JP7437260B2 - 抗ｃ５抗体クロバリマブの使用によるｃ５関連疾患の治療または予防のための薬用量および投与レジメン - Google Patents

抗ｃ５抗体クロバリマブの使用によるｃ５関連疾患の治療または予防のための薬用量および投与レジメン Download PDF

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JP7437260B2
JP7437260B2 JP2020129449A JP2020129449A JP7437260B2 JP 7437260 B2 JP7437260 B2 JP 7437260B2 JP 2020129449 A JP2020129449 A JP 2020129449A JP 2020129449 A JP2020129449 A JP 2020129449A JP 7437260 B2 JP7437260 B2 JP 7437260B2
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clovalimab
antibody
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JP2021038197A5 (enExample
JP2021038197A (ja
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アレクサンドル アントワーヌ ベルナール ソステリ，
シモン ベルトラン マリー ブアトワ，
アントワーヌ ソウブレ，
フェリクス グレゴワール ジャゾン ジャミノン，
グレゴール ジョーダン，
クリストフ ブッチャー，
ジャン－エリク チャロイン，
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エフ・ホフマン－ラ・ロシュ・アクチェンゲゼルシャフト
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JP2020129449A 2019-07-31 2020-07-30 抗ｃ５抗体クロバリマブの使用によるｃ５関連疾患の治療または予防のための薬用量および投与レジメン Active JP7437260B2 (ja)

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JP2022036156A JP7749495B2 (ja) 2019-07-31 2022-03-09 抗ｃ５抗体クロバリマブの使用によるｃ５関連疾患の治療または予防のための薬用量および投与レジメン

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EP19189436 2019-07-31
EP19189436 2019-07-31
EP20174781 2020-05-14
EP20174781 2020-05-14
EP20179590 2020-06-11
EP20179590 2020-06-11

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JP7437260B2 true JP7437260B2 (ja) 2024-02-22

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JP2022036156A Active JP7749495B2 (ja) 2019-07-31 2022-03-09 抗ｃ５抗体クロバリマブの使用によるｃ５関連疾患の治療または予防のための薬用量および投与レジメン

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CN (2) CN114466660A (enExample)
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TW202404632A (zh) * 2022-04-04 2024-02-01 瑞士商赫孚孟拉羅股份公司 用於藉由使用抗ｃ５抗體克羅伐單抗治療或預防格林－巴利症候群之劑量及投予方案

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JP2018123125A (ja) 2017-01-31 2018-08-09 中外製薬株式会社 Ｃ５関連疾患の治療または予防用の医薬組成物およびｃ５関連疾患を治療または予防するための方法

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL85035A0 (en) 1987-01-08 1988-06-30 Int Genetic Eng Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same
DE3883899T3 (de) 1987-03-18 1999-04-22 Sb2, Inc., Danville, Calif. Geänderte antikörper.
EP0940468A1 (en) 1991-06-14 1999-09-08 Genentech, Inc. Humanized antibody variable domain
WO1994029351A2 (en) 1993-06-16 1994-12-22 Celltech Limited Antibodies
US6074642A (en) 1994-05-02 2000-06-13 Alexion Pharmaceuticals, Inc. Use of antibodies specific to human complement component C5 for the treatment of glomerulonephritis
US6194551B1 (en) 1998-04-02 2001-02-27 Genentech, Inc. Polypeptide variants
PT1068241E (pt) 1998-04-02 2007-11-19 Genentech Inc Variantes de anticorpos e respectivos fragmentos
KR101077001B1 (ko) 1999-01-15 2011-10-26 제넨테크, 인크. 효과기 기능이 변화된 폴리펩티드 변이체
US6737056B1 (en) 1999-01-15 2004-05-18 Genentech, Inc. Polypeptide variants with altered effector function
CA2424379C (en) 2000-10-10 2013-10-01 Tanox, Inc. Inhibition of complement c5 activation for the treatment and prevention of delayed xenograft or acute vascular rejection
CN100391537C (zh) 2001-08-17 2008-06-04 建南德克公司 结合至c5和c5a但不阻止c5b形成的补体途径抑制剂
ITMI20021527A1 (it) 2002-07-11 2004-01-12 Consiglio Nazionale Ricerche Anticorpi anti componente c5 del complemento e loro uso
US7361740B2 (en) 2002-10-15 2008-04-22 Pdl Biopharma, Inc. Alteration of FcRn binding affinities or serum half-lives of antibodies by mutagenesis
CN103833854B (zh) 2002-12-16 2017-12-12 健泰科生物技术公司 免疫球蛋白变体及其用途
US20050169921A1 (en) 2004-02-03 2005-08-04 Leonard Bell Method of treating hemolytic disease
US20070116710A1 (en) 2004-02-03 2007-05-24 Leonard Bell Methods of treating hemolytic anemia
WO2005100402A1 (en) 2004-04-13 2005-10-27 F.Hoffmann-La Roche Ag Anti-p-selectin antibodies
TWI309240B (en) 2004-09-17 2009-05-01 Hoffmann La Roche Anti-ox40l antibodies
HUE066795T2 (hu) 2006-03-15 2024-09-28 Alexion Pharma Inc Paroxysmalis nocturnalis haemoglobinuriában szenvedõ betegek kezelése egy komplement inhibitorral
MX2011001371A (es) 2008-08-05 2011-06-16 Novartis Ag Composiciones y metodos para anticuerpos que se dirigen a la proteina de complementos c5.
CA2742802C (en) 2008-11-10 2019-11-26 Alexion Pharmaceuticals, Inc. Methods and compositions for treating complement-associated disorders
TWI617580B (zh) * 2014-12-19 2018-03-11 中外製藥股份有限公司 抗ｃ５抗體及使用方法
IL259256B2 (en) 2015-12-18 2023-02-01 Chugai Pharmaceutical Co Ltd Anti-c5 antibodies and methods of use
EP3402816A1 (en) * 2016-01-11 2018-11-21 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
MA53248A (fr) 2016-01-25 2022-02-16 Takeda Pharmaceuticals Co Anticorps anti-c5 à commutation ph améliorée
KR102579940B1 (ko) * 2016-12-16 2023-09-15 삼성바이오에피스 주식회사 안정한 액상의 항-c5 항체 조성물
JP7518764B2 (ja) * 2017-10-26 2024-07-18 アレクシオン ファーマシューティカルズ， インコーポレイテッド 発作性夜間ヘモグロビン尿症（ＰＮＨ）および非典型溶血性尿毒症症候群（ａＨＵＳ）の処置のための抗Ｃ５抗体の投薬量および投与

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018123125A (ja) 2017-01-31 2018-08-09 中外製薬株式会社 Ｃ５関連疾患の治療または予防用の医薬組成物およびｃ５関連疾患を治療または予防するための方法

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WO2021019033A1 (en) 2021-02-04
TWI886139B (zh) 2025-06-11
CA3144921A1 (en) 2021-02-04
EP4003408A1 (en) 2022-06-01
CR20220040A (es) 2022-03-02
CN115137815A (zh) 2022-10-04
US20220275071A1 (en) 2022-09-01
JP7749495B2 (ja) 2025-10-06
KR102618269B1 (ko) 2023-12-27
TW202120124A (zh) 2021-06-01
AU2020319677A8 (en) 2022-01-27
AU2020319677A1 (en) 2022-01-06
KR20210016332A (ko) 2021-02-15
JP2022104920A (ja) 2022-07-12
CN114466660A (zh) 2022-05-10
IL288636A (en) 2022-02-01
KR20240001329A (ko) 2024-01-03
JP2021038197A (ja) 2021-03-11

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