WO2018124948A8 - ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα - Google Patents

ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα Download PDF

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Publication number
WO2018124948A8
WO2018124948A8 PCT/RU2017/050133 RU2017050133W WO2018124948A8 WO 2018124948 A8 WO2018124948 A8 WO 2018124948A8 RU 2017050133 W RU2017050133 W RU 2017050133W WO 2018124948 A8 WO2018124948 A8 WO 2018124948A8
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WO
WIPO (PCT)
Prior art keywords
tnfα
monoclonal antibody
aqueous pharmaceutical
recombinant monoclonal
pharmaceutical composition
Prior art date
Application number
PCT/RU2017/050133
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English (en)
French (fr)
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WO2018124948A1 (ru
Inventor
Екатерина Александровна ЛОМКОВА
Александр Олегович ЯКОВЛЕВ
Виктория Олеговна ШИТИКОВА
Анастасия Михайловна РЯХОВСКАЯ
Дмитрий Валентинович МОРОЗОВ
Original Assignee
Закрытое Акционерное Общество "Биокад"
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
Priority claimed from RU2016152691A external-priority patent/RU2665966C2/ru
Priority to EP17885720.7A priority Critical patent/EP3563867A4/en
Priority to CN201780087767.4A priority patent/CN110536698B/zh
Priority to MA46169A priority patent/MA46169B2/fr
Priority to MX2019007911A priority patent/MX2019007911A/es
Priority to CR20190316A priority patent/CR20190316A/es
Priority to KR1020197022011A priority patent/KR20190104043A/ko
Priority to AU2017384942A priority patent/AU2017384942A1/en
Priority to PE2019001351A priority patent/PE20191550A1/es
Priority to JP2019556787A priority patent/JP2020506955A/ja
Priority to EA201900360A priority patent/EA201900360A1/ru
Application filed by Закрытое Акционерное Общество "Биокад" filed Critical Закрытое Акционерное Общество "Биокад"
Priority claimed from RU2017146821A external-priority patent/RU2764521C2/ru
Priority to BR112019013673A priority patent/BR112019013673A2/pt
Publication of WO2018124948A1 publication Critical patent/WO2018124948A1/ru
Publication of WO2018124948A8 publication Critical patent/WO2018124948A8/ru
Priority to ZA2019/04305A priority patent/ZA201904305B/en
Priority to PH12019501530A priority patent/PH12019501530A1/en

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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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • 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
    • 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
    • C07K16/241—Tumor Necrosis Factors

Abstract

Изобретение относится к улучшенным водным фармацевтическим композициям рекомбинантного моноклонального антитела к ФНОα и способу его получения. Настоящее изобретение также относится к применению улучшенных водных фармацевтических композиций рекомбинантного моноклонального антитела к ФНОα для лечения заболеваний, опосредованных ФНОα. Предложенное изобретение позволяет предотвращать физико-химическую нестабильность, выраженную в образовании агрегатов и фрагментов белков или модификацию белков в растворе, а также предотвращает нестабильность при замораживании-размораживании, перемешивании и встряхивании.
PCT/RU2017/050133 2016-12-30 2017-12-29 ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα WO2018124948A1 (ru)

Priority Applications (13)

Application Number Priority Date Filing Date Title
BR112019013673A BR112019013673A2 (pt) 2016-12-30 2017-12-29 composição farmacêutica aquosa de anticorpo anti-tnfa monoclonal recombinante
EA201900360A EA201900360A1 (ru) 2017-12-29 2017-12-29 ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα
JP2019556787A JP2020506955A (ja) 2016-12-30 2017-12-29 組換えモノクローナル抗ＴＮＦα抗体の水性薬学的組成物
MX2019007911A MX2019007911A (es) 2016-12-30 2017-12-29 Composicion farmaceutica acuosa de anticuerpo monoclonal anti-tnfa recombinante.
CN201780087767.4A CN110536698B (zh) 2016-12-30 2017-12-29 重组单克隆抗TNFα抗体的水性药用组合物
KR1020197022011A KR20190104043A (ko) 2016-12-30 2017-12-29 TNFα에 대한 재조합 단일클론 항체의 약학적 수성 조성물
AU2017384942A AU2017384942A1 (en) 2016-12-30 2017-12-29 Aqueous Pharmaceutical Composition of Recombinant Monoclonal Anti-TNFα Antibody
EP17885720.7A EP3563867A4 (en) 2016-12-30 2017-12-29 AQUEOUS PHARMACEUTICAL COMPOSITION OF A RECOMBINANT MONOCLONAL ANTIBODY FOR TUMOR NECROSIS FACTOR (TNF)
MA46169A MA46169B2 (fr) 2016-12-30 2017-12-29 Composition pharmaceutique aqueuse d'un anticorps monoclonal recombinant pour le facteur de nécrose tumorale tnfa
CR20190316A CR20190316A (es) 2016-12-30 2017-12-29 COMPOSICIÓN FARMACÉUTICA ACUOSA DE ANTICUERPO MONOCLONAL ANTI-TNFa RECOMBINANTE
PE2019001351A PE20191550A1 (es) 2016-12-30 2017-12-29 COMPOSICION FARMACEUTICA ACUOSA DE ANTICUERPO MONOCLONAL ANTI-TNFalfa RECOMBINANTE
PH12019501530A PH12019501530A1 (en) 2016-12-30 2019-06-28 AQUEOUS PHARMACEUTICAL COMPOSITION OF A RECOMBINANT MONOCLONAL ANTIBODY TO TNFa
ZA2019/04305A ZA201904305B (en) 2016-12-30 2019-06-28 Aqueous pharmaceutical composition of a recombinant monoclonal antibody to tnf¿

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
RU2016152691 2016-12-30
RU2016152691A RU2665966C2 (ru) 2016-12-30 2016-12-30 Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОα
RU2017146821A RU2764521C2 (ru) 2017-12-29 2017-12-29 Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОа
RU2017146821 2017-12-29

Publications (2)

Publication Number Publication Date
WO2018124948A1 WO2018124948A1 (ru) 2018-07-05
WO2018124948A8 true WO2018124948A8 (ru) 2018-09-27

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2017/050133 WO2018124948A1 (ru) 2016-12-30 2017-12-29 ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα

Country Status (15)

Country Link
EP (1) EP3563867A4 (ru)
JP (1) JP2020506955A (ru)
KR (1) KR20190104043A (ru)
AU (1) AU2017384942A1 (ru)
BR (1) BR112019013673A2 (ru)
CL (1) CL2019001818A1 (ru)
CR (1) CR20190316A (ru)
EC (1) ECSP19048656A (ru)
JO (1) JOP20190162A1 (ru)
MX (1) MX2019007911A (ru)
NI (1) NI201900072A (ru)
PE (1) PE20191550A1 (ru)
PH (1) PH12019501530A1 (ru)
WO (1) WO2018124948A1 (ru)
ZA (1) ZA201904305B (ru)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20220152540A (ko) * 2020-03-13 2022-11-16 삼성바이오에피스 주식회사 안정성이 증진된 액상 약제학적 조성물
RU2745814C1 (ru) * 2020-06-05 2021-04-01 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция левилимаба и ее применение
AU2022245592A1 (en) * 2021-03-24 2023-10-19 Jcr Pharmaceuticals Co., Ltd. Stable aqueous pharmaceutical composition or freeze-dried pharmaceutical composition

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Also Published As

Publication number Publication date
JP2020506955A (ja) 2020-03-05
NI201900072A (es) 2019-10-31
MX2019007911A (es) 2019-12-05
JOP20190162A1 (ar) 2019-06-27
EP3563867A1 (en) 2019-11-06
CR20190316A (es) 2019-09-04
BR112019013673A2 (pt) 2020-01-28
EP3563867A4 (en) 2020-12-16
PE20191550A1 (es) 2019-10-24
KR20190104043A (ko) 2019-09-05
ECSP19048656A (es) 2019-07-31
AU2017384942A1 (en) 2019-08-08
ZA201904305B (en) 2022-04-28
PH12019501530A1 (en) 2020-02-24
CL2019001818A1 (es) 2019-11-29
WO2018124948A1 (ru) 2018-07-05

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