chen, chenyan – page 13 – eisai china lnc.-pg电子app

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. 

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.

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.

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.

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.