CN115867316A - 抗pd-1抗体药物组合物及其用途 - Google Patents

抗pd-1抗体药物组合物及其用途 Download PDF

Info

Publication number
CN115867316A
CN115867316A CN202180045879.XA CN202180045879A CN115867316A CN 115867316 A CN115867316 A CN 115867316A CN 202180045879 A CN202180045879 A CN 202180045879A CN 115867316 A CN115867316 A CN 115867316A
Authority
CN
China
Prior art keywords
antibody
seq
cancer
concentration
variable region
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
CN202180045879.XA
Other languages
English (en)
Inventor
莫希叶乐
颜贞
刘洵
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jiangsu Hengrui Medicine Co Ltd
Shanghai Hengrui Pharmaceutical Co Ltd
Original Assignee
Jiangsu Hengrui Medicine Co Ltd
Shanghai Hengrui Pharmaceutical Co Ltd
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 Jiangsu Hengrui Medicine Co Ltd, Shanghai Hengrui Pharmaceutical Co Ltd filed Critical Jiangsu Hengrui Medicine Co Ltd
Publication of CN115867316A publication Critical patent/CN115867316A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IGs], 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
    • 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
    • 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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • 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
    • 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)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

本披露涉及抗PD‑1抗体药物组合物及其用途。具体地，本披露提供一种药物组合物，其包含抗PD‑1抗体以及缓冲液。

Description

PCT国内申请，说明书已公开。

Claims (15)

  1. PCT国内申请，权利要求书已公开。
CN202180045879.XA 2020-07-31 2021-07-30 抗pd-1抗体药物组合物及其用途 Pending CN115867316A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CN2020107559549 2020-07-31
CN202010755954 2020-07-31
CN2021108315758 2021-07-22
CN202110831575 2021-07-22
PCT/CN2021/109438 WO2022022660A1 (zh) 2020-07-31 2021-07-30 抗pd-1抗体药物组合物及其用途

Publications (1)

Publication Number Publication Date
CN115867316A true CN115867316A (zh) 2023-03-28

Family

ID=80037648

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180045879.XA Pending CN115867316A (zh) 2020-07-31 2021-07-30 抗pd-1抗体药物组合物及其用途

Country Status (11)

Country Link
US (1) US20230295329A1 (zh)
EP (1) EP4190353A4 (zh)
JP (1) JP2023535384A (zh)
KR (1) KR20230044448A (zh)
CN (1) CN115867316A (zh)
AU (1) AU2021317805A1 (zh)
BR (1) BR112023001471A2 (zh)
CA (1) CA3189452A1 (zh)
MX (1) MX2023001160A (zh)
TW (1) TW202214298A (zh)
WO (1) WO2022022660A1 (zh)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20210097882A (ko) * 2020-01-30 2021-08-10 삼성바이오에피스 주식회사 안정한 항-pd-1 항체 약제학적 제제
WO2024058289A1 (ko) * 2022-09-15 2024-03-21 주식회사 와이바이오로직스 Pd-1에 특이적으로 결합하는 항체를 유효성분으로 포함하는 신경내분비 신생물의 예방 또는 치료용 약학 조성물

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4683195A (en) 1986-01-30 1987-07-28 Cetus Corporation Process for amplifying, detecting, and/or-cloning nucleic acid sequences
EA035037B1 (ru) * 2013-12-12 2020-04-21 Шанхай Хэнжуй Фармасьютикал Ко., Лтд. Антитело к pd-1, его антигенсвязывающий фрагмент и их медицинское применение
CN106390115A (zh) * 2015-07-29 2017-02-15 上海君实生物医药科技股份有限公司 一种人源化单克隆抗体的稳定制剂
JP6921062B2 (ja) * 2015-09-28 2021-08-18 スーヂョウ サンケイディア バイオファーマスーティカルズ カンパニー リミテッド 安定な抗ｐｄ−１抗体医薬製剤および医薬におけるその適用
CN106699889A (zh) * 2015-11-18 2017-05-24 礼进生物医药科技（上海）有限公司 抗pd-1抗体及其治疗用途
JOP20190260A1 (ar) * 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CN109966487B (zh) * 2017-12-28 2023-08-25 上海复宏汉霖生物制药有限公司 一种包含抗pd-l1单克隆抗体的药物配制剂
JP2021522209A (ja) * 2018-04-25 2021-08-30 メディミューン リミテッド ヒト抗ｐｄ−ｌ１抗体の配合物
US20220002410A1 (en) * 2018-11-07 2022-01-06 Merck Sharp & Dohme Corp. Co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
CN110974958B (zh) * 2019-12-25 2020-08-21 北京东方百泰生物科技有限公司 一种抗pd-l1单克隆抗体的注射制剂
CN110787292B (zh) * 2020-01-06 2020-04-24 上海复宏汉霖生物技术股份有限公司 一种细胞程序性死亡受体1抗体制剂及其用途

Also Published As

Publication number Publication date
EP4190353A4 (en) 2024-02-14
AU2021317805A1 (en) 2023-03-16
US20230295329A1 (en) 2023-09-21
WO2022022660A1 (zh) 2022-02-03
JP2023535384A (ja) 2023-08-17
KR20230044448A (ko) 2023-04-04
EP4190353A1 (en) 2023-06-07
TW202214298A (zh) 2022-04-16
CA3189452A1 (en) 2022-02-03
MX2023001160A (es) 2023-02-22
BR112023001471A2 (pt) 2023-03-14

Similar Documents

Publication Publication Date Title
CN111744007B (zh) 一种抗tigit抗体药物组合物及其用途
TWI829799B (zh) 一種TGF-β受體融合蛋白醫藥組成物及其用途
CN110538321B (zh) 一种cd47抗体药物组合物及其用途
CN112969716B (zh) 抗pd-1抗体、其抗原结合片段及医药用途
CN111356476B (zh) Lag-3抗体药物组合物及其用途
US20230295329A1 (en) Anti-pd-1 antibody pharmaceutical composition and use thereof
US20210261663A1 (en) Anti-tim3 antibody pharmaceutical composition and use thereof
WO2021190582A1 (zh) 一种抗ox40抗体药物组合物及其用途
EP4104858A1 (en) Pharmaceutical composition containing anti-il-4r antibody and use thereof
CN112839961B (zh) 一种cd40抗体药物组合物及其用途
TWI843799B (zh) 抗pd-1抗體、其抗原結合片段及醫藥用途
TW202320847A (zh) 一種抗ａｎｇｐｔｌ３抗體或其抗原結合片段的醫藥組成物及其用途
JP2024500308A (ja) 抗ｔｓｌｐ抗体医薬組成物及びその使用

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination