JP2024538140A - 抗ｏｘ４０モノクローナル抗体を含む医薬製剤 - Google Patents

抗ｏｘ４０モノクローナル抗体を含む医薬製剤 Download PDF

Info

Publication number
JP2024538140A
JP2024538140A JP2024522608A JP2024522608A JP2024538140A JP 2024538140 A JP2024538140 A JP 2024538140A JP 2024522608 A JP2024522608 A JP 2024522608A JP 2024522608 A JP2024522608 A JP 2024522608A JP 2024538140 A JP2024538140 A JP 2024538140A
Authority
JP
Japan
Prior art keywords
mmol
pharmaceutical formulation
concentration
buffer
seq
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.)
Pending
Application number
JP2024522608A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024538140A5 (https=
Inventor
スン，チアン
ジン，ションフア
ファン，ペンチェン
シュー，チーハオ
Original Assignee
インマージーン プライベート リミテッド
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 インマージーン プライベート リミテッド filed Critical インマージーン プライベート リミテッド
Publication of JP2024538140A publication Critical patent/JP2024538140A/ja
Publication of JP2024538140A5 publication Critical patent/JP2024538140A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • 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
    • A61P35/00—Antineoplastic agents
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2024522608A 2021-10-15 2022-10-13 抗ｏｘ４０モノクローナル抗体を含む医薬製剤 Pending JP2024538140A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CN2021124200 2021-10-15
CNPCT/CN2021/124200 2021-10-15
CNPCT/CN2022/118065 2022-09-09
CN2022118065 2022-09-09
PCT/CN2022/125017 WO2023061424A1 (en) 2021-10-15 2022-10-13 Pharmaceutical formulation comprising anti-ox40 monoclonal antibody

Publications (2)

Publication Number Publication Date
JP2024538140A true JP2024538140A (ja) 2024-10-18
JP2024538140A5 JP2024538140A5 (https=) 2025-10-21

Family

ID=85987310

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024522608A Pending JP2024538140A (ja) 2021-10-15 2022-10-13 抗ｏｘ４０モノクローナル抗体を含む医薬製剤

Country Status (13)

Country Link
US (1) US20250282882A1 (https=)
EP (1) EP4415754A4 (https=)
JP (1) JP2024538140A (https=)
KR (1) KR20240109250A (https=)
CN (1) CN118541166A (https=)
AU (1) AU2022367611A1 (https=)
CA (1) CA3235879A1 (https=)
CL (1) CL2024001157A1 (https=)
IL (1) IL312138A (https=)
MX (1) MX2024004619A (https=)
PE (1) PE20241351A1 (https=)
TW (1) TW202323280A (https=)
WO (1) WO2023061424A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20230255A1 (es) * 2020-04-17 2023-02-07 Hutchison Medipharma Ltd Anticuerpo anti-ox40 y usos del mismo
TW202600166A (zh) * 2024-03-04 2026-01-01 新加坡商創響私人有限公司 包含ｏｘ４０靶向抗體的藥物組合物及其用途

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20100014588A (ko) * 2007-02-27 2010-02-10 제넨테크, 인크. 길항제 ｏｘ40 항체 및 염증성 및 자가면역 질환의 치료에서의 이의 용도
SG11201607969XA (en) * 2014-03-31 2016-10-28 Genentech Inc Anti-ox40 antibodies and methods of use
WO2017134292A1 (en) * 2016-02-04 2017-08-10 Glenmark Pharmaceuticals S.A. Anti-ox40 antagonistic antibodies for the treatment of atopic dermatitis
WO2020016417A1 (en) * 2018-07-19 2020-01-23 Ichnos Sciences S.A. Liquid antibody formulation
WO2020063668A1 (zh) * 2018-09-25 2020-04-02 信达生物制药(苏州)有限公司 包含抗ox40抗体的制剂、其制备方法及其用途
US20220273796A1 (en) * 2019-07-19 2022-09-01 Ichnos Sciences SA Lyophilized antibody formulation
WO2021190582A1 (zh) * 2020-03-25 2021-09-30 江苏恒瑞医药股份有限公司 一种抗ox40抗体药物组合物及其用途

Also Published As

Publication number Publication date
MX2024004619A (es) 2024-07-12
TW202323280A (zh) 2023-06-16
CL2024001157A1 (es) 2024-11-15
WO2023061424A1 (en) 2023-04-20
AU2022367611A1 (en) 2024-05-02
KR20240109250A (ko) 2024-07-10
US20250282882A1 (en) 2025-09-11
IL312138A (en) 2024-06-01
EP4415754A1 (en) 2024-08-21
CA3235879A1 (en) 2023-04-20
PE20241351A1 (es) 2024-07-03
CN118541166A (zh) 2024-08-23
EP4415754A4 (en) 2025-09-24

Similar Documents

Publication Publication Date Title
US10689451B2 (en) Anti-BAFFR antibody therapeutic formulations
ES2827180T3 (es) Formulaciones de anticuerpos estables
JP2020138981A (ja) モノクローナル抗体製剤
KR20170117166A (ko) 단클론 항체를 위한 안정한 액체 제형
TWI844034B (zh) 抗ＩＬ１７ａ抗體的水性藥物組合物及其用途
CN113453719A (zh) 包含抗cd47抗体的制剂及其制备方法和用途
US20230173069A1 (en) Formulation comprising anti-il-23p19 antibody, method for preparing same and use thereof
JP2024538140A (ja) 抗ｏｘ４０モノクローナル抗体を含む医薬製剤
KR20240053633A (ko) Vegf 수용체 융합 단백질을 위한 제제
JP2025519600A (ja) 抗ｉｇｆ－１ｒ抗体組成物
EA052372B1 (ru) Фармацевтическая композиция, содержащая моноклональное антитело к ox40
HK40114522A (zh) 包含抗-ox40单克隆抗体的药物制剂
TW202323288A (zh) 配方
JP2025534054A (ja) 抗ｔｉｇｉｔ抗体を含む製剤及びその使用方法
CN118175989A (zh) 制剂
HK40059591A (en) Preparations containing anti-cd47 antibody, and preparation method and use therefor
CN120129697A (zh) 抗体制剂
HK40109619A (zh) 制剂
HK40109650A (zh) 制剂
HK40093315A (zh) 乐维利单抗的水性药用组合物及其用途

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20251010

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20251010