HRP20230383T1 - Pth spojevi s malim omjerima maksimalne prema minimalnoj koncentraciji - Google Patents
Pth spojevi s malim omjerima maksimalne prema minimalnoj koncentraciji Download PDFInfo
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- HRP20230383T1 HRP20230383T1 HRP20230383TT HRP20230383T HRP20230383T1 HR P20230383 T1 HRP20230383 T1 HR P20230383T1 HR P20230383T T HRP20230383T T HR P20230383TT HR P20230383 T HRP20230383 T HR P20230383T HR P20230383 T1 HRP20230383 T1 HR P20230383T1
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- Prior art keywords
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- pharmaceutical preparation
- preparation according
- maximum
- minimum
- Prior art date
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- 150000001875 compounds Chemical class 0.000 title claims 5
- 239000000825 pharmaceutical preparation Substances 0.000 claims 16
- 238000007920 subcutaneous administration Methods 0.000 claims 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
- 241000282693 Cercopithecidae Species 0.000 claims 1
- 238000010976 amide bond formation reaction Methods 0.000 claims 1
- 125000003277 amino group Chemical group 0.000 claims 1
- 229910052757 nitrogen Inorganic materials 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000036470 plasma concentration Effects 0.000 claims 1
- 238000010254 subcutaneous injection Methods 0.000 claims 1
- 239000007929 subcutaneous injection Substances 0.000 claims 1
Classifications
-
- 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
- A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
-
- 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
- A61K47/62—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 a protein, peptide or polyamino acid
- A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
- A61K47/643—Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
-
- 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
-
- 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
- A61K9/0012—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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- 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
-
- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
- Reverberation, Karaoke And Other Acoustics (AREA)
- Bipolar Transistors (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (15)
1. Farmaceutski pripravak koji sadrži PTH spoj, naznačen time, da nakon potkožne primjene na neljudskom primatu, farmakokinetički profil PTH spoja pokazuje omjer maksimuma prema minimumu koncentracije u plazmi, koji je manji od 4 unutar jednog injekcijskog intervala u stabilnom stanju, pri čemu vremenski period između dvije uzastopne primjene iznosi 24 sata i
pri čemu PTH spoj ima formulu (IIf-i):
[image]
u kojoj
neoznačena crtkana linija pokazuje vezanje s dušikom od -D koji je PTH ostatak, putem tvorbe amidne veze; i
crtkana linija označena sa zvjezdicom pokazuje vezanje na ostatak
[image]
pri čemu
m i p su neovisno cijeli broj koji je u rasponu i koji ubraja od 400 do 500.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da -D ima slijed SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 27, SEQ ID NO: 28, SEQ ID NO: 29, SEQ ID NO: 30, SEQ ID NO: 31, SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 34, SEQ ID NO: 35, SEQ ID NO: 36, SEQ ID NO: 37, SEQ ID NO: 38, SEQ ID NO: 39, SEQ ID NO: 40, SEQ ID NO: 41, SEQ ID NO: 42, SEQ ID NO: 43, SEQ ID NO: 44, SEQ ID NO: 45, SEQ ID NO: 46, SEQ ID NO: 47, SEQ ID NO: 48, SEQ ID NO: 49, SEQ ID NO: 50, SEQ ID NO: 51, SEQ ID NO: 52, SEQ ID NO: 53, SEQ ID NO: 54, SEQ ID NO: 55, SEQ ID NO: 56, SEQ ID NO: 57, SEQ ID NO: 58, SEQ ID NO: 59, SEQ ID NO: 60, SEQ ID NO: 61, SEQ ID NO: 62, SEQ ID NO: 63, SEQ ID NO: 64, SEQ ID NO: 65, SEQ ID NO: 66, SEQ ID NO: 67, SEQ ID NO: 68, SEQ ID NO: 69, SEQ ID NO: 70, SEQ ID NO: 71, SEQ ID NO: 72, SEQ ID NO: 73, SEQ ID NO: 74, SEQ ID NO: 75, SEQ ID NO: 76, SEQ ID NO: 77, SEQ ID NO: 78, SEQ ID NO: 79, SEQ ID NO: 80, SEQ ID NO: 81, SEQ ID NO: 82, SEQ ID NO: 83, SEQ ID NO: 84, SEQ ID NO: 85, SEQ ID NO: 86, SEQ ID NO: 87, SEQ ID NO: 88, SEQ ID NO: 89, SEQ ID NO: 90, SEQ ID NO: 91, SEQ ID NO: 92, SEQ ID NO: 93, SEQ ID NO: 94, SEQ ID NO: 95, SEQ ID NO: 96, SEQ ID NO: 97, SEQ ID NO: 98, SEQ ID NO: 99, SEQ ID NO: 100, SEQ ID NO: 101, SEQ ID NO: 102, SEQ ID NO: 103, SEQ ID NO: 104, SEQ ID NO: 105, SEQ ID NO: 106, SEQ ID NO: 107, SEQ ID NO: 108, ID NO: 109, SEQ ID NO: 110, SEQ ID NO: 111, SEQ ID NO: 112, SEQ ID NO: 113, SEQ ID NO: 114, SEQ ID NO: 115, SEQ ID NO: 116, SEQ ID NO: 117, ID NO: 118, SEQ ID NO: 119, SEQ ID NO: 120, ili SEQ ID NO: 121.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili 2, naznačen time, da -D ima slijed SEQ ID NO: 47, SEQ ID NO: 48, SEQ ID NO: 49, SEQ ID NO: 50, SEQ ID NO: 51, SEQ ID NO: 52, SEQ ID NO: 53, SEQ ID NO: 54, SEQ ID NO: 55, SEQ ID NO: 107, SEQ ID NO: 108, SEQ ID NO: 109, SEQ ID NO: 110, SEQ ID NO: 111, SEQ ID NO: 112, SEQ ID NO: 113, SEQ ID NO: 114, ili SEQ ID NO: 115.
4. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da -D ima slijed SEQ ID NO: 51.
5. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da je -D vezan s PTH spojem formule (IIf-i) putem N-završetka funkcionalne amin skupine PTH ostatka.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da potkožna primjena nastaje putem potkožne injekcije.
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da se potkožna primjena izvodi s olovkom za automatsko ubrizgavanje.
8. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da je omjer maksimuma prema minimumu manji od 3.
9. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da je omjer maksimuma prema minimumu manji od 2,6.
10. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da je omjer maksimuma prema minimumu manji od 2,4.
11. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da je omjer maksimuma prema minimumu manji od 2,2.
12. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time, da je omjer maksimuma prema minimumu manji od 2.
13. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 12, naznačen time, da neljudski primat je javanski majmun.
14. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 13, naznačen time, da farmaceutski pripravak ima pH vrijednost u rasponu od i ubrojivo pH 3 do pH 8.
15. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 14, naznačen time, da farmaceutski pripravak ima pH vrijednost u rasponu od i ubrojivo pH 4 do pH 5.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16191454 | 2016-09-29 | ||
| EP17155846 | 2017-02-13 | ||
| EP17781427.4A EP3518961B1 (en) | 2016-09-29 | 2017-09-28 | Pth compounds with low peak-to-trough ratios |
| PCT/EP2017/074594 WO2018060312A1 (en) | 2016-09-29 | 2017-09-28 | Pth compounds with low peak-to-trough ratios |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230383T1 true HRP20230383T1 (hr) | 2023-07-07 |
Family
ID=60051489
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230383TT HRP20230383T1 (hr) | 2016-09-29 | 2017-09-28 | Pth spojevi s malim omjerima maksimalne prema minimalnoj koncentraciji |
Country Status (26)
| Country | Link |
|---|---|
| US (4) | US11759504B2 (hr) |
| EP (2) | EP3518961B1 (hr) |
| JP (2) | JP7085535B2 (hr) |
| KR (2) | KR20230170810A (hr) |
| CN (2) | CN117257922A (hr) |
| AU (1) | AU2017336251B2 (hr) |
| BR (1) | BR112019005793A2 (hr) |
| CA (1) | CA3037447A1 (hr) |
| DK (1) | DK3518961T5 (hr) |
| ES (1) | ES2943720T3 (hr) |
| FI (1) | FI3518961T3 (hr) |
| HR (1) | HRP20230383T1 (hr) |
| HU (1) | HUE062009T2 (hr) |
| IL (2) | IL319949A (hr) |
| LT (1) | LT3518961T (hr) |
| MA (1) | MA46345A (hr) |
| MX (1) | MX2019003182A (hr) |
| NZ (1) | NZ751745A (hr) |
| PL (1) | PL3518961T3 (hr) |
| RS (1) | RS64177B1 (hr) |
| RU (1) | RU2766959C2 (hr) |
| SG (1) | SG11201901558VA (hr) |
| SI (1) | SI3518961T1 (hr) |
| SM (1) | SMT202300124T1 (hr) |
| WO (1) | WO2018060312A1 (hr) |
| ZA (1) | ZA201901813B (hr) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9616109B2 (en) | 2014-10-22 | 2017-04-11 | Extend Biosciences, Inc. | Insulin vitamin D conjugates |
| CA2964463C (en) | 2014-10-22 | 2024-02-13 | Extend Biosciences, Inc. | Therapeutic vitamin d conjugates |
| NZ745318A (en) | 2016-03-01 | 2023-01-27 | Ascendis Pharma Bone Diseases As | Pth prodrugs |
| PT3518982T (pt) * | 2016-09-29 | 2025-01-29 | Ascendis Pharma Bone Diseases As | Descoberta da dose incremental em compostos de pth de libertação controlada |
| NZ792620A (en) * | 2016-09-29 | 2025-03-28 | Ascendis Pharma Bone Diseases As | Dosage regimen for a controlled-release pth compound |
| JP7085535B2 (ja) | 2016-09-29 | 2022-06-16 | アセンディス ファーマ ボーン ディジージズ エー／エス | ピーク対トラフ比が小さいｐｔｈ化合物 |
| JP2021516222A (ja) * | 2018-03-16 | 2021-07-01 | ザ ジェネラル ホスピタル コーポレイション | 副甲状腺ホルモンポリペプチドコンジュゲートおよびその使用方法 |
| AU2019270464B2 (en) * | 2018-05-18 | 2024-09-26 | Ascendis Pharma Bone Diseases A/S | Starting dose of PTH conjugates |
| BR112021014581A2 (pt) | 2019-02-11 | 2021-12-14 | Ascendis Pharma Bone Diseases As | Formulações farmacêuticas líquidas de conjugados de pth |
| JP2023510790A (ja) | 2020-01-13 | 2023-03-15 | アセンディス ファーマ ボーン ディジージズ エー／エス | 副甲状腺機能低下症の治療 |
| EP4217004A1 (en) | 2020-09-28 | 2023-08-02 | Ascendis Pharma Bone Diseases A/S | Improvement of physical and mental well-being of patients with hypoparathyroidism |
| IL311539A (en) | 2021-09-22 | 2024-05-01 | Ascendis Pharma Bone Diseases As | Long-acting pth compound treatments |
| US12233115B2 (en) | 2022-09-30 | 2025-02-25 | Extend Biosciences, Inc. | Long-acting parathyroid hormone |
| WO2024094673A1 (en) * | 2022-11-02 | 2024-05-10 | Ascendis Pharma Bone Diseases A/S | Pth treatment regimen comprising two pth compounds |
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| ZA9811127B (en) | 1997-12-09 | 2000-07-11 | Lilly Co Eli | Stabilized teriparatide solutions. |
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| US20050124537A1 (en) | 2000-04-27 | 2005-06-09 | Amgen Inc. | Modulators of receptors for parathyroid hormone and parathyroid hormone-related protein |
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