news – page 23 – eisai china lnc.-爱游戏(ayx)中国官方网站

news – page 23 – eisai china lnc.-爱游戏(ayx)中国官方网站

it has been 18 years since eisai china launched the eisai china scholarships program (hereafter referred to as “the program”) in 2000. a total of approximately 7.29 million rmb has been contributed to seven universities in china to support more than 1,500 outstanding students and those in straitened circumstances. the 7 universities include sun yat-sen university, medical college of soochow university, school of basic medical sciences of fudan university, peking university health science center, china medical university, west china medical center of sichuan university as well as school of pharmacy of shenyang pharmaceutical university.

the program was initially established to promote the development of higher medical education in china, to award outstanding students, to support those in straitened circumstances, and to train more medical professionals for the society. the program embodies the corporate responsibility of eisai china in repaying the society, and the corporate philosophy of “human health care (hhc)”.

in 2017, eisai china offered scholarships value of 708,000rmb to 296 students from the seven medical universities. among them, 144 students were academically excellent and morally upright, accounting for 49%; 47 students were those attaining all-round development in the domains of ethics, intellect, physique and having excellent performances in communities, accounting for 16%; 105 students were hardworking students with financial difficulties, accounting for 35%. in addition, 14 students gained opportunities for international exchanges, thanks to the program, which could enrich their experiences.

all along, the program has been highly valued and greatly supported by ms. feng yanhui, general manager of eisai china. in 2017, ms. feng, mr. yamada koki, head of pharmaceutical affairs division, mr. zhang jianzhong, head of pharmaceutical business division (pbd), mr. zhang dayong, south regional sales director of nta business unit, pbd, as well as mr. zhang wei, hr director of edcs, were invited to attend the scholarship recognition ceremonies in sichuan university, peking university, china medical university, sun yat-sen university and suzhou university, respectively. in the ceremonies, on behalf of eisai china, they gave their best wishes to the students. meanwhile, eisai china was highly appreciated by the seven universities and their students for its active participation in social welfare undertakings.

eisai china is firmly convinced that public welfare undertakings are corporate responsibilities as well as obligations. in 2018, eisai china will continue in inheriting and carrying forward the spirit of hhc and radiate positive energy of charitable causes.

pictures of the program in 2017


on january 5, 2018, ms. feng yanhui, general manager of eisai china, attended the scholarship recognition ceremony in sichuan university


on december 18, 2017, mr. zhang jianzhong, head of pharmaceutical business division of eisai china, attended the scholarship recognition ceremony in shenyang pharmaceutical university


on december 14, 2017, mr. yamada koki, head of pharmaceutical affairs division of eisai china, participated in the scholarship recognition ceremony in peking university health science center



on march 12, 2018, mr. zhang wei, hr director of edcs of eisai china, participated in the scholarship recognition ceremony in west china medical center of sichuan university

eisai co., ltd. (ceo: haruo naito; headquarters: tokyo, japan) (hereinafter “eisai”), eisai‘s subsidiary for gastrointestinal diseases ea pharma co., ltd. (president & ceo: yuji matsue; headquarters: tokyo, japan) (hereinafter “ea pharma”) and mochida pharmaceutical co., ltd. (president: naoyuki mochida; headquarters: tokyo, japan) (hereinafter “mochida”) today announced that the bile acid transporter inhibitor “goofice® 5mg tablet” (nonproprietary name: elobixibat hydrate; development code: ajg533) (hereinafter “goofice® tablet”) was listed in japan’s national health insurance drug price list as of april 18, 2018, and ea pharma and mochida launched the product onto japan‘s market today.

goofice® tablet, which ea pharma in-licensed from albireo ab (sweden), is a once-daily, orally available constipation treatment with a novel action mechanism. goofice® tablet inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to the colon. the dual action of moisture secretion and bowel movement promotion is expected to enhance natural defecation. goofice® tablet is the first ileal bile acid transporter inhibitor approved anywhere in the world.

constipation is a very common disease. the prevalence is high in young women and both elderly men and women. in japan, the number of patients with subjective symptoms of constipation is estimated to be about 4.5 million. in constipation, symptoms such as sensation of incomplete evacuation and hard stools appear in addition to reduction of bowel movement frequency. when such symptoms become chronic, many patients suffer a decline in qol (quality of life). in a placebo-controlled, double-blind phase 3 clinical study conducted in japan, which was the basis for marketing approval, there were statistically significant improvements observed in changes in spontaneous bowel movement (primary endpoint), complete spontaneous bowel movement (secondary endpoint), time to first spontaneous bowel movement, stool consistency and other parameters for the goofice® tablet-treated group compared to the placebo group. no serious adverse events were observed.

goofice® tablet was jointly developed by ea pharma and mochida. ea pharma and mochida will distribute the product under the same brand name, respectively. ea pharma and eisai have signed a co-promotion agreement and will jointly provide information for proper use of the product.
by providing goofice® tablet with its novel mechanism of action, ea pharma, eisai and mochida strive to broaden treatment options for patients with chronic constipation to make a further contribution to improve patients’ qol.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it has submitted to the u.s. food and drug administration (fda) a supplemental new drug application (snda) for eisai‘s antiepileptic drug (aed) fycompa® (perampanel) seeking approval for an indication expansion to cover pediatric patients with epilepsy.
this snda aims to expand the indication for fycompa in the united states, which currently covers monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older, to also include children with epilepsy 2 years of age and older. based on data accumulated to date, the snda also seeks to potentially expand the pediatric indication to include children 2 years of age and older for the treatment of primary generalized tonic-clonic seizures.

fycompa has been approved in over 55 countries in the world as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) as well as primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa has also been approved as monotherapy use for the treatment of partial-onset seizures (with or without secondarily generalized seizures).

this application was based on the interim results of a phase iii clinical study (study 311) as well as the results from a phase ii clinical study (study 232). both studies suggested the safety and efficacy of adjunctive treatment with fycompa was similar between adult and pediatric patients.

study 311 evaluated the safety, tolerability and exposure-efficacy relationship of fycompa when administered as an adjunctive therapy in children (ages 4 to less than 12 years) with inadequately controlled partial onset seizures or primary generalized tonic clonic seizures. study 232 is evaluated the pharmacokinetics, efficacy and long-term safety of fycompa when given as an adjunctive therapy in pediatric subjects from 2 to less than 12 years of age with epilepsy.

furthermore, regarding the pediatric indication for fycompa, eisai has received from the fda a written request for pediatric studies, which means that priority review designation is possible.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories. it is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic ampa receptors.

epilepsy affects approximately 2.9 million people in the united states, 1 million people in japan, 6 million people in europe, and approximately 60 million people worldwide. while epilepsy affects people of all ages, incidence is particularly high among children and the elderly. as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds, this is a disease with significant unmet medical need.

eisai considers neurology a therapeutic area of focus, and together with the worldwide provision of fycompa, seeks to further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

● first new front-line treatment option for hcc approved in japan in nearly 10 years
● first approval under global strategic collaboration between eisai co., ltd. and merck & co., inc., kenilworth, n.j., u.s.a

tokyo march 23, 2018 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada), today announced that the multiple receptor tyrosine kinase inhibitor lenvima® (generic name: lenvatinib mesylate) has been approved in japan for unresectable hepatocellular carcinoma (hcc). this is the first approval worldwide for lenvima for the indication of unresectable hcc and the first new systemic therapy to be approved in japan for the front-line treatment of hcc in approximately 10 years. additionally, this is the first regulatory approval for lenvima under the global strategic collaboration agreement executed in march 2018 between eisai and merck & co., inc., kenilworth n.j., u.s.a. for the co-development and co-commercialization of lenvima.

this approval was based on a phase iii clinical study (study 304 / reflect study) conducted by eisai investigating lenvima as a first-line treatment in patients with unresectable hcc. in this study, lenvima demonstrated statistically significant non-inferiority of overall survival (os) (13.6 months) compared to sorafenib (12.3 months) (hazard ratio [hr] 0.92, 95% confidence interval [ci]=0.79-1.06). additionally, lenvima showed highly statistically significant and clinically meaningful improvements as compared to sorafenib in the secondary endpoints of progression free survival (pfs) (hr 0.66, 95% ci=0.57-0.77, p<0.00001), time to progression (ttp) (hr 0.63, 95% ci=0.53-0.73, p<0.00001), and objective response rate (orr) (lenvima 24% versus sorafenib 9%, p<0.00001). furthermore, lenvima helped to delay deterioration in several quality of life (qol) and symptom domains (pre-specified secondary endpoint) including in areas such as pain and diarrhea, compared to sorafenib (nominal p-value<0.05).

in this study, the five most common adverse events observed in the lenvima arm were hypertension (42%), diarrhea (39%), decreased appetite (34%), weight loss (31%) and fatigue (30%), which is consistent with the known safety profile of lenvima.

liver cancer is the second leading cause of cancer related deaths with approximately 750,000 deaths per year estimated globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80 percent of which occur in asia, including japan and china. hcc accounts as the primary reason for 85 percent to 90 percent of liver cancer cases. it is estimated that there are approximately 42,000 hcc patients in japan, with approximately 26,000 deaths every year. to-date, treatment options for unresectable hcc have been limited and the prognosis is very poor, emphasizing that this is an area of high unmet medical need.

“with the approval of this additional indication of unresectable hcc for lenvima, we are proud to be able to deliver the first new front-line systemic therapy treatment option for hcc in japan in approximately 10 years, and expect this will contribute to hcc treatment” said dr. takashi owa, eisai oncology business group chief medicine creation officer. “eisai will continue with its efforts in oncology research and development in order to deliver hopes for a potential cure for cancer to patients and their families.”

“today‘s approval is an important first for lenvima and a significant first regulatory event under our collaboration with eisai,” said dr. roy baynes, senior vice president and head of global clinical development, chief medical officer, merck & co, inc. kenilworth, n.j., u.s.a. “we congratulate eisai on the approval of this new indication and look forward to working together to bring this important treatment option to patients.”

having received approval of this indication, eisai will receive a development milestone payment from merck & co., inc., kenilworth n.j. u.s.a. there are no changes to eisai’s consolidated financial results forecasts for the fiscal year ending march 31, 2018 based on the receipt of this milestone payment.

on march 12th, a group of executives from shinsei electronics co., ltd., inclusive of president yamashita noriyuki, division head isobe takashi, and etc., visited eisai (china) headquarter and had friendly and cordial talks with the management staff of eisai (china). the two parties reached a strategic cooperation agreement on “icg clearance meter,” and eisai (china) will become the exclusive distributor of the product in china which will be jointly promoted with indocyanine green for injection, a product of eisai (liaoning) pharmaceutical co., ltd. during the conversation, division head, isobe takashi introduced the development history, business overview and future cooperation prospects of shinsei electronics. both the chairman, kaneko norio, and the general manager, feng yanhui expressed that the cooperation with shinsei electronics is an attempt by eisai (china) to expand the business in new fields, and they look forward to a successful cooperation and mutual benefits. sincere thanks were given to shinsei electronics for choosing eisai (china) as a strategic partner to provide chinese doctors and patients with better treatment solutions. at the same time, misawa yukihiro, manager of business development department of eisai (china), and cai ningbo, senior product manager of merchants department, gave a detailed introduction of eisai (china) and the marketing model and strategy of “icg clearance meter”.

the project aims to break through the barriers in sales of liver reserve function testing through the equipment introduction, and to increase the market competitiveness of eisai (china) in this field. the introduction of the equipment will greatly stimulate the sale of indocyanine green, and also expand new business opportunities for the company to increase its business scope. thorough cooperation of all departments is the key to the success of eisai (china) in obtaining the distributorship of “icg clearance meter” in china.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that its chinese subsidiary, eisai china inc. (eci) has completed construction of a new oral solid dose (osd) production facility and an administration building at the site of its new suzhou plant located within the suzhou industrial park.

aiming to further expand its contribution to patients in china, eisai has been working to establish a new suzhou plant on a new industrial site more than five times larger than the current suzhou plant (osd production facility) to further strengthen the stable supply chain as well as improve production efficiency. eci established a parenteral facility in november 2014, where it manufactures the injection formulation of methycobal®. the newly completed osd production facility stands three floors aboveground and contains floor space of approximately 20,240 m2, and its production capacity (formulation of approximately 3 billion tablets / packaging for approximately 5 billion tablets per year) is approximately double that of the current suzhou plant. operations are expected to commence in the second half of fiscal 2018, and the new osd facility will handle the formulation and packaging of oral solid dose products such as methycobal, aricept® and pariet® for the domestic chinese market. the current plant will be closed after operations fully commence at the new suzhou plant‘s osd production facility.

eisai’s business operations in china are one of its core businesses which is third-largest in scale after japan and the united states. through the completion of the osd production facility at the new suzhou plant, eisai seeks to strengthen its in-house domestic production system in china and expand its stable supply chain of high quality pharmaceuticals, contributing to increasing the benefits to patients and their families in china.

 

1.  outline of new suzhou plant
location: 168 xingpu road, suzhou industrial park, suzhou, jiangsu, china
site area: approximately 134,000 m2

(1)  oral solid dose production facility
(construction completed)
  ·  floor space: approximately 20,240 m2 / three floors
  ·  main functions: formulation, packaging, storage, etc.
  ·  products to be manufactured: methycobal, aricept, pariet and other products

(2)  parenteral production facility
(construction completed in november 2014)
  · floor space: approximately 5,690 m2 / two floors
  · products manufactured: methycobal injection and other products

(3)  administration building
(construction completed)
  · floor space: approximately 2,230 m2 / two floors
  · main facilities: offices, meeting rooms, cafeteria, etc.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) for use in the treatment of hepatocellular carcinoma (hcc), which was submitted for approval in china in october 2017, has been designated for priority review and approval by the china food and drug administration (cfda) due to lenvatinib‘s significant clinical benefit compared to existing treatments.

the priority review and approval procedure was implemented by the cfda in february 2016 with the aim of accelerating research, development and launch of new medicines that have significant clinical value. through designation for priority review and approval, the period of time until approval is expected to be shortened.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. specifically, in china, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide.1 hcc accounts for 85% to 90% of primary liver cancer cases. unresectable hcc, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.

eisai submitted applications for an additional indication for lenvatinib for the treatment of hcc in japan (june 2017), the united states and europe (july 2017), mainland china (october 2017) and chinese taiwan (december 2017).

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai is committed to exploring the potential clinical benefits of lenvatinib 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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that aricept® (donepezil hydrochloride, brand name in china: ) has been approved for the additional indication of severe alzheimer‘s disease in china. aricept is the first alzheimer’s disease treatment with a broad indication that covers mild to severe alzheimer‘s disease in china.

the approval of the additional indication was based on the results of a phase iii clinical study (study 339) in china. study 339 was a multi-center, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of aricept 10 mg per day in 313 chinese patients with severe alzheimer’s disease. in this study, aricept demonstrated a statistically significant improvement in total severe impairment battery scores after 24 weeks compared to placebo, which was the primary endpoint of the study. in the study, the four most commonly observed adverse events in the aricept arm were bradycardia, anorexia, qt interval prolongation, and dizziness.

in china, it has been estimated that approximately 6 million people suffer from alzheimer‘s disease. furthermore, with the progressive aging of the population, the number of patients with dementia is expected to greatly increase in the future. eisai launched aricept in china in september 1999, and in collaboration with various stakeholders including government, hospitals and non-government organizations, is actively promoting dementia disease awareness initiatives for civilians as well as support for establishing memory clinics and other initiatives.

with the approval of this indication covering severe alzheimer’s disease, eisai strives to further contribute to increasing the quality of life of patients with alzheimer‘s disease in china, and as the originator of aricept, continues to make comprehensive contributions in dementia such as improving treatment and care, increasing public awareness of the disease and discovering new treatment methods.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that the china food and drug administration (cfda) has accepted for review a new drug application (nda) submitted for eisai’s in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) for use in the treatment of hepatocellular carcinoma (hcc) in china.

the nda was based on the results of the reflect study (study 304), a multicenter, open-label, randomized, global phase iii trial comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for hcc, as a first-line treatment for the patients with unresectable hcc.

in the reflect study, lenvatinib demonstrated a treatment effect on the primary endpoint of overall survival (os) by the statistical confirmation of non-inferiority to sorafenib. additionally, lenvatinib showed highly statistically significant and clinically meaningful improvements compared to sorafenib in the secondary endpoints of progression free survival (pfs), time to progression (ttp), and objective response rate (orr). in this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. specifically, in china, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide. hcc accounts for 85% to 90% of primary liver cancer cases. treatment options for unresectable hcc are limited. therefore, hcc is extremely difficult to treat, and the development of new treatments is necessary.

eisai submitted applications for an additional indication for lenvatinib for the treatment of hcc in japan (june 2017), the united states and europe (july 2017).

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai is committed to exploring the potential clinical benefits of lenvatinib 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.

results of subpopulation analysis of patients from greater chinese region (mainland china, hksa, and chinese taiwan)

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that the results of a subpopulation analysis of patients from the greater chinese region (mainland china, hksa, and chinese taiwan) in a phase iii trial (reflect / study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) versus sorafenib as a first-line treatment for unresectable hepatocellular carcinoma (hcc) were orally presented for the first time during the 20th annual meeting of the chinese society of clinical oncology (csco), which took place in xiamen (amoy) in the fujian province of china. over half of the world‘s hcc patients come from the greater chinese region.

in the subpopulation analysis, lenvatinib demonstrated efficacy based on extension of overall survival (os) compared to sorafenib (nominal p = 0.026), with improvements also observed in progression free survival (pfs), time to progression (ttp) and objective response rate (orr) (see table below). approximately 80% of patients in the subpopulation were suffering from hcc resulting from chronic hepatitis b virus (hbv). for these patients, median os in the lenvatinib group (123 patients) was 14.9 months, compared to 9.9 months in the sorafenib group (119 patients) (hazard ratio [hr] 0.72, 95% confidence interval [ci] = 0.53-0.97). these findings are consistent with the overall results of the greater chinese region subpopulation.
hbv is considered to be a negative predictor of tumor response to existing drug therapies. however, this data supports the effect of lenvatinib in patients with hcc resulting from hbv. since there are many patients suffering from hcc resulting from hbv in the greater chinese region, lenvatinib is expected to be a new treatment option for hcc patients in this area.

additionally, lenvatinib’s safety profile for the greater chinese region subpopulation was consistent with previous studies.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. specifically, in china, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide. hcc accounts for 85% to 90% of primary liver cancer cases. treatment options for unresectable hcc are limited and the prognosis is very poor, making this an area of high unmet medical need.

following submissions in japan (june 2017), the united states and europe (july 2017), eisai will submit a regulatory application for lenvatinib in hcc in china within the latter half of fiscal 2017. eisai remains committed to generating scientific evidence aimed at maximizing the value of lenvatinib 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.

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