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lenvima® (lenvatinib mesylate) as a single agent for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc) from the ministry of food and drug safety (mfds) in south korea. an application seeking approval of lenvima for use in the treatment of unresectable hcc was submitted in south korea in march 2018. this approval for lenvima in south korea marks the second in asia following approval in japan. lenvima is the first new treatment option approved in ten years as a first-line systemic treatment for hcc in south korea.

tokyo august 23, 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 european commission (ec) has granted a marketing authorization for the oral receptor tyrosine kinase (rtk) inhibitor lenvima® (lenvatinib mesylate) as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have received no prior systemic therapy. this is the first new first-line treatment option for advanced or unresectable hcc to be approved in europe in approximately 10 years.

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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into an agreement to grant exclusive development and marketing rights for its anti-obesity agent lorcaserin hydrochloride (generic name, product name in the united states: belviq®, product name for once-daily formulation in the united states: belviq xr®, “lorcaserin”) in china (including hong kong and macao) to cy biotech (headquarters: taipei, taiwan, “cyb”).

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.