CN106977602B - 一种抗pd1单克隆抗体、其药物组合物及其用途 - Google Patents

一种抗pd1单克隆抗体、其药物组合物及其用途 Download PDF

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Publication number
CN106977602B
CN106977602B CN201610705763.5A CN201610705763A CN106977602B CN 106977602 B CN106977602 B CN 106977602B CN 201610705763 A CN201610705763 A CN 201610705763A CN 106977602 B CN106977602 B CN 106977602B
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antibody
monoclonal antibody
antigen
binding fragment
seq
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Chinese (zh)
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CN106977602A (zh
Inventor
李百勇
夏瑜
王忠民
张鹏
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Zhengda Tianqing Kangfang Shanghai Biomedical Technology Co ltd
Original Assignee
Zhongshan Akesobio Innovation Medicament Research Institute Co ltd
Akeso Biopharma Inc
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Priority to CN201610705763.5A priority Critical patent/CN106977602B/zh
Publication of CN106977602A publication Critical patent/CN106977602A/zh
Priority to HUE17842895A priority patent/HUE069593T2/hu
Priority to AU2017316255A priority patent/AU2017316255C1/en
Priority to SG11201901584UA priority patent/SG11201901584UA/en
Priority to NZ751902A priority patent/NZ751902A/en
Priority to CA3034849A priority patent/CA3034849C/en
Priority to PL17842895.9T priority patent/PL3505535T3/pl
Priority to JP2019531512A priority patent/JP7082620B2/ja
Priority to FIEP17842895.9T priority patent/FI3505535T3/fi
Priority to SI201731577T priority patent/SI3505535T1/sl
Priority to RS20250001A priority patent/RS66372B1/sr
Priority to EP24206755.1A priority patent/EP4509186A3/en
Priority to LTEPPCT/CN2017/098465T priority patent/LT3505535T/lt
Priority to EP17842895.9A priority patent/EP3505535B1/en
Priority to EA201990570A priority patent/EA201990570A1/ru
Priority to KR1020197008464A priority patent/KR102469286B1/ko
Priority to MX2019002268A priority patent/MX2019002268A/es
Priority to BR112019003775A priority patent/BR112019003775A2/pt
Priority to PCT/CN2017/098465 priority patent/WO2018036472A1/zh
Priority to PT178428959T priority patent/PT3505535T/pt
Priority to US16/327,083 priority patent/US12076398B2/en
Priority to ES17842895T priority patent/ES3001154T3/es
Application granted granted Critical
Publication of CN106977602B publication Critical patent/CN106977602B/zh
Priority to IL264956A priority patent/IL264956B2/en
Priority to ZA2019/01781A priority patent/ZA201901781B/en
Priority to AU2024202527A priority patent/AU2024202527A1/en
Priority to US18/780,086 priority patent/US20250041409A1/en
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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
    • 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
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • 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
    • C07K16/2803—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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • 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
    • C07K2317/50—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
    • C07K2317/76—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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/705—Assays involving receptors, cell surface antigens or cell surface determinants
    • G01N2333/70503—Immunoglobulin superfamily, e.g. VCAMs, PECAM, LFA-3
    • G01N2333/70521—CD28, CD152
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/70—Mechanisms involved in disease identification
    • G01N2800/7019—Ischaemia

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  • Life Sciences & Earth Sciences (AREA)
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  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
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  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Diabetes (AREA)
  • Hospice & Palliative Care (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CN201610705763.5A 2016-08-23 2016-08-23 一种抗pd1单克隆抗体、其药物组合物及其用途 Active CN106977602B (zh)

Priority Applications (26)

Application Number Priority Date Filing Date Title
CN201610705763.5A CN106977602B (zh) 2016-08-23 2016-08-23 一种抗pd1单克隆抗体、其药物组合物及其用途
EA201990570A EA201990570A1 (ru) 2016-08-23 2017-08-22 Моноклональное антитело против pd1, его фармацевтическая композиция и их применение
KR1020197008464A KR102469286B1 (ko) 2016-08-23 2017-08-22 항-pd1 단일클론 항체, 이의 약제학적 조성물 및 이의 용도
SG11201901584UA SG11201901584UA (en) 2016-08-23 2017-08-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
NZ751902A NZ751902A (en) 2016-08-23 2017-08-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
CA3034849A CA3034849C (en) 2016-08-23 2017-08-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
PL17842895.9T PL3505535T3 (pl) 2016-08-23 2017-08-22 Przeciwciało monoklonalne anty-pd1, jego kompozycja farmaceutyczna i jego zastosowanie
JP2019531512A JP7082620B2 (ja) 2016-08-23 2017-08-22 抗ｐｄ１モノクローナル抗体、その医薬組成物およびその使用
FIEP17842895.9T FI3505535T3 (fi) 2016-08-23 2017-08-22 Anti-pd1 monoklonaalinen vasta-aine, sen farmaseuttinen koostumus ja sen käyttö
SI201731577T SI3505535T1 (sl) 2016-08-23 2017-08-22 Monoklonsko protitelo proti-PD1, njegov farmacevtski sestavek in njegova uporaba
RS20250001A RS66372B1 (sr) 2016-08-23 2017-08-22 Anti-pd1 monoklonalno antitelo, njegova farmaceutska kompozicija i njegova upotreba
EP24206755.1A EP4509186A3 (en) 2016-08-23 2017-08-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
LTEPPCT/CN2017/098465T LT3505535T (lt) 2016-08-23 2017-08-22 Monokloninis antikūnas prieš pd1, jo farmacinė kompozicija ir panaudojimas
EP17842895.9A EP3505535B1 (en) 2016-08-23 2017-08-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
HUE17842895A HUE069593T2 (hu) 2016-08-23 2017-08-22 PD1 elleni monoklonális ellenanyag, azt tartalmazó gyógyászati készítmény és alkalmazása
BR112019003775A BR112019003775A2 (pt) 2016-08-23 2017-08-22 anticorpo monoclonal anti-pd1, composição farmacêutica do mesmo e uso dos mesmos
US16/327,083 US12076398B2 (en) 2016-08-23 2017-08-22 Anti-PD1 monoclonal antibody, pharmaceutical composition thereof and use thereof
MX2019002268A MX2019002268A (es) 2016-08-23 2017-08-22 Anticuerpo monoclonal anti-pd1, composicion farmaceutica de este y uso de este.
PCT/CN2017/098465 WO2018036472A1 (zh) 2016-08-23 2017-08-22 一种抗pd1单克隆抗体、其药物组合物及其用途
PT178428959T PT3505535T (pt) 2016-08-23 2017-08-22 Anticorpo monoclonal anti-pd1, sua composição farmacêutica e seu uso
AU2017316255A AU2017316255C1 (en) 2016-08-23 2017-08-22 Anti-PD1 monoclonal antibody, pharmaceutical composition thereof and use thereof
ES17842895T ES3001154T3 (es) 2016-08-23 2017-08-22 Anticuerpo monoclonal anti-PD1, composición farmacéutica del mismo y uso del mismo
IL264956A IL264956B2 (en) 2016-08-23 2019-02-21 Anti-pd1 monoclonal antibody, pharmaceutical preparation thereof and use thereof
ZA2019/01781A ZA201901781B (en) 2016-08-23 2019-03-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
AU2024202527A AU2024202527A1 (en) 2016-08-23 2024-04-17 Anti-PD1 monoclonal antibody, pharmaceutical composition thereof and use thereof
US18/780,086 US20250041409A1 (en) 2016-08-23 2024-07-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201610705763.5A CN106977602B (zh) 2016-08-23 2016-08-23 一种抗pd1单克隆抗体、其药物组合物及其用途

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CN106977602A CN106977602A (zh) 2017-07-25
CN106977602B true CN106977602B (zh) 2018-09-25

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US (2) US12076398B2 (cg-RX-API-DMAC7.html)
EP (2) EP4509186A3 (cg-RX-API-DMAC7.html)
JP (1) JP7082620B2 (cg-RX-API-DMAC7.html)
KR (1) KR102469286B1 (cg-RX-API-DMAC7.html)
CN (1) CN106977602B (cg-RX-API-DMAC7.html)
AU (2) AU2017316255C1 (cg-RX-API-DMAC7.html)
BR (1) BR112019003775A2 (cg-RX-API-DMAC7.html)
EA (1) EA201990570A1 (cg-RX-API-DMAC7.html)
ES (1) ES3001154T3 (cg-RX-API-DMAC7.html)
FI (1) FI3505535T3 (cg-RX-API-DMAC7.html)
HU (1) HUE069593T2 (cg-RX-API-DMAC7.html)
IL (1) IL264956B2 (cg-RX-API-DMAC7.html)
LT (1) LT3505535T (cg-RX-API-DMAC7.html)
MX (1) MX2019002268A (cg-RX-API-DMAC7.html)
NZ (1) NZ751902A (cg-RX-API-DMAC7.html)
PL (1) PL3505535T3 (cg-RX-API-DMAC7.html)
PT (1) PT3505535T (cg-RX-API-DMAC7.html)
RS (1) RS66372B1 (cg-RX-API-DMAC7.html)
SG (1) SG11201901584UA (cg-RX-API-DMAC7.html)
SI (1) SI3505535T1 (cg-RX-API-DMAC7.html)
WO (1) WO2018036472A1 (cg-RX-API-DMAC7.html)
ZA (1) ZA201901781B (cg-RX-API-DMAC7.html)

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US11168144B2 (en) 2017-06-01 2021-11-09 Cytomx Therapeutics, Inc. Activatable anti-PDL1 antibodies, and methods of use thereof

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IL292449B2 (en) 2015-03-13 2024-02-01 Cytomx Therapeutics Inc Nucleic acids encoding anti-pdl1 antibodie and methods of producing same
WO2017011580A2 (en) 2015-07-13 2017-01-19 Cytomx Therapeutics, Inc. Anti-pd-1 antibodies, activatable anti-pd-1 antibodies, and methods of use thereof
MA43186B1 (fr) 2015-11-03 2022-03-31 Janssen Biotech Inc Anticorps se liant spécifiquement à pd-1 et leurs utilisations
WO2018035710A1 (en) 2016-08-23 2018-03-01 Akeso Biopharma, Inc. Anti-ctla4 antibodies
CN106977602B (zh) 2016-08-23 2018-09-25 中山康方生物医药有限公司 一种抗pd1单克隆抗体、其药物组合物及其用途
CN106967172B (zh) 2016-08-23 2019-01-08 康方药业有限公司 抗ctla4-抗pd-1 双功能抗体、其药物组合物及其用途
CN109425736B (zh) * 2017-08-25 2021-04-09 北京百普赛斯生物科技股份有限公司 一种检测pd-1抗体血药浓度的方法及试剂盒
SG11202002282TA (en) 2017-09-20 2020-04-29 Regeneron Pharma Immunotherapy methods for patients whose tumors carry a high passenger gene mutation burden
US12398209B2 (en) 2018-01-22 2025-08-26 Janssen Biotech, Inc. Methods of treating cancers with antagonistic anti-PD-1 antibodies
TWI841554B (zh) 2018-03-21 2024-05-11 丹麥商珍美寶股份有限公司 以鉑為主之劑與抗組織因子抗體－藥物共軛物的組合治療癌症之方法
CN112584901A (zh) * 2018-04-04 2021-03-30 真和制药有限公司 用于阻断非糖基化的pd-1多肽之间的相互作用的方法和组合物
KR102882368B1 (ko) 2018-05-07 2025-11-07 젠맵 에이/에스 항-pd-1 항체와 항-조직 인자 항체-약물 접합체의 조합을 사용하여 암을 치료하는 방법
JP7460608B2 (ja) 2018-05-07 2024-04-02 ジェンマブ エー／エス 抗ｐｄ－１抗体と抗組織因子抗体－薬物コンジュゲートとの組み合わせを用いるがんの治療方法
CN112566661B (zh) * 2018-07-18 2024-02-02 正大天晴药业集团股份有限公司 喹啉衍生物与抗体的药物组合
CN109053889B (zh) * 2018-07-25 2019-06-21 博奥信生物技术（南京）有限公司 一种抗人pd1单克隆抗体及用途
CN109053895B (zh) * 2018-08-30 2020-06-09 中山康方生物医药有限公司 抗pd-1-抗vegfa的双功能抗体、其药物组合物及其用途
TWI844571B (zh) 2018-10-30 2024-06-11 丹麥商珍美寶股份有限公司 使用抗血管內皮生長因子（ｖｅｇｆ）抗體與抗組織因子（ｔｆ）抗體－藥物共軛體之組合以治療癌症之方法
US20220175815A1 (en) 2019-04-03 2022-06-09 Orega Biotech Combination therapies based on pd1 and il-17b inhibitors
CN110373415B (zh) * 2019-06-12 2023-06-09 安徽省昂普拓迈生物科技有限责任公司 特异性结合pd-l1蛋白的核酸适配体及其用途
TWI809286B (zh) 2019-07-05 2023-07-21 日商小野藥品工業股份有限公司 以pd-1/cd3雙特異性蛋白質所進行之血液性癌症治療
CA3146780A1 (en) * 2019-08-02 2021-02-11 Akeso Pharmaceuticals, Inc. Anti-ctla4/anti-pd-1 bispecific antibody and use thereof
JP7753186B2 (ja) * 2019-08-02 2025-10-14 シーティーティーキュー－アケソ（シャンハイ） バイオメド テク カンパニー リミテッド 抗ｐｄ－１抗体およびその医学的使用
US20220332825A1 (en) 2019-08-08 2022-10-20 Ono Pharmaceutical Co., Ltd. Bispecific protein
CN110903391B (zh) * 2019-10-25 2021-05-28 东大生物技术(苏州)有限公司 一组pd-l1单克隆抗体及其医药用途
CN112915202B (zh) * 2019-12-06 2025-08-01 正大天晴药业集团股份有限公司 喹啉衍生物与pd-1单抗的药物组合
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