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 [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
    • C07K16/2803—Immunoglobulins [IG], 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 [IG], 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Transplantation (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Otolaryngology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (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

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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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JP2024046063A Pending JP2024075713A (ja) 2016-08-29 2024-03-22 抗－ｃｄ３抗体製剤

Country Status (10)

Country Link
US (3) US10688186B2 (https=)
EP (2) EP3504241B1 (https=)
JP (3) JP7057360B2 (https=)
CN (2) CN116617387A (https=)
AU (2) AU2017319318B2 (https=)
CA (1) CA3032596A1 (https=)
DK (1) DK3504241T3 (https=)
ES (1) ES2986900T3 (https=)
IL (2) IL264502B2 (https=)
WO (1) WO2018044948A1 (https=)

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CN116617387A (zh) 2016-08-29 2023-08-22 迪赞纳生命科学公开有限公司 抗cd3抗体制剂
EP3634478A4 (en) * 2017-06-06 2021-03-24 The Brigham and Women's Hospital, Inc. METHOD OF SUPPRESSION OF MICROGLIA ACTIVATION
EP3488851A1 (en) * 2018-10-03 2019-05-29 AVM Biotechnology, LLC Immunoablative therapies
US20220220202A1 (en) * 2018-10-09 2022-07-14 Monash University Combination therapy for treatment and prevention of autoimmune and inflammatory diseases
US20220008533A1 (en) * 2018-10-31 2022-01-13 Tiziana Life Sciences Plc Composition and methods of treating inflammatory and autoimmune diseases
WO2020232247A1 (en) 2019-05-14 2020-11-19 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
CA3148179A1 (en) 2019-08-20 2021-02-25 Bruce J. Mccreedy Jr. Lymphodepletion dosing regimens for cellular immunotherapies
IL296276A (en) * 2020-03-10 2022-11-01 Tiziana Life Sciences Plc Compositions of il-6/il-6r antibodies and methods of use thereof
GB2595299B (en) 2020-05-21 2022-08-03 Mabsolve Ltd Modified immunoglobulin FC regions
IL298999A (en) 2020-06-11 2023-02-01 Provention Bio Inc Methods and compositions for the prevention of type 1 diabetes
CN116406274B (zh) * 2020-07-30 2026-02-17 迪赞纳生命科学公开有限公司 用于治疗冠状病毒的cd3抗体
EP4188543A1 (en) * 2020-07-31 2023-06-07 GlaxoSmithKline Intellectual Property Development Limited Antigen binding protein
US20220332822A1 (en) * 2021-04-16 2022-10-20 Tiziana Life Sciences Plc Subcutaneous administration of antibodies for the treatment of disease
JP2024520444A (ja) 2021-05-24 2024-05-24 プロヴェンション・バイオ・インコーポレイテッド １型糖尿病を治療するための方法
WO2023218100A1 (en) * 2022-05-13 2023-11-16 Tiziana Life Sciences Plc Nasal formulations of foralumab
US20260055193A1 (en) * 2022-07-27 2026-02-26 Celldex Therapeutics, Inc. Anti-kit antibody formulations and methods
US20250381184A1 (en) 2022-09-09 2025-12-18 Idorsia Pharmaceuticals Ltd Pharmaceutical combination comprising an anti-cd3 antibody and a cxcr3 antagonist
CN121002056A (zh) 2023-02-08 2025-11-21 免疫标记治疗股份公司 β2微球蛋白、HLA重链多肽、和CD47–SIRPα抑制剂的融合蛋白
WO2024182767A1 (en) 2023-03-01 2024-09-06 Provention Bio, Inc. Methods and compositions for treating type 1 diabetes comprising teplizumab and verapamil
KR20250156121A (ko) 2023-03-16 2025-10-31 오노 야꾸힝 고교 가부시키가이샤 항체 제제
WO2024190892A1 (ja) 2023-03-16 2024-09-19 小野薬品工業株式会社 抗体製剤

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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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US20030235583A1 (en) 2002-06-14 2003-12-25 Jeppe Sturis Combined use of a modulator of CD3 and a beta cell resting compound
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CA2778334A1 (en) * 2009-10-20 2011-04-28 Charlotte Mckee Anti-cd3 antibody dosing in autoimmune disease
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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
CN116617387A (zh) 2016-08-29 2023-08-22 迪赞纳生命科学公开有限公司 抗cd3抗体制剂

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

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