CN109963876A - 抗pd-1/抗her2天然抗体结构样异源二聚体形式双特异抗体及其制备 - Google Patents
抗pd-1/抗her2天然抗体结构样异源二聚体形式双特异抗体及其制备 Download PDFInfo
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- CN109963876A CN109963876A CN201780071590.9A CN201780071590A CN109963876A CN 109963876 A CN109963876 A CN 109963876A CN 201780071590 A CN201780071590 A CN 201780071590A CN 109963876 A CN109963876 A CN 109963876A
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- 238000002360 preparation method Methods 0.000 title abstract 2
- 239000000833 heterodimer Substances 0.000 claims abstract 22
- 201000010099 disease Diseases 0.000 claims abstract 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract 5
- 210000004027 cell Anatomy 0.000 claims 15
- 239000000427 antigen Substances 0.000 claims 13
- 102000036639 antigens Human genes 0.000 claims 13
- 108091007433 antigens Proteins 0.000 claims 13
- 102000040430 polynucleotide Human genes 0.000 claims 11
- 108091033319 polynucleotide Proteins 0.000 claims 11
- 239000002157 polynucleotide Substances 0.000 claims 11
- 238000003259 recombinant expression Methods 0.000 claims 10
- 102100023990 60S ribosomal protein L17 Human genes 0.000 claims 8
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims 8
- 101710089372 Programmed cell death protein 1 Proteins 0.000 claims 8
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims 8
- 238000000034 method Methods 0.000 claims 8
- 125000003275 alpha amino acid group Chemical group 0.000 claims 7
- 239000000203 mixture Substances 0.000 claims 7
- 150000001413 amino acids Chemical class 0.000 claims 6
- 238000006467 substitution reaction Methods 0.000 claims 5
- 239000003638 chemical reducing agent Substances 0.000 claims 4
- VHJLVAABSRFDPM-QWWZWVQMSA-N dithiothreitol Chemical compound SC[C@@H](O)[C@H](O)CS VHJLVAABSRFDPM-QWWZWVQMSA-N 0.000 claims 4
- 210000001672 ovary Anatomy 0.000 claims 4
- 238000006722 reduction reaction Methods 0.000 claims 3
- 241000699800 Cricetinae Species 0.000 claims 2
- 241000699802 Cricetulus griseus Species 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 2
- 239000000710 homodimer Substances 0.000 claims 2
- 210000003292 kidney cell Anatomy 0.000 claims 2
- 239000007800 oxidant agent Substances 0.000 claims 2
- 238000007254 oxidation reaction Methods 0.000 claims 2
- 230000001590 oxidative effect Effects 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- 230000009466 transformation Effects 0.000 claims 2
- QEDXSHCYPROEOK-UHFFFAOYSA-N 3-phosphanylpropanoic acid Chemical class OC(=O)CCP QEDXSHCYPROEOK-UHFFFAOYSA-N 0.000 claims 1
- 206010005003 Bladder cancer Diseases 0.000 claims 1
- 208000003174 Brain Neoplasms Diseases 0.000 claims 1
- 206010006187 Breast cancer Diseases 0.000 claims 1
- 208000026310 Breast neoplasm Diseases 0.000 claims 1
- 208000017897 Carcinoma of esophagus Diseases 0.000 claims 1
- 206010009944 Colon cancer Diseases 0.000 claims 1
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 1
- 206010014759 Endometrial neoplasm Diseases 0.000 claims 1
- 208000000461 Esophageal Neoplasms Diseases 0.000 claims 1
- 208000022072 Gallbladder Neoplasms Diseases 0.000 claims 1
- 241000124008 Mammalia Species 0.000 claims 1
- 208000002454 Nasopharyngeal Carcinoma Diseases 0.000 claims 1
- 206010061306 Nasopharyngeal cancer Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 206010061902 Pancreatic neoplasm Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 206010060862 Prostate cancer Diseases 0.000 claims 1
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 1
- 208000000102 Squamous Cell Carcinoma of Head and Neck Diseases 0.000 claims 1
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 1
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 208000019065 cervical carcinoma Diseases 0.000 claims 1
- 208000009060 clear cell adenocarcinoma Diseases 0.000 claims 1
- 238000010612 desalination reaction Methods 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
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- 239000013604 expression vector Substances 0.000 claims 1
- 201000010175 gallbladder cancer Diseases 0.000 claims 1
- 206010017758 gastric cancer Diseases 0.000 claims 1
- 201000000459 head and neck squamous cell carcinoma Diseases 0.000 claims 1
- 208000032839 leukemia Diseases 0.000 claims 1
- 201000007270 liver cancer Diseases 0.000 claims 1
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- 208000015486 malignant pancreatic neoplasm Diseases 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
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- 208000029729 tumor suppressor gene on chromosome 11 Diseases 0.000 claims 1
- 201000005112 urinary bladder cancer Diseases 0.000 claims 1
- 201000003365 uterine corpus sarcoma Diseases 0.000 claims 1
Classifications
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- C07—ORGANIC CHEMISTRY
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- 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
-
- 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
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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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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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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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
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- 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
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- 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
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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
- C07K2317/52—Constant or Fc region; Isotype
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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
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- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
- C07K2317/622—Single chain antibody (scFv)
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- 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
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- 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
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- Health & Medical Sciences (AREA)
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- Organic Chemistry (AREA)
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- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
提供一种具有天然IgG特点的异源二聚体形式的抗PD‑1/抗HER2双特异性抗体及其制备方法，所述抗体同时结合两种靶分子，可治疗复杂疾病。
Description
PCT国内申请，说明书已公开。
Claims (29)
- PCT国内申请，权利要求书已公开。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611016435 | 2016-11-18 | ||
| CN2016110164350 | 2016-11-18 | ||
| PCT/CN2017/111310 WO2018090950A1 (zh) | 2016-11-18 | 2017-11-16 | 抗pd‐1/抗her2天然抗体结构样异源二聚体形式双特异抗体及其制备 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109963876A true CN109963876A (zh) | 2019-07-02 |
| CN109963876B CN109963876B (zh) | 2023-11-14 |
Family
ID=62146170
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201780071590.9A Active CN109963876B (zh) | 2016-11-18 | 2017-11-16 | 抗pd-1/抗her2天然抗体结构样异源二聚体形式双特异抗体及其制备 |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US11319378B2 (zh) |
| EP (1) | EP3533804A4 (zh) |
| JP (1) | JP7031810B2 (zh) |
| KR (1) | KR102247704B1 (zh) |
| CN (1) | CN109963876B (zh) |
| AU (1) | AU2017359813B2 (zh) |
| BR (1) | BR112019010051A2 (zh) |
| CA (1) | CA3043652A1 (zh) |
| CL (1) | CL2019001352A1 (zh) |
| CO (1) | CO2019005101A2 (zh) |
| DO (1) | DOP2019000124A (zh) |
| EA (1) | EA201990894A9 (zh) |
| EC (1) | ECSP19035482A (zh) |
| MX (1) | MX2019005858A (zh) |
| PE (1) | PE20191080A1 (zh) |
| PH (1) | PH12019501089A1 (zh) |
| SG (1) | SG10201913260VA (zh) |
| TN (1) | TN2019000161A1 (zh) |
| WO (1) | WO2018090950A1 (zh) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111995685A (zh) * | 2020-04-30 | 2020-11-27 | 中国科学院上海药物研究所 | 一种靶向her2和pd-1的双特异性抗体及其应用 |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA3035681A1 (en) | 2016-09-29 | 2018-04-05 | Beijing Hanmi Pharmaceutical Co., Ltd. | Heterodimeric immunoglobulin constructs and preparation methods thereof |
| CN109963876B (zh) | 2016-11-18 | 2023-11-14 | 北京韩美药品有限公司 | 抗pd-1/抗her2天然抗体结构样异源二聚体形式双特异抗体及其制备 |
| CA3084626A1 (en) * | 2017-12-04 | 2019-06-13 | Beijing Hanmi Pharmaceutical Co., Ltd. | Anti-pd-l1/anti-cd47 bispecific antibody with structure like natural antibody and in form of heterodimer and preparation thereof |
| WO2019153200A1 (zh) | 2018-02-08 | 2019-08-15 | 北京韩美药品有限公司 | 抗pd-1/抗her2天然抗体结构样异源二聚体形式双特异抗体及其制备 |
| KR20210088611A (ko) * | 2018-11-05 | 2021-07-14 | 베이징 한미 파마슈티컬 컴퍼니 리미티드 | 항TNFα/항IL-17A 천연항체 구조 형태의 헤테로다이머 이중특이성 항체 및 그 제조방법 |
| CN111196856A (zh) * | 2018-11-19 | 2020-05-26 | 三生国健药业（上海）股份有限公司 | 抗her2/pd1双特异性抗体 |
| CN111378045B (zh) * | 2018-12-28 | 2022-08-02 | 长春金赛药业有限责任公司 | 二价双特异性抗体及其制备方法、编码基因、宿主细胞、组合物 |
| CN114206382B (zh) * | 2019-08-07 | 2024-03-26 | 信达生物制药(苏州)有限公司 | 包含抗pd-1/her2双特异性抗体的制剂及其制备方法和用途 |
| WO2024061223A1 (zh) * | 2022-09-20 | 2024-03-28 | 普米斯生物技术(珠海)有限公司 | 抗体及其在抗肿瘤中的应用 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1176659A (zh) * | 1995-03-01 | 1998-03-18 | 基因技术股份有限公司 | 制备异多聚体多肽的方法 |
| CN1299370A (zh) * | 1998-05-06 | 2001-06-13 | 基因技术股份有限公司 | 用离子交换层析纯化蛋白质 |
| CN103429620A (zh) * | 2010-11-05 | 2013-12-04 | 酵活有限公司 | 在Fc结构域中具有突变的稳定异源二聚的抗体设计 |
| CN104114579A (zh) * | 2011-10-27 | 2014-10-22 | 根马布股份公司 | 异二聚体蛋白的生成 |
| US20160193334A1 (en) * | 2013-08-20 | 2016-07-07 | Merck Sharp & Dohme Corp. | Treating cancer with a combination of a pd-1 antagonist and dinaciclib |
| WO2016115274A1 (en) * | 2015-01-14 | 2016-07-21 | Compass Therapeutics Llc | Multispecific immunomodulatory antigen-binding constructs |
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| NL9100352A (nl) | 1991-02-27 | 1992-09-16 | Hoogovens Groep Bv | Werkwijze voor het vervaardigen van ijzerfolie door elektrodepositie. |
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| US20050106667A1 (en) | 2003-08-01 | 2005-05-19 | Genentech, Inc | Binding polypeptides with restricted diversity sequences |
| WO2006031994A2 (en) | 2004-09-14 | 2006-03-23 | Xencor, Inc. | Monomeric immunoglobulin fc domains |
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| PT2235064E (pt) | 2008-01-07 | 2016-03-01 | Amgen Inc | Método de preparação de moléculas heterodiméricas de fc de anticorpos utilizando efeitos de indução eletrostática |
| CN102405230A (zh) | 2009-04-22 | 2012-04-04 | 默克专利有限公司 | 具有修饰的FcRn结合位点的抗体融合蛋白 |
| US9200060B2 (en) | 2009-11-23 | 2015-12-01 | Amgen Inc. | Monomeric antibody Fc |
| US9683052B2 (en) | 2011-03-25 | 2017-06-20 | Glenmark Pharmaceuticals S.A. | Hetero-dimeric immunoglobulins |
| RU2625034C2 (ru) | 2011-04-20 | 2017-07-11 | МЕДИММЬЮН, ЭлЭлСи | Антитела и другие молекулы, которые связывают в7-н1 и pd-1 |
| CN109897103B (zh) | 2011-11-04 | 2024-05-17 | 酵活英属哥伦比亚有限公司 | 在Fc结构域中具有突变的稳定异源二聚的抗体设计 |
| SG10201913376XA (en) | 2012-04-20 | 2020-02-27 | Merus Nv | Methods and means for the production of ig-like molecules |
| US20150239991A1 (en) | 2012-09-25 | 2015-08-27 | Glenmark Pharmaceuticals S.A. | Purification of hetero-dimeric immunoglobulins |
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| US9914785B2 (en) | 2012-11-28 | 2018-03-13 | Zymeworks Inc. | Engineered immunoglobulin heavy chain-light chain pairs and uses thereof |
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| EP3083692B1 (en) | 2013-12-17 | 2020-02-19 | F.Hoffmann-La Roche Ag | Methods of treating her2-positive cancers using pd-1 axis binding antagonists and anti-her2 antibodies |
| WO2015095412A1 (en) | 2013-12-19 | 2015-06-25 | Zhong Wang | Bispecific antibody with two single-domain antigen-binding fragments |
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| PT3180363T (pt) | 2014-08-15 | 2019-11-05 | Merck Patent Gmbh | Proteínas de fusão de sirp-alfa e imunoglobulina |
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| WO2016170039A1 (en) | 2015-04-23 | 2016-10-27 | F. Hoffmann-La Roche Ag | Combination therapy of antibody binding to angiopoietin 2 with antibody binding to programmed death 1 polypeptide |
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| CN105111314B (zh) | 2015-08-13 | 2019-01-08 | 成都百世博生物技术有限公司 | 一种新型融合蛋白、药物组合物及其制备方法和用途 |
| CN105175545B (zh) | 2015-10-20 | 2019-01-25 | 安徽瀚海博兴生物技术有限公司 | 一种抗vegf-抗pd-1双功能抗体及其应用 |
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| KR20200120927A (ko) | 2018-02-11 | 2020-10-22 | 베이징 한미 파마슈티컬 컴퍼니 리미티드 | 항-pd-1/항-vegf 천연 항체 구조-유사 이형이량체형 이중특이성 항체 및 그의 제조 |
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| CN111995685A (zh) * | 2020-04-30 | 2020-11-27 | 中国科学院上海药物研究所 | 一种靶向her2和pd-1的双特异性抗体及其应用 |
| WO2021219127A1 (zh) * | 2020-04-30 | 2021-11-04 | 中国科学院上海药物研究所 | 一种靶向her2和pd-1的双特异性抗体及其应用 |
| CN111995685B (zh) * | 2020-04-30 | 2022-03-08 | 中国科学院上海药物研究所 | 一种靶向her2和pd-1的双特异性抗体及其应用 |
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| AU2017359813B2 (en) | 2024-12-05 |
| CN109963876B (zh) | 2023-11-14 |
| EA201990894A9 (ru) | 2019-11-27 |
| JP2020510407A (ja) | 2020-04-09 |
| US11319378B2 (en) | 2022-05-03 |
| KR102247704B1 (ko) | 2021-05-03 |
| ECSP19035482A (es) | 2019-05-31 |
| EP3533804A1 (en) | 2019-09-04 |
| PE20191080A1 (es) | 2019-08-20 |
| JP7031810B2 (ja) | 2022-03-08 |
| EA201990894A1 (ru) | 2019-09-30 |
| TN2019000161A1 (en) | 2020-10-05 |
| CO2019005101A2 (es) | 2019-05-31 |
| CL2019001352A1 (es) | 2019-08-02 |
| EP3533804A4 (en) | 2020-06-17 |
| MX2019005858A (es) | 2019-08-12 |
| PH12019501089A1 (en) | 2020-03-02 |
| BR112019010051A2 (pt) | 2019-09-03 |
| SG10201913260VA (en) | 2020-03-30 |
| WO2018090950A1 (zh) | 2018-05-24 |
| AU2017359813A1 (en) | 2019-05-30 |
| CA3043652A1 (en) | 2018-05-24 |
| US20190367633A1 (en) | 2019-12-05 |
| KR20190065375A (ko) | 2019-06-11 |
| DOP2019000124A (es) | 2019-11-15 |
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