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Press release
2017年11月29日 16時00分
Source:
Eisai
エーザイ、中国における抗がん剤「ハラヴェン(R)」の新薬承認の再申請が受理
東京, 2017年11月29日 - (JCN Newswire) - エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫)は、本日、抗がん剤エリブリンメシル酸塩(製品名:「ハラヴェン(R)」)について、中国における新薬承認申請を再提出し、国家食品薬品監督管理総局に受理されたことをお知らせします。
当社は、本剤について、2016 年 7 月に中国で局所進行性・転移性乳がんに係る適応で新薬承認申請を行いましたが、追加資料を提出するために、中国の規制に従い、2017年6月に承認申請を一旦取り下げていました。今回、追加資料の提出準備が整ったことから、再申請に至りました。
当社は、がん領域を重点領域の一つと位置づけており、がんの「治癒」に向けた革新的な新薬創出をめざしています。当社は、「ハラヴェン」の臨床的価値を高めることで、中国を含む世界のがん患者様とそのご家族、さらには医療従事者の多様なニーズの充足とベネフィット向上により一層貢献してまいります。
本リリースの詳細は下記をご参照ください。
http://www.eisai.co.jp/news/news201768pdf.pdf
概要:エーザイ株式会社
詳細は www.eisai.co.jp をご覧ください。
Source: Eisai
セクター: バイオテック
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
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