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 PL17842895.9T priority patent/PL3505535T3/pl
Priority to LTEPPCT/CN2017/098465T priority patent/LT3505535T/lt
Priority to PCT/CN2017/098465 priority patent/WO2018036472A1/zh
Priority to JP2019531512A priority patent/JP7082620B2/ja
Priority to MX2019002268A priority patent/MX2019002268A/es
Priority to RS20250001A priority patent/RS66372B1/sr
Priority to EP24206755.1A priority patent/EP4509186A3/en
Priority to US16/327,083 priority patent/US12076398B2/en
Priority to NZ751902A priority patent/NZ751902A/en
Priority to SI201731577T priority patent/SI3505535T1/sl
Priority to CA3034849A priority patent/CA3034849C/en
Priority to SG11201901584UA priority patent/SG11201901584UA/en
Priority to BR112019003775-6A priority patent/BR112019003775A2/pt
Priority to AU2017316255A priority patent/AU2017316255C1/en
Priority to HUE17842895A priority patent/HUE069593T2/hu
Priority to EA201990570A priority patent/EA201990570A1/ru
Priority to EP17842895.9A priority patent/EP3505535B1/en
Priority to FIEP17842895.9T priority patent/FI3505535T3/fi
Priority to KR1020197008464A priority patent/KR102469286B1/ko
Priority to PT178428959T priority patent/PT3505535T/pt
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/AU2024202527B2/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 [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
    • 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
    • C07K16/2803—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 immunoglobulin superfamily
    • C07K16/2818—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 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
    • G01N33/575—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
    • 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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  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Diabetes (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)
  • Hospice & Palliative Care (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
AU2017316255A AU2017316255C1 (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
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
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
MX2019002268A MX2019002268A (es) 2016-08-23 2017-08-22 Anticuerpo monoclonal anti-pd1, composicion farmaceutica de este y uso de este.
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
US16/327,083 US12076398B2 (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
SI201731577T SI3505535T1 (sl) 2016-08-23 2017-08-22 Monoklonsko protitelo proti-PD1, njegov farmacevtski sestavek in njegova uporaba
CA3034849A CA3034849C (en) 2016-08-23 2017-08-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
SG11201901584UA SG11201901584UA (en) 2016-08-23 2017-08-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
BR112019003775-6A BR112019003775A2 (pt) 2016-08-23 2017-08-22 anticorpo monoclonal anti-pd1, composição farmacêutica do mesmo e uso dos mesmos
PL17842895.9T PL3505535T3 (pl) 2016-08-23 2017-08-22 Przeciwciało monoklonalne anty-pd1, jego kompozycja farmaceutyczna i jego zastosowanie
EP17842895.9A EP3505535B1 (en) 2016-08-23 2017-08-22 Anti-pd1 monoclonal antibody, pharmaceutical composition thereof and use thereof
PT178428959T PT3505535T (pt) 2016-08-23 2017-08-22 Anticorpo monoclonal anti-pd1, sua composição farmacêutica e seu uso
EA201990570A EA201990570A1 (ru) 2016-08-23 2017-08-22 Моноклональное антитело против pd1, его фармацевтическая композиция и их применение
FIEP17842895.9T FI3505535T3 (fi) 2016-08-23 2017-08-22 Anti-pd1 monoklonaalinen vasta-aine, sen farmaseuttinen koostumus ja sen käyttö
KR1020197008464A KR102469286B1 (ko) 2016-08-23 2017-08-22 항-pd1 단일클론 항체, 이의 약제학적 조성물 및 이의 용도
LTEPPCT/CN2017/098465T LT3505535T (lt) 2016-08-23 2017-08-22 Monokloninis antikūnas prieš pd1, jo farmacinė kompozicija ir panaudojimas
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 AU2024202527B2 (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 (enExample)
EP (2) EP3505535B1 (enExample)
JP (1) JP7082620B2 (enExample)
KR (1) KR102469286B1 (enExample)
CN (1) CN106977602B (enExample)
AU (2) AU2017316255C1 (enExample)
BR (1) BR112019003775A2 (enExample)
EA (1) EA201990570A1 (enExample)
ES (1) ES3001154T3 (enExample)
FI (1) FI3505535T3 (enExample)
HU (1) HUE069593T2 (enExample)
IL (1) IL264956B2 (enExample)
LT (1) LT3505535T (enExample)
MX (1) MX2019002268A (enExample)
NZ (1) NZ751902A (enExample)
PL (1) PL3505535T3 (enExample)
PT (1) PT3505535T (enExample)
RS (1) RS66372B1 (enExample)
SG (1) SG11201901584UA (enExample)
SI (1) SI3505535T1 (enExample)
WO (1) WO2018036472A1 (enExample)
ZA (1) ZA201901781B (enExample)

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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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CN114591433A (zh) 2015-07-13 2022-06-07 西托姆克斯治疗公司 抗pd-1抗体、可活化抗pd-1抗体及其使用方法
SMT202200118T1 (it) 2015-11-03 2022-05-12 Janssen Biotech Inc Anticorpi che legano specificamente pd-1 e loro usi
WO2018035710A1 (en) 2016-08-23 2018-03-01 Akeso Biopharma, Inc. Anti-ctla4 antibodies
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
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
WO2019025545A1 (en) 2017-08-04 2019-02-07 Genmab A/S BINDING AGENTS BINDING TO PD-L1 AND CD137 AND THEIR USE
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
KR20200059243A (ko) * 2017-09-20 2020-05-28 리제너론 파마슈티칼스 인코포레이티드 패신저 유전자 돌연변이 부담이 높은 종양을 가진 환자에 대한 면역 치료요법
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
SG11202009986QA (en) 2018-05-07 2020-11-27 Genmab As Methods of treating cancer with a combination of an anti-pd-1 antibody and an anti-tissue factor antibody-drug conjugate
CA3099547A1 (en) 2018-05-07 2019-11-14 Reshma Abdulla RANGWALA Methods of treating cancer with a combination of an anti-pd-1 antibody and an anti-tissue factor antibody-drug conjugate
US12390458B2 (en) 2018-07-18 2025-08-19 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Therapeutic combination of quinoline derivative and antibody
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
EP3998081A4 (en) 2019-07-05 2023-07-12 Ono Pharmaceutical Co., Ltd. TREATMENT OF BLOOD CANCER WITH PD-1/CD3 DUAL SPECIFICITY PROTEIN
EP4008351A4 (en) 2019-08-02 2023-08-09 CTTQ-Akeso (ShangHai) Biomed. Tech. Co., Ltd. Anti-pd-1 antibody and medical use thereof
US20220275089A1 (en) * 2019-08-02 2022-09-01 Akeso Pharmaceuticals, Inc. Anti-ctla4-anti-pd-1 bispecific antibody and uses thereof
JP7771749B2 (ja) 2019-08-08 2025-11-18 小野薬品工業株式会社 二重特異性タンパク質
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
WO2021121373A1 (zh) * 2019-12-20 2021-06-24 广东菲鹏制药股份有限公司 抗人程序死亡因子-1单克隆抗体
CN113117072A (zh) * 2020-01-14 2021-07-16 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
US20230045494A1 (en) 2020-02-28 2023-02-09 Orega Biotech Combination therapies based on ctla4 and il-17b inhibitors
PH12022552785A1 (en) * 2020-04-22 2024-03-25 Akeso Biopharma Inc Anti-cd73-anti-pd-1 bispecific antibody and use thereof
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