JP7367262B1 - 抗体含有製剤の調製方法 - Google Patents

抗体含有製剤の調製方法 Download PDF

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Publication number
JP7367262B1
JP7367262B1 JP2023504043A JP2023504043A JP7367262B1 JP 7367262 B1 JP7367262 B1 JP 7367262B1 JP 2023504043 A JP2023504043 A JP 2023504043A JP 2023504043 A JP2023504043 A JP 2023504043A JP 7367262 B1 JP7367262 B1 JP 7367262B1
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poloxamer
minutes
antibody
mobile phase
pharmaceutical formulation
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Japanese (ja)
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JPWO2023100975A5 (https=
JPWO2023100975A1 (https=
Inventor
康平 副田
正和 福田
昌也 高橋
博貴 今井
智 齋藤
デュブッフ，ジェレミー
ラブリ，キショール
ケプフ，ロベルト
チェン，ウエイ
オルトラ，ヌリア・サンチョ
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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Publication of JPWO2023100975A1 publication Critical patent/JPWO2023100975A1/ja
Priority to JP2023176016A priority Critical patent/JP7550286B2/ja
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Publication of JPWO2023100975A5 publication Critical patent/JPWO2023100975A5/ja
Priority to JP2024150452A priority patent/JP2024170482A/ja
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/0005—Vertebrate antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C07K16/248—IL-6
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Diabetes (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2023504043A 2021-12-01 2022-12-01 抗体含有製剤の調製方法 Active JP7367262B1 (ja)

Priority Applications (2)

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JP2023176016A JP7550286B2 (ja) 2021-12-01 2023-10-11 抗体含有製剤の調製方法
JP2024150452A JP2024170482A (ja) 2021-12-01 2024-09-02 抗体含有製剤の調製方法

Applications Claiming Priority (3)

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JP2021195788 2021-12-01
JP2021195788 2021-12-01
PCT/JP2022/044355 WO2023100975A1 (ja) 2021-12-01 2022-12-01 抗体含有製剤の調製方法

Related Child Applications (1)

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JPWO2023100975A1 JPWO2023100975A1 (https=) 2023-06-08
JP7367262B1 true JP7367262B1 (ja) 2023-10-23
JPWO2023100975A5 JPWO2023100975A5 (https=) 2023-11-02

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JP2023176016A Active JP7550286B2 (ja) 2021-12-01 2023-10-11 抗体含有製剤の調製方法
JP2024150452A Pending JP2024170482A (ja) 2021-12-01 2024-09-02 抗体含有製剤の調製方法

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JP2024150452A Pending JP2024170482A (ja) 2021-12-01 2024-09-02 抗体含有製剤の調製方法

Country Status (11)

Country Link
US (2) US12460015B2 (https=)
EP (1) EP4442274A4 (https=)
JP (3) JP7367262B1 (https=)
KR (1) KR20240011866A (https=)
CN (1) CN118414166A (https=)
AU (1) AU2022399314A1 (https=)
CA (1) CA3239389A1 (https=)
IL (1) IL313202A (https=)
MX (1) MX2024006387A (https=)
TW (1) TW202333787A (https=)
WO (1) WO2023100975A1 (https=)

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Publication number Priority date Publication date Assignee Title
AU2024380406A1 (en) * 2023-11-15 2026-04-16 Biotest Ag Method of manufacturing an igm containing composition

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010215664A (ja) * 2003-02-28 2010-09-30 Chugai Pharmaceut Co Ltd タンパク質含有安定化製剤
WO2017188356A1 (ja) * 2016-04-28 2017-11-02 中外製薬株式会社 抗体含有製剤
JP2019511606A (ja) * 2016-03-17 2019-04-25 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツングＭｅｒｃｋ Ｐａｔｅｎｔ Ｇｅｓｅｌｌｓｃｈａｆｔ ｍｉｔ ｂｅｓｃｈｒａｅｎｋｔｅｒ Ｈａｆｔｕｎｇ ポロキサマーを精製するための方法
WO2021241720A1 (ja) * 2020-05-29 2021-12-02 中外製薬株式会社 抗体含有製剤

Family Cites Families (53)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58201994A (ja) 1982-05-21 1983-11-25 Hideaki Hagiwara 抗原特異的ヒト免疫グロブリンの生産方法
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US4676980A (en) 1985-09-23 1987-06-30 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Target specific cross-linked heteroantibodies
GB8607679D0 (en) 1986-03-27 1986-04-30 Winter G P Recombinant dna product
US6548640B1 (en) 1986-03-27 2003-04-15 Btg International Limited Altered antibodies
US6150584A (en) 1990-01-12 2000-11-21 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
EP0585287B1 (en) 1990-07-10 1999-10-13 Cambridge Antibody Technology Limited Methods for producing members of specific binding pairs
ATE300615T1 (de) 1990-08-29 2005-08-15 Genpharm Int Transgene mäuse fähig zur produktion heterologer antikörper
US5770429A (en) 1990-08-29 1998-06-23 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
CA2405246A1 (en) 1990-12-03 1992-06-11 Genentech, Inc. Enrichment method for variant proteins with alterred binding properties
US5696298A (en) 1991-03-19 1997-12-09 Cytrx Corporation Polyoxypropylene/polyoxyethylene copolymers with improved biological activity
EP1400536A1 (en) 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
AU665025B2 (en) 1991-09-23 1995-12-14 Cambridge Antibody Technology Limited Production of chimeric antibodies - a combinatorial approach
WO1993008829A1 (en) 1991-11-04 1993-05-13 The Regents Of The University Of California Compositions that mediate killing of hiv-infected cells
ES2341666T3 (es) 1991-12-02 2010-06-24 Medimmune Limited Produccion de autoanticuerpos de repertorios de segmentos de anticue rpos expresados en la superficie de fagos.
CA2124967C (en) 1991-12-17 2008-04-08 Nils Lonberg Transgenic non-human animals capable of producing heterologous antibodies
DE69333823T2 (de) 1992-03-24 2006-05-04 Cambridge Antibody Technology Ltd., Melbourn Verfahren zur herstellung von gliedern von spezifischen bindungspaaren
NZ255101A (en) 1992-07-24 1997-08-22 Cell Genesys Inc A yeast artificial chromosome (yac) vector containing an hprt minigene expressible in murine stem cells and genetically modified rodent therefor
CA2161351C (en) 1993-04-26 2010-12-21 Nils Lonberg Transgenic non-human animals capable of producing heterologous antibodies
GB9313509D0 (en) 1993-06-30 1993-08-11 Medical Res Council Chemisynthetic libraries
EP0731842A1 (en) 1993-12-03 1996-09-18 Medical Research Council Recombinant binding proteins and peptides
CA2194907A1 (en) 1994-07-13 1996-02-01 Kouji Matsushima Reshaped human antibody against human interleukin-8
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
CA2219361C (en) 1995-04-27 2012-02-28 Abgenix, Inc. Human antibodies derived from immunized xenomice
EP0823941A4 (en) 1995-04-28 2001-09-19 Abgenix Inc HUMAN ANTIBODIES DERIVED FROM IMMUNIZED XENO MOUSES
US6610833B1 (en) 1997-11-24 2003-08-26 The Institute For Human Genetics And Biochemistry Monoclonal human natural antibodies
ES2375931T3 (es) 1997-12-05 2012-03-07 The Scripps Research Institute Humanización de anticuerpo murino.
AU784983B2 (en) 1999-12-15 2006-08-17 Genentech Inc. Shotgun scanning, a combinatorial method for mapping functional protein epitopes
CN101289511A (zh) 2000-04-11 2008-10-22 杰南技术公司 多价抗体及其应用
US6596541B2 (en) 2000-10-31 2003-07-22 Regeneron Pharmaceuticals, Inc. Methods of modifying eukaryotic cells
CN1487996B (zh) 2000-11-30 2010-06-16 米德列斯公司 用于生产人类抗体的转基因转染色体啮齿动物
EP1513879B1 (en) 2002-06-03 2018-08-22 Genentech, Inc. Synthetic antibody phage libraries
CA2510003A1 (en) 2003-01-16 2004-08-05 Genentech, Inc. Synthetic antibody phage libraries
CN1961003B (zh) 2004-03-31 2013-03-27 健泰科生物技术公司 人源化抗TGF-β抗体
US7785903B2 (en) 2004-04-09 2010-08-31 Genentech, Inc. Variable domain library and uses
ATE547161T1 (de) 2005-09-14 2012-03-15 Ares Trading Sa Verfahren zur quantitativen bestimmung von poloxameren
EP1951395B1 (en) 2005-09-14 2012-02-29 Ares Trading S.A. Method for the quantitative determination of poloxamers
EP1957531B1 (en) 2005-11-07 2016-04-13 Genentech, Inc. Binding polypeptides with diversified and consensus vh/vl hypervariable sequences
WO2007064919A2 (en) 2005-12-02 2007-06-07 Genentech, Inc. Binding polypeptides with restricted diversity sequences
JP2009536527A (ja) 2006-05-09 2009-10-15 ジェネンテック・インコーポレーテッド 最適化されたスキャフォールドを備えた結合ポリペプチド
WO2008027236A2 (en) 2006-08-30 2008-03-06 Genentech, Inc. Multispecific antibodies
CN100592373C (zh) 2007-05-25 2010-02-24 群康科技(深圳)有限公司 液晶显示面板驱动装置及其驱动方法
AU2008304748C1 (en) 2007-09-26 2014-06-12 Chugai Seiyaku Kabushiki Kaisha Modified antibody constant region
ES2563027T3 (es) 2008-01-07 2016-03-10 Amgen Inc. Método para fabricación de moléculas heterodímeras Fc de anticuerpos utilizando efectos de conducción electrostática
PH12016502073B1 (en) * 2010-11-17 2024-04-05 Chugai Pharmaceutical Co Ltd Multi-specific antigen-binding molecule having alternative function to function of blood coagulation factor viii
KR101343040B1 (ko) 2010-12-28 2013-12-18 주식회사 삼양바이오팜 정제된 폴록사머 및 그의 정제방법
PL3160552T3 (pl) 2014-06-30 2020-03-31 Syqe Medical Ltd. Wkład z dawką leku dla urządzenia inhalacyjnego
KR102482733B1 (ko) 2014-06-30 2022-12-29 사이키 메디컬 엘티디. 유동 조절 흡입기 디바이스
JP6130983B2 (ja) 2015-02-27 2017-05-17 中外製薬株式会社 Ｉｌ−６関連疾患治療用組成物
RU2766233C2 (ru) 2016-09-06 2022-02-10 Чугаи Сейяку Кабусики Кайся Способы применения биспецифического антитела, которое распознает фактор свертывания ix и/или активированный фактор свертывания ix и фактор свертывания x и/или активированный фактор свертывания x
WO2019060062A1 (en) 2017-09-19 2019-03-28 Regeneron Pharmaceuticals Inc. METHODS OF REDUCING PARTICLE FORMATION AND COMPOSITIONS FORMED THEREFROM

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010215664A (ja) * 2003-02-28 2010-09-30 Chugai Pharmaceut Co Ltd タンパク質含有安定化製剤
JP2019511606A (ja) * 2016-03-17 2019-04-25 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツングＭｅｒｃｋ Ｐａｔｅｎｔ Ｇｅｓｅｌｌｓｃｈａｆｔ ｍｉｔ ｂｅｓｃｈｒａｅｎｋｔｅｒ Ｈａｆｔｕｎｇ ポロキサマーを精製するための方法
WO2017188356A1 (ja) * 2016-04-28 2017-11-02 中外製薬株式会社 抗体含有製剤
WO2021241720A1 (ja) * 2020-05-29 2021-12-02 中外製薬株式会社 抗体含有製剤

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
エンスプリング皮下注１２０ＭＧシリンジ審議結果報告書［オンライン］, JPN6022054984, 2020, ISSN: 0005079228 *
エンスプリング皮下注１２０ｍｇシリンジ審議結果報告書［オンライン］，2020年，［検索日2022.12.21］インターネット:<URL:>https://www.pmda.go.jp/drugs/2020/20200710002_30200AMX00488_A100_1.pdf>
ヘムライブラ米国添付文書［オンライン］, JPN7022005984, 2017, ISSN: 0005079227 *
ヘムライブラ米国添付文書［オンライン］，2017年，[検索日2022.12.19]，インターネット：<URL: https://accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf>

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EP4442274A4 (en) 2025-12-24
US20250136716A1 (en) 2025-05-01
MX2024006387A (es) 2024-06-04
AU2022399314A1 (en) 2024-06-20
TW202333787A (zh) 2023-09-01
WO2023100975A1 (ja) 2023-06-08
EP4442274A1 (en) 2024-10-09
US20260022194A1 (en) 2026-01-22
JP2024170482A (ja) 2024-12-10
IL313202A (en) 2024-07-01
KR20240011866A (ko) 2024-01-26
CA3239389A1 (en) 2023-06-08
CN118414166A (zh) 2024-07-30
JP7550286B2 (ja) 2024-09-12
JP2024009927A (ja) 2024-01-23
US12460015B2 (en) 2025-11-04
JPWO2023100975A1 (https=) 2023-06-08

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