news – eisai china lnc.-pg电子app

tokyo and cambridge, mass., may 27, 2024 – 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 ministry of food and drug safety
(mfds) in south korea has approved humanized anti-soluble aggregated amyloid-beta (aβ)
monoclonal antibody “leqembi®” (lecanemab) for treatment in adult patients with mild cognitive
impairment due to alzheimer’s disease (ad) or mild ad (early ad).

leqembi selectively binds to soluble aβ aggregates (protofibrils*), as well as insoluble aβ aggregates
(fibrils) which are a major component of aβ plaques in ad, 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. south korea
is the fourth country to grant approval, following approvals in the u.s., japan, and china.

it is estimated there were approximately 900,000 dementia patients in south korea in 2021,1 with one
in ten people over the age of 65 suffering from dementia, and one in five from mild cognitive impairment
(mci). the average annual nursing care and medical costs per dementia patient is estimated to be
21.1 million krw, while the cost for patients with severe dementia reaches 33.1 million krw.

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 south korea, eisai korea inc. will distribute the product and conduct information provision
activities. eisai is committed to working together with healthcare professionals and other stakeholders
to realize the early diagnosis and treatment of ad.

* protofibrils are believed to contribute to the brain injury that occurs with ad and are considered to be
the most toxic form of aβ, having a primary role in the cognitive decline associated with this
progressive, debilitating condition. protofibrils cause injury to neurons in the brain, which in turn, can
negatively impact cognitive function via multiple mechanisms, not only increasing the development
of insoluble aβ plaques but also increasing direct damage to brain cell membranes and the
connections that transmit signals between nerve cells or nerve cells and other cells. it is believed the
reduction of protofibrils may prevent the progression of ad by reducing damage to neurons in the
brain and cognitive dysfunction.

tokyo and cambridge, mass., may 15, 2024 – 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 eisai has initiated the rolling
submission of a biologics license application (bla) to the u.s. food and drug administration (fda)
for lecanemab-irmb (u.s. brand name: leqembi®) subcutaneous autoinjector for weekly maintenance
dosing after it was granted fast track designation by the fda. leqembi is indicated for the treatment
of alzheimer’s disease (ad) in patients with mild cognitive impairment (mci) or mild dementia stage of
disease (collectively referred to as early ad).

the bla is based on data from the clarity ad (study 301) open-label extension (ole) and modeling
of observed data. if approved by the fda, the leqembi autoinjector could be used to administer
leqembi at home or at medical facilities. the injection process requires less time than the iv
formulation. as part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under
review, patients who have completed the biweekly iv initiation phase would receive weekly doses that
maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils* which can
continue to cause neuronal injury even after the amyloid-beta (aβ) plaque has been cleared from the
brain.

ad is an ongoing neurotoxic process that begins before and continues after plaque deposition. data
suggest that early and continuing treatment may prolong the benefit even after plaque is cleared from
the brain. this sc autoinjector is easier for patients and their care partners to use, and may reduce the
need for hospital visits and nursing care compared to intravenous (iv) administration. in addition to
potentially maintaining the clinical and biomarker benefits, subcutaneous maintenance dosing may be
more convenient for patients and their care partners to continue the treatment.

leqembi is now approved in the u.s., japan and china, and applications have been submitted for
review in the european union, australia, brazil, canada, hong kong, great britain, india, israel, russia,
saudi arabia, south korea, taiwan, singapore and switzerland. eisai submitted to the fda a
supplemental biologics license application (sbla) for monthly leqembi intravenous (iv)
maintenance dosing in march 2024.

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

* protofibrils are believed to contribute to the brain injury that occurs with ad and are considered to be
the most toxic form of aβ, having a primary role in the cognitive decline associated with this progressive,
debilitating condition. protofibrils cause injury to neurons in the brain, which in turn, can negatively
impact cognitive function via multiple mechanisms, not only increasing the development of insoluble aβ
plaques but also increasing direct damage to brain cell membranes and the connections that transmit
signals between nerve cells or nerve cells and other cells. it is believed the reduction of protofibrils may
prevent the progression of ad by reducing damage to neurons in the brain and cognitive dysfunction.

addressing medical needs for patients who cannot take the medication orally

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the injection formulation of its in-house discovered antiepileptic drug (aed) fycompa® (perampanel hydrate) for intravenous (iv) infusion has been launched in japan. the injection formulation of fycompa received manufacturing and marketing approval on january 18, 2024 and was included in the japan’s national health insurance (nhi) drug price list today.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories. the agent is a selective, noncompetitive ampa receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes.

two oral formulations of fycompa are available in japan: a tablet and a fine granule formulation. due to concern about the risks of seizures associated with interruption of administration when the drug cannot be taken orally temporarily, such as during surgery, it is suggested that epilepsy patients should continue treatment via routes other than oral administration.

since fycompa is the only ampa receptor antagonist-based aed, eisai developed this injection formulation to meet the needs of patients who are unable to use oral administration, and leading to the launch today.

eisai considers neurology, including epilepsy, a therapeutic area of focus. as a human health care company, eisai pursues its mission to provide “seizure freedom” to a greater number of patients with epilepsy. eisai remains committed to further addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.

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 drug discovery research conducted on lemborexant (brand name: dayvigo®), the dual orexin receptor antagonist discovered by eisai, has been honored with the pharmaceutical society of japan (psj) award for drug research and development 2024 by the psj.

the psj award for drug research and development is one of a series of awards presented by the psj and is dedicated to researchers who have conducted outstanding research work that has contributed to medicine through the innovative development of a pharmaceutical drug or applicable technology related to the pharmaceutical sciences. award recipients are evaluated by the psj based on the ingenuity of the research itself as well as the effectiveness and safety of the related pharmaceutical product(s) or the innovativeness of the related medical treatment or treatment technology. eisai was a four-time winner of the award for drug discovery research: in 1998 on donepezil hydrochloride, an alzheimer’s disease treatment; in 2013 on eribulin mesylate, an anti-cancer agent; in 2020 on lenvatinib, a multikinase inhibitor; and in 2021 on perampanel, an ampa-type glutamate receptor antagonist.

psj shared the following rationale for selecting lemborexant: “unlike conventional drugs, based on the fact that the main cause of insomnia is the nocturnal hyperactivation of the wakefulness pathway, the compound targets inhibition of the wakefulness system, which is considered a rational therapeutic approach. the compound is highly original in its unique structure based on trisubstituted cyclopropanes, and has overcome many challenges in its optimization to a compound with a balanced profile by overcoming many pharmacokinetic and safety issues. in preclinical and clinical studies, it has demonstrated a superior efficacy and safety profile that sets it apart from conventional drugs, and the compound is meeting the unmet medical needs of many insomnia patients both in japan and overseas.”

lemborexant is currently approved for the indication of insomnia in over 15 countries, including japan, the u.s., canada, australia, and countries in asia.

eisai considers neurology, including insomnia, a therapeutic area of focus. eisai strives to create innovative products in therapeutic areas with high unmet medical needs as soon as possible, and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with the disease and their families.

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced on jan.26 that it has submitted a new drug application (nda) for ultrahigh-dose mecobalamin (development code: e0302) for the indication of amyotrophic lateral sclerosis (als) to the pharmaceuticals and medical devices agency (pdma) in japan. in may 2022, ultrahigh-dose mecobalamin received orphan drug designation by the ministry of health, labour and welfare (mhlw).

this application is based on the results of jetals (the japan early-stage trial of ultrahigh-dose methylcobalamin for als), a phase iii trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin (mecobalamin) in early onset als patients, that was conducted as an investigator-initiated trial by a research team with extraordinary professor ryuji kaji (principal investigator), tokushima university, and professor yuishin izumi (coordinating investigator), the department of neurology, tokushima university graduate school of biomedical sciences, and professor satoshi kuwabara (coordinating investigator), the department of neurology, chiba university graduate school of medicine. the results of jetals were published in the peer-reviewed journal jama neurology.

als is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction. as the main cause of death is respiratory failure due to paralysis of the respiratory muscles, without the use of an artificial respirator, death occurs within approximately 3 to 6 years from the onset of the disease. the number of patients in japan is estimated to be approximately 10,000. currently, there is no curative treatment established for als, and since there are only limited number of medicines approved in japan and abroad, this is a disease with significant unmet medical needs.

eisai considers neurology a therapeutic area of focus. as a human healthcare company, eisai is committed to fulfill unmet medical needs in neurology and further its contribution to improving the benefit of patients and the people in the daily living domain.

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

highest ranked global pharmaceutical company

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been listed in the 2024 global 100 most sustainable corporations in the world (global 100), a global ranking by canada-based media and investment advisory company, corporate knights, inc. this marks eisai’s eighth inclusion on the list. ranked 35th, eisai is the highest ranking company among global pharmaceutical companies. also, eisai became the highest ranking japanese company among the three japanese companies listed in the global 100 (please visit for the global 100 ranking).

the global 100 evaluates the sustainability of more than 6,700 of the world’s major corporations based on various corporate initiatives in areas such as esg (environment, society and governance). since 2005, those companies ranking among the top 100 in the world have been announced each year. the global 100 is based on up to 25 key performance indicators covering esg initiatives, with the evaluations carried out based on data publicly disclosed in financial filings, integrated reports, or through other such channels. eisai was highly evaluated, particularly in indicators for reducing greenhouse gas emissions, and enhancing employee value such as safe work environment, sick leave support system and employee retention rate.

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. based on this human health care (hhc) corporate concept, eisai is striving to sustainably enhance corporate value by strengthening its esg initiatives and increasing non-financial 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 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

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