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on september 20, 2020, the “2020 ads summit” (ads: advance dementia science) hosted by eisai china inc. was successfully held. featuring the theme of “run into the next decade”, the summit was made up of one main venue (online) and four sub-venues (offline) in beijing, shanghai, guangzhou and chengdu. famous experts from china, japan and south korea and nearly 1,000 guests online and offline made exchanges on the frontier progress of dementia and cognitive disorders. the ads summit is another doctor information exchange platform built by eisai china inc, and is in the third session since it was first held in 2018.

at the beginning of the summit, ms. yanhui feng, senior vice president of eisai global and president of eisai china inc., delivered a speech at the main venue. ms. feng gave a warm welcome to all the experts and guests to the 2020 ads summit and sincerely thanked them for their strong support to the summit. eisai china inc. will devote itself to building an academic exchange platform for cognitive disorders and continue to increase research and development of new drugs in this field. at the same time, adhering to its business philosophy of hhc (human health care), it will work hand in hand with all walks of life to make contributions in disease cognition, prevention and control, patient care and other aspects.

feng yanhui delivered a speech at the main venue (online)

at this summit, prof. jianping jia from xuanwu hospital of capital medical university was invited as the chairman of the summit. prof. jia expressed thanks to eisai china inc. for setting up such an academic exchange platform that allows chinese, japanese and korean experts and participants to share academic frontier progress and clinical practice, and wished the summit a complete success.

after that, prof. yeon-sil moon from the affiliated hospital of konkuk university in south korea and prof. kenjiro ono from the affiliated hospital of showa university in japan brought the topics of “the most ‘in’ ad biomarkers and applications” and “new drugs for ad are braving the wind and wave” respectively, sharing their professional and in-depth insights with online and offline audiences.

at the sub-venues in beijing, shanghai, guangzhou and chengdu, the hot issues and key topics about dementia and cognitive disorders, such as “2020 aaic hot issues” and “ad whole-process management”, were set. in the “expert sofa show”, a number of experts in the field also made wonderful and valuable comments and hot discussions on topics such as “ad risk factors and prevention guidelines”, “prospects and future of ad treatment”, and “how to conduct whole-process management of ad”. the atmosphere at the scene was warm.

prof. jianping jia chairman of the summit (left), and mr. jianzhong zhang, vice president of eisai china inc. delivered speeches

this summit showed warmly online and offline interaction, and experts and scholars in this field from various regions gathered together, sharing the latest academic frontier progress and clinical practice experience.

sub-venues in beijing, shanghai, guangzhou and chengdu (offline)

the statistics of the alzheimer’s disease international (adi) in 2019 show that the number of dementia patients in the world has exceeded 50 million, and it is estimated that the number of dementia patients will increase to 152 million by 2050, with one new patient every 3 seconds. in china, the number of dementia patients has exceeded 10 million, and the average survival time of patients is only 5.9 years. however, despite the huge demand for clinical treatment, the pathogenesis of ad is not clear at present, and most of the existing drugs on the market can only relieve symptoms. there is no effective drug to reverse or prevent the progression of the disease so far. moreover, many international clinical trials on ad drugs have failed. therefore, it is still necessary to increase efforts in the research and development of ad therapeutic drugs.

alzheimer’s disease is a disease that eisai has been paying close attention to for a long time. eisai not only introduced donepezil into china and facilitated its inclusion into the medical reimbursement system, but also invested in the research and development of new drugs on a long-term basis. eisai china has always adhered to its business philosophy of hhc (human health care), and has brought rich experience that it has gained in other markets around the world to the chinese market. during the 20 years of its development in china, it has joined forces with all walks of life and enhanced people’s attention to and correct understanding of alzheimer’s disease in the whole chinese society, and benefited patients and their families by carrying out science popularization activities, such as the “remember i love you” alzheimer’s disease philanthropy campaign, “yellow bracelet campaign”, “memory clinic”, and “cognitive college”, etc..

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that the latest results from the cohort targeting patients with her2-negative breast cancer in the phase i clinical trial for the new liposomal formulation (e7389-lf) of the in-house discovered anti-cancer treatment halaven^® (generic name: eribulin mesylate, “eribulin”) were presented (abstract number: 346p) at the european society for medical oncology (esmo) virtual congress 2020.

e7389-lf is a new formulation using liposomes made of a lipid bilayer to encapsulate the halichondrin-class microtubule dynamics inhibitor eribulin. in tumor tissue, gaps exist among vascular endothelial cells due to incomplete vasculature, which is thought to allow for penetration by macromolecules. this condition, in addition to incomplete lymphatic function, is predicted to enable high-molecular-weight drugs including liposomal formulations to be respectively delivered and retained in greater amounts in tumors as compared to in normal tissue, through enhanced permeability and retention (epr) effects. thus e7389-lf is expected to improve the concentration of eribulin in tumor tissues.

this presentation reported efficacy and safety results of e7389-lf in a cohort enrolling 28 patients with recurrent (her2-negative) breast cancer (hormone receptor positive: 21, triple negative: 7) who had previously undergone treatment with anthracycline or taxane class treatments and had no prior treatment with eribulin (data cutoff: january 24, 2020, progression free survival and overall survival cutoff: april 17, 2020), as part of the open-label, phase i clinical trial (study 114) on patients with select solid tumors who had previously undergone treatment. patients were treated with e7389-lf 2.0 mg/m² body surface area (as free eribulin) intravenously once every three weeks, and demonstrated an overall response rate (orr) of 35.7% (95% confidence interval (ci): 18.6-55.9) in the her2-negative breast cancer cohort as a whole. within the cohort, hormone receptor positive patients demonstrated an orr of 42.9% (95% ci: 21.8-66.6) and triple negative patients demonstrated an orr of 14.3% (95% ci: 0.4-57.9). the disease control rate combining stable disease rate, partial response rate, and complete response rate was 89.3% (95% ci: 71.8-97.7). additionally, progression-free survival (pfs) was a median of 5.7 months (95% ci: 3.9-8.3), and the median overall survival (os) was not reached (95% ci: 10.3 – not reached). adverse events of grade 3 or above (top 5) were neutropenia (67.9%), leukopenia (42.9%), thrombocytopenia (32.1%), febrile neutropenia (25.0%), and increased alanine aminotransferase (21.4%), which were consistent with the safety profile of eribulin to date. additionally, preventive treatment with the g-csf (granulocyte colony stimulating factor) pegfilgrastim demonstrated a decrease in the ratio of febrile neutropenia occurrence (with treatment: 10.0%, without treatment: 33.3%).

eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.

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

[notes to editors]

1. about e7389-lf

e7389-lf is a new formulation designed for more efficient delivery of the halichondrin-class microtubule dynamics inhibitor “halaven” (eribulin mesylate) into cancer cells by liposome envelopment. a phase i clinical study is currently being conducted on select solid tumors in japan. additionally, a phase ib/ii clinical trial on the combination therapy of e7389-lf and nivolumab targeting select solid tumors is currently being conducted in japan in collaboration with ono pharmaceutical co., ltd.

(figure modified with permission from professor nishikawa at tokyo university of science)

2. about halaven (generic name: eribulin mesylate)

halaven is in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. structurally, halaven is a simplified and synthetically produced version of halichondrin b, a natural product isolated from the marine sponge halichondria okadai. halaven is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. in addition, non-clinical studies showed halaven’s unique actions in the tumor microenvironment such as an increase in vascular perfusion and permeability in tumor cores¹, promotion of the epithelial state, decrease in capacity of breast cancer cells to migrate², etc.

halaven was first approved as a treatment in the united states in november 2010 for patients with metastatic breast cancer. halaven is currently approved for use in the treatment of breast cancer in over 75 countries worldwide, including japan, china and countries in europe, the americas and asia. furthermore, halaven was first approved as a treatment for soft tissue sarcoma in the united states in january 2016, and is approved in over 65 countries including japan and in europe and asia. furthermore, halaven has been designated as an orphan drug for soft tissue sarcoma in the united states and japan.
specifically, halaven is approved for the following indications.
in the united states for the treatment of patients with:

metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

in japan for the treatment of patients with:

inoperable or recurrent breast cancer, soft tissue sarcoma

in europe for the treatment of adult patients with:

locally advanced or metastatic breast cancer who have received a prior anthracycline-containing regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

two open-label, randomized, phase iii trials (embrace and study 301) were conducted for halaven in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. based on the pooled analysis of the combined results³, overall survival (os) was extended significantly in the halaven group compared to the control group (hazard ratio 0.85 [95% confidence interval (ci) = 0.77-0.95] p = 0.003, halaven median os: 15.2 months vs. control median os: 12.8 months). progression free survival (pfs) was also extended in the halaven group compared to the control group (hazard ratio 0.90 [95% ci = 0.81-0.997] p = 0.046, halaven median pfs: 4.0 months vs. control median pfs: 3.4 months).

the overall response rate (orr) in the her2-negative breast cancer group was 13.5%. within the group, an orr of hormone receptor positive patients was 14.3% and that of triple negative patients was 12.0%. median pfs in the her2-negative breast cancer group was 4.0 months.

regarding the safety profile from the combined analysis, there were no major differences among the respective clinical studies. patients in these phase iii studies received halaven (1.4 mg/m² administered intravenously on day 1 and day 8) every 21 days.

¹ funahashi y et al., eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. cancer sci., 2014; 105, 1334-1342² yoshida t et al., eribulin mesilate suppresses experimental metastasis of breast cancer cells by reversing phenotype from epithelial-mesenchymal transition (emt) to mesenchymal-epithelial transition (met) states. br j cancer, 2014; 110, 1497-1505³ twelves c et al., efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies. breast cancer res treat, 2014; 148, 553-561

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that a series of abstracts will be presented at the european society for medical oncology (esmo) virtual congress 2020 from september 19 to 21, 2020. the abstracts highlight updates regarding eisai’s in-house discovered lenvima^® (lenvatinib mesylate, the orally available kinase inhibitor, “lenvatinib”), halaven^® (eribulin mesylate, halichondrin class microtubule dynamics inhibitor, “eribulin”) and its liposomal formulation.

there will be two oral presentations regarding the combination therapy of lenvatinib and merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside of the united states and canada)’s anti-pd-1 antibody, keytruda^® (pembrolizumab). both of these presentations have been selected as late-breaking abstracts. the interim results of the phase 2 study (leap-004) in advanced melanoma which had been treated with an anti-pd-1 or pd-l1 antibody (abstract no: lba44), as well as the interim results of the basket-type phase 2 study (leap-005) for 6 types (triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, glioblastoma, and biliary tract cancer) of previously treated, advanced solid tumors (abstract no: lba41) will be presented.

there will also be an e-poster presentation (abstract no: 346p) on the expansion cohort of her2-negative breast cancer in a phase 1 study evaluating the eribulin liposomal formulation (e7389-lf) which aims to realize the efficient delivery to tumors.

in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

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.

oral presentations*:

product / compound abstract no.	abstract title and scheduled presentation date and time (cest)
lenvatinib lba44	lenvatinib (len) plus pembrolizumab (pembro) for advanced melanoma that progressed on a pd-1 or pd-l1 inhibitor: initial results of leap-004 september 19 (sat), 16:32-16:44
lenvatinib lba41	leap-005: phase 2 study of lenvatinib plus pembrolizumab in patients with previously treated advanced solid tumors september 20 (sun), 14:25-14:37

*late breaking abstracts will be available on demand via esmo’s website on september 19.

e-poster presentations**:

product / compound abstract no.	abstract title
lenvatinib 1313p	phase 3 leap-006 safety run-in (part 1): 1l pembrolizumab (pembro) chemotherapy (chemo) with lenvatinib (len) for metastatic nsclc
lenvatinib 973tip	leap-010: phase 3 study of first-line pembrolizumab with or without lenvatinib in patients (pts) with recurrent/metastatic (r/m) head and neck squamous cell carcinoma (hnscc)
lenvatinib 1016tip	leap-012 trial in progress: pembrolizumab plus lenvatinib and transarterial chemoembolization (tace) in patients with intermediate-stage hepatocellular carcinoma (hcc) not amenable to curative treatment
lenvatinib 710p	phase 2 trial of lenvatinib (len) plus pembrolizumab (pembro) for disease progression after pd-1/pd-l1 immune checkpoint inhibitor (ici) in metastatic clear cell (mcc) renal cell carcinoma (rcc): results by independent imaging review and subgroup analyses
lenvatinib 719p	correlative serum biomarker analyses: lenvatinib (len) plus pembrolizumab (pembro) in a phase 1b/2 trial in advanced renal cell carcinoma (rcc)
lenvatinib 1668tip	a multicenter, open-label, randomized phase 2 study to compare the efficacy and safety of lenvatinib in combination with ifosfamide and etoposide versus ifosfamide and etoposide in children, adolescents and young adults with relapsed or refractory osteosarcoma (olie; itcc-082)
lenvatinib 1923p	assessment of the efficacy and safety of lenvatinib for the treatment of radioiodine-refractory thyroid cancer in real-life practice in russia
e7389-lf 346p	phase 1 study of the liposomal formulation of eribulin (e7389-lf): results from the her2-negative breast cancer expansion
e7389-lf 583p	effect of infusion rate, premedication, and prophylactic peg-filgrastim treatment on the safety of the liposomal formulation of eribulin (e7389-lf): results from the expansion part of a phase 1 study
eribulin 316p	real-world treatment patterns and clinical effectiveness outcomes of eribulin in metastatic breast cancer patients in community oncology centers in the united states

**abstracts and e-posters will be available on demand via esmo’s website on september 14 and 17 respectively.

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

[notes to editors]

1. about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration
in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., 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 lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as monotherapy and in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy keytruda.

in addition to ongoing clinical studies evaluating the lenvima plus keytruda combination across several different tumor types, the companies have jointly initiated new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program and are evaluating the combination in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer) across 19 clinical trials.

2. eisai’s focus on cancer
eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment with experience and knowledge from halaven and lenvima and the driver gene mutation and aberrant splicing leveraging rna splicing platform as areas (ricchi) where real patient needs are still unmet, and where eisai can become a frontrunner in oncology area. eisai will discover innovative new drugs with new targets and mechanisms of action from these ricchi, and aims to contribute to curing cancers.

keytruda^® is a registered trademark of merck sharp & dohme corp., a subsidiary of merck & co., inc., kenilworth, n.j., usa.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it will take over by transfer the manufacturing and marketing approval of parkinson’s disease treatment equfina^® 50mg tablets (safinamide mesilate, “equfina”) in japan from meiji seika pharma co., ltd. (headquarters: tokyo, “meiji”), effective september 23, 2020.

in japan, meiji conducted clinical studies of equfina and obtained its manufacturing and marketing approval in september 2019. eisai has exclusively sold equfina in japan as a distributor. based on the license agreement signed between eisai and meiji, eisai will take over by transfer the manufacturing and marketing approval of equfina from meiji. eisai, as the manufacturer and distributor of equfina in japan, will continue to provide information on the proper usage of equfina.

equfina, developed by meiji in japan, is a once-daily oral treatment for parkinson’s disease. it is a selective and reversible monoamine oxidase b (mao-b) inhibitor that helps to maintain the density of endogenous dopamine and exogenous dopamine from levodopa-containing drugs in the brain (dopaminergic mechanism). in addition, equfina blocks voltage-dependent sodium ion channels and inhibits glutamate release (non-dopaminergic mechanism). in the clinical studies conducted in japan for parkinson’s disease patients under treatment with a drug containing levodopa, the extension of levodopa’s duration of effect (“on” time) of one hour or more and improvement of motor functions were shown. improvement effect on the wearing off phenomenon is expected.

following the completion of the transfer, eisai will continue to deliver equfina, a new option for parkinson’s disease treatment in japan to patients, thereby increasing the amount of time that they can freely engage in activities on their own initiative. eisai will further contribute to improving the qol of patients and enabling their families to create a vibrant daily life.

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

[notes to editors]

1. about equfina (safinamide mesylate “safinamide”)

safinamide is a selective monoamine oxidase b (mao-b) inhibitor that reduces the degradation of excreted dopamine, helping to maintain the density of dopamine in the brain. additionally, safinamide blocks sodium ion channels and inhibits glutamate release, and as such has potential as a new parkinson’s disease treatment which possesses both dopaminergic and non-dopaminergic mechanisms.

safinamide was discovered and developed by newron pharmaceuticals s.p.a. (headquarters: milan, italy, “newron”). in 2011, newron entered into a licensing agreement with meiji, granting meiji exclusive rights to develop, manufacture and commercialize the drug in japan and asia. eisai has exclusive rights for marketing in japan, as well as for development and marketing in asia* based on a licensing agreement signed between eisai and meiji. safinamide mesilate is marketed under the name “xadago” in 15 countries in europe, the united states and australia, and under the name “onstryv” in canada.

* south korea, chinese taiwan, brunei, cambodia, laos, malaysia, the philippines, indonesia, thailand, vietnam, myanmar, singapore, hksa, and chinese macau

2．about parkinson’s disease

parkinson’s disease is a neurodegenerative disease that causes motor impairment such as shaking in the limbs, muscular rigidity and shuffling gait, as well as non-motor impairment such as sensation impairment with pain, insomnia, and autonomic failure. it is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. according to an estimate by the japanese society of neurology, there are approximately 200,000 patients suffering from parkinson’s disease in japan.¹ also, approximately 3 million patients suffer from parkinson’s disease in asia.² the number of patients is increasing due to aging of the population.³ levodopa is widely used to treat parkinson’s disease by replenishing the brain’s supply of dopamine. however, as the disease progresses, the duration of effect of a drug containing levodopa (“on” time) decreases, and there are cases of parkinson’s disease symptoms returning before the next dose (“wearing-off” phenomenon). to prevent the “wearing-off” phenomenon, combination therapy with a drug that has a different mechanism of action to a drug containing levodopa is administered.

3. about meiji seika pharma

in order to protect and improve people’s health and lives, meiji seika pharma, as a “speciality and generic pharmaceuticals company”, runs its pharmaceutical business in two main fields: infectious disease and central nervous system disorders, as well as generic drugs. meiji seika pharma strives to respond to diversified medical needs and to contribute to the well-being of people worldwide.

for details, please visit its corporate website:

¹ japanese society of neurology. treatment and management guideline 2018 for parkinson’s disease² e ray dorsey et al. global, regional, and national burden of parkinson’s disease, 1990–2016: a systematic analysis for the global burden of disease study 2016 lancet neurol. 2018;17:939–53³ japan intractable diseases information center:

the 7th “award ceremony for 2020 greater suzhou best employer and employer brand forum” was grandly held in the studio of suzhou radio and television general station recently. eisai china inc. stood out among thousands of participating enterprises with its good employer brand image, excellent performance of employer social responsibilities and excellent employee engagement, and has been awarded the “greater suzhou best employer” award for four consecutive years.

eisai china inc. wins “greater suzhou best employer” award for four consecutive years

the “greater suzhou best employer” project has been held for 7 consecutive years since 2013. the selection of the best employers in 2020 underwent four processes: expert review, employee survey, public voting and brand diagnosis, which lasted for three months. more than 200 entrepreneurs and human resources professionals in suzhou witnessed the birth of the “2020 greater suzhou best employer”. the “greater suzhou best employer” project is the most influential and appealing employer brand and selection activity in suzhou at present, and has become the annual employer brand display ceremony in suzhou. it has won this heavyweight trophy for four consecutive years, which represents the great recognition and affirmation of its years of devotion to its employer brand by the expert jury, society and employees.

photo of eisai china inc. at scene of award ceremony

since its entry into suzhou industrial park in 1996, eisai china inc. promotes tens of pharmaceutical brands in china, specializing in neurology, oncology and gastrointestinal areas, and has been rooted in suzhou industrial park for 24 years. it has always adhered to its business philosophy of hhc (human health care), provided chinese doctors with medical treatment support, and provided patients and their families with high-quality, environmentally friendly, safe and satisfactory products and services. it requires every employee to devote 1% of their working time to hhc activities every year, walk into communities together, approach patients, listen to the voices of patients and their families, and understand their sufferings, so as to better meet their needs.

it always regards the improvement of employees’ ability as one of its long-term strategies. in order to enhance the sense of belonging of employees and strengthen the corporate cohesiveness, the “honorary staff award” has been set up for employees who have served the company for 5, 10, 15 and 20 years respectively. the enhancement of employees’ ability and loyalty is the greatest reward and affirmation for an enterprise. it attaches importance to the personal value of each employee, and through the skill development system, it gives employees systematic training paths and clear development channels, and encourages everyone to solve problems with innovative thinking. meanwhile, it offers competitive remuneration and welfare, and provides employees with comprehensive care and protection. it is committed to providing a healthy and happy working environment for its employees and hopes to work with them to build itself into a respectable hhc company.

on september 1, 2020, the second hhc summit of eisai china holdings ltd. (hereinafter referred to as “eisai china”) was successfully held in shanghai. feng yanhui, senior vice president of eisai global, president of eisai china, and chairman of eisai china hhc committee, led the senior management team of eisai china and leaders of various departments to attend the summit.

feng yanhui delivered a speech

feng yanhui said at the summit that hhc is based on well-being improvement for patients and their families to achieve business innovation; hhc is the mission, core philosophy and original intention of eisai china. all employees of eisai china should not forget the original intention, carry forward the hhc spirit, meet the unmet needs of patients and their families, and keep increasing their business innovation ability in their daily work.

the highlight of this summit was the combination of theory and practice. at the same time, 8 groups of patients were invited, and all participants were divided into 8 groups. a socialization process was undergone, that is, the staff members communicated with the patients, their families and people living together with them, discovered their needs, and shared and discussed hhc needs and put forward innovative ideas.

communication with patients (socialization)

at the summit, awards were presented to those award-winning hhc projects and outstanding hhc fulfillers of eisai china in the 2019 fiscal year.

hhc committee members had a group photo taken with hhc award-winning representatives

hhc stands for the initials of “human health care”, is the foundation of the global concept of eisai, and is consistent with the nursing concept of florence nightingale, the founder of modern nursing. the hhc logo is directly derived from the handwriting of florence nightingale.

the hhc philosophy is realized through the knowledge creation model -seci model, which is socialization, externalization, combination, and internalization respectively. the unmet needs of patients and their families are discovered through practice with the above model, and are met through actual work to realize business innovation.

on august 30, 2020, “the 37^th china pharmaceutical industry information annual conference2020″ hosted by china pharmaceutical industry information center was held in zhuhai, guangdong province, and the conference released the list of the top 100 pharmaceutical enterprises in china in 2019, which attracted much attention from the industry. eisai china holdings ltd. (hereinafter referred to as “eisai china”) ranked the 71st, being on this list for five consecutive years. the ranking has risen from the 97th in 2015 to the 71st in 2019, manifesting the strong development of eisai china in recent years.

eisai china ranks 71st in list of top 100 pharmaceutical enterprises in china

with the theme of “innovation power”, this conference focused on the thoughts and explorations of new paths of innovation and development of chinese medicine in the post-covid19 period. the list of top 100 pharmaceutical enterprises in china reflects the economic operation of china’s pharmaceutical industry, in which enterprises are ranked according to the annual chinese pharmaceutical statistics report published by the ministry of industry and information technology. the entry threshold of the top 100 in 2019 was increased from 2.61 billion yuan in 2018 to 2.86 billion yuan. according to the statistics and analysis of china pharmaceutical industry information center, the top 100 enterprises in 2019 continued their consistent strong growth momentum, with their main business income reaching 929.64 billion yuan, up by 10.7%. driven by the leading role of the top 100 enterprises, the pharmaceutical industry enterprises have maintained strong revenue capacity and sufficient development momentum. the list of top 100 pharmaceutical enterprises in china can stimulate the innovative impetus of more enterprises, drive more enterprises to transform and upgrade, and promote the high-quality development of china’s pharmaceutical industry.

ms. rao ying from access management division of eisai china received the award on behalf of the company

eisai china has been developing smoothly since it entered the chinese market in the early 1990s. it has set up shenyang eisai pharmaceutical co., ltd and eisai (suzhou) pharmaceutical co., ltd. since 1991, and was officially renamed eisai china inc. in 2002. with the business development in china, eisai (suzhou) trade co., ltd. was established in 2010, eisai holdings ltd. was established in 2014, and eisai (liaoning) pharmaceutical co., ltd. was officially established in 2015 through full acquisition of local generic pharmaceutical enterprises. so far, a development mode has been formed, consisting of eisai china holdings ltd. for capital control and management, while eisai china inc., eisai (liaoning) pharmaceutical co., ltd. and eisai (suzhou) trading co., ltd. for business support. in november 2018, the new factory in suzhou of eisai china was opened for business. it is one of the main factories of the group, and the products it produces will not only meet the demand of the chinese market, but also be supplied to 23 countries and regions such as east asia, southeast asia, middle east, central and south america and europe. eisai china’s sales have been among the highest among the japanese-funded pharmaceutical companies in china for more than 10 consecutive years.

eisai china will always uphold its business philosophy of hhc (human health care) and provide patients and their families with high-quality, environmentally friendly, safe and satisfactory products and services. hopefully eisai china can work with all its employees to build itself into a respectable hhc company.

sahne medical spray is the first otc drug spray-type lotion containing heparinoid

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has launched sahne^® medical spray and sahne^® medical cream (both are category-2 otc drugs, “sahne medical”) on august 25, 2020 at pharmacies and drugstores throughout japan, as a new product of the sahne brand lineup which has been a favored hand care for generations.

eisai conducted a survey of 1,000 women in their 40s to 50s in april 2020. as a result, it was found that approximately 70% of the subjects felt that the dryness of their skin and/or the dry skin expanse had increased compared to its condition five years ago. additionally, a number of comments regarding the discomfort of dryness from people with dry skin were received as follows: “the dryness has spread to my thighs, shins, sides, and back.”, “i’m distracted just by my underwear rubbing against my skin.”, and “my dry skin flakes stick inside my clothes whenever i get undressed, which makes me uncomfortable.” it is considered that the skin condition of women after their late 30s requires more reliable moisturizing effects of pharmaceuticals, since the amounts of sebum, natural moisturizing factors, and intercellular lipids in the stratum corneum necessary for water retention of the skin decrease.

“sahne medical” is a category-2 otc drug containing the active ingredient “heparinoid”, which exerts a high moisturizing effect against dry skin (xeroderma) that worsens with age. heparinoid penetrates into the stratum corneum, increases natural moisturizing factors, and restores the structure of intercellular lipids in the stratum corneum to moisturize dry skin.

there are two types of product lines, spray and cream, which can be selected depending on the part of the body where the product is applied and/or the principles of tpo (time, place and occasion). “sahne medical spray” is the first otc drug spray-type lotion containing heparinoid. this product is handy for the consumer to use on the back, side and back of thigh, where it is difficult to apply the medicine by themselves, as it features a container that can be sprayed upside down and a fine mist-like lotion. in addition, the tube-type “sahne medical cream” is recommended for relieving unbearable discomfort of dryness upon going out, as it is convenient to carry.

the sahne brand has continued to be a gentle companion to the daily lives of many people for 66 years since its launch. with the new launch of sahne medical, a pharmaceutical product, eisai is now able to provide a remedy for skin problems that it had not been able to contribute to before. eisai will further respond to the wishes of consumers who want to be relieved of the discomfort of dry skin, with the moisturizing effect of pharmaceutical care products and the gentle nature of sahne products.

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 a total of 10 presentations including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: dayvigotm civ) will be given at the 34th annual meeting of the associated professional sleep societies (sleep 2020), to be held virtually from august 27 to 30, 2020.

the main presentations from eisai at this conference include presentations relating to the sunrise 2 phase iii clinical trial conducted globally, including sites in japan: long-term efficacy and safety results of lemborexant in elderly adults with insomnia (oral presentation, presentation number o-01, 474), responder profiles on treatment with lemborexant (poster number 479), efficacy and safety results of lemborexant in perimenopausal female subjects with insomnia (poster number 480), and others.

lemborexant is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (ox1r and ox2r). lemborexant acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythms. lemborexant was approved in the u.s. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, and was approved in japan for the treatment of insomnia. the clinical development of lemborexant in patients with irregular sleep wake rhythm disorder (iswrd) associated with mild-to-moderate alzheimer’s dementia is ongoing.

insomnia is characterized by difficulty falling asleep, staying asleep, or both, despite an adequate opportunity to sleep, that can lead to daytime consequences, such as fatigue, difficulty concentrating and irritability.^1,2 insomnia is one of the most common sleep-wake disorders. approximately 30% of adults worldwide have symptoms of insomnia.^3,4 in particular, older adults tend to have a higher prevalence rate with many experiencing insomnia symptoms for months to years. as a result, insomnia causes various social losses, such as long absences and reduced productivity.

eisai positions neurology as a key therapeutic area, and it will continue to create innovation in the development of new drugs based on cutting-edge neurology research as it seeks to contribute further to improving the benefits of patients and their families in diseases with high unmet needs, such as insomnia.

■ virtual oral presentation:

presentation number	title・planned date and time (central daylight time)
oral o-01 474	long-term efficacy and safety of lemborexant in elderly adults with insomnia disorder: results from sunrise-2 august 28 (fri) 11:52 am – 12:03 pm

■ virtual poster presentation:

presentation number	title
poster 473	effectiveness and safety of lemborexant in subjects previously treated with placebo for 6 months in sunrise-2
poster 477	characteristics of insomnia subjects screened for transitioning from zolpidem tartrate to lemborexant in a multicenter pilot study
poster 478	a multicenter pilot study to evaluate next-dose transition from zolpidem to lemborexant for the treatment of insomnia
poster 479	sleep onset and sleep maintenance responder profiles over 12 months of treatment with lemborexant: results from sunrise-2
poster 480	efficacy and safety of lemborexant in female subjects of perimenopausal age with insomnia disorder
poster 481	impact of lemborexant on fatigue severity in subjects with clinically significant levels of fatigue at baseline
poster 484	how much improvement in subject-reported sleep onset latency is needed for patients to report a positive impact of their insomnia medication?
poster 485	experience and attitudes about prescription insomnia medications: results from an online survey of individuals with sleeping difficulties and insomnia
poster 486	impact of intrinsic factors on efficacy of lemborexant: subgroup analyses of sunrise-2

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

[notes to editors]

1. about lemborexant

lemborexant is eisai’s in-house discovered and developed small molecule that binds to orexin receptors, ox1r and ox2r, and acts as a competitive antagonist (ic50 values of 6.1 nm and 2.6 nm, respectively). the mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. the orexin neuropeptide signaling system plays a role in wakefulness. blocking the binding of wake-promoting neuropeptides orexin to receptors ox1r and ox2r is thought to suppress wake drive (ki values of 8.1 nm and 0.48 nm, respectively). higher affinity and faster on/off receptor kinetics of lemborexant to orexin receptor 2, which also suppresses non-rem sleep, indicates its potential to facilitate non-sedative onset and maintenance of sleep. in june 2020, dayvigo was launched in the u.s. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; and in july 2020, dayvigo was launched in japan for the treatment of insomnia. in addition, eisai has submitted new drug applications seeking approval of dayvigo in canada, australia and hksa. in addition, a phase ii clinical study of lemborexant in patients with irregular sleep wake rhythm disorder (iswrd) associated with mild-to-moderate alzheimer’s dementia is underway.

2. about sunrise 2（study 303）

sunrise 2 is a 12-month multicenter, global (japan, north america, south america, europe, asia, and oceania), randomized, placebo-controlled, double-blind, parallel group phase iii study of 949 male or female adult participants (18 to 88 years of age) with insomnia disorder. sunrise 2 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a six-month placebo-controlled treatment period, a six-month period of only active treatment, and a two-week period without treatment prior to the end-of-study-visit. lemborexant 5 mg, 10 mg or matching placebo was taken orally in tablet form at home each night immediately before the patient intended to try to sleep for the first six months of study. patients who received placebo during the first six-month period were administered lemborexant 5 mg or 10 mg for the second six-month period. patients who received active treatment during the first period continued on the treatment to which they were originally randomized.

the primary outcome measure was mean change from baseline in subjective sleep onset latency after six months of placebo-controlled treatment. key secondary outcome measures were mean change from baseline in subjective sleep efficiency and subjective wake after sleep onset after six months of placebo-controlled treatment.

from the results, the primary endpoint and all secondary endpoints for efficacy were achieved for lemborexant arms, and statistically significant improvements in sleep onset and sleep maintenance were confirmed for lemborexant arms compared to placebo during the six-month treatment period. the common adverse events in the lemborexant arms were somnolence, nasopharyngitis, headache and influenza.

¹ institute of medicine. sleep disorders and sleep deprivation: an unmet public health problem. washington, dc: national academies press. 2006.
² ohayon mm, et al. epidemiology of insomnia: what we know and what we still need to learn. sleep med rev. 2002;6(2):97-111.
³ ferrie je, et al. sleep epidemiology – a rapidly growing field. int j epidemiol. 2011;40(6):1431–1437.
⁴ roth t. insomnia: definition, prevalence, etiology and consequences. j clin sleep med. 2007;3(5 suppl):s7–s10.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and msd k.k. (headquarters: tokyo, president: jannie oothuizen, “msd”), a subsidiary of merck & co., inc., kenilworth, n.j., u.s.a., announced today that eisai has submitted an application in japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor lenvima ^® (generic name: lenvatinib mesylate). in june 2020, lenvima received orphan drug designation in japan for unresectable thymic carcinoma.

this application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase ii study (ncch1508) conducted in japan, evaluating lenvima as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.

the primary endpoint of this study, objective response rate (orr, assessed by independent imaging review) was 38.1% (90% confident interval (ci): 25.6-52.0). this study met its endpoint as the lower value of the ci exceeded the pre-specified statistical criteria, a threshold orr of 10%. the most common three treatment-related adverse events were hypertension (88.1%), proteinuria (71.4%), and palmar-plantar erythrodysesthesia syndrome (69.0%), which is consistent with the safety profile observed in the previously approved indications.

thymic carcinoma is an extremely rare disease with low prevelance. it is estimated that there are only 140 to 200 patients in japan. for unresectable thymic carcinoma, platinum-based first-line therapy is recommended. however, since the standard treatment has not yet been established for second-line or later therapy, it remains a disease with a poor prognosis, thus the development of new therapeutic agents is desired.

eisai and msd have been collaborating through the provision of information on lenvima in japan since october 2018, and will work together to expedite the maximization of lenvima’s contribution to patients with cancer.

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

msd k.k.
communication department
tel： 81-(0)3-6272-1001

1. about lenvima^® (generic name: lenvatinib mesylate)
lenvima, discovered and developed by eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (vegf) receptors vegfr1 (flt1), vegfr2 (kdr), and vegfr3 (flt4). lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (fgf) receptors fgfr1-4, the platelet derived growth factor receptor alpha (pdgfrα), kit, and ret. in syngeneic mouse tumor models, lenvima decreased tumor-associated macrophages, increased activated cytotoxic t cells. currently, lenvima has been approved for monotherapy as a treatment for thyroid cancer in over 65 countries including japan, the united states, in europe and in asia, and for unresectable hepatocellular carcinoma in over 65 countries including japan, the united states, in europe, china and in asia. additionally, it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 55 countries, including the united states, in europe (where it was launched under the brand name kisplyx^® for renal cell carcinoma) and in asia. in addition, it is approved in combination with keytruda^® (generic name: pembrolizumab) as a treatment for advanced endometrial cancer that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in countries including the united states, australia, and canada. continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.

2. about ncch1508 (remora study)*
this study is an open-label, single-group, multicenter, investigator initiated clinical phase ii study (8 centers nationwide including the national cancer center hospital). forty-two patients with thymic carcinoma were enrolled who had progressed after at least one prior platinum-based therapy. the primary endpoint is objective response rate (orr) by independent image review using recist1.1, and secondary efficacy endpoints include progression free survival (pfs), disease control rate (dcr), and overall survival (os). lenvatinib was administered at a starting dose of 24 mg once daily, and the dose was appropriately reduced according to the patient’s condition until the disease progressed or unacceptable toxicity was observed.

for efficacy analysis, orr was 38.1% (90% confidence interval (ci): 25.6-52.0) and the best overall response was 38.1% for partial response, 57.1% for stable disease, and 4.8% for disease progression. pfs (median) was 9.3 months (95% ci: 7.7-13.9), dcr was 95.2% (95% ci: 83.8-99.4), and the median os was not reached (95% ci: 16.1-nr (not reached)). the major treatment-related adverse events** (more than 30%) were hypertension (88.1%), proteinuria (71.4%), palmar-plantar erythrodysesthesia syndrome (69.0%), hypothyroidism (64.3%), diarrhea (57.1%), thrombocytopenia (54.8%), decreased appetite (42.9%), weight loss (40.5%), dysphonia (40.5%), increased aspartate aminotransferase (33.3%), malaise (33.3%), and stomatitis (33.3%).

* jun sato, miyako satouchi, shoichi itoh, yusuke okuma, seiji niho, hidenori mizugaki, haruyasu murakami, yasuhito fujisaka, toshiyuki kozuki, kenichi nakamura, yukari nagasaka, mamiko kawasaki, tomoaki yamada, ryunosuke machida, aya kuchiba, yuichiro ohe, noboru yamamoto; lenvatinib in patients with advanced or metastatic thymic carcinoma (remora): a multicentre, phase 2 trial. the lancet oncology, 2020, vol.21, no. 6, p843-850
** the adverse event data used for the application has beed updated from the data in the paper.

3. about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration
in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., 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 lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as a monotherapy and in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy keytruda^® (generic name: pembrolizumab).

4. about eisai co., ltd.
eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. eisai defines our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care(hhc) philosophy. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, eisai takes that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit (for global), (for u.s.) or (for europe, middle east, africa), and connect with us on twitter ( and ) and (for u.s.).

5. about msd
for more than 125 years, msd has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. msd is a trade name of merck & co., inc., with headquarters in kenilworth, n.j., u.s.a. we demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. today, msd continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as hiv and ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. for more information, visit and connect with us on , and .

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