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eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has submitted a marketing authorization application in japan for its in-house discovered fibroblast growth factor (fgf) receptor (fgfr1, fgfr2, fgfr3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: e7090, “tasurgratinib”) for biliary tract cancer with fgfr2 gene fusion. in japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with fgfr2 gene fusion by the ministry of health, labour and welfare, (mhlw). under this system, this application will be subject to priority review.

“leqembi® intravenous infusion” (lecanemab) for the treatment of alzheimer’s disease to be launched in japan on december 20

tokyo and cambridge, mass., december 13, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that humanized anti- soluble aggregated amyloid-beta (aβ) monoclonal antibody “leqembi® intravenous infusion” (200 mg, 500mg, lecanemab) will be launched in japan on december 20, following its scheduled inclusion in the price listing on the japan national health insurance (nhi) drug price list.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and msd k.k. (headquarters: tokyo, president: kyle tattle, “msd”), a subsidiary of merck & co., inc., kenilworth, n.j., u.s.a., (known as msd outside the united states and canada) announced today that eisai has submitted an application in japan for the additional indication of its in-house discovered and developed multiple receptor tyrosine kinase inhibitor, lenvima® (generic name: lenvatinib mesylate), in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s keytruda® (generic name: pembrolizumab) as a treatment for patients with advanced renal cell carcinoma (rcc). this is the first application to be submitted in japan for this combination therapy.

kyorin pharmaceutical co., ltd. (headquarters: chiyoda-ku, tokyo, president and ceo: shigeru ogihara, “kyorin”), a subsidiary of kyorin holdings, inc. (headquarters: chiyoda-ku, tokyo, president and ceo: yutaka ogihara), and eisai co., ltd. (headquarters: bunkyo-ku, tokyo, ceo: haruo naito, “eisai”) have entered into a license agreement for development and distribution of vibegron, a therapeutic agent for overactive bladder, in four asean (association of southeast asian nations) member states; thailand, the philippines, malaysia and brunei. based on this agreement, eisai will acquire exclusive development and marketing rights from kyorin for the agent in the said four countries, and will be responsible for submitting a new drug application for the agent.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the european medicines agency (ema) has confirmed it has accepted for review applications for the use of its in-house discovered multiple receptor tyrosine kinase inhibitor, lenvatinib mesylate (product name: lenvima® / kisplyx®, “lenvatinib”), in combination with anti-pd-1 therapy pembrolizumab (brand name: keytruda®), developed by merck & co., inc., kenilworth, n.j., u.s.a., (known as msd outside the united states and canada) as a treatment f or patients with advanced renal cell carcinoma (rcc) and advanced endometrial carcinoma (ec), respectively.

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