JP2019523764A5 - - Google Patents
Download PDFInfo
- Publication number
- JP2019523764A5 JP2019523764A5 JP2018562562A JP2018562562A JP2019523764A5 JP 2019523764 A5 JP2019523764 A5 JP 2019523764A5 JP 2018562562 A JP2018562562 A JP 2018562562A JP 2018562562 A JP2018562562 A JP 2018562562A JP 2019523764 A5 JP2019523764 A5 JP 2019523764A5
- Authority
- JP
- Japan
- Prior art keywords
- seq
- concentration
- formulation
- amino acid
- range
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
- 238000009472 formulation Methods 0.000 description 85
- 239000000203 mixture Substances 0.000 description 85
- 150000001413 amino acids Chemical group 0.000 description 58
- 239000004094 surface-active agent Substances 0.000 description 17
- 229940024606 amino acid Drugs 0.000 description 12
- 229920005862 polyol Polymers 0.000 description 11
- 150000003077 polyols Chemical class 0.000 description 11
- 102000017914 EDNRA Human genes 0.000 description 9
- 101150062404 EDNRA gene Proteins 0.000 description 9
- 239000003963 antioxidant agent Substances 0.000 description 9
- 230000003078 antioxidant effect Effects 0.000 description 9
- 235000006708 antioxidants Nutrition 0.000 description 9
- 239000002738 chelating agent Substances 0.000 description 9
- 239000002184 metal Substances 0.000 description 9
- 239000003223 protective agent Substances 0.000 description 9
- 238000000034 method Methods 0.000 description 8
- 108091026890 Coding region Proteins 0.000 description 3
- 206010028980 Neoplasm Diseases 0.000 description 3
- 201000011510 cancer Diseases 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 210000004392 genitalia Anatomy 0.000 description 3
- 108091033319 polynucleotide Proteins 0.000 description 3
- 102000040430 polynucleotide Human genes 0.000 description 3
- 239000002157 polynucleotide Substances 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 2
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 2
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 230000004872 arterial blood pressure Effects 0.000 description 2
- 230000004071 biological effect Effects 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 229930182817 methionine Natural products 0.000 description 2
- 230000002685 pulmonary effect Effects 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000000600 sorbitol Substances 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- DHCDFWKWKRSZHF-UHFFFAOYSA-N sulfurothioic S-acid Chemical compound OS(O)(=O)=S DHCDFWKWKRSZHF-UHFFFAOYSA-N 0.000 description 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 1
- FOOSYQFGVYKUAE-NSHDSACASA-N (2s)-2-(benzylazaniumyl)-4-methylsulfanylbutanoate Chemical compound CSCC[C@@H](C(O)=O)NCC1=CC=CC=C1 FOOSYQFGVYKUAE-NSHDSACASA-N 0.000 description 1
- 239000004475 Arginine Substances 0.000 description 1
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 description 1
- 102000002045 Endothelin Human genes 0.000 description 1
- 108050009340 Endothelin Proteins 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 description 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 1
- 241001529936 Murinae Species 0.000 description 1
- QPCDCPDFJACHGM-UHFFFAOYSA-N N,N-bis{2-[bis(carboxymethyl)amino]ethyl}glycine Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(=O)O)CCN(CC(O)=O)CC(O)=O QPCDCPDFJACHGM-UHFFFAOYSA-N 0.000 description 1
- 229920001213 Polysorbate 20 Polymers 0.000 description 1
- 206010064911 Pulmonary arterial hypertension Diseases 0.000 description 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 1
- 229930003268 Vitamin C Natural products 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 229960003121 arginine Drugs 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 229960003589 arginine hydrochloride Drugs 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- ZUBDGKVDJUIMQQ-UBFCDGJISA-N endothelin-1 Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(O)=O)NC(=O)[C@H]1NC(=O)[C@H](CC=2C=CC=CC=2)NC(=O)[C@@H](CC=2C=CC(O)=CC=2)NC(=O)[C@H](C(C)C)NC(=O)[C@H]2CSSC[C@@H](C(N[C@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(O)=O)C(=O)N2)=O)NC(=O)[C@@H](CO)NC(=O)[C@H](N)CSSC1)C1=CNC=N1 ZUBDGKVDJUIMQQ-UBFCDGJISA-N 0.000 description 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229960003330 pentetic acid Drugs 0.000 description 1
- 239000003186 pharmaceutical solution Substances 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229940068977 polysorbate 20 Drugs 0.000 description 1
- 229920000053 polysorbate 80 Polymers 0.000 description 1
- 229940068968 polysorbate 80 Drugs 0.000 description 1
- 230000011664 signaling Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610376600 | 2016-05-31 | ||
| CN201610376600.7 | 2016-05-31 | ||
| CN201610954533.2A CN107987162A (zh) | 2016-10-27 | 2016-10-27 | Etar抗体,其药物组合物及其应用 |
| CN201610954533.2 | 2016-10-27 | ||
| PCT/CN2017/086369 WO2017206840A1 (zh) | 2016-05-31 | 2017-05-27 | Etar抗体,其药物组合物及其应用 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019523764A JP2019523764A (ja) | 2019-08-29 |
| JP2019523764A5 true JP2019523764A5 (enExample) | 2020-07-16 |
| JP7090557B2 JP7090557B2 (ja) | 2022-06-24 |
Family
ID=60479108
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018562562A Active JP7090557B2 (ja) | 2016-05-31 | 2017-05-27 | Etar抗体、ならびにその医薬組成物および使用 |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US20190134196A1 (enExample) |
| EP (1) | EP3476864A4 (enExample) |
| JP (1) | JP7090557B2 (enExample) |
| KR (2) | KR102669444B1 (enExample) |
| AU (1) | AU2017273959B2 (enExample) |
| CA (1) | CA3025714A1 (enExample) |
| TW (1) | TWI826351B (enExample) |
| WO (1) | WO2017206840A1 (enExample) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111018987B (zh) | 2014-12-05 | 2023-11-21 | 鸿运华宁(杭州)生物医药有限公司 | 一种能与人内皮素受体特异性结合的抗体及其应用 |
| FR3077574B1 (fr) * | 2018-02-07 | 2022-04-01 | Commissariat Energie Atomique | Anticorps dirige contre le sous-type a des recepteurs aux endothelines et ses utilisations. |
| MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
| CN112239507A (zh) * | 2019-07-17 | 2021-01-19 | 鸿运华宁(杭州)生物医药有限公司 | ETA抗体与TGF-β Trap的融合蛋白质,以及其药物组合物和应用 |
| CN115141276A (zh) * | 2021-03-31 | 2022-10-04 | 鸿运华宁(杭州)生物医药有限公司 | 一种能与人内皮素受体特异性结合的抗体及其在糖尿病肾病和慢性肾病治疗中的应用 |
Family Cites Families (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4179337A (en) | 1973-07-20 | 1979-12-18 | Davis Frank F | Non-immunogenic polypeptides |
| JPS6023084B2 (ja) | 1979-07-11 | 1985-06-05 | 味の素株式会社 | 代用血液 |
| US4331647A (en) | 1980-03-03 | 1982-05-25 | Goldenberg Milton David | Tumor localization and therapy with labeled antibody fragments specific to tumor-associated markers |
| US4640835A (en) | 1981-10-30 | 1987-02-03 | Nippon Chemiphar Company, Ltd. | Plasminogen activator derivatives |
| US4737462A (en) | 1982-10-19 | 1988-04-12 | Cetus Corporation | Structural genes, plasmids and transformed cells for producing cysteine depleted muteins of interferon-β |
| US4518584A (en) | 1983-04-15 | 1985-05-21 | Cetus Corporation | Human recombinant interleukin-2 muteins |
| US4496689A (en) | 1983-12-27 | 1985-01-29 | Miles Laboratories, Inc. | Covalently attached complex of alpha-1-proteinase inhibitor with a water soluble polymer |
| US4751180A (en) | 1985-03-28 | 1988-06-14 | Chiron Corporation | Expression using fused genes providing for protein product |
| EP0206448B1 (en) | 1985-06-19 | 1990-11-14 | Ajinomoto Co., Inc. | Hemoglobin combined with a poly(alkylene oxide) |
| US4935233A (en) | 1985-12-02 | 1990-06-19 | G. D. Searle And Company | Covalently linked polypeptide cell modulators |
| US4791192A (en) | 1986-06-26 | 1988-12-13 | Takeda Chemical Industries, Ltd. | Chemically modified protein with polyethyleneglycol |
| US4946778A (en) | 1987-09-21 | 1990-08-07 | Genex Corporation | Single polypeptide chain binding molecules |
| US5011912A (en) | 1986-12-19 | 1991-04-30 | Immunex Corporation | Hybridoma and monoclonal antibody for use in an immunoaffinity purification system |
| US5262522A (en) | 1991-11-22 | 1993-11-16 | Immunex Corporation | Receptor for oncostatin M and leukemia inhibitory factor |
| JP3589665B2 (ja) | 1992-10-23 | 2004-11-17 | イミュネックス・コーポレーション | 可溶性オリゴマー蛋白質の調製法 |
| US5457035A (en) | 1993-07-23 | 1995-10-10 | Immunex Corporation | Cytokine which is a ligand for OX40 |
| US6133426A (en) | 1997-02-21 | 2000-10-17 | Genentech, Inc. | Humanized anti-IL-8 monoclonal antibodies |
| EP0985039B1 (en) | 1997-06-12 | 2008-02-20 | Novartis International Pharmaceutical Ltd. | Artificial antibody polypeptides |
| GB9722131D0 (en) | 1997-10-20 | 1997-12-17 | Medical Res Council | Method |
| US6210924B1 (en) | 1998-08-11 | 2001-04-03 | Amgen Inc. | Overexpressing cyclin D 1 in a eukaryotic cell line |
| GB9928787D0 (en) | 1999-12-03 | 2000-02-02 | Medical Res Council | Direct screening method |
| US20020055457A1 (en) * | 2000-08-07 | 2002-05-09 | Janus Todd J. | Methods of treating cancer and the pain associated therewith using endothelin antagonists |
| GB0025144D0 (en) | 2000-10-13 | 2000-11-29 | Medical Res Council | Concatenated nucleic acid sequences |
| US20030133939A1 (en) | 2001-01-17 | 2003-07-17 | Genecraft, Inc. | Binding domain-immunoglobulin fusion proteins |
| US20040202995A1 (en) | 2003-04-09 | 2004-10-14 | Domantis | Nucleic acids, proteins, and screening methods |
| DOP2006000029A (es) * | 2005-02-07 | 2006-08-15 | Genentech Inc | Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas) |
| CN101171337A (zh) * | 2005-03-09 | 2008-04-30 | 得克萨斯大学体系董事会 | 与基因表达的体内成像相关的方法和组合物 |
| CN101426527A (zh) * | 2006-02-03 | 2009-05-06 | 米迪缪尼有限公司 | 蛋白质制剂 |
| GEP20125628B (en) * | 2006-04-21 | 2012-09-10 | Novartis Ag | Pharmaceutical compositions containing antagonist anti-cd40 antibody |
| JP2008280266A (ja) * | 2007-05-09 | 2008-11-20 | Sekisui Chem Co Ltd | モノクローナル抗体 |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| JP2010006745A (ja) * | 2008-06-27 | 2010-01-14 | Sekisui Chem Co Ltd | 融合タンパク質、融合タンパク質固定化担体、化合物のスクリーニング方法、スクリーニング用組成物、並びに、スクリーニング用キット |
| JP2010138165A (ja) * | 2008-11-14 | 2010-06-24 | Sekisui Chem Co Ltd | 抗ヒトエンドセリン受容体タイプaモノクローナル抗体、並びに、ハイブリドーマ |
| RU2626512C2 (ru) * | 2010-03-01 | 2017-07-28 | Цитодин, Инк. | Концентрированные белковые фармацевтические составы и их применение |
| EP2648750B1 (en) * | 2010-12-10 | 2017-01-25 | Novartis AG | Antibody formulation |
| US20140004131A1 (en) * | 2012-05-04 | 2014-01-02 | Novartis Ag | Antibody formulation |
| CN103728454B (zh) * | 2012-10-10 | 2016-05-18 | 吴庄民 | 基于表位抗原肽的抗内皮素受体a抗体酶联免疫试剂盒及其应用 |
| CN104513313B (zh) * | 2013-09-27 | 2018-11-09 | 鸿运华宁(杭州)生物医药有限公司 | 一种跨膜受体的单克隆抗体的筛选方法 |
| CN111018987B (zh) * | 2014-12-05 | 2023-11-21 | 鸿运华宁(杭州)生物医药有限公司 | 一种能与人内皮素受体特异性结合的抗体及其应用 |
-
2017
- 2017-05-26 TW TW106117760A patent/TWI826351B/zh active
- 2017-05-27 CA CA3025714A patent/CA3025714A1/en active Pending
- 2017-05-27 JP JP2018562562A patent/JP7090557B2/ja active Active
- 2017-05-27 KR KR1020237021437A patent/KR102669444B1/ko active Active
- 2017-05-27 EP EP17805785.7A patent/EP3476864A4/en active Pending
- 2017-05-27 AU AU2017273959A patent/AU2017273959B2/en active Active
- 2017-05-27 KR KR1020187037647A patent/KR102549008B1/ko active Active
- 2017-05-27 US US16/305,828 patent/US20190134196A1/en not_active Abandoned
- 2017-05-27 WO PCT/CN2017/086369 patent/WO2017206840A1/zh not_active Ceased
-
2023
- 2023-01-17 US US18/155,644 patent/US20230346932A1/en active Pending