JP2016533345A5 - - Google Patents
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- Publication number
- JP2016533345A5 JP2016533345A5 JP2016518140A JP2016518140A JP2016533345A5 JP 2016533345 A5 JP2016533345 A5 JP 2016533345A5 JP 2016518140 A JP2016518140 A JP 2016518140A JP 2016518140 A JP2016518140 A JP 2016518140A JP 2016533345 A5 JP2016533345 A5 JP 2016533345A5
- Authority
- JP
- Japan
- Prior art keywords
- growth hormone
- human growth
- sustained
- preparation according
- conjugate
- 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
- 108010000521 Human Growth Hormone Proteins 0.000 claims 59
- 102000002265 Human Growth Hormone Human genes 0.000 claims 57
- 239000000854 Human Growth Hormone Substances 0.000 claims 57
- 238000002360 preparation method Methods 0.000 claims 36
- 108060003951 Immunoglobulin Proteins 0.000 claims 13
- 102000018358 immunoglobulin Human genes 0.000 claims 13
- 150000005846 sugar alcohols Chemical class 0.000 claims 10
- 230000002459 sustained effect Effects 0.000 claims 9
- 239000007864 aqueous solution Substances 0.000 claims 8
- 239000000203 mixture Substances 0.000 claims 8
- 239000007853 buffer solution Substances 0.000 claims 7
- 238000000034 method Methods 0.000 claims 7
- 239000002736 nonionic surfactant Substances 0.000 claims 7
- 238000009472 formulation Methods 0.000 claims 6
- 239000000243 solution Substances 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 230000000975 bioactive effect Effects 0.000 claims 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 150000001413 amino acids Chemical class 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 239000012931 lyophilized formulation Substances 0.000 claims 3
- 229920000747 poly(lactic acid) Polymers 0.000 claims 3
- 239000004626 polylactic acid Substances 0.000 claims 3
- 229920000642 polymer Polymers 0.000 claims 3
- 239000003755 preservative agent Substances 0.000 claims 3
- 230000002335 preservative effect Effects 0.000 claims 3
- 108090000765 processed proteins & peptides Proteins 0.000 claims 3
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 2
- 230000009977 dual effect Effects 0.000 claims 2
- 239000007951 isotonicity adjuster Substances 0.000 claims 2
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims 2
- 230000002085 persistent effect Effects 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000003381 stabilizer Substances 0.000 claims 2
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- 229920002101 Chitin Polymers 0.000 claims 1
- 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 claims 1
- 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 claims 1
- 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 claims 1
- 229920002307 Dextran Polymers 0.000 claims 1
- 206010013883 Dwarfism Diseases 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Natural products OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims 1
- 206010056438 Growth hormone deficiency Diseases 0.000 claims 1
- 206010053759 Growth retardation Diseases 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 1
- 201000010769 Prader-Willi syndrome Diseases 0.000 claims 1
- 229920002988 biodegradable polymer Polymers 0.000 claims 1
- 239000004621 biodegradable polymer Substances 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 239000000539 dimer Substances 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 150000004676 glycans Chemical class 0.000 claims 1
- 229920002674 hyaluronan Polymers 0.000 claims 1
- 229960003160 hyaluronic acid Drugs 0.000 claims 1
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims 1
- 150000002632 lipids Chemical class 0.000 claims 1
- 239000012669 liquid formulation Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical group O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 claims 1
- 208000003068 pituitary dwarfism Diseases 0.000 claims 1
- 229920001583 poly(oxyethylated polyols) Polymers 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229920001451 polypropylene glycol Polymers 0.000 claims 1
- 229920001282 polysaccharide Polymers 0.000 claims 1
- 239000005017 polysaccharide Substances 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 230000006798 recombination Effects 0.000 claims 1
- 238000005215 recombination Methods 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 235000000346 sugar Nutrition 0.000 claims 1
- 150000008163 sugars Chemical class 0.000 claims 1
- 239000012929 tonicity agent Substances 0.000 claims 1
- 229920002554 vinyl polymer Polymers 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000008215 water for injection Substances 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20130115177 | 2013-09-27 | ||
| KR10-2013-0115177 | 2013-09-27 | ||
| PCT/KR2014/009059 WO2015046974A1 (ko) | 2013-09-27 | 2014-09-26 | 지속형 인간 성장 호르몬 제제 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016533345A JP2016533345A (ja) | 2016-10-27 |
| JP2016533345A5 true JP2016533345A5 (enExample) | 2017-11-02 |
| JP6549104B2 JP6549104B2 (ja) | 2019-07-24 |
Family
ID=52743982
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016518140A Active JP6549104B2 (ja) | 2013-09-27 | 2014-09-26 | 持続型ヒト成長ホルモン製剤 |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US10987425B2 (enExample) |
| EP (2) | EP3050559B1 (enExample) |
| JP (1) | JP6549104B2 (enExample) |
| KR (1) | KR102276304B1 (enExample) |
| CN (2) | CN105848645A (enExample) |
| AR (1) | AR097840A1 (enExample) |
| AU (1) | AU2014329003A1 (enExample) |
| BR (1) | BR112016006455A2 (enExample) |
| CA (1) | CA2925416A1 (enExample) |
| HK (1) | HK1225976A1 (enExample) |
| IL (1) | IL244769A0 (enExample) |
| MX (1) | MX2016003705A (enExample) |
| RU (1) | RU2683823C2 (enExample) |
| TW (1) | TW201605468A (enExample) |
| WO (1) | WO2015046974A1 (enExample) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20130049671A (ko) | 2011-11-04 | 2013-05-14 | 한미사이언스 주식회사 | 생리활성 폴리펩타이드 결합체 제조 방법 |
| AR090281A1 (es) | 2012-03-08 | 2014-10-29 | Hanmi Science Co Ltd | Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo |
| KR102385120B1 (ko) * | 2014-03-31 | 2022-04-12 | 한미약품 주식회사 | 면역글로불린 Fc 단편 결합을 이용한 단백질 및 펩타이드의 용해도를 개선시키는 방법 |
| KR101808234B1 (ko) * | 2015-06-23 | 2017-12-12 | (주)알테오젠 | IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제 |
| KR20170079409A (ko) * | 2015-12-30 | 2017-07-10 | 한미약품 주식회사 | 지속형 인간 성장 호르몬 결합체의 신규 액상 제제 |
| CN106256835A (zh) * | 2016-08-19 | 2016-12-28 | 安源医药科技（上海）有限公司 | 高糖基化人生长激素融合蛋白及其制备方法与用途 |
| KR101861163B1 (ko) * | 2017-04-26 | 2018-05-25 | 삼천당제약주식회사 | 안과용 약학 조성물 |
| CA3179603A1 (en) * | 2020-05-22 | 2021-11-25 | Hanmi Pharm. Co., Ltd. | Liquid formulation of long-acting conjugate of glucagon derivative |
| CN115845032B (zh) * | 2022-10-28 | 2026-02-06 | 深圳科兴药业有限公司 | 生长激素fc融合蛋白注射液及其用途 |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9201073D0 (sv) * | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| FR2719479B1 (fr) * | 1994-05-04 | 1996-07-26 | Sanofi Elf | Formulation stable lyophilisée comprenant une protéine: kit de dosage. |
| US6096871A (en) | 1995-04-14 | 2000-08-01 | Genentech, Inc. | Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life |
| ZA966075B (en) | 1995-07-27 | 1998-01-19 | Genentech Inc | Protein formulation. |
| JPH10265404A (ja) * | 1996-02-02 | 1998-10-06 | Mitsui Chem Inc | ヒト成長ホルモンを含有する医薬製剤 |
| AUPN801296A0 (en) * | 1996-02-12 | 1996-03-07 | Csl Limited | Stabilised growth hormone formulation and method of preparation thereof |
| CA2249195A1 (en) | 1996-03-18 | 1997-09-25 | Board Of Regents, The University Of Texas System | Immunoglobin-like domains with increased half lives |
| US20070179096A1 (en) | 1996-04-24 | 2007-08-02 | Novo Nordisk A/S | Pharmaceutical Formulation |
| US20020077461A1 (en) * | 1996-04-24 | 2002-06-20 | Soren Bjorn | Pharmaceutical formulation |
| SE9704405D0 (sv) * | 1997-11-28 | 1997-11-28 | Pharmacia & Upjohn Ab | New syringe |
| RU2190129C2 (ru) | 2000-10-17 | 2002-09-27 | Открытое акционерное общество "Павловский машиностроительный завод "Восход" | Резервированный электрогидравлический привод |
| ATE454137T1 (de) * | 2001-07-25 | 2010-01-15 | Facet Biotech Corp | Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab |
| US20050176108A1 (en) | 2003-03-13 | 2005-08-11 | Young-Min Kim | Physiologically active polypeptide conjugate having prolonged in vivo half-life |
| BRPI0406605B8 (pt) | 2003-11-13 | 2021-05-25 | Hanmi Holdings Co Ltd | conjugado de proteína, método para a preparação do mesmo e composição farmacêutica para intensificar a duração e estabilidade in vivo de um polipeptídeo fisiologicamente ativo |
| JP4845741B2 (ja) * | 2003-12-23 | 2011-12-28 | ファルマシア コーポレーション | 安定な成長ホルモン液体製剤 |
| BRPI0519170A8 (pt) | 2004-12-22 | 2018-05-08 | Ambrx Inc | formulações de hormônio de crescimento humano que compreendem um aminoácido não naturalmente codificado |
| JP4283776B2 (ja) * | 2005-03-07 | 2009-06-24 | ラボラトワール セローノ ソシエテ アノニム | Ｈｇｈ含有医薬組成物 |
| KR100754667B1 (ko) * | 2005-04-08 | 2007-09-03 | 한미약품 주식회사 | 비펩타이드성 중합체로 개질된 면역글로불린 Ｆｃ 단편 및이를 포함하는 약제학적 조성물 |
| CA2618068C (en) * | 2005-08-05 | 2016-02-16 | Amgen Inc. | Stable aqueous protein or antibody pharmaceutical formulations and their preparation |
| PT2032606E (pt) * | 2006-05-30 | 2014-02-05 | Genentech Inc | Anticorpos e imunoconjugados e respetivas utilizações |
| EP2512450B1 (en) * | 2009-12-15 | 2018-02-07 | Ascendis Pharma Endocrinology Division A/S | Dry growth hormone composition transiently linked to a polymer carrier |
| KR101337797B1 (ko) | 2010-07-14 | 2013-12-06 | 한미사이언스 주식회사 | 지속형 인간 성장 호르몬 결합체 액상 제제 |
| EP2606908A1 (en) * | 2011-12-19 | 2013-06-26 | Ipsen Pharma S.A.S. | Novel pharmaceutical composition for a long acting growth hormone fusion protein (LAGH) |
| US10064951B2 (en) * | 2012-03-30 | 2018-09-04 | Hanmi Science Co., Ltd. | Liquid formulation of highly concentrated long-acting human growth hormone conjugate |
-
2014
- 2014-09-26 CN CN201480064028.XA patent/CN105848645A/zh active Pending
- 2014-09-26 CA CA2925416A patent/CA2925416A1/en not_active Abandoned
- 2014-09-26 RU RU2016113684A patent/RU2683823C2/ru not_active IP Right Cessation
- 2014-09-26 WO PCT/KR2014/009059 patent/WO2015046974A1/ko not_active Ceased
- 2014-09-26 MX MX2016003705A patent/MX2016003705A/es unknown
- 2014-09-26 CN CN202210040339.9A patent/CN114288254A/zh active Pending
- 2014-09-26 HK HK16114361.4A patent/HK1225976A1/en unknown
- 2014-09-26 BR BR112016006455A patent/BR112016006455A2/pt not_active Application Discontinuation
- 2014-09-26 EP EP14847086.7A patent/EP3050559B1/en active Active
- 2014-09-26 AU AU2014329003A patent/AU2014329003A1/en not_active Abandoned
- 2014-09-26 EP EP20166812.6A patent/EP3689335A1/en active Pending
- 2014-09-26 KR KR1020140129476A patent/KR102276304B1/ko active Active
- 2014-09-26 US US15/025,127 patent/US10987425B2/en active Active
- 2014-09-26 JP JP2016518140A patent/JP6549104B2/ja active Active
- 2014-09-26 TW TW103133464A patent/TW201605468A/zh unknown
- 2014-09-29 AR ARP140103607A patent/AR097840A1/es unknown
-
2016
- 2016-03-27 IL IL244769A patent/IL244769A0/en unknown
-
2020
- 2020-12-28 US US17/135,468 patent/US12274750B2/en active Active
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