HRP20171016T1 - VISOKOKONCENTRIRANE FORMULACIJE TOPLJIVIH RECEPTORA Fcγ - Google Patents
VISOKOKONCENTRIRANE FORMULACIJE TOPLJIVIH RECEPTORA Fcγ Download PDFInfo
- Publication number
- HRP20171016T1 HRP20171016T1 HRP20171016TT HRP20171016T HRP20171016T1 HR P20171016 T1 HRP20171016 T1 HR P20171016T1 HR P20171016T T HRP20171016T T HR P20171016TT HR P20171016 T HRP20171016 T HR P20171016T HR P20171016 T1 HRP20171016 T1 HR P20171016T1
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- Prior art keywords
- formulation
- receptor
- formulation according
- buffered
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- 238000009472 formulation Methods 0.000 title claims 16
- 239000000203 mixture Substances 0.000 title claims 16
- 108010073807 IgG Receptors Proteins 0.000 title claims 5
- 102000009490 IgG Receptors Human genes 0.000 title claims 5
- 108020003175 receptors Proteins 0.000 claims 5
- 102000005962 receptors Human genes 0.000 claims 5
- 239000000243 solution Substances 0.000 claims 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 208000023275 Autoimmune disease Diseases 0.000 claims 2
- 239000012928 buffer substance Substances 0.000 claims 2
- 230000002265 prevention Effects 0.000 claims 2
- 108010021472 Fc gamma receptor IIB Proteins 0.000 claims 1
- 208000035186 Hemolytic Autoimmune Anemia Diseases 0.000 claims 1
- 208000028622 Immune thrombocytopenia Diseases 0.000 claims 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- 102100029205 Low affinity immunoglobulin gamma Fc region receptor II-b Human genes 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 208000031981 Thrombocytopenic Idiopathic Purpura Diseases 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 201000000448 autoimmune hemolytic anemia Diseases 0.000 claims 1
- 208000037979 autoimmune inflammatory disease Diseases 0.000 claims 1
- 201000003710 autoimmune thrombocytopenic purpura Diseases 0.000 claims 1
- 239000008366 buffered solution Substances 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 239000003599 detergent Substances 0.000 claims 1
- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 238000010254 subcutaneous injection Methods 0.000 claims 1
- 239000007929 subcutaneous injection Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 1
- 201000003067 thrombocytopenia due to platelet alloimmunization Diseases 0.000 claims 1
Classifications
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- 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
- A61K38/00—Medicinal preparations containing peptides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
-
- 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
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- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- 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
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61P17/10—Anti-acne agents
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Diabetes (AREA)
- Dermatology (AREA)
- Gastroenterology & Hepatology (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Cell Biology (AREA)
- Endocrinology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Neurology (AREA)
- Rheumatology (AREA)
- Transplantation (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Ophthalmology & Optometry (AREA)
- Emergency Medicine (AREA)
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Claims (14)
1. Formulacija koja sadrži topljivi receptor Fcγ (sFcγR) u vodenoj puferiranoj otopini, naznačena time što je koncentracija topljivog receptora Fcγ viša od 60 mg/ml, te što sadrži fiziološki prihvatljivu pufersku tvar.
2. Formulacija u skladu s patentnim zahtjevom 1, naznačena time što se puferska tvar bira između histidina, citrata, fosfata ili bilo koje njihove kombinacije.
3. Formulacija u skladu s patentnim zahtjevom 1 ili 2, naznačena time što je receptor receptor FcγRII, po mogućnosti FcγRIIB.
4. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je koncentracija receptora Fcγ viša od 80 mg/ml, po mogućnosti viša od 100 mg/ml, poželjnije viša od 150 mg/ml, a najpoželjnije viša od 200 mg/ml.
5. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži dodatne tvari, koje se biraju između šećera, soli i detergenata.
6. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je receptor prisutna u otopljenom obliku ili formulacija sadrži receptor in a mikrokristalnom oblik.
7. Formulacija u skladu s patentnim zahtjevima 5 ili 6, naznačena time što je otopina puferirana citratom, a pH formulacije je podešen na 6,0 do 7,5.
8. Formulacija u skladu s patentnim zahtjevima 5 ili 6, naznačena time što je otopina puferirana histidinom, a pH joj je podešen na 5,2 do 5,9.
9. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačena time što sadrži receptor u kristalnom obliku.
10. Formulacija u skladu s bilo kojim od patentnih zahtjeva 6 i 9, naznačena time što je otopina puferirana citratom, a njezin pH je podešen na 5,2 do 5,9.
11. Formulacija u skladu s bilo kojim od patentnih zahtjeva 6 i 9, naznačena time što je otopina puferirana histidinom, a njezin pH je podešen na 6,0 do 7,5.
12. Farmaceutski pripravak, naznačen time što sadrži formulaciju u skladu s bilo kojim od patentnih zahtjeva 1 do 11, izborno u kombinaciji s farmaceutski prihvatljivim pomoćnim tvarima i/ili adjuvansima i/ili nosačima.
13. Farmaceutski pripravak u skladu s patentnim zahtjevom 12, namijenjen supkutanoj injekciji djelotvorne količine receptora Fcγ, naznačen time što je namijenjen upotrebi u sprječavanju ili liječenju autoimunih bolesti ili upalnih bolesti.
14. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 11 ili farmaceutski pripravak u skladu s patentnim zahtjevima 12 ili 13, naznačeni time što su namijenjeni upotrebi u liječenju ili sprječavanju autoimunih bolesti, osobito multiple skleroze, sistemnog eritematoznog lupusa, reumatoidnog artritisa, primarne imunosne trombocitopenije ili autoimune hemolitične anemije.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP13002211.4A EP2796144A1 (en) | 2013-04-26 | 2013-04-26 | Highly concentrated Formulations of soluble Fc receptors |
PCT/EP2014/001029 WO2014173510A1 (en) | 2013-04-26 | 2014-04-16 | HIGHLY CONCENTRATED FORMULATIONS OF SOLUBLE Fc RECEPTORS |
EP14722097.4A EP2991667B1 (en) | 2013-04-26 | 2014-04-16 | Highly concentrated formulations of soluble fc gamma receptors |
Publications (2)
Publication Number | Publication Date |
---|---|
HRP20171016T1 true HRP20171016T1 (hr) | 2017-10-06 |
HRP20171016T8 HRP20171016T8 (hr) | 2017-12-15 |
Family
ID=48326051
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20171016TT HRP20171016T8 (hr) | 2013-04-26 | 2017-07-04 | VISOKOKONCENTRIRANE FORMULACIJE TOPLJIVIH RECEPTORA Fcγ |
Country Status (17)
Country | Link |
---|---|
US (3) | US10226504B2 (hr) |
EP (2) | EP2796144A1 (hr) |
JP (2) | JP6562901B2 (hr) |
KR (1) | KR20160036530A (hr) |
CN (1) | CN105555294B (hr) |
AU (1) | AU2014256510B2 (hr) |
EA (1) | EA033742B1 (hr) |
ES (1) | ES2632971T3 (hr) |
HK (1) | HK1223035A1 (hr) |
HR (1) | HRP20171016T8 (hr) |
IL (1) | IL242257B (hr) |
MX (1) | MX366110B (hr) |
PH (1) | PH12015502358B1 (hr) |
PL (1) | PL2991667T3 (hr) |
PT (1) | PT2991667T (hr) |
SG (1) | SG11201508621PA (hr) |
WO (1) | WO2014173510A1 (hr) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2796144A1 (en) | 2013-04-26 | 2014-10-29 | SuppreMol GmbH | Highly concentrated Formulations of soluble Fc receptors |
JP6665414B2 (ja) * | 2015-03-25 | 2020-03-13 | 東ソー株式会社 | Fc結合性タンパク質の保存方法 |
RU2766340C1 (ru) * | 2021-02-10 | 2022-03-15 | Игорь Закванович Зайцев | Пептидный толерогенный компаунд |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998031806A2 (en) * | 1997-01-21 | 1998-07-23 | Human Genome Sciences, Inc. | Fc RECEPTORS AND POLYPEPTIDES |
EP1006183A1 (en) * | 1998-12-03 | 2000-06-07 | Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. | Recombinant soluble Fc receptors |
DE10157290A1 (de) | 2001-11-22 | 2003-06-05 | Max Planck Gesellschaft | Pharmazeutische Zusammensetzung enthaltend sFcRgamma IIb oder sFcRgamma III |
ATE499384T1 (de) * | 2005-12-13 | 2011-03-15 | Suppremol Gmbh | Multimere fc-rezeptor-polypeptide |
CN101426527A (zh) * | 2006-02-03 | 2009-05-06 | 米迪缪尼有限公司 | 蛋白质制剂 |
WO2007092772A2 (en) * | 2006-02-03 | 2007-08-16 | Medimmune, Inc. | Protein formulations |
WO2009158696A1 (en) * | 2008-06-27 | 2009-12-30 | Zymogenetics, Inc. | SOLUBLE HYBRID Fcγ RECEPTORS AND RELATED METHODS |
EP2161031A1 (en) * | 2008-09-05 | 2010-03-10 | SuppreMol GmbH | Fc gamma receptor for the treatment of B cell mediated multiple sclerosis |
CA2829629A1 (en) | 2011-03-10 | 2012-09-13 | Board Of Regents, The University Of Texas System | Protein nanoparticle dispersions |
US10028998B2 (en) * | 2012-10-30 | 2018-07-24 | Suppremol Gmbh | Method for treating an inflammatory disease and/or an autoimmune disease with a soluble FcγRIIb |
EP2796144A1 (en) | 2013-04-26 | 2014-10-29 | SuppreMol GmbH | Highly concentrated Formulations of soluble Fc receptors |
NZ719745A (en) * | 2013-10-16 | 2018-10-26 | Suppremol Gmbh | Soluble fc gamma receptor for treatment of autoimmune bullous diseases |
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2013
- 2013-04-26 EP EP13002211.4A patent/EP2796144A1/en not_active Withdrawn
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2014
- 2014-04-16 KR KR1020157033827A patent/KR20160036530A/ko not_active Application Discontinuation
- 2014-04-16 AU AU2014256510A patent/AU2014256510B2/en active Active
- 2014-04-16 WO PCT/EP2014/001029 patent/WO2014173510A1/en active Application Filing
- 2014-04-16 PL PL14722097T patent/PL2991667T3/pl unknown
- 2014-04-16 ES ES14722097.4T patent/ES2632971T3/es active Active
- 2014-04-16 PT PT147220974T patent/PT2991667T/pt unknown
- 2014-04-16 JP JP2016509323A patent/JP6562901B2/ja active Active
- 2014-04-16 MX MX2015014814A patent/MX366110B/es active IP Right Grant
- 2014-04-16 EA EA201592056A patent/EA033742B1/ru not_active IP Right Cessation
- 2014-04-16 CN CN201480036693.8A patent/CN105555294B/zh active Active
- 2014-04-16 US US14/787,097 patent/US10226504B2/en active Active
- 2014-04-16 SG SG11201508621PA patent/SG11201508621PA/en unknown
- 2014-04-16 EP EP14722097.4A patent/EP2991667B1/en active Active
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2015
- 2015-10-09 PH PH12015502358A patent/PH12015502358B1/en unknown
- 2015-10-25 IL IL242257A patent/IL242257B/en active IP Right Grant
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2016
- 2016-09-29 HK HK16111389.8A patent/HK1223035A1/zh unknown
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2017
- 2017-07-04 HR HRP20171016TT patent/HRP20171016T8/hr unknown
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2019
- 2019-01-04 US US16/240,504 patent/US11266708B2/en active Active
- 2019-07-23 JP JP2019135044A patent/JP6979427B2/ja active Active
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2022
- 2022-01-25 US US17/583,503 patent/US20220296668A1/en active Pending
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Publication number | Publication date |
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US10226504B2 (en) | 2019-03-12 |
JP2019203011A (ja) | 2019-11-28 |
EP2991667A1 (en) | 2016-03-09 |
MX366110B (es) | 2019-06-26 |
EA033742B1 (ru) | 2019-11-21 |
MX2015014814A (es) | 2016-03-09 |
PH12015502358A1 (en) | 2016-02-22 |
EP2991667B1 (en) | 2017-04-12 |
HK1223035A1 (zh) | 2017-07-21 |
US20160095895A1 (en) | 2016-04-07 |
IL242257B (en) | 2018-10-31 |
AU2014256510B2 (en) | 2019-04-11 |
JP2016522812A (ja) | 2016-08-04 |
US11266708B2 (en) | 2022-03-08 |
HRP20171016T8 (hr) | 2017-12-15 |
PT2991667T (pt) | 2017-07-13 |
WO2014173510A1 (en) | 2014-10-30 |
US20220296668A1 (en) | 2022-09-22 |
ES2632971T3 (es) | 2017-09-18 |
EP2796144A1 (en) | 2014-10-29 |
PL2991667T3 (pl) | 2017-09-29 |
JP6562901B2 (ja) | 2019-08-21 |
CN105555294B (zh) | 2019-04-09 |
SG11201508621PA (en) | 2015-11-27 |
US20190231842A1 (en) | 2019-08-01 |
PH12015502358B1 (en) | 2016-02-22 |
KR20160036530A (ko) | 2016-04-04 |
AU2014256510A1 (en) | 2015-12-10 |
EA201592056A1 (ru) | 2016-03-31 |
NZ714292A (en) | 2020-11-27 |
JP6979427B2 (ja) | 2021-12-15 |
CN105555294A (zh) | 2016-05-04 |
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