Komori
GNI Group (2160) · RiskMaterialised

Rejection of the application to register tamibarotene as an imported drug in China

First written in FY2020-Q3. 1 of 1 entries say "Materialised", first in FY2020-Q3. Latest entry: FY2020-Q3.

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Rejection of Tamibarotene's Chinese Imported-Drug Registration Application and Response to Potential ResubmissionA theme 1 companies write about · 3 as a headwind · 0 as a tailwind

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  1. FY2020-Q3MaterialisedAnnual report

    「その後、東光製薬工業株式会社は、NMPAの審査やNMPAから求められた追加データを提出しましたが、この申請は却下されました。」

    タミバロテンの中国輸入薬登録申請について、NMPAの審査及び追加データ提出後に申請が却下された。NMPAは臨床試験継続による再申請の可能性を示している。
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