JP2019534863A - 液体医薬組成物 - Google Patents

液体医薬組成物 Download PDF

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Publication number
JP2019534863A
JP2019534863A JP2019515630A JP2019515630A JP2019534863A JP 2019534863 A JP2019534863 A JP 2019534863A JP 2019515630 A JP2019515630 A JP 2019515630A JP 2019515630 A JP2019515630 A JP 2019515630A JP 2019534863 A JP2019534863 A JP 2019534863A
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Japan
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
antibody
concentration
buffer
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Pending
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JP2019515630A
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English (en)
Japanese (ja)
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JP2019534863A5 (enExample
Inventor
リオ，アレッサンドラ デル
リオ，アレッサンドラ デル
サビーナ，カルメラ
Original Assignee
フレゼニウス カービ ドイチュラント ゲーエムベーハー
フレゼニウス カービ ドイチュラント ゲーエムベーハー
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Application filed by フレゼニウス カービ ドイチュラント ゲーエムベーハー, フレゼニウス カービ ドイチュラント ゲーエムベーハー filed Critical フレゼニウス カービ ドイチュラント ゲーエムベーハー
Publication of JP2019534863A publication Critical patent/JP2019534863A/ja
Publication of JP2019534863A5 publication Critical patent/JP2019534863A5/ja
Priority to JP2022146770A priority Critical patent/JP2022188075A/ja
Priority to JP2024148123A priority patent/JP2024178197A/ja
Pending legal-status Critical Current

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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
    • C07K16/28—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
    • 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
    • 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
    • A61K47/02—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
    • A61K47/16—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
    • A61K47/20—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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
    • C07K2317/50—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
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • 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

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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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Cardiology (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2019515630A 2016-09-27 2017-09-26 液体医薬組成物 Pending JP2019534863A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022146770A JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16190957 2016-09-27
EP16190957.7 2016-09-27
PCT/EP2017/074413 WO2018060210A1 (en) 2016-09-27 2017-09-26 Liquid pharmaceutical composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022146770A Division JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物

Publications (2)

Publication Number Publication Date
JP2019534863A true JP2019534863A (ja) 2019-12-05
JP2019534863A5 JP2019534863A5 (enExample) 2020-08-20

Family

ID=57047015

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2019515630A Pending JP2019534863A (ja) 2016-09-27 2017-09-26 液体医薬組成物
JP2022146770A Pending JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A Pending JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2022146770A Pending JP2022188075A (ja) 2016-09-27 2022-09-15 液体医薬組成物
JP2024148123A Pending JP2024178197A (ja) 2016-09-27 2024-08-30 液体医薬組成物

Country Status (12)

Country Link
US (3) US10961314B2 (enExample)
EP (1) EP3518891A1 (enExample)
JP (3) JP2019534863A (enExample)
KR (1) KR102546471B1 (enExample)
CN (1) CN109862880A (enExample)
AU (1) AU2017333367A1 (enExample)
BR (1) BR112019005328A2 (enExample)
CA (1) CA3037440A1 (enExample)
MA (1) MA46334A (enExample)
RU (1) RU2019112680A (enExample)
WO (1) WO2018060210A1 (enExample)
ZA (1) ZA201901590B (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023528068A (ja) * 2020-06-05 2023-07-03 ジョイント・ストック・カンパニー “バイオキャド” レビリマブの水性医薬組成物
JP2023540072A (ja) * 2020-08-31 2023-09-21 セルトリオン インク 安定した薬剤学的製剤
JP2024178197A (ja) * 2016-09-27 2024-12-24 フレゼニウス カービ ドイチュラント ゲーエムベーハー 液体医薬組成物

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PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
KR101933197B1 (ko) 2010-11-08 2018-12-27 제넨테크, 인크. 피하 투여용 항―ｉｌ―6 수용체 항체
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
MX2020005630A (es) * 2017-11-30 2020-08-20 Bio Thera Solutions Ltd Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6.
US11427639B2 (en) * 2018-04-02 2022-08-30 Richter Gedeon Nyrt. Antibody-containing aqueous formulation and use thereof
WO2020088346A1 (en) 2018-10-31 2020-05-07 Mycenax Biotech Inc. Aqueous pharmaceutical formulations
KR20210124308A (ko) 2019-01-30 2021-10-14 트루바인딩 아이엔씨. 항-gal3 항체 및 이의 용도
CN110179746A (zh) 2019-05-17 2019-08-30 通化东宝生物科技有限公司 一种稳定的苏金单抗注射剂及其制备方法
EP3714902B1 (en) * 2020-03-13 2024-08-28 LEK Pharmaceuticals d.d. Stabilization of pharmaceutical compositions comprising polysorbate
CN113456582B (zh) * 2020-03-30 2024-06-14 鲁南制药集团股份有限公司 重组人源化抗pd-1单克隆抗体的液体制剂
CN115605184A (zh) * 2020-05-15 2023-01-13 豪夫迈·罗氏有限公司（Ch） 防止胃肠外蛋白质溶液中的可见颗粒形成
MX2022014786A (es) 2020-05-26 2023-01-16 Truebinding Inc Metodos para tratar enfermedades inflamatorias mediante el bloqueo de galectina-3.
WO2022006051A1 (en) * 2020-06-29 2022-01-06 Anovent Pharmaceutical (U.S.), Llc Formulation of tocilizumab and method for treating covid-19 by inhalation
WO2022037606A1 (en) * 2020-08-19 2022-02-24 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases
WO2022139457A1 (ko) * 2020-12-24 2022-06-30 이니스트에스티 주식회사 봉독 추출물로부터 bvPLA2를 50~99% 함량으로 포함하는 봉독 주사제 조성물 및 이의 제조방법
WO2024245170A1 (en) * 2023-05-26 2024-12-05 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases
WO2026117626A1 (en) * 2024-11-27 2026-06-04 Disc Medicine, Inc. Antibody compositions and uses thereof

Citations (4)

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JP2012510468A (ja) * 2008-11-28 2012-05-10 アボット・ラボラトリーズ 安定な抗体組成物およびこれを安定させるための方法
JP2013516481A (ja) * 2010-01-08 2013-05-13 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン６受容体（ｉｌ−６ｒ）抗体を含有する安定化製剤
JP2013541594A (ja) * 2010-11-08 2013-11-14 ジェネンテック， インコーポレイテッド 皮下投与される抗ｉｌ−６受容体抗体
JP2015536934A (ja) * 2012-10-25 2015-12-24 メディミューン，エルエルシー 安定した低粘度の抗体製剤

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AU668349B2 (en) 1991-04-25 1996-05-02 Chugai Seiyaku Kabushiki Kaisha Reconstituted human antibody against human interleukin 6 receptor
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
WO2003068260A1 (fr) 2002-02-14 2003-08-21 Chugai Seiyaku Kabushiki Kaisha Produits pharmaceutiques en solution contenant des anticorps
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
CN102387814A (zh) * 2009-01-29 2012-03-21 米迪缪尼有限公司 延长体内半衰期的人抗il-6抗体及其在治疗肿瘤、自身免疫性疾病和炎症性疾病中的应用
RU2565809C2 (ru) * 2009-03-19 2015-10-20 Чугаи Сейяку Кабусики Кайся Фармацевтический состав, содержащий молекулы антител с улучшенными свойствами
PL3721904T3 (pl) * 2009-11-20 2022-01-31 Biocon Limited Formulacje przeciwciała t1h
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UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
BR112019005328A2 (pt) * 2016-09-27 2019-06-18 Fresenius Kabi Deutschland Gmbh composição farmacêutica líquida
MX2020005630A (es) * 2017-11-30 2020-08-20 Bio Thera Solutions Ltd Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6.
WO2022037606A1 (en) * 2020-08-19 2022-02-24 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases
WO2023020563A1 (en) * 2021-08-18 2023-02-23 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Patent Citations (4)

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JP2012510468A (ja) * 2008-11-28 2012-05-10 アボット・ラボラトリーズ 安定な抗体組成物およびこれを安定させるための方法
JP2013516481A (ja) * 2010-01-08 2013-05-13 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン６受容体（ｉｌ−６ｒ）抗体を含有する安定化製剤
JP2013541594A (ja) * 2010-11-08 2013-11-14 ジェネンテック， インコーポレイテッド 皮下投与される抗ｉｌ−６受容体抗体
JP2015536934A (ja) * 2012-10-25 2015-12-24 メディミューン，エルエルシー 安定した低粘度の抗体製剤

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024178197A (ja) * 2016-09-27 2024-12-24 フレゼニウス カービ ドイチュラント ゲーエムベーハー 液体医薬組成物
JP2023528068A (ja) * 2020-06-05 2023-07-03 ジョイント・ストック・カンパニー “バイオキャド” レビリマブの水性医薬組成物
JP7894322B2 (ja) 2020-06-05 2026-07-23 ジョイント・ストック・カンパニー “バイオキャド” レビリマブの水性医薬組成物
JP2023540072A (ja) * 2020-08-31 2023-09-21 セルトリオン インク 安定した薬剤学的製剤

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Publication number Publication date
JP2022188075A (ja) 2022-12-20
WO2018060210A1 (en) 2018-04-05
AU2017333367A1 (en) 2019-04-04
KR20190062440A (ko) 2019-06-05
US20240150479A1 (en) 2024-05-09
BR112019005328A2 (pt) 2019-06-18
KR102546471B1 (ko) 2023-06-21
CN109862880A (zh) 2019-06-07
US20190218300A1 (en) 2019-07-18
EP3518891A1 (en) 2019-08-07
JP2024178197A (ja) 2024-12-24
CA3037440A1 (en) 2018-04-05
US20210261673A1 (en) 2021-08-26
RU2019112680A3 (enExample) 2020-12-15
ZA201901590B (en) 2020-10-28
MA46334A (fr) 2019-08-07
RU2019112680A (ru) 2020-10-29
US10961314B2 (en) 2021-03-30

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