news – page 23 – eisai china lnc.-pg电子app

grand launching campaign

june 20, 2018, eisai china region held a grand launching campaign for its rk-1000 model a, a new generation of icg clearance meter, in jw marriott hotel shanghai. the staff from merchants department and partners in china region got together witnessing the company’s first clinical diagnosis device hitting the market. the device will be promoted together with indocyanine green for injection, a product of eisai (liaoning) pharmaceutical co. ltd. this is an attempt of eisai china to expend its business to a new field, which will enrich its product line in the treatment of hepatic diseases such as hepatic carcinoma, hepatic injury, hepatic encephalopathy, and etc., greatly improve its market competitiveness and provide better solution of diagnosis and treatment for both doctors and patients in china.

mr. dali wang and mr. ningbo cai introduced the company and the product

eisai china always gives first thought to patients and their families, and contributes to increasing the benefits provided to them. 
mr. dali wang, director of merchants department, indicated in his speech, “as a multi-national company focusing on the r&d of pharmaceutical products, eisai always gives first thought to patients and their families, and contributes to increasing the benefits provided to them; and as a japanese pharmaceutical company in china, we always adhere to our company philosophy, “human health care (hhc)”. in december 2015, through the full acquisition of a local pharmaceutical enterprise, eisai china established eisai (liaoning) to enter the generic pharmaceutical business to expand its existing business focused on new medicines, in a bid to adapt to chinese market. by providing a stable supply of high quality generic pharmaceuticals with reasonable price, eisai china is able to fulfill an even wider range of medical needs in china. this is the mission of eisai, in accordance with the company’s hhc philosophy. the new business in medical devices bears the same philosophy and spirit. we look forward to working together with our partners to better serve medical practitioners and benefit more chinese patients.

grand launching campaign

liver reserve function testing is the technical basis of precise liver resection of the hepatobiliary surgery.
yangqing huang, head of shanghai public health clinical center, introduced the importance of the liver reserve function testing to hepatobiliary surgeons. huang indicated that the liver reserve function testing is the technical basis for the precise liver resection in the hepatobiliary surgery, and icg clearance test, currently a widely used quantitative assay method of the liver reserve function, is regarded as the standard evaluation index in a large number of guiding documents in both china and overseas. preoperative icg clearance test helps assess the safe range of liver resection and reduce the incidence rate of postoperative liver failure and death, while the postoperative icg clearance test can predict the incidence rate of liver dysfunction and severe complications.

in the campaign, the sponsor introduced in detail the clinically applicable departments of liver reserve function testing and the clinical benefits it brings, explained the guide documents, marketing strategies and gave product demonstrations.

liver reserve function testing is applicable to multiple departments including hepatobiliary surgery, liver transplantation, hepatology, intervention, and etc. in the hepatobiliary surgery department it can be used to assess the safe range of liver resection, to reduce the risks of postoperative liver failure and death, and to predict the incidence rate of postoperative liver dysfunction. in the liver transplant department it can be used to evaluate the quality of the donor liver and the success rate of the operation. in the hepatology department it is manly used in the early diagnosis of liver injury and prognosis evaluation of cirrhosis. in the interventional department it can be used to guide the interventional operation plan and to evaluate the prognosis of operation.

rk-1000 model a, a new generation of icg clearance meter

the new generation icg clearance tester rk-1000 model a is a professional liver reserve function testing device with exclusive dynamic calibration technology and continuous spectrophotometric method bringing a lot of advantages such as dynamic, real-time, accurate, convenient test and so on. this device will be sure to bring more benefits to the broad masses of patients and clinical practitioners.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced the u.s. food and drug administration (fda) has accepted for review the supplemental new drug application (snda) for eisai‘s antiepileptic drug (aed) fycompa^®(perampanel). this application seeks approval for an indication expansion to cover pediatric patients with partial onset seizures and primary generalized tonic-clonic seizures (pgtc) seizures. furthermore, eisai has included a study in this snda requested by the fda in a pediatric written request, and therefore fda has designated this application for priority review, which means the review period will be six months. the fda has assigned a prescription drug user fee act (pdufa) action date of september 28, 2018.

this snda 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 pediatric patients and patients 12 years of age and older. the application 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 the age range down to 2 years of age. based on data accumulated to date, the snda also seeks to expand the pediatric indication to include children 2 years of age and older for the adjunctive treatment of pgtc seizures.

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. fycompa has been approved in countries around the world including the united states as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) as well as pgtc seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa has also been approved as monotherapy for the treatment of partial-onset seizures (with or without secondarily generalized seizures). a new oral suspension formulation has also been approved and is available in the united states.

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,¹ this is a disease with significant unmet medical need.

eisai considers neurology including epilepsy, a therapeutic area of focus, and strives to deliver fycompa throughout the world in pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy. eisai seeks to further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

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

[notes to editors]

about study 311
study 311 is a global (united states, europe, japan, asia) multicenter, open-label, single-arm trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of fycompa oral suspension when administered as an adjunctive therapy in approximately 160 pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
following the 23 week treatment phase in which patients were titrated to receive 2 to 16 mg of fycompa orally once-daily, long term safety was assessed during an extension phase. in japan, pediatric patients with partial-onset seizures were titrated to receive 2 to 12 mg of fycompa orally once-daily. the adverse events (≥10% in the perampanel arms) observed in study 311 at the time of interim analysis were somnolence, nasopharyngitis, dizziness, and irritability.

about study 232
study 232 was a global (united states, europe), multicenter, open-label, long-term administration clinical study in approximately 63 pediatric patients with epilepsy (ages 2 to less than 12). the study evaluated the pharmacokinetics, safety, tolerability and efficacy of fycompa oral suspension taken at the same time as other aeds. administration of once-daily fycompa was titrated from 0.015 mg/kg to 0.18 mg/kg, and long-term safety was confirmed after 11 weeks of treatment and an extension phase (41 weeks). the most common adverse events (≥10% in the perampanel arms) observed in study 232 were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.

1. “the epilepsies and seizures: hope through research. what are the epilepsies?” national institute of neurological disorders and stroke, accessed may 24, 2016, 

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. (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.

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.