KR102767553B1 - 제제 - Google Patents

제제 Download PDF

Info

Publication number
KR102767553B1
KR102767553B1 KR1020207017469A KR20207017469A KR102767553B1 KR 102767553 B1 KR102767553 B1 KR 102767553B1 KR 1020207017469 A KR1020207017469 A KR 1020207017469A KR 20207017469 A KR20207017469 A KR 20207017469A KR 102767553 B1 KR102767553 B1 KR 102767553B1
Authority
KR
South Korea
Prior art keywords
antibody
pharmaceutical composition
formulations
formulation
antigen
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
KR1020207017469A
Other languages
English (en)
Korean (ko)
Other versions
KR20200090829A (ko
Inventor
산드린 두란
앤드루 제프리 예이츠
Original Assignee
유씨비 바이오파마 에스알엘
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 유씨비 바이오파마 에스알엘 filed Critical 유씨비 바이오파마 에스알엘
Publication of KR20200090829A publication Critical patent/KR20200090829A/ko
Application granted granted Critical
Publication of KR102767553B1 publication Critical patent/KR102767553B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
KR1020207017469A 2017-11-23 2018-11-13 제제 Active KR102767553B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1719447.3A GB201719447D0 (en) 2017-11-23 2017-11-23 Pharmaceutical composition
GB1719447.3 2017-11-23
PCT/EP2018/081129 WO2019101582A1 (en) 2017-11-23 2018-11-13 Formulation

Publications (2)

Publication Number Publication Date
KR20200090829A KR20200090829A (ko) 2020-07-29
KR102767553B1 true KR102767553B1 (ko) 2025-02-12

Family

ID=60950516

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020207017469A Active KR102767553B1 (ko) 2017-11-23 2018-11-13 제제

Country Status (19)

Country Link
US (2) US11857625B2 (https=)
EP (1) EP3713602A1 (https=)
JP (1) JP6955632B2 (https=)
KR (1) KR102767553B1 (https=)
CN (1) CN111511399A (https=)
AR (1) AR113534A1 (https=)
AU (1) AU2018371056B2 (https=)
BR (1) BR112020009866A2 (https=)
CA (1) CA3082832C (https=)
CL (1) CL2020001307A1 (https=)
CO (1) CO2020006120A2 (https=)
EA (1) EA202091295A1 (https=)
GB (1) GB201719447D0 (https=)
IL (1) IL274719B2 (https=)
MX (1) MX2020004747A (https=)
MY (1) MY194682A (https=)
RU (1) RU2020120547A (https=)
SG (1) SG11202004601YA (https=)
WO (1) WO2019101582A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
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
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
CN113769082A (zh) * 2020-06-10 2021-12-10 上海君实生物医药科技股份有限公司 抗il-17a抗体药物组合物及其用途

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016103153A1 (en) * 2014-12-22 2016-06-30 Novartis Ag Pharmaceutical products and stable liquid compositions of il-17 antibodies
WO2017102830A1 (en) * 2015-12-18 2017-06-22 Ucb Biopharma Sprl Multi-specific antibody molecules having specificity for tnf-alpha, il-17a and il-17f

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007019232A2 (en) 2005-08-03 2007-02-15 Immunogen, Inc. Immunoconjugate formulations
GB0620729D0 (en) * 2006-10-18 2006-11-29 Ucb Sa Biological products
WO2009120684A1 (en) 2008-03-25 2009-10-01 Medimmune, Llc Antibody formulation
MX2012007676A (es) 2009-12-29 2012-08-03 Hoffmann La Roche Nueva formulacion de anticuerpo.
HRP20171939T1 (hr) 2010-01-15 2018-03-23 Kirin-Amgen, Inc. Formulacija protutijela i režimi terapije
US9956165B2 (en) 2010-03-01 2018-05-01 Cytodyn Inc. Concentrated protein formulations and uses thereof
SMT202000095T1 (it) * 2010-05-14 2020-03-13 Amgen Inc Formulazioni di anticorpi anti-sclerostina ad alta concentrazione
FR2962650B1 (fr) 2010-07-19 2013-04-05 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines concentrees
MX362591B (es) * 2010-11-05 2019-01-25 Novartis Ag Uso de antagonistas de il-17.
SG10201510762YA (en) * 2011-01-14 2016-01-28 Ucb Pharma Sa Antibody molecules which bind il-17a and il-17f
PE20150190A1 (es) * 2012-06-21 2015-02-13 Ucb Pharma Sa Formulacion farmaceutica
CN107148283A (zh) * 2014-10-31 2017-09-08 豪夫迈·罗氏有限公司 抗il‑17a和il‑17f交叉反应性抗体变体、包含其的组合物及其制备和使用方法
CA2995222C (en) 2015-08-19 2021-07-13 Medimmune, Llc Stable anti-ifnar1 formulation
MY206805A (en) 2015-10-27 2025-01-08 UCB Biopharma SRL Methods of treatment using anti-il-17a/f antibodies
US20190060241A1 (en) 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
KR102329490B1 (ko) 2016-09-14 2021-11-23 베이징 한미 파마슈티컬 컴퍼니 리미티드 Il-17a에 특이적으로 결합하는 항체 및 그의 기능성 단편

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016103153A1 (en) * 2014-12-22 2016-06-30 Novartis Ag Pharmaceutical products and stable liquid compositions of il-17 antibodies
WO2017102830A1 (en) * 2015-12-18 2017-06-22 Ucb Biopharma Sprl Multi-specific antibody molecules having specificity for tnf-alpha, il-17a and il-17f

Also Published As

Publication number Publication date
BR112020009866A2 (pt) 2020-11-17
AU2018371056A1 (en) 2020-06-04
MY194682A (en) 2022-12-14
JP6955632B2 (ja) 2021-10-27
CA3082832A1 (en) 2019-05-31
JP2021504321A (ja) 2021-02-15
CA3082832C (en) 2023-07-18
EA202091295A1 (ru) 2020-09-03
EP3713602A1 (en) 2020-09-30
AR113534A1 (es) 2020-05-13
AU2018371056B2 (en) 2024-06-20
CO2020006120A2 (es) 2020-05-29
IL274719A (en) 2020-07-30
WO2019101582A1 (en) 2019-05-31
RU2020120547A (ru) 2021-12-23
GB201719447D0 (en) 2018-01-10
US11857625B2 (en) 2024-01-02
KR20200090829A (ko) 2020-07-29
MX2020004747A (es) 2020-08-20
US20210106683A1 (en) 2021-04-15
RU2020120547A3 (https=) 2021-12-23
CL2020001307A1 (es) 2020-10-16
IL274719B1 (en) 2024-06-01
US20240123065A1 (en) 2024-04-18
SG11202004601YA (en) 2020-06-29
CN111511399A (zh) 2020-08-07
IL274719B2 (en) 2024-10-01

Similar Documents

Publication Publication Date Title
KR102767553B1 (ko) 제제
CN110769851B (zh) 兽用抗il31抗体
AU2011227335B2 (en) Anti-nerve growth factor (NGF) antibody compositions
EP2473191B1 (en) Antibody coformulations
KR102436694B1 (ko) 약학 조성물
US20240309080A1 (en) Pharmaceutical composition containing anti-tslp antibody
JP6769879B2 (ja) Gm−csf中和化合物を含む液体製剤
KR102474765B1 (ko) 항-TNFα-항체 및 이의 기능성 단편
MX2014015262A (es) Formulacion de anticuerpos.
JP6346189B2 (ja) Gm−csf中和化合物を含む液体製剤
KR20130137653A (ko) 생물약제학적 약물을 포함하는 약제학적 제제
KR20220158877A (ko) 항-TNFα-항체 및 이의 기능성 단편
KR102392746B1 (ko) 항-TNFα-항체 및 이의 기능성 단편
KR20210029789A (ko) 고농도 액체 항체 제형
AU2017235465A1 (en) Anti-TNFα-antibodies and functional fragments thereof
EP3714902B1 (en) Stabilization of pharmaceutical compositions comprising polysorbate
WO2018204156A1 (en) Anti-cgrp/anti-il-23 bispecific antibodies and uses thereof
EA041921B1 (ru) Фармацевтическая композиция

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20200617

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20210917

Comment text: Request for Examination of Application

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

Comment text: Notification of reason for refusal

Patent event date: 20240103

Patent event code: PE09021S01D

E601 Decision to refuse application
PE0601 Decision on rejection of patent

Patent event date: 20240831

Comment text: Decision to Refuse Application

Patent event code: PE06012S01D

AMND Amendment
PX0901 Re-examination

Patent event code: PX09012R01I

Patent event date: 20241126

Comment text: Amendment to Specification, etc.

PX0701 Decision of registration after re-examination

Patent event date: 20241203

Comment text: Decision to Grant Registration

Patent event code: PX07013S01D

X701 Decision to grant (after re-examination)
GRNT Written decision to grant
PR0701 Registration of establishment

Comment text: Registration of Establishment

Patent event date: 20250210

Patent event code: PR07011E01D

PR1002 Payment of registration fee

Payment date: 20250210

End annual number: 3

Start annual number: 1

PG1601 Publication of registration