RU2020124273A - Новые анти-pd-1 антитела - Google Patents
Новые анти-pd-1 антитела Download PDFInfo
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- 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
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
- A61P37/04—Immunostimulants
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- A—HUMAN NECESSITIES
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- 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
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- 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
-
- 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
- C07K16/2827—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 B7 molecules, e.g. CD80, CD86
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/10—Cells modified by introduction of foreign genetic material
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/22—Immunoglobulins specific features characterized by taxonomic origin from camelids, e.g. camel, llama or dromedary
-
- 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
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
-
- 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
- C07K2317/30—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
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- 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
- C07K2317/74—Inducing cell proliferation
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- 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
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Claims (49)
1. Выделенный полинуклеотид, кодирующий анти-PD-1-антитело, содержащее
а) вариабельную область тяжелой цепи, содержащую:
CDR1 тяжелой цепи с последовательностью SEQ ID NO:1,
CDR2 тяжелой цепи с последовательностью SEQ ID NO:15 и
CDR3 тяжелой цепи с последовательностью SEQ ID NO:5; и
b) вариабельную область легкой цепи, содержащую:
CDR1 легкой цепи с последовательностью SEQ ID NO:7,
CDR2 легкой цепи с последовательностью SEQ ID NO:17 и
CDR3 легкой цепи с последовательностью SEQ ID NO:65.
2. Выделенный полинуклеотид по п.1, где антитело содержит
вариабельную область тяжелой цепи, содержащую SEQ ID NO:53; и вариабельную область легкой цепи, содержащую SEQ ID NO:67.
3. Выделенный полинуклеотид по п.1 или п.2, где антитело способно специфически связываться с PD-1 человека со значением KD не более 10-8 М, как измерено анализом связывания на основе поверхностного плазмонного резонанса.
4. Выделенный полинуклеотид по любому из предыдущих пунктов, где антитело связывается с PD-1 обезьяны со значением EC50 не более 100 нМ или не более 10 нМ и/или не связывается с PD-1 мыши.
5. Выделенный полинуклеотид по любому из предыдущих пунктов, где антитело способно ингибировать связывание PD-1 человека или обезьяны со своим лигандом со значением IC50 не более 100 нМ.
6. Выделенный полинуклеотид по любому из предыдущих пунктов, где антитело существенно не связывается с CD28 или CTLA4.
7. Выделенный полинуклеотид по любому из предыдущих пунктов, где антитело не опосредует ADCC или CDC, или и то, и другое.
8. Выделенный полинуклеотид по любому из предыдущих пунктов, где антитело является полностью человеческим моноклональным антителом.
9. Выделенный полинуклеотид по любому из предыдущих пунктов, где антитело способно блокировать связывание PD-1 человека со своим лигандом и тем самым обеспечивать по меньшей мере одну из следующих активностей:
а) индуцировать продукцию IL-2 в CD4+ Т-клетках;
b) индуцировать продукцию IFNγ в CD4+ T клетках;
с) индуцировать пролиферации CD4+ Т-клеток; и
d) обращать супрессирующую функцию T-reg.
10. Выделенный полинуклеотид по п.8, где полностью человеческое моноклональное антитело представляет собой антитело IgG4.
11. Вектор экспрессии, содержащий выделенный полинуклеотид по любому из предыдущих пунктов.
12. Клетка-хозяин для экспрессии анти-PD-1 антитела, содержащая вектор по п. 11.
13. Способ экспрессии анти-PD-1 антитела, включающий культивирование клетки-хозяина по п. 12 в условиях, при которых экспрессируется анти-P-1 антитело.
14. Выделенное анти-PD-1-антитело, содержащее
а) вариабельную область тяжелой цепи, содержащую:
CDR1 тяжелой цепи с последовательностью SEQ ID NO:1,
CDR2 тяжелой цепи с последовательностью SEQ ID NO:15 и
CDR3 тяжелой цепи с последовательностью SEQ ID NO:5; и
b) вариабельную область легкой цепи, содержащую:
CDR1 легкой цепи с последовательностью SEQ ID NO:7,
CDR2 легкой цепи с последовательностью SEQ ID NO:17 и
CDR3 легкой цепи с последовательностью SEQ ID NO:65.
15. Выделенное анти-PD-1 антител по п.14, где антитело содержит
вариабельную область тяжелой цепи, содержащую SEQ ID NO:53; и вариабельную область легкой цепи, содержащую SEQ ID NO:67.
16. Выделенное анти-PD-1 антитело по п.14 или п.15, где антитело способно специфически связываться с PD-1 человека со значением KD не более 10-8 М, как измерено анализом связывания на основе поверхностного плазмонного резонанса.
17. Выделенное анти-PD-1 антитело по любому из пп.14-16, где антитело связывается с PD-1 обезьяны со значением EC50 не более 100 нМ или не более 10 нМ и/или не связывается с PD-1 мыши.
18. Выделенное анти-PD-1 антитело по любому из пп.14-17, где антитело способно ингибировать связывание PD-1 человека или обезьяны со своим лигандом со значением IC50 не более 100 нМ.
19. Выделенное анти-PD-1 антитело по любому из пп.14-18, где антитело по существу не связывается с CD28 или CTLA4.
20. Выделенное анти-PD-1 антитело по любому из пп.14-19, где антитело не опосредует ADCC или CDC, или и то, и другое.
21. Выделенное анти-PD-1 антитело по любому из пп.14-20, где антитело представляет собой полностью человеческое моноклональное антитело.
22. Выделенное анти-PD-1 антитело по любому из пп.14-21, где антитело способно блокировать связывание PD-1 человека со своим лигандом и тем самым обеспечивать по меньшей мере одну из следующих активностей:
а) индуцировать продукцию IL-2 в CD4+ Т-клетках;
b) индуцировать продукцию IFNγ в CD4+ T клетках;
с) индуцировать пролиферации CD4+ Т-клеток; и
d) обращать супрессирующую функцию T-reg.
23. Выделенное анти-PD-1 антитело по п.21, где полностью человеческое моноклональное антитело представляет собой антитело IgG4.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNPCT/CN2015/086594 | 2015-08-11 | ||
| PCT/CN2015/086594 WO2017024515A1 (en) | 2015-08-11 | 2015-08-11 | Novel anti-pd-1 antibodies |
| CN2016071374 | 2016-01-19 | ||
| CNPCT/CN2016/071374 | 2016-01-19 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018108048A Division RU2729830C2 (ru) | 2015-08-11 | 2016-08-11 | Новые анти-pd-1 антитела |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2020124273A true RU2020124273A (ru) | 2020-12-03 |
Family
ID=57982964
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2020124273A RU2020124273A (ru) | 2015-08-11 | 2016-08-11 | Новые анти-pd-1 антитела |
| RU2018108048A RU2729830C2 (ru) | 2015-08-11 | 2016-08-11 | Новые анти-pd-1 антитела |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018108048A RU2729830C2 (ru) | 2015-08-11 | 2016-08-11 | Новые анти-pd-1 антитела |
Country Status (22)
| Country | Link |
|---|---|
| US (3) | US11008391B2 (ru) |
| EP (1) | EP3334763A4 (ru) |
| JP (3) | JP6883579B2 (ru) |
| KR (1) | KR102055396B1 (ru) |
| AU (2) | AU2016305697B2 (ru) |
| BR (1) | BR112018002824A2 (ru) |
| CA (1) | CA2993276A1 (ru) |
| CL (1) | CL2018000370A1 (ru) |
| CO (1) | CO2018000992A2 (ru) |
| EA (1) | EA201890468A1 (ru) |
| EC (1) | ECSP18018842A (ru) |
| IL (2) | IL293385A (ru) |
| MA (1) | MA42626A (ru) |
| MX (2) | MX2018001644A (ru) |
| MY (1) | MY187739A (ru) |
| PE (1) | PE20181018A1 (ru) |
| PH (1) | PH12018500183A1 (ru) |
| RU (2) | RU2020124273A (ru) |
| SA (2) | SA518390903B1 (ru) |
| SG (1) | SG10201914109VA (ru) |
| UA (1) | UA124379C2 (ru) |
| WO (1) | WO2017025051A1 (ru) |
Families Citing this family (92)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2991976A1 (en) | 2015-07-13 | 2017-01-19 | Cytomx Therapeutics, Inc. | Anti-pd-1 antibodies, activatable anti-pd-1 antibodies, and methods of use thereof |
| UA124379C2 (uk) | 2015-08-11 | 2021-09-08 | Усі Байолоджікс Айрленд Лімітед | Нові антитіла проти білка pd-1 |
| AR106184A1 (es) | 2015-09-29 | 2017-12-20 | Celgene Corp | Proteínas de unión a pd-1 y sus métodos de uso |
| TW202216787A (zh) | 2015-11-18 | 2022-05-01 | 美商默沙東藥廠 | Pd1及／或 lag3結合劑 |
| CN109475603B (zh) | 2016-06-20 | 2023-06-13 | 科马布有限公司 | 抗pd-l1抗体 |
| EP3515944A4 (en) | 2016-09-19 | 2020-05-06 | Celgene Corporation | METHODS OF TREATING IMMUNE DISORDERS WITH PD-1 BINDING PROTEINS |
| EP3515943A4 (en) | 2016-09-19 | 2020-05-06 | Celgene Corporation | METHODS OF TREATING VITILIGO WITH PD-1 BINDING PROTEINS |
| CA3037407C (en) | 2016-09-21 | 2022-10-18 | Cstone Pharmaceuticals | The novel monoclonal antibodies to programmed death 1 (pd-1) |
| JP7258747B2 (ja) | 2016-10-28 | 2023-04-17 | ブリストル－マイヤーズ スクイブ カンパニー | 抗ｐｄ－１抗体を用いた尿路上皮癌の処置方法 |
| BR112019008223A2 (pt) | 2016-11-03 | 2019-07-16 | Bristol-Myers Squibb Company | anticorpos anti-ctla-4 ativáveis e usos dos mesmos |
| JP7458188B2 (ja) | 2017-03-31 | 2024-03-29 | ブリストル－マイヤーズ スクイブ カンパニー | 腫瘍を処置する方法 |
| TWI788340B (zh) | 2017-04-07 | 2023-01-01 | 美商必治妥美雅史谷比公司 | 抗icos促效劑抗體及其用途 |
| CN106939049B (zh) * | 2017-04-20 | 2019-10-01 | 苏州思坦维生物技术股份有限公司 | 拮抗抑制人pd-1抗原与其配体结合的单克隆抗体及其制备方法与应用 |
| CA3060989A1 (en) | 2017-05-30 | 2018-12-06 | Bristol-Myers Squibb Company | Compositions comprising a combination of an anti-lag-3 antibody, a pd-1 pathway inhibitor, and an immunotherapeutic agent |
| BR112019020610A2 (pt) | 2017-05-30 | 2020-04-22 | Bristol-Myers Squibb Company | tratamento de tumores positivos para o lag-3 |
| CN110678200B (zh) | 2017-05-30 | 2024-05-17 | 百时美施贵宝公司 | 包含抗lag-3抗体或抗lag-3抗体和抗pd-1或抗pd-l1抗体的组合物 |
| WO2018223040A1 (en) | 2017-06-01 | 2018-12-06 | Bristol-Myers Squibb Company | Methods of treating a tumor using an anti-pd-1 antibody |
| AU2018282094A1 (en) | 2017-06-05 | 2019-12-12 | Janssen Biotech, Inc. | Antibodies that specifically bind PD-1 and methods of use |
| CN111164100B (zh) | 2017-08-03 | 2024-03-12 | 美国安进公司 | 白介素-21突变蛋白和治疗方法 |
| JP2020536894A (ja) | 2017-10-15 | 2020-12-17 | ブリストル−マイヤーズ スクイブ カンパニーＢｒｉｓｔｏｌ−Ｍｙｅｒｓ Ｓｑｕｉｂｂ Ｃｏｍｐａｎｙ | 腫瘍処置法 |
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| KR20190015408A (ko) | 2016-06-03 | 2019-02-13 | 브리스톨-마이어스 스큅 컴퍼니 | 종양을 치료하는 방법에 사용하기 위한 항-pd-1 항체 |
| EP3988570A1 (en) | 2016-06-03 | 2022-04-27 | Bristol-Myers Squibb Company | Use of anti-pd-1 antibody in the treatment of patients with colorectal cancer |
| CA3037407C (en) | 2016-09-21 | 2022-10-18 | Cstone Pharmaceuticals | The novel monoclonal antibodies to programmed death 1 (pd-1) |
| JP7258747B2 (ja) | 2016-10-28 | 2023-04-17 | ブリストル－マイヤーズ スクイブ カンパニー | 抗ｐｄ－１抗体を用いた尿路上皮癌の処置方法 |
| AU2017361868A1 (en) | 2016-11-18 | 2019-05-16 | Les Laboratoires Servier | Anti-PD-1 antibodies and compositions |
| WO2018132287A1 (en) | 2017-01-11 | 2018-07-19 | Dana-Farber Cancer Institute, Inc. | Pbrm1 biomarkers predictive of anti-immune checkpoint response |
| AU2018225102A1 (en) | 2017-02-21 | 2019-09-05 | Regeneron Pharmaceuticals, Inc. | Anti-PD-1 antibodies for treatment of lung cancer |
| JP7458188B2 (ja) | 2017-03-31 | 2024-03-29 | ブリストル－マイヤーズ スクイブ カンパニー | 腫瘍を処置する方法 |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| WO2018223040A1 (en) | 2017-06-01 | 2018-12-06 | Bristol-Myers Squibb Company | Methods of treating a tumor using an anti-pd-1 antibody |
| KR20200033930A (ko) | 2017-07-28 | 2020-03-30 | 브리스톨-마이어스 스큅 컴퍼니 | 체크포인트 억제제에 대한 예측성 말초 혈액 바이오마커 |
| CN109575140B (zh) | 2017-09-29 | 2021-02-23 | 北京比洋生物技术有限公司 | 靶向pd-1或pd-l1且靶向vegf家族的双靶向融合蛋白及其用途 |
| JP2020536894A (ja) | 2017-10-15 | 2020-12-17 | ブリストル−マイヤーズ スクイブ カンパニーＢｒｉｓｔｏｌ−Ｍｙｅｒｓ Ｓｑｕｉｂｂ Ｃｏｍｐａｎｙ | 腫瘍処置法 |
| CN109721657B (zh) | 2017-10-27 | 2021-11-02 | 北京比洋生物技术有限公司 | 阻断pd-1/pd-l1信号传导途径且活化t细胞的融合蛋白及其用途 |
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