news – page 24 – eisai china lnc.-开元体育官网下载手机版

news – page 24 – eisai china lnc.-开元体育官网下载手机版

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.

results of subpopulation analysis of patients with hepatitis b virus coinfection

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that the results of a subpopulation analysis of patients with hepatitis b virus (hbv) coinfection 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 hcc were presented for the first time during the 11th annual conference of the international liver cancer association (ilca) held in seoul, south korea.

in the total population analysis of this study, the treatment effect of lenvatinib for all patients on the primary endpoint of overall survival (os) was demonstrated by statistical confirmation of non-inferiority to sorafenib. lenvatinib showed highly statistically significant and clinically meaningful improvements in the secondary endpoints of progression free survival (pfs), time to progression (ttp), and objective response rate (orr).
the analysis results presented at ilca indicate that in comparison to the total population, lenvatinib demonstrated a lower hazard ratio for os, fps, and ttp, and a higher odds ratio for orr in the subpopulation of patients with hbv (see table below). hbv is considered to be a negative predictor of tumor response to existing drug therapies, so lenvatinib, which demonstrated a therapeutic effect in patients with hbv, is expected to be a new treatment option for patients with hcc.

additionally, safety results were similar in patients with hbv and the total population in the lenvatinib arm. the five most common treatment-emergent adverse events in patients with hbv in the lenvatinib arm were hypertension, diarrhea, decreased weight, fatigue and decreased appetite.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for 750,000 deaths per year globally. additionally, 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. 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.

on september 15, 2017, china population welfare foundation, alzheimer’s disease chinese (adc) and eisai china inc. (eci) jointly kicked off the “yellow bracelet” activity for caring the patients with alzheimer‘s disease. in line with the corporate philosophy of “human health care (hhc)” and according to the actual situation of chinese patients, eisai introduced into china the experiences for the treatment and care of the aging people of japan in hope of continuously enhancing the attention of the whole chinese society to the alzheimer’s disease and improving the grim situation of china‘s insufficient treatments and care concerning this disease through upgrading the entire solution that covering recognition, trainings and care. chairman hao linna of china population welfare foundation, professor wang luning from alzheimer’s disease chinese, professor xie hengge from the general hospital of people‘s liberation army of china, professor wang huali from peking university sixth hospital (institute of mental health), professor liu xueyuan from the tenth people’s hospital affricated to tongji university, professor he jincai from the first affiliated hospital of wenzhou medical college, mr. kaneko norio, the president of eci and ms. feng yanhui, the general manager of eci attended the conference and delivered speeches. the guests jointly kicked off the “alzheimer‘s care” activity and witnessed the important moment.

since the establishment of the company, eisai made “hhc” as its mission and the criterion of the company’s operation and charity activities. “in eisai, every employee gives first thought to patients and their families, and to increasing the benefits that health care provides them. every year the eisai employees spend 1% of their working time practicing the hhc mission together with the patients, experiencing their sufferings in a bid to provide better services for them. eisai carries out extensive health activities according to the needs of different countries. for example, eisai opened clinics and provided free clinical services, patient-care services and doctor educations in india, thailand, philippines, britain, canada, and etc. in india, eisai has provided over 1,000 free clinic services for patients with alzheimer‘s disease. the amount of patients with alzheimer’s disease got treatments there increased about 6 times in 5 years since eisai opened memory clinics there and trained relevant medical staff. eisai also brings this mission to china,” said mr. kaneko norio, the president of eci when talking about the original purpose of the hhc” activities.

the “world alzheimer report 2016” indicated that the figure of patients with alzheimer‘s disease showed a rapid growth in china and the country saw a stark contrast of the huge patient amount to the insufficient treatment and care. only a few patients accepted standard diagnosis, and a considerable proportion of patients were mistaken for experiencing a natural part of the aging process and missed the best treatment time. what’s more, the coverage rate of professional medical care resources was obviously insufficient. based on the current situation, the “alzheimer‘s care” activity will establish a community-centered, comprehensive, hierarchical diagnosis and treatment system and a professional home-care platform, which help combat the disease with 5 practical measures as follow:


firstly, to strengthen the education to potential patients
distribute yellow bracelets to more elderly and help them better use it. enhance the technology of the yellow bracelet and enrich the relevant functions to reduce the risk of old people from getting lost;

secondly, to give full play to the power of yellow bracelet in wechat platform
rely on the wechat platform to promote the early diagnosis and treatment of the elders with alzheimer’s disease, give them early cognitive tests, recommend them the nearby memory clinic, show them care-introducing videos and provide them better caring methods;

thirdly, to explore and promote the community care model
make communities and pension institutions as the centers to establish home-care training platforms and livable environments. eisai plans to pilot this model in 6 chinese cities for the first batch;

fourthly, to carry out professional training in caring skills
to learn the global advanced caring experiences, design and develop standard courses to conduct professional trainings to improve the skills of medical staff.

fifthly, to strengthen the guidance on public awareness
carry out propaganda and education of disease-related knowledge and construct social environment that encourages respecting, loving and caring the elderly.

japan is a country with serious aging problem and experienced at elderly care. as a leading japanese pharmaceutical company, considering alzheimer‘s disease as a focus area for the long-term, eisai has introduced aricept® to china, made all efforts for its accessibility, and continuously increased the investments in the research and development of new drugs. what’s more, since 2012, eisai china began to support the yellow bracelet project, which helps prevent the elderly with alzheimer‘s disease from getting lost; eisai china has conducted a series of projects – “remember that i love you” patient-care activities, and has supported over 100 free clinical services, distributed 245,000 yellow bracelets and provided free drugs to 136 families. “the ’alzheimer‘s care’ activity is an upgrade of eisai‘s former hhc activities. based on the 20-year experiences in serving chinese families and communities, eisai china joins hands with institutions in different fields to help more patients get standard treatments at early stage, and to guide their families in taking care of the patients. eisai would like to introduce health management experiences accumulated for years through charitable organizations and academic institutions, and to protect the happiness of chinese families with the comprehensive alzheimer-treatment solutions,” said ms. feng yanhui, the general manager of eci.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been selected for a fifth consecutive year of membership in the dow jones sustainability asia pacific index (djsi asia pacific), the asia pacific version of the dow jones sustainability indices (djsi), which are a family of premier global indices for socially responsible investment (sri).

the djsi family was jointly established between robecosam ag (switzerland) and s&p dow jones indices llc (united states) in 1999 as the first global sri indices in the world and assesses the corporate sustainability performance of eligible member companies based on economic, environmental and social criteria. this year, the djsi asia pacific has selected 152 companies leading the way in sustainability (72 of which are from japan) from among the region‘s top 614 companies. eisai received high scores particularly in categories such as codes of business conduct, product quality and recall management, labor practice indicators as well as strategy to improve access to drugs or products.

in addition to the djsi asia pacific, eisai has been selected for the 16th consecutive year since 2002 as a member of the ftse4good index series, another global benchmark sri index.

the eisai group’s corporate philosophy is to give first thought to patients and their families, and increase the benefits that health care provides as well as address diverse healthcare needs worldwide. guided by this philosophy, eisai will continue to develop innovative new drugs and make them available to patients around the world as early as possible to fulfill its social responsibility and secure the trust of stakeholders.

eisai co., ltd. (headquarters: bunkyo-ku, tokyo, ceo: haruo naito, “eisai”) and ono pharmaceutical co., ltd. (headquarters: chuo-ku, osaka, representative director and president: gyo sagara, “ono”) have announced that they have entered into a collaboration agreement to jointly develop the combination therapy of eisai‘s multi-kinase inhibitor, lenvima® (lenvatinib mesylate) and ono’s human anti-human pd-1 (programmed cell death-1) monoclonal antibody, opdivo® (nivolumab) for the treatment of hepatocellular carcinoma (hcc).

based on this agreement, eisai and ono will swiftly implement a phase ib clinical trial in japan to investigate the safety, tolerability, and efficacy of the combination of lenvima and opdivo in patients with hcc. details relating to the financial and other conditions of this agreement are confidential.

liver cancer is the second most common cause of cancer related deaths, with an estimated 750,000 deaths per year globally. additionally, 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions, including japan and china. hcc accounts for approximately 85% to 90% of liver cancer cases. it is estimated that there are approximately 42,000 hcc patients in japan, with 26,000 deaths per year. treatment options for unresectable hcc are limited and the prognosis is very poor, so this remains an area with high unmet medical needs.
eisai submitted an application for an additional indication of lenvima for the treatment of hcc in japan in june 2017. ono is currently conducting a phase iii clinical trial of opdivo for the treatment of hcc in japan.

dr. takashi owa, vice president, chief medicine creation officer, oncology business group, eisai, commented, “our non-clinical research has demonstrated synergistic antitumor activities in the lenvima and anti-pd1 antibody combination, which are considered to be a result of an immunostimulatory response through a reduction in immunosuppressive tumor-associated macrophages and an increase in cytotoxic t lymphocytes by lenvima. through the development of a combination therapy that has the potential to produce synergistic effects between lenvima and nivolumab, both drugs of japanese origin, we anticipate being able to further contribute to addressing the high unmet medical needs of hcc patients and their families and improving their benefits.”

hiroshi awata, vice president executive officer / executive director, clinical development, ono, commented, “we have been actively engaged in the development of opdivo not only in monotherapy, but combination therapies with other agents. as we believe that the combination therapy may exert more excellent therapeutic efficacy compared to the monotherapy, we are very pleased to pursue the potential for developing the combination therapy of opdivo with lenvatinib. we expect that the combination therapy with opdivo and lenvatinib will be a new treatment option for the patients with hepatocellular carcinoma.”

following the 101st place in 2014 and the 97th place in 2015, eisai china inc., harvested the 92nd place in the 2016 china top 100 pharmaceutical enterprises list announced by china national pharmaceutical industry information center. mr. zhang jiekui, senior director of policy administration of eisai china inc., accepted the award on behalf of the company.


medal won by eisai china inc.

 


scene of the awarding ceremony

during more than 20 years‘ industrious endeavors, eisai’s staff always sticks to the corporate philosophy to “give first thought to patients and their families, and to increasing the benefits health care provides”, continuously brings in high-quality pharmaceutical products, proactively expands and innovates the business models, roots in china and serves chinese patients and their families. along with the fast development in china market, led by the management team headed by the president, mr. kaneko norio, and the general manager, ms. feng yanhui, eisai‘s staff follows the core principles of hhc, innovation, access, autonomy”, adheres strictly to the compliance, and continuously carries out tasks, such as talent development, structure optimization, cost control, efficiency improvement, innovation encouragement and etc. every eisai’s employee spends at least 1% of their working time to contact the patients and profoundly feel their sufferings. eisai is endeavoring to make itself a respectable “hhc” company in china.

eisai has invested 230 million us dollars in total in china and established entities including eisai china holdings ltd., eisai (suzhou) trading co., ltd., eisai (liaoning) pharmaceutical co., ltd., and etc., with registered capital of 78.54 million us dollars, nearly 2,000 employees and creating value worth over rmb 3 billion yuan every year. china region has become one of eisai group‘s global top 5 independent regions and contributes 8% to the group’s global sales, ranking the 3rd place, just following japan and the us market. eisai kept two-digit growth in 2014, 2015 and 2016, and has been the top 1st japanese pharmaceutical company in china for nearly 10 successive years.

eisai has identified neurology and oncology as important areas, and focus on marketing campaigns in 4,800 hospitals in over 100 cities with population of more than one million. in the future, eisai will further strengthen its strategic production pipelines, penetrate into the lower market, bring in more high-quality drugs in the central neurology and oncology areas, and continuously provide high-quality generic drugs through eisai (liaoning) pharmaceutical co. ltd. to better satisfy the needs of chinese patients.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that on july 26, 2017 (u.s. time), its u.s. subsidiary eisai inc. received approval from the u.s. food and drug administration (fda) for a supplemental new drug application (snda) for eisai’s antiepileptic drug (aed) fycompa (perampanel) as monotherapy use for the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older.

 

the fda’s regulatory pathway for monotherapy use, which was communicated in september 2016, states that “it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial-onset seizures to their use as monotherapy for the treatment of partial-onset seizures.” fycompa is the first aed to be approved as monotherapy for partial-onset seizures in accordance with this regulatory pathway.

 

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. it was originally approved in the united states as an adjunctive therapy for the treatment of partial-onset seizures (with or without secondarily generalized seizures) and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. with the approval of monotherapy for partial-onset seizures, fycompa can now be prescribed to all patients with partial-onset seizures 12 years of age and older in the united states.

 

epilepsy affects approximately 2.9 million people in the united states. epilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of epilepsy cases. eisai considers neurology a therapeutic area of focus, and through the provision of new treatment options such as fycompa monotherapy for partial-onset seizures in the united states, seeks to further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

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