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MX2015010724A - Terapia de combinacion que involucra anticuerpos contra claudina 18.2 para tratamiento de cancer. - Google Patents

Terapia de combinacion que involucra anticuerpos contra claudina 18.2 para tratamiento de cancer.

Info

Publication number
MX2015010724A
MX2015010724A MX2015010724A MX2015010724A MX2015010724A MX 2015010724 A MX2015010724 A MX 2015010724A MX 2015010724 A MX2015010724 A MX 2015010724A MX 2015010724 A MX2015010724 A MX 2015010724A MX 2015010724 A MX2015010724 A MX 2015010724A
Authority
MX
Mexico
Prior art keywords
cancer
combination therapy
treatment
antibodies against
therapy involving
Prior art date
Application number
MX2015010724A
Other languages
English (en)
Inventor
Ugur Sahin
Özlem Türeci
Stefan Wöll
Rita Mitnacht-Kraus
Cornelia Heinz
Stefan Jacobs
Original Assignee
Ganymed Pharmaceuticals Ag
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 Ganymed Pharmaceuticals Ag filed Critical Ganymed Pharmaceuticals Ag
Publication of MX2015010724A publication Critical patent/MX2015010724A/es

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2013—IL-2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
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    • A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
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    • A61K31/66—Phosphorus compounds
    • A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
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    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • 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
    • 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
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/303—Liver or Pancreas
    • 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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • 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
    • C07K2317/32—Immunoglobulins specific features characterized by aspects of specificity or valency specific for a neo-epitope on a complex, e.g. antibody-antigen or ligand-receptor
    • 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
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • 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
    • C07K2317/74—Inducing cell proliferation

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  • Health & Medical Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Cell Biology (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La invención actual proporciona una terapia de combinación para tratar y/o prevenir efectivamente enfermedades asociadas con células que expresan CLDN18.2, incluyendo enfermedades de cáncer tales como cáncer pancreático y metástasis del mismo.
MX2015010724A 2013-02-20 2014-02-18 Terapia de combinacion que involucra anticuerpos contra claudina 18.2 para tratamiento de cancer. MX2015010724A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/EP2013/000505 WO2014127785A1 (en) 2013-02-20 2013-02-20 Combination therapy involving antibodies against claudin 18.2 for treatment of cancer
PCT/EP2014/000433 WO2014127906A1 (en) 2013-02-20 2014-02-18 Combination therapy involving antibodies against claudin 18.2 for treatment of cancer

Publications (1)

Publication Number Publication Date
MX2015010724A true MX2015010724A (es) 2016-04-11

Family

ID=47843230

Family Applications (3)

Application Number Title Priority Date Filing Date
MX2015010724A MX2015010724A (es) 2013-02-20 2014-02-18 Terapia de combinacion que involucra anticuerpos contra claudina 18.2 para tratamiento de cancer.
MX2020011783A MX2020011783A (es) 2013-02-20 2015-08-19 Terapia de combinacion que involucra anticuerpos contra claudina 18.2 para tratamiento de cancer.
MX2020011772A MX2020011772A (es) 2013-02-20 2015-08-19 Terapia de combinacion que involucra anticuerpos contra claudina 18.2 para tratamiento de cancer.

Family Applications After (2)

Application Number Title Priority Date Filing Date
MX2020011783A MX2020011783A (es) 2013-02-20 2015-08-19 Terapia de combinacion que involucra anticuerpos contra claudina 18.2 para tratamiento de cancer.
MX2020011772A MX2020011772A (es) 2013-02-20 2015-08-19 Terapia de combinacion que involucra anticuerpos contra claudina 18.2 para tratamiento de cancer.

Country Status (23)

Country Link
US (5) US9770487B2 (es)
JP (5) JP6389478B2 (es)
KR (3) KR20230143186A (es)
CN (3) CN115282269A (es)
AR (1) AR094849A1 (es)
AU (1) AU2014221035B2 (es)
BR (1) BR112015019995A2 (es)
CA (1) CA2899754C (es)
DK (1) DK2958945T3 (es)
ES (1) ES2930654T3 (es)
HK (1) HK1213925A1 (es)
HU (1) HUE060192T2 (es)
IL (2) IL302093A (es)
LT (1) LT2958945T (es)
MX (3) MX2015010724A (es)
MY (1) MY184332A (es)
PL (1) PL2958945T3 (es)
PT (1) PT2958945T (es)
RU (1) RU2699549C2 (es)
SA (1) SA515360926B1 (es)
SG (2) SG10201610412YA (es)
UA (1) UA118664C2 (es)
WO (2) WO2014127785A1 (es)

Families Citing this family (42)

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DE10254601A1 (de) * 2002-11-22 2004-06-03 Ganymed Pharmaceuticals Ag Differentiell in Tumoren exprimierte Genprodukte und deren Verwendung
DE102004024617A1 (de) 2004-05-18 2005-12-29 Ganymed Pharmaceuticals Ag Differentiell in Tumoren exprimierte Genprodukte und deren Verwendung
WO2013174404A1 (en) 2012-05-23 2013-11-28 Ganymed Pharmaceuticals Ag Combination therapy involving antibodies against claudin 18.2 for treatment of cancer
UA128182C2 (uk) 2012-11-13 2024-05-01 Біонтех Аґ Агенти для лікування експресуючих клаудин ракових захворювань
WO2014127785A1 (en) 2013-02-20 2014-08-28 Ganymed Pharmaceuticals Ag Combination therapy involving antibodies against claudin 18.2 for treatment of cancer
WO2014146672A1 (en) 2013-03-18 2014-09-25 Ganymed Pharmaceuticals Ag Therapy involving antibodies against claudin 18.2 for treatment of cancer
KR20230132604A (ko) 2015-01-27 2023-09-15 라바 테라퓨틱스 엔.브이. Cd1d를 표적화하는 단일 도메인 항체
BR112019000327A8 (pt) * 2016-07-08 2022-10-18 Carsgen Therapeutics Co Ltd Anticorpo para anticlaudina 18a2 e uso do mesmo
DK3625259T3 (da) 2017-05-16 2024-07-08 Byondis Bv Anti-sirpalpha-antistoffer
JP7398380B2 (ja) * 2018-03-08 2023-12-14 フェインズ セラピューティクス，インコーポレーテッド 抗クローディン１８．２抗体及びその使用
CN110577597B (zh) * 2018-06-11 2021-10-22 康诺亚生物医药科技（成都）有限公司 一种阻断CD47和SIRPα相互作用的抗体
CN112513093B (zh) * 2018-07-18 2024-08-09 奥美药业有限公司 一种新型抗体及其制备方法和应用
WO2020043044A1 (zh) * 2018-08-27 2020-03-05 南京圣和药业股份有限公司 一种抗Claudin18.2抗体及其应用
CN113272325A (zh) 2018-09-19 2021-08-17 拉法医疗有限公司 双作用CD1d免疫球蛋白
WO2020063988A1 (zh) * 2018-09-30 2020-04-02 科济生物医药（上海）有限公司 Cldn18的抗体和化疗药物的联合治疗
CN109402075A (zh) * 2018-11-28 2019-03-01 深圳先进技术研究院 一种用于清除氧自由基的小分子蛋白质及其应用
US20220073643A1 (en) * 2018-12-28 2022-03-10 Nanjing GenScript Biotech Co., Ltd. Claudin18.2 binding moieties and uses thereof
JP7520848B2 (ja) * 2018-12-28 2024-07-23 スパークス・セラピューティクス・インコーポレイテッド 癌および他の疾患の治療のための、クローディン１８．２に特異的な結合分子、その組成物および方法
WO2020143631A1 (zh) * 2019-01-07 2020-07-16 科济生物医药（上海）有限公司 细胞免疫治疗的组合
CN109762067B (zh) * 2019-01-17 2020-02-28 北京天广实生物技术股份有限公司 结合人Claudin 18.2的抗体及其用途
AU2020217012A1 (en) 2019-02-01 2021-08-19 Novarock Biotherapeutics, Ltd. Anti-claudin 18 antibodies and methods of use thereof
JP2022529703A (ja) * 2019-04-19 2022-06-23 康▲諾▼▲亞▼生物医葯科技（成都）有限公司 腫瘍治療薬及びその応用
CN117264059A (zh) * 2019-05-16 2023-12-22 启愈生物技术(上海)有限公司 抗cldn抗体及其药物组合物和检测方法
AU2020273695B2 (en) * 2019-05-16 2024-10-31 Qilu Pharmaceutical Co., Ltd. Antibody against claudin 18A2 and use thereof
BR112021023897A2 (pt) * 2019-05-30 2022-01-25 Shandong Boan Biotechnology Co Ltd Anticorpo ou receptor de antígeno quimérico que visa claudina18.2
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