharon cohen and dr. lutz frölich, who will provide insights on the ad landscape, evolving diagnostic workflow, identifying appropriate patients, and addressing patient needs on wednesday, march 29. the session aims to provide guidance on the clinical management of patients and drive effective communication between physicians and patients.

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

* protofibrils are large aβ aggregated soluble species of 75-5000 kd.¹

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

eisai europe, ltd.

(europe, australia, new zealand and russia)

emea communications department

44 (0) 786 601 1272

eisai, inc. (u.s.)

libby holman

1-201-753-1945

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it was selected as the winner of the “basic achievement grand prize” at the “2023 j-win diversity award” held by non-profit organization japan women’s innovative network (npo j-win).

the “j-win diversity award” has been held annually since 2008 with the aim of accelerating the promotion of diversity and inclusion (d&i) in japanese companies by awarding leading businesses that are promoting d&i. among the company prizes, eisai was selected as the winner of the “basic achievement grand prize”, which is the highest award within the “basic category” covering businesses who demonstrate the significance and purpose of female empowerment, developing systems and frameworks with set goals, and are taking action as a first step towards d&i promotion.

● reasons for award-winner selection

promoting d&i by viewing acquisition of diverse human talents and their successes as essential for realizing their corporate concept. while promoting company-wide initatives with the “de&i (diversity, equity & inclusion) promotion committee”, encouraging independent activities appropriate to onsite challenges through “de&i projects” at each department. further expansion in the number of female managers is expected down the road.

● highly regarded measures/initiatives

1) top management commitment and promotional framework for d&i

・promoting d&i by regarding acquisition and retention of diverse human talents and their successes as essential to evolve the “hhc (human health care)” concept and realize an “hhceco company”

・promoting activities by division, setting up “de&i projects” for global functions, such as corporate, r&d and manufacturing operations as well as each regional function, in parallel with implementing the ”de&i promotion committee” throughout the company.

・plans to introduce a new personnel assessment system from fy 2023, which utilizes a behavioral assessment item “diversity & synergy” to further focus on diversity.

2) developing female leaders

・implementing e-win (eisai women’s innovative network) program to encourage personal growth and foster career awareness/aspirations

3) reforming corporate culture/promoting increased awareness

・promoting dialogues within the organization by leveraging monthly engagement survey

eisai’s corporate concept (also known as the hhc concept) is to give first thought to patients and the people in the daily living domain, and increase the benefits that healthcare provides to them as well as meet their diversified healthcare needs worldwide. eisai aims to realize the spiral of knowledge generated by diversity, regardless of differences in nationality, gender, age, etc., leading to the creation of innovation. eisai also acquired third party appraisals including “platinum kurumin”, an accreditation for organizations implementing high level parenting support by ministry of health, labour and welfare, as well as “the new diversity management selection 100” and “health & productivity management outstanding organizations” by ministry of economy, trade and industry.

eisai is promoting de&i throughout the company to ensure it has the diversity to meet increasingly diverse needs of patients and the people in the daily living domain.

for more information about eisai’s de&i promotion, please visit it’s .

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been certified as a health and productivity management outstanding organization in the large enterprise category (white 500) by japan’s ministry of economy, trade and industry and the nippon kenko kaigi.

under the certified health and productivity management outstanding organization recognition program, the nippon kenko kaigi examines large enterprises, small and medium enterprises and other organizations engaging in initiatives for overcoming health-related challenges in regional communities or for promoting health-conscious activities led by the nippon kenko kaigi. it recognizes outstanding enterprises engaging in efforts for health and productivity management by evaluating from a business-management perspective based on the following criteria: “management philosophy and policies”, “organized frameworks”, “systems and implementation of measures”, and “evaluation and improvement”. eisai exceeded the average of its industry peers in all criteria, receiving particularly high scores for items such as “well adopted by employees” (in the criteria of organized frameworks), “lifestyle improvement” and “other measures*” (in the criteria of systems and implementation of measures). the program was launched in 2017, and this is the fifth time that eisai was certified as a “white 500” company.

eisai’s corporate concept is to give first thought to patients and the people in the daily living domain, and increase the benefits that health care provides to them as well as meet their diversified healthcare needs worldwide. eisai calls this the “human health care (hhc)” concept. eisai regards its employees as an important stakeholder and asset for the realization of its hhc concept. eisai believes that its commitment to maintaining and improving the health of human resources is fundamental to develop highly engaged employees who are motivated to contribute voluntarily toward the realization of the hhc concept. eisai issued the “eisai health declaration” in 2019, and has strategically implemented health management for employees from a management perspective.

eisai will continue to promote health and productivity management to increase non-financial value and further contribute to increasing the benefits of patients and the people in the daily living domain.

* measures to address health issues specific to women and the elderly, long working hours, mental health, dependents of the company’s employees, and prevention of infectious disease during covid-19 pandemic.

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

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

tokyo and cambridge, mass., march 6, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that the u.s. food and drug administration (fda) has accepted eisai’s supplemental biologics license application (sbla) for leqembi™ (lecanemab-irmb) 100 mg/ml injection for intravenous use, supporting the conversion of the accelerated approval of leqembi to a traditional approval. the leqembi application has been granted priority review, with a prescription drug user fee act (pdufa) action date of july 6, 2023. the fda is currently planning to hold an advisory committee to discuss this application but has not yet publicly announced the date of the meeting.

leqembi is a humanized immunoglobulin gamma 1 (igg1) monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (aβ), approved under the accelerated approval pathway for the treatment of alzheimer’s disease (ad) on january 6, 2023. treatment with leqembi should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of aβ pathology. on the same day that leqembi received its accelerated approval, eisai submitted the sbla to the fda for approval under the traditional pathway.

the sbla is based on the findings from eisai’s recently published large, global confirmatory phase 3 clinical trial, clarity ad. leqembi met the primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, results of the clarity ad study were presented at the clinical trials on alzheimer’s disease (ctad) conference and simultaneously published in the peer-reviewed medical journal, the new england journal of medicine.

leqembi was approved under accelerated approval in the u.s. and was launched in the u.s. on january 18, 2023. the accelerated approval was based on phase 2 data that demonstrated that leqembi reduced the accumulation of aβ plaque in the brain, a defining feature of ad, and its continued approval may be contingent upon verification of leqembi’s clinical benefit in a confirmatory trial. the fda has determined that the results of clarity ad can serve as the confirmatory study to verify the clinical benefit of lecanemab.

eisai serves as the lead of leqembi development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

contacts
eisai media contact: eisai co., ltd. public relations department tel: 81 (0)3-3817-5120 eisai inc. (u.s.) libby holman 1-201-753-1945 eisai europe, ltd. (uk, europe, australia, new zealand and russia) emea communications department 44 (0) 786 601 1272 investor contact: eisai co., ltd. investor relations department tel: 81 (0) 3-3817-5122	biogen inc. media contact: natacha gassenbach 1-857-777-6573 investor contact: mike hencke 1-781-464-2442

tokyo and cambridge, mass., february 28, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that the biologics license application (bla) for lecanemab (brand name in the u.s.: leqembi™), an investigational anti-amyloid beta (aβ) protofibril antibody, has been designated for priority review by the national medical products administration (nmpa) in china. the priority review and approval procedure was implemented by the nmpa with the aim of accelerating research, development and launch of new medicines that have significant clinical value. under this procedure, the assessment period is expected to be shortened.

in china, eisai initiated submission of data for the bla to the nmpa in december 2022. eisai initially submitted a package that includes data from the phase ii clinical trial (study 201) and the top-line data of the large global phase iii clarity ad study in mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad) with confirmed aβ accumulation in the brain. eisai will submit additional data including full data of the clarity ad study, as directed by the nmpa.

lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, the results of the clarity ad study were presented at the 2022 clinical trials on alzheimer’s disease (ctad) conference, and simultaneously published in the new england journal of medicine, a peer-reviewed medical journal.

in the u.s., lecanemab was granted accelerated approval by the u.s. food and drug administration (fda) on january 6, 2023. on the same day, eisai submitted a supplemental biologics license application (sbla) to the fda for approval under the traditional pathway. in europe, eisai submitted a marketing authorization application (maa) to the european medicines agency (ema) on january 9, 2023, which was accepted on january 26, 2023. in japan, eisai submitted a marketing authorization application to the pharmaceuticals and medical devices agency (pmda) on january 16, 2023, and priority review was designated by the ministry of health, labour and welfare (mhlw) on january 26, 2023.

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

contacts

media contact:

eisai co., ltd.

public relations department

tel: 81-(0)3-3817-5120

investor contact:

eisai co., ltd.

investor relations department

tel: 81-(0)3-3817-5122

media contact:

biogen inc.

natacha gassenbach

1-857-777-6573

public.affairs@biogen.com

investor contact:

biogen inc.

mike hencke

1-781-464-2442

ir@biogen.com

as a global drug discovery center aiming for connecting human and human, and data, and the world

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

confirmatory phase 3 clarity ad data to be evaluated by fda in determining whether to convert accelerated approval of leqembi to a traditional approval

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