DK3126373T3 - Fremgangsmåde til fremstilling af amg 416 - Google Patents
Fremgangsmåde til fremstilling af amg 416 Download PDFInfo
- Publication number
- DK3126373T3 DK3126373T3 DK15773570.5T DK15773570T DK3126373T3 DK 3126373 T3 DK3126373 T3 DK 3126373T3 DK 15773570 T DK15773570 T DK 15773570T DK 3126373 T3 DK3126373 T3 DK 3126373T3
- Authority
- DK
- Denmark
- Prior art keywords
- amg
- procedure
- manufacturing
- manufacturing amg
- Prior art date
Links
- ANIAZGVDEUQPRI-ZJQCGQFWSA-N etelcalcetide Chemical compound NC(N)=NCCC[C@H](C(N)=O)NC(=O)[C@@H](C)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](C)NC(=O)[C@@H](CSSC[C@H](N)C(O)=O)NC(C)=O ANIAZGVDEUQPRI-ZJQCGQFWSA-N 0.000 title 1
- 229950006502 etelcalcetide Drugs 0.000 title 1
- 108091022127 etelcalcetide hydrochloride Proteins 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 title 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/04—Linear peptides containing only normal peptide links
- C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/02—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length in solution
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/107—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
- C07K1/1072—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups
- C07K1/1075—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups by covalent attachment of amino acids or peptide residues
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
- A61P5/20—Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Analytical Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
- Glass Compositions (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461974899P | 2014-04-03 | 2014-04-03 | |
| PCT/US2015/024347 WO2015154031A1 (en) | 2014-04-03 | 2015-04-03 | Method for preparing amg 416 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3126373T3 true DK3126373T3 (da) | 2020-05-04 |
Family
ID=54241346
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15773570.5T DK3126373T3 (da) | 2014-04-03 | 2015-04-03 | Fremgangsmåde til fremstilling af amg 416 |
Country Status (27)
| Country | Link |
|---|---|
| US (3) | US10407464B2 (da) |
| EP (3) | EP3126373B1 (da) |
| JP (1) | JP6710158B2 (da) |
| KR (1) | KR102397271B1 (da) |
| CN (3) | CN106795201A (da) |
| AU (1) | AU2015240527B2 (da) |
| CA (1) | CA2944194C (da) |
| CL (1) | CL2016002513A1 (da) |
| CY (1) | CY1123100T1 (da) |
| DK (1) | DK3126373T3 (da) |
| EA (1) | EA032597B1 (da) |
| ES (2) | ES2943671T3 (da) |
| HR (1) | HRP20200527T1 (da) |
| HU (1) | HUE048489T2 (da) |
| IL (1) | IL248059B2 (da) |
| LT (1) | LT3126373T (da) |
| MA (2) | MA52906A (da) |
| ME (1) | ME03781B (da) |
| MX (1) | MX374205B (da) |
| PL (1) | PL3126373T3 (da) |
| PT (1) | PT3126373T (da) |
| RS (1) | RS60187B1 (da) |
| SG (1) | SG11201608176VA (da) |
| SI (1) | SI3126373T1 (da) |
| SM (1) | SMT202000207T1 (da) |
| WO (1) | WO2015154031A1 (da) |
| ZA (1) | ZA201606844B (da) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014210489A1 (en) * | 2013-06-28 | 2014-12-31 | Amgen Inc. | Stable liquid formulation of amg 416 (velcalcetide) |
| WO2015154031A1 (en) | 2014-04-03 | 2015-10-08 | Amgen Inc. | Method for preparing amg 416 |
| CN106928320B (zh) * | 2015-12-31 | 2021-01-15 | 深圳翰宇药业股份有限公司 | 一种合成Etelcalcetide的方法 |
| CN106928321B (zh) * | 2015-12-31 | 2019-07-26 | 深圳翰宇药业股份有限公司 | 一种合成Etelcalcetide的方法 |
| CN109641946A (zh) * | 2016-03-23 | 2019-04-16 | 巴切姆股份公司 | 胰高血糖素样肽的制备方法 |
| US10858390B2 (en) | 2016-09-02 | 2020-12-08 | Cem Corporation | Use of excess carbodiimide for peptide synthesis at elevated temperatures |
| CN108101959B (zh) * | 2016-11-24 | 2021-07-09 | 四川科伦药物研究院有限公司 | 一种制备高纯度多肽或其类似物的方法 |
| CN106928171B (zh) * | 2017-05-03 | 2019-08-13 | 成都郑源生化科技有限公司 | Fmoc-Arg(Pbf)-OH的合成方法 |
| TW201915009A (zh) * | 2017-10-03 | 2019-04-16 | 中化合成生技股份有限公司 | 合成依特卡肽(Etelcalcetide)或其鹽類之方法 |
| CN110498835B (zh) * | 2018-05-17 | 2021-06-08 | 深圳翰宇药业股份有限公司 | 一种合成etelcalcetide的方法 |
| CN109280078B (zh) * | 2018-10-30 | 2019-06-25 | 成都诺和晟泰生物科技有限公司 | 一种制备维拉卡肽的方法 |
| CN112062811B (zh) * | 2019-06-10 | 2022-03-25 | 深圳翰宇药业股份有限公司 | 一种维拉卡肽的合成方法 |
| US20220298206A1 (en) * | 2019-08-26 | 2022-09-22 | Auro Peptides Ltd | An improved process for the preparation of Etelcalcetide Hydrochloride |
| EP3875466A1 (en) * | 2020-03-05 | 2021-09-08 | Fresenius Kabi iPSUM S.r.l. | Process for the synthesis of etelcalcetide |
| CN115698032A (zh) | 2020-06-03 | 2023-02-03 | 中外制药株式会社 | 困难序列的高效的肽缩合法 |
| CN111925415A (zh) * | 2020-08-10 | 2020-11-13 | 海南中和药业股份有限公司 | 一种维拉卡肽杂质的制备方法 |
| TWI792442B (zh) | 2021-07-23 | 2023-02-11 | 建誼生技股份有限公司 | 依特卡肽鹽酸鹽之製造方法 |
| CN114524860B (zh) * | 2021-12-29 | 2025-01-24 | 深圳翰宇药业股份有限公司 | 一种Etelcalcetide的合成方法及其应用 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3941763A (en) | 1975-03-28 | 1976-03-02 | American Home Products Corporation | PGlu-D-Met-Trp-Ser-Tyr-D-Ala-Leu-Arg-Pro-Gly-NH2 and intermediates |
| EP0339695A3 (en) | 1988-04-29 | 1990-05-30 | Stichting Voor De Technische Wetenschappen | A process for preparing an antigenic or immunogenic conjugate as well as the use of such conjugates |
| SE9603465D0 (sv) | 1996-09-23 | 1996-09-23 | Astra Ab | New compounds |
| NO311807B1 (no) * | 1999-03-04 | 2002-01-28 | Bionor Immuno As | HIV-peptider, antigener, vaksinepreparater, immunoassay- testsett og en metode for påvisning av antistoffer fremkalt av HIV |
| CN101835794A (zh) | 2007-10-27 | 2010-09-15 | 霍夫曼-拉罗奇有限公司 | 使用固相和溶液相组合技术的促胰岛素肽合成法 |
| CN101250172B (zh) | 2008-03-07 | 2012-05-02 | 上海瀚鸿化工科技有限公司 | 精氨酸双保护制备工艺 |
| EP2427474A1 (en) | 2009-05-06 | 2012-03-14 | Mallinckrodt LLC | Solid support for fmoc-solid phase synthesis of peptide acids |
| LT3192520T (lt) * | 2009-07-29 | 2019-06-25 | Kai Pharmaceuticals, Inc. | Terapiniai agentai, skirti paratiroidinio hormono lygių sumažinimui |
| WO2011133346A1 (en) * | 2010-04-21 | 2011-10-27 | Pharmacofore, Inc. | Peripheral opioid agonists and peripheral opioid antagonists |
| AU2011301147A1 (en) * | 2010-09-08 | 2013-04-18 | Howard Florey Institute Of Experimental Physiology And Medicine | Modified relaxin polypeptides |
| WO2013042129A1 (en) | 2011-09-23 | 2013-03-28 | Natco Pharma Limited | Improved process for preparation of bivalirudin |
| WO2014210489A1 (en) | 2013-06-28 | 2014-12-31 | Amgen Inc. | Stable liquid formulation of amg 416 (velcalcetide) |
| WO2015154031A1 (en) | 2014-04-03 | 2015-10-08 | Amgen Inc. | Method for preparing amg 416 |
| CN105504012A (zh) * | 2014-09-30 | 2016-04-20 | 深圳翰宇药业股份有限公司 | 一种多肽的制备方法 |
| CN107434820A (zh) * | 2017-08-07 | 2017-12-05 | 南京工业大学 | 一种维拉卡肽的合成方法 |
-
2015
- 2015-04-03 WO PCT/US2015/024347 patent/WO2015154031A1/en not_active Ceased
- 2015-04-03 PT PT157735705T patent/PT3126373T/pt unknown
- 2015-04-03 ME MEP-2020-83A patent/ME03781B/me unknown
- 2015-04-03 DK DK15773570.5T patent/DK3126373T3/da active
- 2015-04-03 AU AU2015240527A patent/AU2015240527B2/en active Active
- 2015-04-03 SG SG11201608176VA patent/SG11201608176VA/en unknown
- 2015-04-03 MA MA052906A patent/MA52906A/fr unknown
- 2015-04-03 LT LTEP15773570.5T patent/LT3126373T/lt unknown
- 2015-04-03 KR KR1020167030590A patent/KR102397271B1/ko active Active
- 2015-04-03 EP EP15773570.5A patent/EP3126373B1/en active Active
- 2015-04-03 CN CN201580029560.2A patent/CN106795201A/zh active Pending
- 2015-04-03 HR HRP20200527TT patent/HRP20200527T1/hr unknown
- 2015-04-03 US US15/300,209 patent/US10407464B2/en active Active
- 2015-04-03 HU HUE15773570A patent/HUE048489T2/hu unknown
- 2015-04-03 SM SM20200207T patent/SMT202000207T1/it unknown
- 2015-04-03 SI SI201531173T patent/SI3126373T1/sl unknown
- 2015-04-03 MX MX2016012965A patent/MX374205B/es active IP Right Grant
- 2015-04-03 ES ES20160369T patent/ES2943671T3/es active Active
- 2015-04-03 EP EP23150870.6A patent/EP4219526A3/en not_active Withdrawn
- 2015-04-03 EA EA201692001A patent/EA032597B1/ru not_active IP Right Cessation
- 2015-04-03 IL IL248059A patent/IL248059B2/en unknown
- 2015-04-03 CN CN202510112970.9A patent/CN119874825A/zh active Pending
- 2015-04-03 JP JP2016560462A patent/JP6710158B2/ja active Active
- 2015-04-03 ES ES15773570T patent/ES2786225T3/es active Active
- 2015-04-03 EP EP20160369.3A patent/EP3708576B1/en active Active
- 2015-04-03 RS RS20200448A patent/RS60187B1/sr unknown
- 2015-04-03 CN CN202510112966.2A patent/CN119899242A/zh active Pending
- 2015-04-03 CA CA2944194A patent/CA2944194C/en active Active
- 2015-04-03 PL PL15773570T patent/PL3126373T3/pl unknown
- 2015-04-03 MA MA39628A patent/MA39628B1/fr unknown
-
2016
- 2016-10-03 CL CL2016002513A patent/CL2016002513A1/es unknown
- 2016-10-05 ZA ZA2016/06844A patent/ZA201606844B/en unknown
-
2019
- 2019-08-05 US US16/532,344 patent/US11377474B2/en active Active
-
2020
- 2020-04-29 CY CY20201100391T patent/CY1123100T1/el unknown
-
2022
- 2022-06-28 US US17/852,263 patent/US20230099078A1/en not_active Abandoned
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