news – page 25 – eisai china lnc.-pg电子app

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 101^st place in 2014 and the 97^th place in 2015, eisai china inc., harvested the 92^nd 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 3^rdplace, just following japan and the us market. eisai kept two-digit growth in 2014, 2015 and 2016, and has been the top 1^st 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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that it has submitted applications to the us food and drug administration (fda) and the european medicines agency (ema) for its in-house discovered and developed anticancer agent lenvatinib mesylate (lenvatinib) for the treatment of hepatocellular carcinoma (hcc). this follows the application in japan. lenvatinib for the treatment of hcc is designated as an orphan drug by the fda.

this application is 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 954 patients with unresectable hcc.

in the reflect study, lenvatinib met the primary endpoint and demonstrated an overall survival (os) treatment effect by the statistical confirmation of non-inferiority compared to sorafenib. developing first-line treatments for hcc is challenging, and over the past 10 years, four previous first-line phase iii studies investigating other agents compared to sorafenib have failed to achieve this endpoint in os.

additionally, 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). 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 death and is estimated to be responsible for 750,000 deaths per year globally (27,000 per year in the us, 62,000 per year in europe), with 780,000 cases newly diagnosed each year (30,000 per year in the us, 63,000 per year in europe). hcc accounts for 85% to 90% of 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.

lenvatinib is approved as a treatment for refractory thyroid cancer in over 50 countries, including the united states, japan, and in europe, under the brand name lenvima®. additionally, lenvatinib in combination with everolimus is approved for the treatment of renal cell carcinoma (rcc) in over 35 countries, including the united states and in europe. in europe, lenvatinib was launched under the brand name kisplyx® for rcc.

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.

primary endpoint achieved and statistically significant improvement of secondary endpoints compared with sorafenib

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the results of a phase iii trial (study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) against the comparator sorafenib as first-line treatment for unresectable hepatocellular carcinoma, will be orally presented during the 53rd annual meeting of the american society of clinical oncology (asco), taking place in chicago, the united states. in this study, lenvatinib was the first agent to demonstrate statistical non-inferiority against sorafenib in the primary endpoint of overall survival (os) and showed statistically significant and clinically meaningful improvements in the secondary endpoints of progression free survival (pfs), time to progression (ttp), and objective response rate (orr), doubling sorafenib‘s median values and ratios.

according to the results of the study, lenvatinib (13.6 months) met the statistical criteria for non-inferiority in the primary endpoint of median os compared to sorafenib (12.3 months). (hazard ratio [hr] 0.92, 95% confidence interval [ci] = 0.79-1.06)
additionally, lenvatinib showed statistically significant improvements in the three secondary endpoints compared to sorafenib: median pfs (lenvatinib 7.4 months versus sorafenib 3.7 months, hr 0.66, 95% ci = 0.57-0.77, p<0.00001), median ttp (lenvatinib 8.9 months versus sorafenib 3.7 months, hr 0.63, 95% ci = 0.53-0.73, p<0.00001) and orr (lenvatinib 24% versus sorafenib 9%, p<0.00001).
furthermore, when overall quality of life (qol) was evaluated based on the eortc qlq-c30 questionnaire, it was found that lenvatinib helped to delay deterioration of qol, 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 lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.

based on the results of this study, eisai will submit regulatory applications for lenvatinib for the treatment of hepatocellular carcinoma in japan, the united states, and europe during the first half of fiscal 2017, and china within fiscal 2017.

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, including japan and china. hepatocellular carcinoma accounts for 85% to 90% of primary liver cancer cases. early stage hepatocellular carcinoma is treatable by a wide variety of means, including surgery, radiofrequency ablation, ethanol injection, and chemoembolization therapy, but treatment opinions for unresectable hepatocellular carcinoma are limited and the prognosis is very poor, meaning that this is an area of high unmet medical need.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. 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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced the first results for metastatic endometrial carcinoma obtained from a phase ib/ii study (study 111) of its in-house developed multi-kinase inhibitor lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) in combination with the msd (known as merck & co., inc, kenilworth, nj, usa in the united states and canada) anti-pd-1 antibody pembrolizumab (brand name: keytruda®^*), during a presentation at the 53rd annual meeting of the american society of clinical oncology (asco), taking place in chicago, the united states. the two companies are collaborating to develop this combination therapy. study 111 is being conducted to evaluate the activity of the lenvatinib/pembrolizumab combination in select solid tumors.

the presentation covers an analysis of a combined total of 23 endometrial carcinoma patients over both the phase ib and phase ii parts of the study, who had previously undergone at least one chemotherapy regimen. after being treated with a combination of lenvatinib and pembrolizumab, the results of the analysis showed the primary endpoint of objective response rate was 52.2% (95% confidence interval [ci] = 30.6 – 73.2) based on an independent radiologic review (irr) and 47.8% (95% ci: 26.8 – 69.4) by investigator review.
the secondary endpoints of clinical benefit rate^** were 65.2% (95% ci: 42.7 – 83.6) by irr and 73.9% (95% ci: 51.6 – 89.8) by investigator review. disease control rate^***were 91.3% (95% ci: 72.0 – 98.9) by irr and 95.7% (95% ci: 78.1 – 99.9) by investigator review. median progression-free survival was 9.7 months (95% ci: 4.2 – ne) based on investigator assessment and was not reached by irr. median duration of response was not reached at the time of analysis.
anti-pd-1 antibodies are generally more effective in patients with a high frequency of microsatellite instability (msi), a biomarker that results in dysfunctional dna mismatch repair, and less effective in other patients. however, in this study, the combination therapy resulted in tumor response regardless of the state of their msi.
the most frequently observed adverse events for the combination regimen (top 5) were hypertension, fatigue, arthralgia, diarrhea, and nausea.

endometrial cancer is the sixth most common cancer in women worldwide, with 320,000 new cases diagnosed in 2012. in the united states, it is estimated that approximately 60,000 women will be newly diagnosed with endometrial cancer, and approximately 10,000 women will die from the disease in 2017. therefore, this remains a disease with significant unmet medical needs and necessitates the development of new treatments.

eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. 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.

* keytruda® is a registered trademark of merck sharp & dohme corp., a subsidiary of merck & co., inc. kenilworth, nj, usa.
** clinical benefit rate: percentage of patients who had complete response, partial response, or maintained disease stability for 23 weeks or longer.
*** disease control rate: percentage of patients who had complete response, partial response, or maintained disease stability for 5 weeks or longer.

eisai commits funding to the 2nd phase of global health innovative technology fund activities

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it will grant a total of 500 million yen to the global health innovative technology fund (“ghit fund”) to fund the second phase of its activities, which will take place in the five-year period from fy 2018 to fy 2022. the ghit fund is a public-private partnership, co-established in april 2013 by multiple japanese pharmaceutical companies (including eisai), the japanese government, and the bill & melinda gates foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in japan and overseas.

in order to develop treatments for the numerous people suffering from infectious diseases such as neglected tropical diseases (ntds) and malaria in developing and emerging countries, there are disease-specific development and marketability issues to overcome. it is also necessary to establish local supply systems and help patients secure access to diagnosis and treatments. the key to overcoming these challenges are industry-government-academia partnerships which transcend the usual sector boundaries.

eisai is proactively collaborating with academia and research organizations and has participated in 11 joint research projects to develop new medicines and vaccines for malaria, chagas disease, leishmaniasis, and filariasis, with the support of the ghit fund.
currently, eisai is conducting a phase ii clinical trial of its in-house developed agent e1224 (generic name: fosravuconazole) for the treatment of chagas disease in partnership with the non-profit organization drugs for neglected diseases initiative(dndi). eisai is also conducting a phase i clinical trial of antimalarial agent sj733 in collaboration with non-profit public-private partnership medicines for malaria venture (mmv) and the university of kentucky. furthermore, several pre-clinical stage projects are underway, including joint research with the broad institute and mmv to develop an antimalarial agent with a new mechanism of action, which has been newly adopted by the ghit fund this year.

in accordance with its human health care (hhc) philosophy, eisai will continue to proactively engage in initiatives which contribute to improving the health and welfare of people in developing and emerging countries. eisai considers this to be a long term investment in economic growth and the expansion of the middle-income class.

on april 19, 2017, eisai china inc. (hereinafter referred to as: eisai (china)) was invited to attend the “health to countryside” activity held in yudu county, jiangxi province by the national committee for education, science, culture, health and sports of chinese people’s political consultative conference (cppcc), and donated medicines worth rmb540,000 yuan to the local hospitals. according to the statistics, eisai (china), practicing the philosophy of hhc (human health care) all along, donated medicines worth rmb450,000, rmb490,000, rmb500,000 and rmb540,000 respectively to this activity from the year 2014 to 2017, with the total worth of medicines reaching up to rmb1.98 million yuan.

eisai (china) donated medicines worth rmb540, 000 yuan to the “health to countryside” activity.

the “health to countryside” is an important and traditional activity annually organized by the national committee for education, science, culture, health and sports of cppcc, implementing cppcc’s articles of association. this activity not only delivers doctors, medicines, concepts, technologies and management to the grassroots, but also narrows the distance between the committee members, the experts and the masses. it coincides with what eisai (china) has always been pursuing – the hhc philosophy. eisai (china) advocates that every year every eisai staff shall spend about 1% of their working hours on practicing hhc with patients, for the simple fact that only with the empathy of patients’ feelings and pains can eisai provide better services as well as products in need to earn the trust from patients and their families. eisai (china) will, led by its president mr. kaneko norio and the general manager ms. feng yanhui (fendy feng), continuously contribute to the medical and health services in poor areas by donating medicines to the “health to countryside” activity.

the donation certificate granted to eisai china inc.

on the donation ceremony, the chinese hospital association’s president mr. huang jiefu, the deputy secretary of cpc yudu county committee, the director of yudu county health and family planning commission and other leaders made their speeches. mr. xue xiaolin, the executive vice president of chinese hospital association, signed an agreement of donation with yudu county health and family planning commission. after the ceremony, president huang jiefu, executive vice president xue xiaolin and other leaders praised eisai (china)’s years of participation in this activity and expressed their high recognition for eisai’s hhc philosophy. finally, president huang jiefu said that the “health to countryside” activity would continue and more medical and health institutions would be welcomed to join the team for more contributions to the development of medical and health services.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that, approaching the 65^th anniversary of its chocola bb brand, it will launch chocola bb® gold rich (designated quasi-drug), a supplement drink recommended to relieve fatigue, on monday, april 17.

chocola bb gold rich is a luxurious combination of 16 active ingredients, the highest number in the chocola bb series. it contains active ingredients including b-complex vitamins and taurine 1500mg to help a fatigued body produce energy, and six natural herbs carefully selected by female developers to please female consumers, including angelica acutiloba, ginseng, and royal jelly. the bergamot orange flavor, which is also used in earl grey tea and other products, is easy to drink, and the gold and pink packaging is elegantly designed to give off a sense of luxury. this boxed supplement drink from the chocola bb brand has been designed to be approachable for female consumers.

in recent years, along with the increasing social advancement of women, the market catering to female supplement drink consumers is also growing. additionally, consumers drink different products depending on their level of fatigue. this product is designed to respond to the needs of women who want a high performance drink. chocola bb gold rich is a speedy fatigue reliever perfect for busy women in the office or at home.

the chocola bb supplement drink series includes chocola bb® light 2 for day-to-day fatigue, chocola bb® royal 2 for extreme fatigue, and chocola bb® hyper for weak constitutions, all of which are marketed as designated quasi-drug products designed to help relieve fatigue.

through the chocola bb brand, eisai will continue to respond to the diverse needs of female consumers and support an ever-growing number of people to achieve health and beauty in their everyday lives.

news – page 25 – eisai china lnc.-pg电子app

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