MX2016003705A - Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada. - Google Patents
Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada.Info
- Publication number
- MX2016003705A MX2016003705A MX2016003705A MX2016003705A MX2016003705A MX 2016003705 A MX2016003705 A MX 2016003705A MX 2016003705 A MX2016003705 A MX 2016003705A MX 2016003705 A MX2016003705 A MX 2016003705A MX 2016003705 A MX2016003705 A MX 2016003705A
- Authority
- MX
- Mexico
- Prior art keywords
- growth hormone
- human growth
- type human
- preparation
- sustained type
- Prior art date
Links
- 102000002265 Human Growth Hormone Human genes 0.000 title abstract 7
- 108010000521 Human Growth Hormone Proteins 0.000 title abstract 7
- 239000000854 Human Growth Hormone Substances 0.000 title abstract 7
- 230000002459 sustained effect Effects 0.000 title abstract 4
- 108060003951 Immunoglobulin Proteins 0.000 abstract 1
- 230000000975 bioactive effect Effects 0.000 abstract 1
- 239000007853 buffer solution Substances 0.000 abstract 1
- 230000021615 conjugation Effects 0.000 abstract 1
- 102000018358 immunoglobulin Human genes 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 1
- 239000000243 solution Substances 0.000 abstract 1
- 150000005846 sugar alcohols Chemical class 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/27—Growth hormone [GH], i.e. somatotropin
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
- A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
- A61K47/6883—Polymer-drug antibody conjugates, e.g. mitomycin-dextran-Ab; DNA-polylysine-antibody complex or conjugate used for therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Biotechnology (AREA)
- Dermatology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20130115177 | 2013-09-27 | ||
| PCT/KR2014/009059 WO2015046974A1 (ko) | 2013-09-27 | 2014-09-26 | 지속형 인간 성장 호르몬 제제 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2016003705A true MX2016003705A (es) | 2016-05-16 |
Family
ID=52743982
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2016003705A MX2016003705A (es) | 2013-09-27 | 2014-09-26 | Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada. |
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 |
| DK3127923T3 (da) * | 2014-03-31 | 2021-11-22 | Hanmi Pharm Ind Co Ltd | Fremgangsmåde til forbedring af oppløselighed af protein og peptid ved hjælp af immunoglobulin-fc-fragment-binding |
| 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 |
| IL298396A (en) * | 2020-05-22 | 2023-01-01 | Hanmi Pharm Ind Co Ltd | Liquid formulation of long-acting conjugate of glucagon derivative |
| CN115845032A (zh) * | 2022-10-28 | 2023-03-28 | 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 |
| WO1997034631A1 (en) | 1996-03-18 | 1997-09-25 | Board Of Regents, The University Of Texas System | Immunoglobin-like domains with increased half lives |
| US20020077461A1 (en) * | 1996-04-24 | 2002-06-20 | Soren Bjorn | Pharmaceutical formulation |
| US20070179096A1 (en) | 1996-04-24 | 2007-08-02 | Novo Nordisk A/S | 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 |
| BRPI0406606A (pt) | 2003-11-13 | 2005-12-06 | Hanmi Pharm Ind Co Ltd | Composição farmacêutica compreendendo uma região fc de imunoglobulina como um veìculo |
| 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 |
| CA2594561C (en) | 2004-12-22 | 2014-12-23 | Ambrx, Inc. | Formulations of human growth hormone comprising a non-naturally encoded amino acid |
| 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 |
| EP1916997B1 (en) * | 2005-08-05 | 2018-04-18 | Amgen Inc. | Stable aqueous protein pharmaceutical formulations and their preparation |
| HRP20140172T1 (hr) * | 2006-05-30 | 2014-03-28 | Genentech, Inc. | Protutijela i imunokonjugati kao i njihove uporabe |
| SG181648A1 (en) * | 2009-12-15 | 2012-07-30 | Ascendis Pharma As | 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 WO PCT/KR2014/009059 patent/WO2015046974A1/ko not_active Ceased
- 2014-09-26 AU AU2014329003A patent/AU2014329003A1/en not_active Abandoned
- 2014-09-26 EP EP14847086.7A patent/EP3050559B1/en active Active
- 2014-09-26 CN CN201480064028.XA patent/CN105848645A/zh active Pending
- 2014-09-26 KR KR1020140129476A patent/KR102276304B1/ko active Active
- 2014-09-26 HK HK16114361.4A patent/HK1225976A1/en unknown
- 2014-09-26 RU RU2016113684A patent/RU2683823C2/ru not_active IP Right Cessation
- 2014-09-26 TW TW103133464A patent/TW201605468A/zh unknown
- 2014-09-26 MX MX2016003705A patent/MX2016003705A/es unknown
- 2014-09-26 EP EP20166812.6A patent/EP3689335A1/en active Pending
- 2014-09-26 JP JP2016518140A patent/JP6549104B2/ja active Active
- 2014-09-26 CA CA2925416A patent/CA2925416A1/en not_active Abandoned
- 2014-09-26 BR BR112016006455A patent/BR112016006455A2/pt not_active Application Discontinuation
- 2014-09-26 US US15/025,127 patent/US10987425B2/en active Active
- 2014-09-26 CN CN202210040339.9A patent/CN114288254A/zh active Pending
- 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
Also Published As
| Publication number | Publication date |
|---|---|
| RU2016113684A (ru) | 2017-11-01 |
| US10987425B2 (en) | 2021-04-27 |
| EP3050559B1 (en) | 2020-06-03 |
| TW201605468A (zh) | 2016-02-16 |
| US20160213789A1 (en) | 2016-07-28 |
| US12274750B2 (en) | 2025-04-15 |
| AR097840A1 (es) | 2016-04-20 |
| HK1225976A1 (en) | 2017-09-22 |
| IL244769A0 (en) | 2016-04-21 |
| EP3689335A1 (en) | 2020-08-05 |
| KR102276304B1 (ko) | 2021-07-14 |
| WO2015046974A1 (ko) | 2015-04-02 |
| KR20150035681A (ko) | 2015-04-07 |
| BR112016006455A2 (pt) | 2017-08-01 |
| US20210138070A1 (en) | 2021-05-13 |
| JP6549104B2 (ja) | 2019-07-24 |
| EP3050559A4 (en) | 2017-05-31 |
| CN105848645A (zh) | 2016-08-10 |
| CA2925416A1 (en) | 2015-04-02 |
| AU2014329003A1 (en) | 2016-05-12 |
| EP3050559A1 (en) | 2016-08-03 |
| JP2016533345A (ja) | 2016-10-27 |
| CN114288254A (zh) | 2022-04-08 |
| RU2016113684A3 (enExample) | 2018-06-28 |
| RU2683823C2 (ru) | 2019-04-02 |
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