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医薬品の一般的名称について（令和7年11月26日医薬薬審発1126第1号） (7 ページ)
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| 公開元URL | https://www.mhlw.go.jp/hourei/doc/tsuchi/T251127I0020.pdf |
| 出典情報 | 医薬品の一般的名称について（11／26付 通知）《厚生労働省》 |
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and constant regions of anti-CD3ε H-chain, respectively, and amino acid residues of anti-CD3ε L-chain at positions of
1 – 125 and 126 – 232 correspond to VH of anti-CD3ε H-chain and CL of anti-CD3ε L-chain, respectively. The
complementarity-determining regions of each chain are derived from mouse antibodies and other regions are derived
from human IgG1. In the anti-CD20 H-chain, the amino acid residues are substituted at 9 positions (K149E, K215E,
L236A, L237A, P331G, Y351C, T368S, L370A, Y409V), and in the anti-CD20 L-chain, the amino acid residues are
substituted at 2 positions (E128R, Q129K), and in the anti-CD20/CD3ε H-chain, the amino acid residues are substituted
at 7 positions (K149E, K215E, L461A, L462A, P556G, S581C, T593W). Glofitamab is produced in CHO cells.
Glofitamab is a glycoprotein (molecular weight: ca. 197,000) composed of an anti-CD20 H-chain (γ1-chain) consisting
of 449 amino acid residues, two anti-CD20 L-chains (κ-chains) consisting of 219 amino acid residues each, an antiCD20/CD3ε H-chain (γ1-chain) consisting of 674 amino acid residues, and an anti-CD3ε L-chain consisting of 232
amino acid residues, in which anti-CD3ε variable region of anti-CD20/CD3ε H-chain and constant region of anti-CD3ε
L-chain are derived from λ-chain and κ-chain, respectively.
※
JAN 以外の情報は、参考として掲載しました。
1 – 125 and 126 – 232 correspond to VH of anti-CD3ε H-chain and CL of anti-CD3ε L-chain, respectively. The
complementarity-determining regions of each chain are derived from mouse antibodies and other regions are derived
from human IgG1. In the anti-CD20 H-chain, the amino acid residues are substituted at 9 positions (K149E, K215E,
L236A, L237A, P331G, Y351C, T368S, L370A, Y409V), and in the anti-CD20 L-chain, the amino acid residues are
substituted at 2 positions (E128R, Q129K), and in the anti-CD20/CD3ε H-chain, the amino acid residues are substituted
at 7 positions (K149E, K215E, L461A, L462A, P556G, S581C, T593W). Glofitamab is produced in CHO cells.
Glofitamab is a glycoprotein (molecular weight: ca. 197,000) composed of an anti-CD20 H-chain (γ1-chain) consisting
of 449 amino acid residues, two anti-CD20 L-chains (κ-chains) consisting of 219 amino acid residues each, an antiCD20/CD3ε H-chain (γ1-chain) consisting of 674 amino acid residues, and an anti-CD3ε L-chain consisting of 232
amino acid residues, in which anti-CD3ε variable region of anti-CD20/CD3ε H-chain and constant region of anti-CD3ε
L-chain are derived from λ-chain and κ-chain, respectively.
※
JAN 以外の情報は、参考として掲載しました。