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

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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

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