news – page 2 – eisai china lnc.-pg电子app

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has submitted a marketing authorization application in japan for its in-house discovered fibroblast growth factor (fgf) receptor (fgfr1, fgfr2, fgfr3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: e7090, “tasurgratinib”) for biliary tract cancer with fgfr2 gene fusion. in japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with fgfr2 gene fusion by the ministry of health, labour and welfare, (mhlw). under this system, this application will be subject to priority review.

this application is based on the results of a multicenter, open-label, single-arm clinical phase ii trial (study 201) in japan and china conducted by eisai. study 201 enrolled patients with unresectable biliary tract cancer with fgfr2 gene fusion previously treated with gemcitabine-based combination chemotherapy. the primary endpoint of this study was objective response rate, and secondary endpoints included safety. detailed results of the study will be presented at upcoming academic conferences.

the estimated number of patients with biliary tract cancer is approximately 25,000 in japan^{1, 2} and the five-year survival rate for the cancer is approximately 25%, which makes it an intractable cancer with the second worst prognosis following pancreatic cancer.¹ drug therapy options are limited in comparison with other cancers, and as such it is a disease with significant unmet medical needs. fgfr2 gene fusion is observed in approximately 14% of intrahepatic cholangiocarcinoma, which account for 15-30% of biliary tract cancers.³ fgfr genetic aberrations such as the gene fusions are known to be deeply involved in the proliferation, survival and migration of cancer cells as well as tumor angiogenesis and drug resistance. as these genetic aberrations in fgfrs have been observed in various other types of cancers including biliary tract cancer, there is growing interest in fgfrs as a promising target for cancer therapy. by selectively inhibiting fgfr1, 2 and 3, and blocking those signals, tasurgratinib has been expected to become a new molecular targeted therapy for cancers with fgfr genetic aberrations.⁴

eisai acknowledges “oncology” as one of its key strategic areas, and will continue to focus on the discovery and development of anti-cancer drugs within drug discovery domains including “tumor microenvironment”, “proteostasis disruption”, “cell linage and cell differentiation”, and “inflammation, hypoxia, oxidative stress and cell senescence” under the deep human biology learning (dhbl) drug discovery and development organization. eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains with the aim of contributing to the cure of cancers.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

tokyo and cambridge, mass., december 13, 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 humanized anti- soluble aggregated amyloid-beta (aβ) monoclonal antibody “leqembi^® intravenous infusion” (200mg, 500mg, lecanemab) will be launched in japan on december 20, following its scheduled inclusion in the price listing on the japan national health insurance (nhi) drug price list.

leqembi received manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (mci) and mild dementia due to alzheimer’s disease (ad) in japan on september 25, 2023. in addition to inclusion in japan’s nhi drug price list, the product’s optimal clinical use guidelines were agreed at a general meeting of the central social insurance medical council, an advisory body of the japanese ministry of heath, labour and welfare, held today. the launch in japan marks the second country to have leqembi on the market, following the u.s.
in japan, eisai and biogen japan will co-promote leqembi, with eisai distributing the product as the marketing authorization holder.

leqembi selectively binds to soluble amyloid-beta (aβ) aggregates (protofibrils), as well as insoluble aβ aggregates (fibrils) which are a major component of aβ plaques, thereby reducing both aβ protofibrils and aβ plaques in the brain. leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

“i am keenly aware of the weight of our responsibility moving forward as we launch leqembi, the world first anti-amyloid alzheimer’s disease treatment shown to slow the progress of the disease, in japan, where eisai’s value creation has started” said haruo naito, chief executive officer at eisai. “the establishment of an optimal and fast alzheimer’s disease diagnosis and treatment pathway for patients is a top priority, and close collaboration among the government, dementia specialists, primary care physicians, radiologists, pharmacists, nurses, clinical psychologists, radiology staff, medical office personnel, and caregivers is essential for this purpose. in consideration of the importance of alzheimer’s disease in japan, we believe it is imperative that such pathways be established. we are committed to taking this first step towards changing the future of alzheimer’s disease together with our stakeholders.”

“the availability of leqembi opens a new era in the treatment of alzheimer’s disease potentially giving patients and their families additional valuable time together and further positions japan as a leader in caring for an elderly population,” said christopher a. viehbacher, president and chief executive officer of biogen “we will work alongside eisai to engage the medical community and support the patient journey, especially early diagnosis, as mounting evidence suggests early intervention may provide greater impact on disease progression.”

eisai will conduct a post-marketing special use results survey in all patients who are administered leqembi (all-case surveillance) until data from a certain number of patients are accumulated, in accordance with an approval condition imposed by the ministry of health, labour and welfare. in addition, the appropriate use of leqembi will be promoted in accordance with the package insert and the optimal clinical use guidelines, and training materials will be provided for healthcare professionals to assist with the management and monitoring of amyloid-related imaging abnormalities (aria).

eisai and biogen are committed to promoting the early detection and diagnosis of ad towards its early treatment, and will do their utmost to deliver leqembi the people with early ad and realize a dementia-inclusive society.

tokyo and cambridge, mass., november 20, 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 alzheimer’s disease (ad) treatment leqembi^® (lecanemab-irmb) was awarded both the best new drug and clinical advance of the year for the phase iii clarity ad study at the scrip awards 2023, held by citeline (headquarters: new york).

the scrip awards, now in its 19th year, celebrates the best innovations and achievements of the international biopharma industry.

the award for best new drug recognizes excellence in pharmaceutical development and celebrates leqembi as the first and only treatment approved in japan and the united states shown to reduce the rate of disease progression and to slow cognitive and functional decline, which acts on the underlying pathology of ad.

the award for clinical advance of the year recognizes the success of a new drug product in a clinical trial that is expected to lead to an advance in healthcare. it was awarded for the success of the phase iii clarity ad study of leqembi.

eisai and biogen deeply appreciate the cooperation of people living with ad and healthcare professionals who participated in leqembi’s clinical studies.

ad is a progressive, fatal disease, and a global healthcare issue that greatly impacts not only the people living with the disease, but also their loved ones, care partners and society. eisai and biogen will deliver leqembi to the people with early ad who need it, as well as aim to continue creating impact on global issues surrounding dementia.

eisai serves as the lead of leqembi development and regulatory submissions globally, with both eisai and biogen inc. (u.s.) co-commercializing and co-promoting the product. eisai has the final decision-making authority.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been named by the japan investor relations association (chairman: naoki izumiya, “jira”) as one of the “greatest ir improvement premium company” and “best continual ir efforts premium company” at the jira 30^th anniversary commemorative awards.

the awards commemorate the 30th anniversary of jira, and are a special recognition of member companies that have continued ir activities over the medium to long term and have been recognized for their efforts to raise the level of appropriate information disclosure and constructive dialogue. member companies have been selected for this recognition by the judging committee of the best ir awards based on the screening results for the past 17 years from 2007 to 2023. during this period, companies which have steadily been evaluated highly by committee members and have been recognized for their efforts to improve ir are selected as “greatest ir improvement premium company”, and companies which have continuously applied for the best ir awards and have been recognized for their continual ir efforts over the long term are selected as “best continual ir efforts premium company”. 70 companies were selected each for “greatest ir improvement premium company” and “best continual ir efforts premium company”.

please visit the jira homepage for further details.

eisai’s corporate concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” under this concept, we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. this human health care (hhc) concept is also stipulated in our articles of incorporation, and to realize this concept, we have worked to quantify the value of non-financial capital, including social impact calculations and employee impact accounting to create long-term, sustainable corporate value, and have focused on communicating information on the link between financial and non-financial value, as well as the visualization of non-financial value, through dialogue between investors and top management and the publication of the value creation report.

eisai will continue to respect the rights of shareholders and investors, ensure fairness and transparency in management, and work on its ir activities to aid the enhancement of corporate value.

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 time has selected alzheimer’s disease (ad) treatment leqembi^® (lecanemab-irmb) as one of the best inventions of 2023 in the medical care category.

time’s annual list of the best inventions features “200 extraordinary innovations changing lives.” to compile the list, time solicited nominations from its editors and correspondents around the world, and through an open online application process, paying special attention to growing fields, such as ai, green energy, and sustainability. time then evaluated each contender on a number of key factors, including originality, efficacy, ambition, and impact. (for more information, please visit )

leqembi is the first and only treatment approved in japan and the united states shown to reduce the rate of disease progression and to slow cognitive and functional decline, that acts on the underlying pathology of ad.

ad is a progressive, fatal disease, and a global healthcare issue that greatly impacts not only the people living with the disease, but also their loved ones, care partners and society. based on our corporate concept of “human health care (hhc),” we have taken on the challenge of this difficult issue through our nearly 40 years of drug discovery activities in the field of dementia, while spending time with patients and their families. we will deliver leqembi to the people with early ad who need it and their families, and aim to continue creating impact on global issues surrounding dementia.

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

please see full , including boxed warning in the united states.

media contacts:
eisai co., ltd.
public relations department
tel: 81 (0)3-3817-5120

update on leqembi investigational subcutaneous formulation

eisai co. ltd (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the company will present new data from the phase 3 clarity ad study for its alzheimer’s disease (ad) treatment leqembi^® (lecanemab-irmb) 100 mg/ml injection for intravenous use and new data on the subcutaneous formulation in development at the 16th annual clinical trials on alzheimer’s disease (ctad) conference. the conference will be held in boston, massachusetts, united states and virtually from october 24 to 27, 2023. in addition to the data presented on eisai’s anti-amyloid beta (aβ) protofibril* antibody leqembi, phase 1 data for e2511, an investigational tropomyosin receptor kinase a (trka) positive allosteric modulator (pam), will be presented as well as other research from the company’s ad pipeline. at the conference, eisai will present data and research in five oral and ten poster presentations. bioarctic will give an oral presentation on lecanemab.

late-breaking symposium 4 – lecanemab for early alzheimer’s disease: long-term outcomes, predictive biomarkers, and novel subcutaneous administration

in a late-breaking symposium on october 25 from 17:25-18:05 edt, eisai will present the latest data from the clarity ad optional tau pet longitudinal substudy. the presentation will include a post-hoc analysis of the low and intermediate high-tau subgroups, with the low-tau subgroup representing early stages of disease studied specifically in the phase 3 core study, and the open-label extension study. an update on the investigational subcutaneous formulation, including interim safety and effect on amyloid in the brain measured by amyloid pet, will be provided.
distinguished faculty members christopher van dyck m.d., keith johnson m.d. and reisa sperling m.d. will discuss the findings in a panel led by michael irizarry, m.d., mph, eisai.
a live webcast of this symposium can be viewed on the .

“alzheimer’s disease is a progressive and relentless condition that requires early diagnosis and continued treatment. leqembi supports neuronal function in alzheimer’s disease by clearing highly toxic protofibrils that can continue to cause neuronal injury and death well after plaques are cleared,” said michael irizarry, md, mph, senior vice president, clinical research, neurology, deputy chief clinical officer, clinical evidence generation, eisai. “we look forward to sharing the new leqembi low-tau subgroup data and subcutaneous data at ctad 2023.”

other major oral presentations include:

lecanemab: binding profiles of lecanemab and donanemab to different amyloid-beta species (oc19, presentation by bioarctic).
e2511, a novel trka modulator, engages its cns cholinergic target in a phase 1 clinical study (oc34).
novel csf tau biomarkers can be used for disease staging of sporadic alzheimer’s disease (oc2).

the full list of presentations about eisai assets and research follows.

this release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

media contacts:
eisai co., ltd.
public relations department
tel: 81 (0)3-3817-5120

eisai inc. (u.s.)
libby holman
1-201-753-1945
libby_holman@eisai.com

eisai europe, ltd.
(uk, europe, australia, new zealand and russia)
emea communications department
44 (0) 786 601 1272
emea-comms@eisai.net

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the european society for medical oncology (esmo) congress 2023, which is taking place virtually and in-person in madrid, spain from october 20 to 24.

notable presentations include a post-hoc analysis of tumor response by baseline characteristics of the metastases from the pivotal phase 3 clear (study 307)/keynote-581 trial, which evaluated lenvatinib (lenvima^®), the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus pembrolizumab (keytruda^®), anti-pd-1 therapy from merck & co., inc., kenilworth, versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (; presentation: #1903p). an exploratory analysis from the pivotal phase 3 study 309/keynote-775 trial of outcomes for patients with advanced endometrial cancer who completed treatment with pembrolizumab and continued with lenvatinib will also be presented (; presentation: #748p).

“as a research and development-focused company driven by our hhc (human health care) concept, we strive to make a difference in the lives of patients and their families by advancing the science of cancer medicine with our robust portfolio and pipeline,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “at this year’s esmo meeting, analyses from the pivotal phase 3 clear and study 309/keynote-775 trials may provide greater insights into the treatment of patients with advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. we also look forward to sharing data for lenvatinib and from our pipeline, as well as engaging in critical scientific exchange with the community in service of moving oncology research forward.”

additional data from the leap (lenvatinib and pembrolizumab) clinical program to be presented include safety-run-in results from the phase 3 leap-014 trial evaluating lenvatinib plus pembrolizumab and chemotherapy as a treatment option for patients with metastatic esophageal squamous cell carcinoma (; presentation: #1534p). a network meta-analysis of lenvatinib versus key comparators as first-line treatment for patients with unresectable hepatocellular carcinoma will also be presented during a poster session (presentation: #1007p).

research from eisai’s pipeline will be featured in a poster presentation of findings from the dose-expansion portion of a phase 1 study evaluating e7389-lf, a liposomal formulation of eribulin, as a potential first-line chemotherapy treatment option for patients with metastatic/advanced her2-negative breast cancer (presentation: #405p). additionally, insights from preclinical research on farletuzumab ecteribulin (fzec, formerly known as morab-202), a folate receptor alpha (frα)-targeting antibody drug conjugate (adc), in endometrial cancer will be presented (presentation: #786p).

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 presentations is included below. these abstracts will be made available via the esmo website on monday, october 16, 2023, at 12:05 am cest.

in march 2018, eisai and merck & co., inc., rahway, nj, usa (known as msd outside 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 the pembrolizumab, anti-pd-1 therapy from merck & co., inc., kenilworth, nj, usa. eisai and merck & co., inc., kenilworth, nj, usa are studying the lenvatinib plus pembrolizumab combination through the leap (lenvatinib and pembrolizumab) clinical program in various tumor types across multiple clinical trials.

in june 2021, eisai and bristol myers squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of fzec. eisai and bristol myers squibb are currently investigating fzec in multiple studies including: a phase 1/2 clinical study for select solid tumors including endometrial cancer, a phase 2 clinical study for non-small cell lung cancer, and a phase 2 clinical study for ovarian cancer, peritoneal cancer and fallopian tube cancer.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

tokyo and cambridge, mass., september 25, 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 humanized anti- soluble aggregated amyloid-beta (aβ) monoclonal antibody “leqembi^® intravenous infusion” (200 mg, 500mg, lecanemab) has been approved in japan as a treatment for slowing progression of mild cognitive impairment (mci) and mild dementia due to alzheimer’s disease (ad).

leqembi is a humanized immunoglobulin gamma 1 (igg1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of aβ. leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline by selectively binding to and eliminating the most toxic aβ aggregates (protofibrils) that contribute to neurotoxicity in ad. in japan, an application for marketing approval was filed and was designated for priority review in january 2023. japan is the second country to grant approval, following the traditional approval in the u.s. in july 2023.

leqembi’s approval is based on phase 3 data from eisai’s large, global clarity ad clinical trial, in which leqembi met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of leqembi. the primary endpoint was the global cognitive and functional scale, clinical dementia rating sum of boxes (cdr-sb). in the clarity ad clinical trial, treatment with leqembi reduced clinical decline on cdr-sb by 27% at 18 months compared to placebo. in addition, the secondary endpoint from the ad cooperative study-activities of daily living scale for mild cognitive impairment (adcs mci-adl), which measures information provided by people caring for patients with ad, noted a statistically significant benefit of 37% compared to placebo. the adcs mci-adl assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. the most common adverse events (>10%) in the leqembi group were infusion reactions, aria-h (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), aria-e (edema/effusion), headache, and fall. full results of the clarity ad study were presented at the and simultaneously published in the peer-reviewed medical journal on november 29, 2022.

“today leqembi received approval, making it the first approved anti-amyloid alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease in japan. we believe that we have turned a new page in the history of alzheimer’s disease treatment. alzheimer’s disease is a progressive and serious disease that not only causes significant impairment and burden for the people living with it and their care partners, but also has a tremendous impact on society as a whole,” said haruo naito, chief executive officer at eisai. “for around 40 years since we began research on dementia at our tsukuba research laboratories, eisai has interacted with people with dementia and their care partners, and made efforts to understand their sincere feelings. in response, we have been taking on the challenge to develop therapeutic agents that act on the underlying pathology of alzheimer’s disease. we are committed to delivering leqembi to the people with early alzheimer’s disease who need it and their families as a new treatment that removes the cause of the disease. through these efforts, we aim to create impact on issues surrounding dementia in japanese society.”

“with this approval, alongside eisai, we will be able to help address the devastating impact alzheimer’s has on people living with the condition as well the emotional, social and financial burden it places on care partners,” said christopher a. viehbacher, president and chief executive officer of biogen. “this is a significant step in the work of biogen and eisai to usher in a new era of treatments for this disease which impacts millions. we look forward to working alongside eisai to build on the approvals in the u.s. and now japan to bring this option to patients and their families worldwide.”

eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered leqembi until data from a certain number of patients are accumulated after market launch, in accordance with an approval condition imposed by the ministry of health, labour and welfare. in addition, the appropriate use of leqembi will be promoted in accordance with the package insert and training materials will be developed for healthcare professionals to assist the management and monitoring of amyloid-related imaging abnormalities (aria).

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. in japan, eisai and biogen japan will co-promote leqembi, with eisai distributing the product as the marketing authorization holder.

media contacts:
eisai
eisai co., ltd.
public relations department
tel: 81 (0)3-3817-5120

eisai inc. (u.s.)
libby holman
1-201-753-1945
libby_holman@eisai.com

biogen inc.
jack cox
1 781-464-3260
public.affairs@biogen.com

investor contacts:
eisai co., ltd.
investor relations department
tel: 81 (0) 3-3817-5122

biogen inc.
chuck triano
1-781-464-2442
ir@biogen.com

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has established a digital business company theoria technologies co., ltd. (“theoria technologies”) which will accelerate the development of a dementia ecosystem. theoria technologies is a wholly owned subsidiary of eisai.

with the aim of relieving the anxieties of people with dementia and their families and addressing social issues, eisai is not only creating therapeutic drugs, but also working to build a dementia ecosystem through the development of digital solutions and collaboration with other industries. theoria technologies will serve as the core of a highly transparent and neutral dementia platform, and the foundation for the development of an ecosystem to empower the people with dementia, regardless of the type or stage of the disease, to “live their fullest lives”.

theoria technologies will accelerate decision-making and strengthen the hiring and training of digital talent under an organizational structure optimized for digital business, and will utilize clinical study data that eisai has accumulated over many years as well as cohort study data, personal health records (phr), and other data to develop various prediction algorithms, create digital solutions and provide data. theoria technologies will commence business activities in april 2024, with the aim of providing services for a risk prediction algorithm for early detection of mild cognitive impairment (mci) and dementia in fy2024. in addition, together with eisai, theoria technologies will develop and provide sasaeru, an application that helps facilitate communication between people with dementia, doctors, and caregivers by recording activities of daily living (adl) of the people with dementia. furthermore, theoria technologies will promote the development of digital services by strengthening collaboration with other companies.

eisai is aiming to create social impact by realizing a dementia inclusive society where people with dementia and the people in the daily living domain can live their lives how they would like, through the development of an ecosystem.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo) and biogen inc. (headquarters: cambridge, massachusetts) announced the following joint statement regarding today’s recommendation by japan’s first committee on new drugs of the pharmaceutical affairs and food sanitation council of the ministry of health, labour and welfare that the manufacturing and marketing authorization application for lecanemab (product names: leqembi 200 mg for intravenous infusion and leqembi 500 mg for intravenous infusion) should be approved.

joint statement:

today, the first committee on new drugs of the pharmaceutical affairs and food sanitation council of the ministry of health, labour and welfare (mhlw) has recommended that lecanemab’s manufacturing and marketing authorization application for the treatment of early alzheimer’s disease should be approved, which is a major step forward in the treatment of alzheimer’s disease in japan. we would like to express our deepest gratitude to all patients, caregivers, and healthcare professionals who participated in the lecanemab clinical trials. once approved, we will do our best to appropriately deliver lecanemab, which was the first to demonstrate a clear reduction in the rate of alzheimer’s disease progression and slowing of cognitive and functional decline, as a new treatment option for patients suffering from early alzheimer’s disease in japan.

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