KR102669174B1 - 안정한 항-ｉｆｎａｒ1 제형 - Google Patents

안정한 항-ｉｆｎａｒ1 제형 Download PDF

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Publication number
KR102669174B1
KR102669174B1 KR1020207029325A KR20207029325A KR102669174B1 KR 102669174 B1 KR102669174 B1 KR 102669174B1 KR 1020207029325 A KR1020207029325 A KR 1020207029325A KR 20207029325 A KR20207029325 A KR 20207029325A KR 102669174 B1 KR102669174 B1 KR 102669174B1
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antibody
formulation
lysine
histidine
buffer
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Korean (ko)
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KR20200119916A (ko
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로버토 데파즈
나탈리 데지저스
재레드 비
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아스트라제네카 아베
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=58052002&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR102669174(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 아스트라제네카 아베 filed Critical 아스트라제네카 아베
Priority to KR1020227031079A priority Critical patent/KR20220127378A/ko
Priority to KR1020247016705A priority patent/KR20240090616A/ko
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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
    • 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
    • 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
    • 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
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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
    • 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
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • 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
    • 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
    • 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
    • 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
    • C07K16/2866—Immunoglobulins [IGs], 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins
    • 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
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • 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

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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)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
KR1020207029325A 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형 Active KR102669174B1 (ko)

Priority Applications (2)

Application Number Priority Date Filing Date Title
KR1020227031079A KR20220127378A (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형
KR1020247016705A KR20240090616A (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562207164P 2015-08-19 2015-08-19
US62/207,164 2015-08-19
PCT/US2016/047506 WO2017031288A1 (en) 2015-08-19 2016-08-18 Stable anti-ifnar1 formulation
KR1020187007314A KR102168005B1 (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020187007314A Division KR102168005B1 (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형

Related Child Applications (2)

Application Number Title Priority Date Filing Date
KR1020227031079A Division KR20220127378A (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형
KR1020247016705A Division KR20240090616A (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형

Publications (2)

Publication Number Publication Date
KR20200119916A KR20200119916A (ko) 2020-10-20
KR102669174B1 true KR102669174B1 (ko) 2024-06-10

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ID=58052002

Family Applications (4)

Application Number Title Priority Date Filing Date
KR1020207029325A Active KR102669174B1 (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형
KR1020247016705A Pending KR20240090616A (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형
KR1020227031079A Ceased KR20220127378A (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형
KR1020187007314A Active KR102168005B1 (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형

Family Applications After (3)

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KR1020247016705A Pending KR20240090616A (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형
KR1020227031079A Ceased KR20220127378A (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형
KR1020187007314A Active KR102168005B1 (ko) 2015-08-19 2016-08-18 안정한 항-ｉｆｎａｒ1 제형

Country Status (23)

Country Link
US (1) US10125195B2 (enExample)
EP (3) EP4233892A3 (enExample)
JP (4) JP6720293B2 (enExample)
KR (4) KR102669174B1 (enExample)
CN (1) CN107921109A (enExample)
AU (3) AU2016308262C1 (enExample)
CA (1) CA2995222C (enExample)
CY (2) CY1123657T1 (enExample)
DK (2) DK3769781T5 (enExample)
ES (2) ES2947488T3 (enExample)
FI (1) FI3769781T3 (enExample)
HR (2) HRP20230463T1 (enExample)
HU (2) HUE051862T2 (enExample)
IL (1) IL257279B2 (enExample)
LT (2) LT3769781T (enExample)
PL (2) PL3337502T3 (enExample)
PT (2) PT3769781T (enExample)
RS (2) RS64263B1 (enExample)
RU (1) RU2731737C2 (enExample)
SG (1) SG10202106970XA (enExample)
SI (2) SI3769781T1 (enExample)
SM (2) SMT202300176T1 (enExample)
WO (1) WO2017031288A1 (enExample)

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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
PL4058060T3 (pl) * 2019-11-11 2025-07-28 Astrazeneca Ab Hamowanie interferonu typu i w toczniu rumieniowatym układowym
KR20230018446A (ko) * 2020-05-29 2023-02-07 아스트라제네카 아베 I형 인터페론 신호전달 억제제를 이용한 심장대사 질환의 치료
WO2021260193A1 (en) 2020-06-25 2021-12-30 Medimmune Limited Prevention of axonal damage using antibody binding to amyloid beta 1-42
TW202237647A (zh) 2020-10-08 2022-10-01 瑞典商阿斯特捷利康公司 狼瘡發作之治療
PT4192882T (pt) 2021-04-23 2025-05-02 Astrazeneca Ab Tratamento de nefrite lúpica com anticorpo anifrolumab de recetor inf anti-tipo i
CN117157099A (zh) * 2021-04-23 2023-12-01 阿斯利康(瑞典)有限公司 用于皮下注射的抗ifnar1给药方案
WO2022223770A1 (en) 2021-04-23 2022-10-27 Astrazeneca Ab Treatment of cutaneous lupus erythematous
EP4306541A3 (en) 2021-04-23 2024-03-27 Astrazeneca AB Anti-ifnar1 dosing regime for subcutaneous injection
JP2024516886A (ja) 2021-05-12 2024-04-17 アストラゼネカ・アクチエボラーグ 全身性エリテマトーデス患者における１型インターフェロン受容体阻害剤のステロイド節約
CN113521276B (zh) * 2021-07-13 2022-04-12 江苏荃信生物医药股份有限公司 包含抗人干扰素α受体1(IFNAR1)单克隆抗体的液体制剂
WO2023284073A1 (zh) * 2021-07-13 2023-01-19 江苏荃信生物医药股份有限公司 降低单克隆抗体生产中宿主细胞蛋白含量的亲和纯化方法、抗人ifnar1单克隆抗体浓缩溶液的制备方法以及液体制剂
CN113527490B (zh) * 2021-07-13 2022-03-01 江苏荃信生物医药股份有限公司 一种抗人ifnar1单克隆抗体浓缩溶液的制备方法
WO2023006700A1 (en) 2021-07-27 2023-02-02 Astrazeneca Ab Treatment of lupus
CN118076379A (zh) 2021-10-04 2024-05-24 阿斯利康(瑞典)有限公司 狼疮的治疗
WO2023073469A1 (en) * 2021-10-29 2023-05-04 Intas Pharmaceuticals Ltd. STABLE LYOPHILIZED FORMULATION OF AN ANTI-α4ß7 ANTIBODY
WO2023155902A1 (en) * 2022-02-18 2023-08-24 Chongqing Mingdao Haoyue Biotechnology Co., Ltd. Intranasal formulations and anti-sars-cov-2-spike protein antibodies
WO2024009205A1 (en) * 2022-07-06 2024-01-11 Intas Pharmaceuticals Ltd. STABLE LIQUID FORMULATION OF AN ANTI-Α4ß7 ANTIBODY
JP2025533978A (ja) 2022-10-13 2025-10-09 アストラゼネカ・アクチエボラーグ ループスの治療
WO2024241156A1 (en) 2023-05-19 2024-11-28 Astrazeneca Ab Treatment of lupus
WO2025022280A1 (en) 2023-07-21 2025-01-30 Astrazeneca Ab Treatment of neurodegenerative diseases
GB202315831D0 (en) 2023-10-16 2023-11-29 Astrazeneca Ab Treatment of skin disease
GB202402824D0 (en) 2024-02-28 2024-04-10 Astrazeneca Ab Treatment of chronic kidney disease

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