EA201992570A1 - Составы на основе человеческих антител к rankl, а также способы их применения - Google Patents

Составы на основе человеческих антител к rankl, а также способы их применения

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Publication number
EA201992570A1
EA201992570A1 EA201992570A EA201992570A EA201992570A1 EA 201992570 A1 EA201992570 A1 EA 201992570A1 EA 201992570 A EA201992570 A EA 201992570A EA 201992570 A EA201992570 A EA 201992570A EA 201992570 A1 EA201992570 A1 EA 201992570A1
Authority
EA
Eurasian Patent Office
Prior art keywords
rankl
ways
application
human antibodies
compositions based
Prior art date
Application number
EA201992570A
Other languages
English (en)
Inventor
Стивен Роберт Брич
Лиэнн М. Вонг
Джеймилл Фэллон
Моника Мичелл Госс
Цзянь Хуа Гу
Паван К. Гхаттивенкатакришна
Original Assignee
Эмджен Инк.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Эмджен Инк. filed Critical Эмджен Инк.
Publication of EA201992570A1 publication Critical patent/EA201992570A1/ru

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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
    • A61K39/39591—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
    • A61K47/16—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
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • 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
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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
    • C07K16/2875—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 NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • C07K2317/20—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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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

Abstract

В данном документе раскрыты водные фармацевтические составы, содержащие деносумаб или другое человеческое моноклональное антитело к RANKL или его часть, а также характеристики pH, буферных систем и аминокислотных ингибиторов агрегации. Также раскрыты форма выпуска состава для применения, например, в виде одноразового флакона, одноразового шприца или стеклянного контейнера, способы применения составов и изделий для предупреждения или лечения заболеваний и соответствующие наборы.
EA201992570A 2017-04-28 2018-04-27 Составы на основе человеческих антител к rankl, а также способы их применения EA201992570A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762492056P 2017-04-28 2017-04-28
PCT/US2018/029728 WO2018200918A1 (en) 2017-04-28 2018-04-27 Formulations of human anti-rankl antibodies, and methods of using the same

Publications (1)

Publication Number Publication Date
EA201992570A1 true EA201992570A1 (ru) 2020-03-20

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EA201992570A EA201992570A1 (ru) 2017-04-28 2018-04-27 Составы на основе человеческих антител к rankl, а также способы их применения

Country Status (31)

Country Link
US (2) US11192952B2 (ru)
EP (2) EP3615066B1 (ru)
JP (3) JP7190822B2 (ru)
KR (1) KR20190140464A (ru)
CN (1) CN110621342A (ru)
AR (1) AR111497A1 (ru)
AU (1) AU2018260750A1 (ru)
BR (1) BR112019022188A2 (ru)
CA (1) CA3054165A1 (ru)
CL (3) CL2019003032A1 (ru)
CO (1) CO2019011463A2 (ru)
CR (1) CR20190538A (ru)
DK (1) DK3615066T3 (ru)
EA (1) EA201992570A1 (ru)
FI (1) FI3615066T3 (ru)
HR (1) HRP20240167T1 (ru)
IL (2) IL293127B1 (ru)
JO (1) JOP20190255A1 (ru)
LT (1) LT3615066T (ru)
MA (1) MA48462A (ru)
MY (1) MY202479A (ru)
PE (1) PE20200343A1 (ru)
PH (1) PH12019502444A1 (ru)
PL (1) PL3615066T3 (ru)
PT (1) PT3615066T (ru)
RS (1) RS65299B1 (ru)
SG (1) SG11201909998TA (ru)
SI (1) SI3615066T1 (ru)
TN (2) TN2021000055A1 (ru)
UY (1) UY37707A (ru)
WO (1) WO2018200918A1 (ru)

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TW202033216A (zh) * 2018-11-16 2020-09-16 南韓商三星Ｂｉｏｅｐｉｓ股份有限公司 包含蛋白質的穩定液體組成物
CN109374779A (zh) * 2018-12-17 2019-02-22 杭州奕安济世生物药业有限公司 一种蔗糖含量的快速检测方法
AU2020225202B2 (en) 2019-02-18 2023-10-26 Eli Lilly And Company Therapeutic antibody formulation
CN111704670B (zh) * 2020-08-18 2020-11-03 迈威(上海)生物科技股份有限公司 重组抗RANKL抗体IgG2型的二硫键异构体及其纯化方法
BR112023022707A2 (pt) * 2021-05-12 2024-01-16 Jiangsu Hengrui Pharmaceuticals Co Ltd Molécula de ligação ao antígeno a qual se liga especificamente a rankl e ngf, e seu uso médico
CA3228269A1 (en) 2021-08-12 2023-02-16 Amgen Inc. Antibody formulations
WO2023092177A1 (en) * 2021-11-23 2023-06-01 Adalta Limited Rank-l binding molecules
WO2023179791A1 (en) * 2022-03-24 2023-09-28 Angitia Biomedicines Limited Treatment of musculoskeletal disorders
WO2024064878A1 (en) 2022-09-23 2024-03-28 The University Of North Carolina At Chapel Hill Methods and compositions for the treatment of melanoma

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CL2019003032A1 (es) 2020-02-21
US11873343B2 (en) 2024-01-16
RS65299B1 (sr) 2024-04-30
CL2023002505A1 (es) 2024-03-08
PL3615066T3 (pl) 2024-04-29
TW201841654A (zh) 2018-12-01
MY202479A (en) 2024-04-30
CL2020002012A1 (es) 2020-10-16
CR20190538A (es) 2020-02-26
IL268704B (en) 2022-06-01
IL293127B1 (en) 2024-02-01
US20220143181A1 (en) 2022-05-12
TN2021000055A1 (en) 2022-10-03
US11192952B2 (en) 2021-12-07
TN2019000297A1 (en) 2021-05-07
DK3615066T3 (da) 2024-03-11
EP4190355A1 (en) 2023-06-07
PT3615066T (pt) 2024-03-08
FI3615066T3 (fi) 2024-02-29
JP2018188430A (ja) 2018-11-29
CA3054165A1 (en) 2018-11-01
JP2023166396A (ja) 2023-11-21
WO2018200918A1 (en) 2018-11-01
JP2022062059A (ja) 2022-04-19
HRP20240167T1 (hr) 2024-04-26
AR111497A1 (es) 2019-07-17
CN110621342A (zh) 2019-12-27
US20200354463A1 (en) 2020-11-12
MA48462A (fr) 2020-03-04
BR112019022188A2 (pt) 2020-05-12
SG11201909998TA (en) 2019-11-28
WO2018200918A8 (en) 2019-10-17
PE20200343A1 (es) 2020-02-14
KR20190140464A (ko) 2019-12-19
PH12019502444A1 (en) 2020-07-20
JOP20190255A1 (ar) 2019-10-27
IL268704A (en) 2019-10-31
UY37707A (es) 2018-10-31
JP7190822B2 (ja) 2022-12-16
CO2019011463A2 (es) 2019-10-31
IL293127A (en) 2022-07-01
SI3615066T1 (sl) 2024-04-30
EP3615066A1 (en) 2020-03-04
LT3615066T (lt) 2024-02-26
AU2018260750A1 (en) 2019-08-29
JP7356525B2 (ja) 2023-10-04
EP3615066B1 (en) 2023-12-27

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