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DK3506886T3 - Højkoncentrerede lavviskositets-masp-2-inhiberende antistofformuleringer, kits og fremgangsmåder - Google Patents

Højkoncentrerede lavviskositets-masp-2-inhiberende antistofformuleringer, kits og fremgangsmåder Download PDF

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Publication number
DK3506886T3
DK3506886T3 DK17847485.4T DK17847485T DK3506886T3 DK 3506886 T3 DK3506886 T3 DK 3506886T3 DK 17847485 T DK17847485 T DK 17847485T DK 3506886 T3 DK3506886 T3 DK 3506886T3
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Denmark
Prior art keywords
kits
methods
low viscosity
highly concentrated
antibody formulations
Prior art date
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DK17847485.4T
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English (en)
Inventor
Gregory A Demopulos
Kenneth M Ferguson
William Joseph Lambert
John Steven Whitaker
Original Assignee
Omeros Corp
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Publication of DK3506886T3 publication Critical patent/DK3506886T3/da

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    • 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
    • A61K47/06—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
    • A61K9/0019—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
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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
    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61P7/06—Antianaemics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Psychiatry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Ophthalmology & Optometry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
DK17847485.4T 2016-08-31 2017-08-30 Højkoncentrerede lavviskositets-masp-2-inhiberende antistofformuleringer, kits og fremgangsmåder DK3506886T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662382156P 2016-08-31 2016-08-31
PCT/US2017/049415 WO2018045054A1 (en) 2016-08-31 2017-08-30 Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods

Publications (1)

Publication Number Publication Date
DK3506886T3 true DK3506886T3 (da) 2024-08-19

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
DK17847485.4T DK3506886T3 (da) 2016-08-31 2017-08-30 Højkoncentrerede lavviskositets-masp-2-inhiberende antistofformuleringer, kits og fremgangsmåder

Country Status (39)

Country Link
US (2) US11628217B2 (da)
EP (2) EP3506886B1 (da)
JP (2) JP6864747B2 (da)
KR (2) KR102444154B1 (da)
CN (3) CN116327917A (da)
AR (1) AR109494A1 (da)
AU (2) AU2017321605B2 (da)
CA (1) CA3035252C (da)
CL (1) CL2019000508A1 (da)
CO (1) CO2019002239A2 (da)
CR (1) CR20190150A (da)
CU (1) CU20190015A7 (da)
DK (1) DK3506886T3 (da)
EA (1) EA201990598A1 (da)
EC (1) ECSP19021312A (da)
ES (1) ES2986902T3 (da)
FI (1) FI3506886T3 (da)
GE (1) GEP20217252B (da)
HR (1) HRP20241131T1 (da)
HU (1) HUE068084T2 (da)
IL (1) IL265071B2 (da)
JO (1) JOP20170170B1 (da)
LT (1) LT3506886T (da)
MA (1) MA46109A (da)
MX (2) MX2019002338A (da)
MY (1) MY189411A (da)
PE (1) PE20190469A1 (da)
PH (1) PH12019500365A1 (da)
PL (1) PL3506886T3 (da)
PT (1) PT3506886T (da)
RS (1) RS65845B1 (da)
SG (2) SG11201901444PA (da)
SI (1) SI3506886T1 (da)
SM (1) SMT202400333T1 (da)
TW (2) TWI730310B (da)
UA (1) UA122733C2 (da)
UY (1) UY37391A (da)
WO (1) WO2018045054A1 (da)
ZA (1) ZA201901891B (da)

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JP6682653B2 (ja) * 2016-01-05 2020-04-15 ユニバーシティー オブ レスター 線維症の阻害を必要とする対象において線維症を阻害するための方法
JOP20170170B1 (ar) * 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق
JOP20190068A1 (ar) * 2016-10-13 2019-04-01 Omeros Corp طرق لتقليل البول البروتيني في خاضع بشري يعاني من الاعتلال الكلوي a الناتج عن الجلوبيولين المناعي
MA49960A (fr) * 2017-08-25 2021-06-02 Omeros Corp Formulations d'anticorps inhibiteurs de masp-2 hautement concentrées à faible viscosité, kits et méthodes de traitement de sujets souffrant d'un syndrome hémolytique atypique
SG11202010925UA (en) 2018-05-29 2020-12-30 Omeros Corp Masp-2 inhibitors and methods of use
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
EP3999537A1 (en) * 2019-07-19 2022-05-25 Ichnos Sciences SA Lyophilized antibody formulation
EP4065165A4 (en) * 2019-11-26 2024-10-16 Omeros Corporation METHODS FOR TREATING AND/OR PREVENTING IDIOPATHIC PNEUMONIA SYNDROME (IPS) AND/OR CAPILLARY LEAK SYNDROME (CLS) AND/OR ENGRAFTMENT SYNDROME (ES) AND/OR FLUID OVERLOAD (FO) ASSOCIATED WITH HEMATOPOETIC STEM CELL TRANSPLANTATION
CA3159167A1 (en) 2019-12-04 2021-06-10 Neil S. Cutshall Masp-2 inhibitors and methods of use
EP4069238A1 (en) 2019-12-04 2022-10-12 Omeros Corporation Masp-2 inhibitors and methods of use
WO2021113698A1 (en) 2019-12-04 2021-06-10 Omeros Corporation Masp-2 inhibitors and methods of use
MX2022006750A (es) 2019-12-04 2022-06-14 Omeros Corp Inhibidores de masp-2 y metodos de uso.
US11912764B2 (en) 2020-07-31 2024-02-27 Alamab Therapeutics, Inc. Anti-connexin antibody formulations
AU2021365008A1 (en) * 2020-10-22 2023-06-08 Allakos Inc. Anti-siglec-8 antibody formulations
JP2024523846A (ja) * 2021-06-08 2024-07-02 シャンハイ ジェミンケア ファーマシューティカル カンパニー，リミティド 抗ｍａｓｐ－２抗体及びその使用
US20230265215A1 (en) 2021-12-10 2023-08-24 Omeros Corporation Therapeutic antibodies that bind to the serine protease domain of masp-2 and uses thereof
US20240228499A1 (en) 2022-11-30 2024-07-11 Omeros Corporation Masp-2 inhibitors and methods of use
WO2024140939A2 (zh) * 2022-12-29 2024-07-04 苏州创胜医药集团有限公司 含有治疗性抗体的药物制剂及其用途
WO2024226573A2 (en) * 2023-04-25 2024-10-31 Nuvance Health Masp-2 directed cancer treatment methods
US12216123B2 (en) 2023-04-25 2025-02-04 Nuvance Health Extracellular vesicle derived MASP-2 directed cancer treatment methods
CN116712390B (zh) * 2023-08-04 2023-11-14 上海览屹医药科技有限公司 一种高浓度高稳定性的抗体制剂及其制备方法
WO2025054172A1 (en) * 2023-09-05 2025-03-13 E-Star Biotech, LLC Formulations of manp and uses thereof
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EA201891132A1 (ru) 2015-11-09 2018-10-31 Омерос Корпорейшн Способы лечения состояний, связанных с masp-2 зависимой активацией комплемента
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JP6682653B2 (ja) 2016-01-05 2020-04-15 ユニバーシティー オブ レスター 線維症の阻害を必要とする対象において線維症を阻害するための方法
US10870708B2 (en) 2016-03-31 2020-12-22 University Of Leicester Methods for inhibiting angiogenesis in a subject in need thereof
JOP20170170B1 (ar) 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق

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EP3506886A4 (en) 2019-10-09
SG10202100697PA (en) 2021-02-25
ZA201901891B (en) 2019-12-18
AR109494A1 (es) 2018-12-12
GEP20217252B (en) 2021-05-13
EP3506886B1 (en) 2024-05-22
CN109890367B (zh) 2022-08-30
CN116327917A (zh) 2023-06-27
TW201944983A (zh) 2019-12-01
SG11201901444PA (en) 2019-03-28
RS65845B1 (sr) 2024-09-30
TW201811365A (zh) 2018-04-01
UY37391A (es) 2018-02-28
JP7197623B2 (ja) 2022-12-27
EP4438060A2 (en) 2024-10-02
PH12019500365A1 (en) 2019-11-04
JOP20170170A1 (ar) 2019-01-30
ECSP19021312A (es) 2019-04-30
TWI719245B (zh) 2021-02-21
SI3506886T1 (sl) 2024-09-30
AU2017321605B2 (en) 2020-10-08
CO2019002239A2 (es) 2019-03-18
PL3506886T3 (pl) 2024-12-16
US20180153988A1 (en) 2018-06-07
MY189411A (en) 2022-02-10
KR20190043161A (ko) 2019-04-25
EP3506886A1 (en) 2019-07-10
MX2019002338A (es) 2019-08-16
KR102444154B1 (ko) 2022-09-16
NZ751988A (en) 2021-09-24
CL2019000508A1 (es) 2019-06-28
US11628217B2 (en) 2023-04-18
MX2023014120A (es) 2023-12-12
JP2019531341A (ja) 2019-10-31
SMT202400333T1 (it) 2024-09-16
CA3035252C (en) 2021-08-10
AU2017321605A1 (en) 2019-02-07
US20230226178A1 (en) 2023-07-20
PT3506886T (pt) 2024-08-21
EP4438060A3 (en) 2024-12-25
HRP20241131T1 (hr) 2024-11-22
FI3506886T3 (fi) 2024-08-20
ES2986902T3 (es) 2024-11-13
KR20210135618A (ko) 2021-11-15
IL265071B2 (en) 2023-12-01
IL265071B1 (en) 2023-08-01
CR20190150A (es) 2019-05-14
EA201990598A1 (ru) 2019-07-31
HUE068084T2 (hu) 2024-12-28
CN116327695A (zh) 2023-06-27
MA46109A (fr) 2019-07-10
CU20190015A7 (es) 2019-11-04
AU2020277135B2 (en) 2023-11-02
AU2020277135A1 (en) 2020-12-24
JOP20170170B1 (ar) 2022-09-15
PE20190469A1 (es) 2019-04-04
TWI730310B (zh) 2021-06-11
UA122733C2 (uk) 2020-12-28
JP2021105033A (ja) 2021-07-26
IL265071A (da) 2019-04-30
BR112019003479A2 (pt) 2019-05-21
LT3506886T (lt) 2024-09-10
CA3035252A1 (en) 2018-03-08
WO2018045054A1 (en) 2018-03-08
JP6864747B2 (ja) 2021-04-28
CN109890367A (zh) 2019-06-14

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