chen, chenyan – page 12 – eisai china lnc.-pg电子app

tokyo august 17, 2018 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and merck & co., inc., kenilworth n.j., u.s.a., known as msd outside of the united states and canada, announced today that the u.s. food and drug administration (fda) approved the kinase inhibitor lenvima® (lenvatinib mesylate) for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc). this approval was based on results from reflect (study 304), where lenvima demonstrated a proven treatment effect on overall survival (os) *1 by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival (pfs) *2 and objective response rate (orr) *3 when compared with sorafenib in patients with previously untreated unresectable hcc. this is the second approval of lenvima for use in the treatment of hcc following approval in japan earlier this year, and the first new systemic therapy to be approved in the u.s. for the first-line treatment of unresectable hcc in approximately 10 years.

tokyo & kenilworth, n.j., july 31, 2018 – eisai co., ltd. and merck & co., inc. kenilworth, n.j., u.s.a. (nyse:mrk), known as msd outside the united states and canada, announced today that the u.s. food and drug administration (fda) granted breakthrough therapy designation for lenvima® (generic name: lenvatinib mesylate), the orally available kinase inhibitor discovered by eisai, in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy keytruda® (generic name: pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high (msi-h)/proficient mismatch repair (pmmr) endometrial carcinoma (ec) who have progressed following at least one prior systemic therapy.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib) (headquarters: cambridge, massachusetts, united states, ceo: michel vounatsos, “biogen”) announced detailed results from the phase ii study (study 201) with ban2401, an anti-amyloid beta (aβ) protofibril antibody, in 856 patients with early alzheimer‘s disease as part of session dt-01 “recent developments in therapeutics (presentation number: dt-01-07) at the alzheimer’s association international conference (aaic) 2018 being held in chicago, illinois, united states on july 25. this abstract was accepted for late breaking oral presentation at aaic.

tokyo, june 21, 2018 – abbvie gk (headquarters: tokyo, president: james feliciano, “abbvie”) and eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that humira® for subcutaneous injection 20 mg syringe 0.2 ml, a new pediatric formulation of humira ® (generic name: adalimumab [recombinant], “humira”), a fully human anti-tnf-α monoclonal antibody formulation, has been launched today after being listed in the national health insurance reimbursement price list on june 15.