JP2024505128A - 抗cd73抗体の製剤 - Google Patents

抗cd73抗体の製剤 Download PDF

Info

Publication number
JP2024505128A
JP2024505128A JP2023540516A JP2023540516A JP2024505128A JP 2024505128 A JP2024505128 A JP 2024505128A JP 2023540516 A JP2023540516 A JP 2023540516A JP 2023540516 A JP2023540516 A JP 2023540516A JP 2024505128 A JP2024505128 A JP 2024505128A
Authority
JP
Japan
Prior art keywords
volume
mass
cancer
results
histidine
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
JP2023540516A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024505128A5 (cg-RX-API-DMAC10.html
Inventor
ジン ジュー,
ジェルー ジャン,
シャンピン ジュー,
ヤーリー ユー,
Original Assignee
アイ-エムエービー バイオファーマ カンパニー 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 アイ-エムエービー バイオファーマ カンパニー リミテッド filed Critical アイ-エムエービー バイオファーマ カンパニー リミテッド
Publication of JP2024505128A publication Critical patent/JP2024505128A/ja
Publication of JP2024505128A5 publication Critical patent/JP2024505128A5/ja
Pending legal-status Critical Current

Links

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
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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 [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
    • C07K16/2875—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/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2023540516A 2020-12-30 2021-05-08 抗cd73抗体の製剤 Pending JP2024505128A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2020141601 2020-12-30
CNPCT/CN2020/141601 2020-12-30
PCT/CN2021/092485 WO2022142053A1 (en) 2020-12-30 2021-05-08 Formulations of anti-cd73 antibodies

Publications (2)

Publication Number Publication Date
JP2024505128A true JP2024505128A (ja) 2024-02-05
JP2024505128A5 JP2024505128A5 (cg-RX-API-DMAC10.html) 2024-05-17

Family

ID=82258959

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023540516A Pending JP2024505128A (ja) 2020-12-30 2021-05-08 抗cd73抗体の製剤

Country Status (8)

Country Link
US (1) US20240101698A1 (cg-RX-API-DMAC10.html)
EP (1) EP4271410A4 (cg-RX-API-DMAC10.html)
JP (1) JP2024505128A (cg-RX-API-DMAC10.html)
KR (1) KR20230127292A (cg-RX-API-DMAC10.html)
CN (1) CN116615458A (cg-RX-API-DMAC10.html)
AU (1) AU2021415180A1 (cg-RX-API-DMAC10.html)
CA (1) CA3203441A1 (cg-RX-API-DMAC10.html)
WO (1) WO2022142053A1 (cg-RX-API-DMAC10.html)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025021098A1 (zh) * 2023-07-24 2025-01-30 石药集团巨石生物制药有限公司 重组人源化抗cd73单克隆抗体的药物组合物

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018137598A1 (en) * 2017-01-24 2018-08-02 I-Mab Anti-cd73 antibodies and uses thereof

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2578131A1 (en) * 2004-09-10 2006-03-23 Wyeth Humanized anti-5t4 antibodies and anti-5t4 antibody/calicheamicin conjugates
WO2010056804A1 (en) * 2008-11-12 2010-05-20 Medimmune, Llc Antibody formulation
CN102413839A (zh) * 2009-03-06 2012-04-11 医学免疫有限责任公司 人源化抗cd19抗体制剂
CN102512384B (zh) * 2011-12-29 2014-11-26 嘉和生物药业有限公司 一种冻干剂型蛋白组合物及其制备方法
CN108025072A (zh) * 2015-09-22 2018-05-11 辉瑞公司 制备治疗用蛋白质制剂的方法和由这种方法生产的抗体制剂
JP2019514889A (ja) * 2016-04-25 2019-06-06 メディミューン,エルエルシー 抗pd−l1および抗ctla−4抗体の共製剤を含む組成物
US20210054079A1 (en) * 2018-04-25 2021-02-25 Medimmune Limited Formulations of human anti-pd-li antibodies
CN112041348B (zh) * 2018-07-25 2023-09-22 天境生物科技(上海)有限公司 抗cd73抗pd-l1双特异性抗体
SG11202105152YA (en) * 2018-11-30 2021-06-29 Abl Bio Inc Anti-pd-l1/anti-4-1bb bispecific antibodies and uses thereof
CN111686247B (zh) * 2019-03-13 2022-07-29 苏州康乃德生物医药有限公司 包含人白介素-4受体α的抗体的液体组合物

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018137598A1 (en) * 2017-01-24 2018-08-02 I-Mab Anti-cd73 antibodies and uses thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
EUR. J. PHARM. BIOPHARM., vol. 78, JPN6025025820, 2011, pages 208 - 212, ISSN: 0005825097 *
J. PHARM. SCI., vol. 96, no. 1, JPN6025025821, 2007, pages 1 - 26, ISSN: 0005825098 *

Also Published As

Publication number Publication date
CN116615458A (zh) 2023-08-18
EP4271410A1 (en) 2023-11-08
WO2022142053A1 (en) 2022-07-07
AU2021415180A1 (en) 2023-07-06
KR20230127292A (ko) 2023-08-31
CA3203441A1 (en) 2022-07-07
EP4271410A4 (en) 2025-08-13
US20240101698A1 (en) 2024-03-28

Similar Documents

Publication Publication Date Title
JP7653465B2 (ja) 単独およびプログラム死受容体1(pd-1)抗体と組み合わされた抗ctla4抗体の安定な製剤、ならびにその使用方法
UA128202C2 (uk) Стабільна композиція антитіла до рецептора програмованої загибелі 1 (pd-1) і спосіб її застосування
KR102697026B1 (ko) 항-pd-l1 항체 아벨루맙을 포함하는 수성 약학 제형
CN105163763A (zh) 抗egfr抗体药物偶联物制剂
JP7805289B2 (ja) 抗コネキシン抗体製剤
WO2022128716A1 (en) Pharmaceutical composition comprising a bispecific anti-muc1/egfr antibody-drug conjugate
EP4374874A1 (en) Pharmaceutical composition containing anti-trop2 antibody drug conjugate and use thereof
CA3252354A1 (en) Pharmaceutical composition containing an anti-nectin-4 antibody conjugate and its use
US20190240345A1 (en) Novel stable formulation
KR20240024941A (ko) 항-pd1 항체의 제제
CN116459335A (zh) 抗cldn-18.2抗体药物组合物及其用途
CN116615458A (zh) 抗cd73抗体的制剂
KR20260058842A (ko) 항-psma adc 접합체 조성물 및 이의 사용 방법
TWI880260B (zh) 抗pd-l1/抗-4-1bb雙特異性抗體製劑
CN116725961A (zh) 抗cd39抗体药物组合物及其用途
CN116172947A (zh) 一种含特异性结合vegf和ang2的双特异性抗体的药物组合物
CN119095618B (zh) 用于治疗巨噬细胞活化综合征的组合物和方法
EP4548931A1 (en) Anti-pcsk9 antibody preparation and use thereof
EA053317B1 (ru) Фармацевтическая композиция, содержащая конъюгат антитела к нектину-4 и лекарственного средства, и ее применение
HK40103088A (en) Anti-il5r antibody formulations
TW202432601A (zh) 包含抗人類tslp受體抗體之醫藥組成物及其使用方法
HK40077586A (en) Anto-connexin antibody formulations
WO2021034228A1 (ru) Водная фармацевтическая композиция антитела к pd-1 пролголимаба и ее применение

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240507

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20240507

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20250625

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20250829

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20251224

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20260325

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20260703

A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20260803