KR102506173B1 - Il-17 항체의 제약 제품 및 안정한 액체 조성물 - Google Patents

Il-17 항체의 제약 제품 및 안정한 액체 조성물 Download PDF

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KR102506173B1
KR102506173B1 KR1020177016756A KR20177016756A KR102506173B1 KR 102506173 B1 KR102506173 B1 KR 102506173B1 KR 1020177016756 A KR1020177016756 A KR 1020177016756A KR 20177016756 A KR20177016756 A KR 20177016756A KR 102506173 B1 KR102506173 B1 KR 102506173B1
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secukinumab
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KR20170095878A (ko
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수잔 외르크
카트린 세르노-쉐르슈
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노파르티스 아게
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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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/26—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
    • 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
    • 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
    • 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
    • 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
    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L5/00—Arrangements affording multiple use of the transmission path
    • H04L5/0001—Arrangements for dividing the transmission path
    • H04L5/0014—Three-dimensional division
    • H04L5/0016—Time-frequency-code
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L5/00—Arrangements affording multiple use of the transmission path
    • H04L5/0001—Arrangements for dividing the transmission path
    • H04L5/0014—Three-dimensional division
    • H04L5/0023—Time-frequency-space
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L5/00—Arrangements affording multiple use of the transmission path
    • H04L5/003—Arrangements for allocating sub-channels of the transmission path
    • H04L5/0048—Allocation of pilot signals, i.e. of signals known to the receiver
    • H04L5/0051—Allocation of pilot signals, i.e. of signals known to the receiver of dedicated pilots, i.e. pilots destined for a single user or terminal
    • 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
    • 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
    • C07K2317/90—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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Signal Processing (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
KR1020177016756A 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물 Active KR102506173B1 (ko)

Priority Applications (1)

Application Number Priority Date Filing Date Title
KR1020237007135A KR102614921B1 (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462095210P 2014-12-22 2014-12-22
US62/095,210 2014-12-22
PCT/IB2015/059836 WO2016103153A1 (en) 2014-12-22 2015-12-21 Pharmaceutical products and stable liquid compositions of il-17 antibodies

Related Child Applications (1)

Application Number Title Priority Date Filing Date
KR1020237007135A Division KR102614921B1 (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물

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KR20170095878A KR20170095878A (ko) 2017-08-23
KR102506173B1 true KR102506173B1 (ko) 2023-03-07

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KR1020237007135A Active KR102614921B1 (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물
KR1020237043038A Active KR102749243B1 (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물
KR1020177016756A Active KR102506173B1 (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물
KR1020247043157A Pending KR20250008977A (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물

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KR1020237007135A Active KR102614921B1 (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물
KR1020237043038A Active KR102749243B1 (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물

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KR1020247043157A Pending KR20250008977A (ko) 2014-12-22 2015-12-21 Il-17 항체의 제약 제품 및 안정한 액체 조성물

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US (6) US11801300B2 (enExample)
EP (4) EP4559935A3 (enExample)
JP (4) JP6770974B2 (enExample)
KR (4) KR102614921B1 (enExample)
CN (5) CN113855800A (enExample)
AR (1) AR103173A1 (enExample)
AU (1) AU2015370522B2 (enExample)
BR (1) BR112017013240A2 (enExample)
CA (1) CA2971800A1 (enExample)
CL (1) CL2017001638A1 (enExample)
CO (1) CO2017005950A2 (enExample)
DK (1) DK3237001T5 (enExample)
EA (1) EA033824B1 (enExample)
EC (1) ECSP17047155A (enExample)
ES (1) ES2976305T3 (enExample)
FI (1) FI3237001T3 (enExample)
HR (1) HRP20240253T1 (enExample)
HU (1) HUE066126T2 (enExample)
IL (4) IL322000A (enExample)
LT (1) LT3237001T (enExample)
MX (1) MX2017008412A (enExample)
PE (1) PE20170952A1 (enExample)
PH (1) PH12017500966A1 (enExample)
PL (1) PL3237001T3 (enExample)
PT (1) PT3237001T (enExample)
RS (1) RS65387B1 (enExample)
SG (1) SG11201703828VA (enExample)
SI (1) SI3237001T1 (enExample)
TN (1) TN2017000181A1 (enExample)
TW (1) TW201641104A (enExample)
WO (1) WO2016103153A1 (enExample)

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AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
AR103172A1 (es) * 2014-12-22 2017-04-19 Novartis Ag Reducción selectiva de residuos de cisteina en anticuerpos il-17
ES2992409T3 (es) * 2016-07-19 2024-12-12 Novartis Ag Métodos de tratamiento de la psoriasis en placas de nueva aparición usando antagonistas de IL-17
TW202348250A (zh) * 2017-07-24 2023-12-16 美商再生元醫藥公司 穩定化之抗體組合物及其製法
WO2019087133A1 (en) * 2017-11-02 2019-05-09 Novartis Ag Method of treating tendinopathy using interleukin-17 (il-17)
GB201719447D0 (en) * 2017-11-23 2018-01-10 Ucb Biopharma Sprl Pharmaceutical composition
KR20200093628A (ko) * 2017-11-30 2020-08-05 바이오-테라 솔루션즈 리미티드 Il-6 관련 질병을 치료하는 인간화항체의 액체 제제
CN111303283A (zh) * 2018-12-12 2020-06-19 上海君实生物医药科技股份有限公司 抗il-17a抗体及其应用
US20210346380A1 (en) * 2018-12-25 2021-11-11 Sol-Gel Technologies Ltd. Treatment of skin disorders with compositions comprising an egfr inhibitor
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
RU2754760C2 (ru) * 2019-04-02 2021-09-07 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция анти-il17a антитела и ее применение
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
CN110124030A (zh) * 2019-06-10 2019-08-16 通化东宝生物科技有限公司 一种苏金单抗注射液及其制备方法
TWI844666B (zh) * 2019-08-22 2024-06-11 俄羅斯聯邦商拜奧卡德聯合股份公司 抗ＰＤ－１抗體Ｐｒｏｌｇｏｌｉｍａｂ的水性藥物組合物及其用途
BR112022004941A2 (pt) 2019-09-20 2022-06-28 Novartis Ag Métodos para tratar doenças autoimunes com o uso de antagonistas de interleucina-17 (il-17)
CN110585430B (zh) * 2019-09-29 2023-09-08 华博生物医药技术（上海）有限公司 一种人源化抗人il-17a单克隆抗体的药物组合物
AU2020386669A1 (en) 2019-11-19 2022-06-02 Novartis Ag Methods of treating Lupus Nephritis using interleukin-17 (IL-17) antagonists
CN112915201B (zh) * 2019-12-06 2023-06-27 珠海市丽珠单抗生物技术有限公司 包含抗il-17抗体的液体制剂
US20230190880A1 (en) * 2020-03-30 2023-06-22 Sichuan Luzhou Buchang Bio-Pharmaceutical Co., Ltd. Formulations of Human Parathyroid Hormone (PTH) and Methods for Producing Same
WO2022113105A1 (en) * 2020-11-25 2022-06-02 Dr. Reddy's Laboratories Limited Stable therapeutic protein formulation and methods of making the same
WO2022135395A1 (zh) * 2020-12-22 2022-06-30 百奥泰生物制药股份有限公司 稳定的抗体制剂及其制备方法和应用
CN117529506A (zh) * 2021-06-11 2024-02-06 海南先声药业有限公司 抗人il-17抗体和taci的双功能融合蛋白分子
CN113999300B (zh) * 2021-12-13 2022-09-13 青岛润达生物科技有限公司 一种高效提取卵黄抗体的复合沉降剂及方法
CN114452383B (zh) * 2022-02-17 2023-06-06 中国中医科学院中药研究所 司库奇尤单抗在治疗糖尿病溃疡中的用途
WO2024156841A1 (en) * 2023-01-27 2024-08-02 Fresenius Kabi Deutschland Gmbh Biopharmaceutical composition
EP4406553A1 (en) * 2023-01-27 2024-07-31 Fresenius Kabi Deutschland GmbH Stable secukinumab biopharmaceutical composition
KR20240141083A (ko) * 2023-03-17 2024-09-25 (주)셀트리온 안정한 약제학적 제제 및 완제의약품의 제조공정
WO2025071335A1 (ko) * 2023-09-27 2025-04-03 삼성바이오에피스 주식회사 항-il-17 항체의 안정한 액상 제형
CN117883376B (zh) * 2024-03-14 2024-06-25 北京四环生物制药有限公司 含重组人白细胞介素-2的药物制剂及其制备方法

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