JP7057360B2 - 抗－ｃｄ３抗体製剤 - Google Patents

抗－ｃｄ３抗体製剤 Download PDF

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JP7057360B2
JP7057360B2 JP2019531579A JP2019531579A JP7057360B2 JP 7057360 B2 JP7057360 B2 JP 7057360B2 JP 2019531579 A JP2019531579 A JP 2019531579A JP 2019531579 A JP2019531579 A JP 2019531579A JP 7057360 B2 JP7057360 B2 JP 7057360B2
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antibody
formulation
oral
amino acid
preparation
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JP2019526627A (ja
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シャイルバイ クンワー
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ティジアーナ ライフ サイエンシズ パブリック リミティド カンパニー
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    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/0043—Nose
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Rheumatology (AREA)
  • Otolaryngology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2019531579A 2016-08-29 2017-08-29 抗－ｃｄ３抗体製剤 Active JP7057360B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022063973A JP7461401B2 (ja) 2016-08-29 2022-04-07 抗－ｃｄ３抗体製剤
JP2024046063A JP2024075713A (ja) 2016-08-29 2024-03-22 抗－ｃｄ３抗体製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662380652P 2016-08-29 2016-08-29
US62/380,652 2016-08-29
PCT/US2017/049211 WO2018044948A1 (en) 2016-08-29 2017-08-29 Anti-cd3 antibody formulations

Related Child Applications (1)

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JP2022063973A Division JP7461401B2 (ja) 2016-08-29 2022-04-07 抗－ｃｄ３抗体製剤

Publications (2)

Publication Number Publication Date
JP2019526627A JP2019526627A (ja) 2019-09-19
JP7057360B2 true JP7057360B2 (ja) 2022-04-19

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JP2019531579A Active JP7057360B2 (ja) 2016-08-29 2017-08-29 抗－ｃｄ３抗体製剤
JP2022063973A Active JP7461401B2 (ja) 2016-08-29 2022-04-07 抗－ｃｄ３抗体製剤
JP2024046063A Pending JP2024075713A (ja) 2016-08-29 2024-03-22 抗－ｃｄ３抗体製剤

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JP2022063973A Active JP7461401B2 (ja) 2016-08-29 2022-04-07 抗－ｃｄ３抗体製剤
JP2024046063A Pending JP2024075713A (ja) 2016-08-29 2024-03-22 抗－ｃｄ３抗体製剤

Country Status (10)

Country Link
US (3) US10688186B2 (enExample)
EP (2) EP3504241B1 (enExample)
JP (3) JP7057360B2 (enExample)
CN (2) CN116617387A (enExample)
AU (2) AU2017319318B2 (enExample)
CA (1) CA3032596A1 (enExample)
DK (1) DK3504241T3 (enExample)
ES (1) ES2986900T3 (enExample)
IL (2) IL301948B2 (enExample)
WO (1) WO2018044948A1 (enExample)

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EP3504241B1 (en) 2016-08-29 2024-05-15 Tiziana Life Sciences PLC Anti-cd3 antibody formulations
WO2018226833A1 (en) * 2017-06-06 2018-12-13 The Brigham And Women's Hospital, Inc. Methods of suppressing microglial activation
EP3488851A1 (en) * 2018-10-03 2019-05-29 AVM Biotechnology, LLC Immunoablative therapies
AU2019358875B2 (en) * 2018-10-09 2025-08-21 Monash University Combination therapy for treatment and prevention of autoimmune and inflammatory diseases
JP2022512709A (ja) * 2018-10-31 2022-02-07 ティジアーナ ライフ サイエンシズ パブリック リミティド カンパニー 炎症性疾患及び自己免疫疾患を処置する組成物及び方法
KR102503349B1 (ko) 2019-05-14 2023-02-23 프로벤션 바이오, 인코포레이티드 제1형 당뇨병을 예방하기 위한 방법 및 조성물
WO2021035054A1 (en) 2019-08-20 2021-02-25 Precision Biosciences, Inc. Lymphodepletion dosing regimens for cellular immunotherapies
JP2023517611A (ja) * 2020-03-10 2023-04-26 ティジアーナ ライフ サイエンシズ パブリック リミティド カンパニー Ｉｌ－６／ｉｌ－６ｒ抗体の組成物及びその使用方法
GB2595299B (en) 2020-05-21 2022-08-03 Mabsolve Ltd Modified immunoglobulin FC regions
US12006366B2 (en) 2020-06-11 2024-06-11 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
JP2023535792A (ja) * 2020-07-30 2023-08-21 ティジアーナ ライフ サイエンシズ パブリック リミティド カンパニー コロナウイルス治療のための抗ｃｄ３抗体
IL300088A (en) * 2020-07-31 2023-03-01 Glaxosmithkline Ip Dev Ltd Antigen binding protein
WO2022221767A1 (en) * 2021-04-16 2022-10-20 Tiziana Life Sciences Plc Subcutaneous administration of antibodies for the treatment of disease
US20230365689A1 (en) * 2022-05-13 2023-11-16 Tiziana Life Sciences Plc Nasal formulations of foralumab
IL318326A (en) * 2022-07-27 2025-03-01 Celldex Therapeutics Inc Anti-Kit Antibody Formulations and Methods
KR20250067152A (ko) 2022-09-09 2025-05-14 이도르시아 파마슈티컬스 리미티드 항-cd3 항체 및 cxcr3 길항제를 포함하는 약학 병용물
AU2024217729A1 (en) 2023-02-08 2025-08-21 Immunos Therapeutics Ag FUSION PROTEINS OF ß2 MICROGLOBULIN, HLA HEAVY CHAIN POLYPEPTIDES, AND INHIBITOR OF CD47-SIRPA
TW202448505A (zh) 2023-03-01 2024-12-16 美商普泛森生技公司 用於治療第1型糖尿病的方法及組成物
CN120752054A (zh) 2023-03-16 2025-10-03 小野药品工业株式会社 抗体制剂
TW202502380A (zh) * 2023-03-16 2025-01-16 日商小野藥品工業股份有限公司 抗體製劑

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JP2009507838A (ja) 2005-09-12 2009-02-26 ノビミューン エスアー 抗ｃｄ３抗体製剤
JP2011504933A (ja) 2007-11-28 2011-02-17 メディミューン，エルエルシー タンパク質製剤
JP2012530721A (ja) 2009-06-18 2012-12-06 ワイス・エルエルシー 小モジュール免疫薬のための凍結乾燥製剤
JP2013504540A (ja) 2009-09-11 2013-02-07 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 高度に濃縮された薬学的製剤
JP2013515754A (ja) 2009-12-29 2013-05-09 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 新規な抗体製剤

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CA2778334A1 (en) * 2009-10-20 2011-04-28 Charlotte Mckee Anti-cd3 antibody dosing in autoimmune disease
JP2013508391A (ja) * 2009-10-20 2013-03-07 グラクソ グループ リミテッド 体重増加を予防するために抗ｃｄ３抗体を使用する方法
WO2012098238A1 (en) * 2011-01-21 2012-07-26 Novimmune S.A. Combination therapies and methods using anti-cd3 modulating agents and anti-il-6 antagonists
UA118028C2 (uk) * 2013-04-03 2018-11-12 Рош Глікарт Аг Біспецифічне антитіло, специфічне щодо fap і dr5, антитіло, специфічне щодо dr5, і спосіб їх застосування
EP3504241B1 (en) 2016-08-29 2024-05-15 Tiziana Life Sciences PLC Anti-cd3 antibody formulations

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009507838A (ja) 2005-09-12 2009-02-26 ノビミューン エスアー 抗ｃｄ３抗体製剤
JP2011504933A (ja) 2007-11-28 2011-02-17 メディミューン，エルエルシー タンパク質製剤
JP2012530721A (ja) 2009-06-18 2012-12-06 ワイス・エルエルシー 小モジュール免疫薬のための凍結乾燥製剤
JP2013504540A (ja) 2009-09-11 2013-02-07 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 高度に濃縮された薬学的製剤
JP2013515754A (ja) 2009-12-29 2013-05-09 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 新規な抗体製剤

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IL301948B2 (en) 2024-09-01
CN109843920B (zh) 2023-01-13
JP2022082757A (ja) 2022-06-02
US20210000957A1 (en) 2021-01-07
EP4406554A3 (en) 2024-10-30
JP2024075713A (ja) 2024-06-04
US20250228946A1 (en) 2025-07-17
EP4406554A2 (en) 2024-07-31
US20180177880A1 (en) 2018-06-28
DK3504241T3 (da) 2024-08-19
ES2986900T3 (es) 2024-11-13
IL301948A (en) 2023-06-01
AU2017319318B2 (en) 2024-09-19
IL301948B1 (en) 2024-05-01
CA3032596A1 (en) 2018-03-08
US10688186B2 (en) 2020-06-23
CN116617387A (zh) 2023-08-22
IL264502B2 (en) 2023-09-01
CN109843920A (zh) 2019-06-04
JP7461401B2 (ja) 2024-04-03
IL264502A (en) 2019-02-28
WO2018044948A1 (en) 2018-03-08
EP3504241A1 (en) 2019-07-03
JP2019526627A (ja) 2019-09-19
IL264502B1 (en) 2023-05-01
EP3504241B1 (en) 2024-05-15
AU2024278457A1 (en) 2025-01-09
AU2017319318A1 (en) 2019-02-21

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