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医薬品の一般的名称について（医薬・生活衛生局医薬品審査管理課）（令和４年４月18日薬生薬審発0418第１号） (8 ページ)
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| 公開元URL | https://www.mhlw.go.jp/hourei/doc/tsuchi/T220419I0010.pdf |
| 出典情報 | 医薬品の一般的名称について（4／18付 通知）《厚生労働省》 |
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Datopotamab Deruxtecan is an antibody-drug-conjugate (molecular weight: ca. 152,000) consisting of deruxtecan
((3RS)-1-[(10S)-10-benzyl-1-{[(1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro1H,12H-benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl]amino}-1,6,9,12,15,18-hexaoxo-3-oxa5,8,11,14,17-pentaazatricosan-23-yl]-2,5-dioxopyrrolidin-3-yl group (C52H57FN9O13; molecular weight: 1,035.06)),
which is composed of camptothecin derivative and linker, attached to an average of four cysteine residues of a
recombinant monoclonal antibody. The antibody moiety is an anti-cell surface glycoprotein Trop-2 monoclonal
antibody, the complementarity-determining regions of which are derived from mouse antibody and other regions are
derived from human IgG1 and produced in CHO cells. The protein moiety is a glycoprotein (molecular weight: ca.
148,000) composed of 2 H-chains (γ1-chains) consisting of 451 amino acid residues each and 2 L-chains (κ-chains)
consisting of 214 amino acid residues each.
((3RS)-1-[(10S)-10-benzyl-1-{[(1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro1H,12H-benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl]amino}-1,6,9,12,15,18-hexaoxo-3-oxa5,8,11,14,17-pentaazatricosan-23-yl]-2,5-dioxopyrrolidin-3-yl group (C52H57FN9O13; molecular weight: 1,035.06)),
which is composed of camptothecin derivative and linker, attached to an average of four cysteine residues of a
recombinant monoclonal antibody. The antibody moiety is an anti-cell surface glycoprotein Trop-2 monoclonal
antibody, the complementarity-determining regions of which are derived from mouse antibody and other regions are
derived from human IgG1 and produced in CHO cells. The protein moiety is a glycoprotein (molecular weight: ca.
148,000) composed of 2 H-chains (γ1-chains) consisting of 451 amino acid residues each and 2 L-chains (κ-chains)
consisting of 214 amino acid residues each.