HRP20192246T1 - Marker za poremećaje kisele sfingomijelinaze i njegova uporaba - Google Patents
Marker za poremećaje kisele sfingomijelinaze i njegova uporaba Download PDFInfo
- Publication number
- HRP20192246T1 HRP20192246T1 HRP20192246TT HRP20192246T HRP20192246T1 HR P20192246 T1 HRP20192246 T1 HR P20192246T1 HR P20192246T T HRP20192246T T HR P20192246TT HR P20192246 T HRP20192246 T HR P20192246T HR P20192246 T1 HRP20192246 T1 HR P20192246T1
- Authority
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- Croatia
- Prior art keywords
- therapeutic agent
- dose
- use according
- subject
- lyso
- Prior art date
Links
- 108010061312 Sphingomyelin Phosphodiesterase Proteins 0.000 title 1
- 102000010126 acid sphingomyelin phosphodiesterase activity proteins Human genes 0.000 title 1
- 239000003550 marker Substances 0.000 title 1
- 239000003814 drug Substances 0.000 claims 28
- 229940124597 therapeutic agent Drugs 0.000 claims 28
- OKTWQKXBJUBAKS-WQADZSDSSA-N 2-[[(e,2r,3s)-2-amino-3-hydroxyoctadec-4-enoxy]-hydroxyphosphoryl]oxyethyl-trimethylazanium;chloride Chemical compound [Cl-].CCCCCCCCCCCCC\C=C\[C@H](O)[C@H](N)COP(O)(=O)OCC[N+](C)(C)C OKTWQKXBJUBAKS-WQADZSDSSA-N 0.000 claims 8
- 208000034012 Acid sphingomyelinase deficiency Diseases 0.000 claims 6
- 239000012472 biological sample Substances 0.000 claims 5
- 208000014060 Niemann-Pick disease Diseases 0.000 claims 3
- 238000012423 maintenance Methods 0.000 claims 3
- 101000785978 Homo sapiens Sphingomyelin phosphodiesterase Proteins 0.000 claims 2
- 239000008280 blood Substances 0.000 claims 2
- 210000004369 blood Anatomy 0.000 claims 2
- 102000048866 human SMPD1 Human genes 0.000 claims 2
- 210000002966 serum Anatomy 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
Classifications
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- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/92—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol, lipoproteins, or their receptors
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y301/00—Hydrolases acting on ester bonds (3.1)
- C12Y301/04—Phosphoric diester hydrolases (3.1.4)
- C12Y301/04012—Sphingomyelin phosphodiesterase (3.1.4.12)
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/90—Enzymes; Proenzymes
- G01N2333/914—Hydrolases (3)
- G01N2333/916—Hydrolases (3) acting on ester bonds (3.1), e.g. phosphatases (3.1.3), phospholipases C or phospholipases D (3.1.4)
- G01N2333/922—Ribonucleases (RNAses); Deoxyribonucleases (DNAses)
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2405/00—Assays, e.g. immunoassays or enzyme assays, involving lipids
- G01N2405/08—Sphingolipids
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/04—Endocrine or metabolic disorders
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Cell Biology (AREA)
- Pathology (AREA)
- General Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Endocrinology (AREA)
- Biophysics (AREA)
- Diabetes (AREA)
- Pulmonology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Genetics & Genomics (AREA)
- General Engineering & Computer Science (AREA)
Claims (12)
1. Terapijsko sredstvo za uporabu u postupku liječenja ljudskog subjekta s nedostatkom kisele sfingomijelinaze (ASMD), naznačeno time što:
(a) subjektu se daje prva doza terapijskog sredstva koja ima prvu koncentraciju za liječenje ASMD-a; i
(b) subjektu se daje druga doza terapijskog sredstva koja ima drugu koncentraciju jednaku ili veću od prve koncentracije ako je za biološki uzorak subjekta utvrđeno da ima razinu lizo-sfingomijelina (lizo-SPM) koja je manja ili jednaka referentnoj razini nakon primjene prve doze,
pri čemu terapijsko sredstvo sadrži rekombinantnu ljudsku kiselu sfingomijelinazu (rhASM),
pri čemu prva doza terapijskog sredstva sadrži 0,03 do 1,0 mg/kg rhASM.
2. Terapijsko sredstvo za uporabu u postupku liječenja ljudskog subjekta s nedostatkom kisele sfingomijelinaze (ASMD), naznačeno time što:
(a) se terapijsko sredstvo opetovano daje subjektu; i
(b) periodično se mjeri razina lizo-sfingomijelina (lizo-SPM) u biološkom uzorku dobivenom nakon primjene doze terapijskog sredstva subjektu, pri čemu smanjenje razine lizo-SPM u odnosu na referentnu razinu ukazuje na djelotvornost terapijskog sredstva,
pri čemu terapijsko sredstvo sadrži rekombinantnu ljudsku kiselu sfingomijelinazu (rhASM),
pri čemu prva doza terapijskog sredstva sadrži 0,03 do 1,0 mg/kg rhASM.
3. Terapijsko sredstvo za uporabu prema patentnom zahtjevu 2, naznačeno time što se razina lizo-sfingomijelina (lizo-SPM) mjeri u biološkom uzorku dobivenom od subjekta od tri dana do 4 tjedna nakon posljednje doze i pri čemu je doza terapijskog sredstva povećane koncentracije.
4. Terapijsko sredstvo za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeno time što je referentna razina osnovna razina lizo-SPM subjekta prije bilo kakvog tretmana terapijskim sredstvom.
5. Terapijsko sredstvo za uporabu prema bilo kojem od patentnih zahtjeva 1-3, naznačeno time što se svaka doza terapijskog sredstva primjenjuje dva tjedna nakon prethodne doze i povećane je koncentracije.
6. Terapijsko sredstvo za uporabu prema patentnom zahtjevu 1, naznačeno time što se svaka doza terapijskog sredstva u određenoj koncentraciji primjenjuje najmanje dva puta.
7. Terapijsko sredstvo za uporabu prema bilo kojem od patentnih zahtjeva 1-6, naznačeno time što se biološki uzorak prikuplja prije primjene sljedeće doze.
8. Terapijsko sredstvo za uporabu prema bilo kojem od patentnih zahtjeva 1-7, naznačeno time što je biološki uzorak puna krv, osušena mrlja krvi, plazma ili serum.
9. Terapijsko sredstvo za uporabu prema bilo kojem od patentnih zahtjeva 1-8, naznačeno time što se terapijsko sredstvo primjenjuje intravenski.
10. Terapijsko sredstvo za uporabu prema bilo kojem od patentnih zahtjeva 1-9, naznačeno time što se dalje primjenjuje doza održavanja terapijskog sredstva, pri čemu je doza održavanja jednaka ili manja od najveće doze terapijskog sredstva koju subjekt podnosi.
11. Terapijsko sredstvo za uporabu prema bilo kojem od patentnih zahtjeva 1-10, naznačeno time što ASMD je Niemann-Pickova bolest (NPD) tip A ili NPD tip B.
12. Terapijsko sredstvo za uporabu prema patentnom zahtjevu 10, naznačeno time što se primjenjuje doza održavanja terapijskog sredstva koja sadrži rhASM u količini 1, 2, ili 3 mg/kg.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361832302P | 2013-06-07 | 2013-06-07 | |
| EP14735056.5A EP3004896B1 (en) | 2013-06-07 | 2014-06-06 | Marker for acid sphingomyelinase disorders and uses thereof |
| PCT/US2014/041405 WO2014197859A1 (en) | 2013-06-07 | 2014-06-06 | Marker for acid sphingomyelinase disorders and uses thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20192246T1 true HRP20192246T1 (hr) | 2020-03-06 |
Family
ID=51062988
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20192246TT HRP20192246T1 (hr) | 2013-06-07 | 2019-12-13 | Marker za poremećaje kisele sfingomijelinaze i njegova uporaba |
Country Status (31)
| Country | Link |
|---|---|
| US (3) | US10022428B2 (hr) |
| EP (2) | EP3004896B1 (hr) |
| JP (4) | JP6457501B2 (hr) |
| KR (3) | KR102228367B1 (hr) |
| CN (2) | CN105474017A (hr) |
| AU (4) | AU2014274670B2 (hr) |
| BR (1) | BR112015030099A2 (hr) |
| CA (1) | CA2914751C (hr) |
| CL (1) | CL2015003563A1 (hr) |
| CR (1) | CR20150638A (hr) |
| DK (1) | DK3004896T3 (hr) |
| EA (1) | EA035342B1 (hr) |
| ES (1) | ES2762608T3 (hr) |
| HK (1) | HK1217534A1 (hr) |
| HR (1) | HRP20192246T1 (hr) |
| HU (1) | HUE047863T2 (hr) |
| IL (3) | IL298675A (hr) |
| LT (1) | LT3004896T (hr) |
| MA (1) | MA38638B1 (hr) |
| MX (1) | MX370570B (hr) |
| MY (1) | MY185990A (hr) |
| NZ (1) | NZ754328A (hr) |
| PH (1) | PH12015502687A1 (hr) |
| PL (1) | PL3004896T3 (hr) |
| PT (1) | PT3004896T (hr) |
| RS (1) | RS59677B1 (hr) |
| SG (2) | SG11201509622WA (hr) |
| SI (1) | SI3004896T1 (hr) |
| UA (1) | UA120591C2 (hr) |
| WO (1) | WO2014197859A1 (hr) |
| ZA (1) | ZA201508630B (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RS59677B1 (sr) * | 2013-06-07 | 2020-01-31 | Genzyme Corp | Marker za poremećaje povezane sa sfingomijelinazom kiselom i njegove upotrebe |
| JP6984854B2 (ja) * | 2015-10-08 | 2021-12-22 | 国立大学法人千葉大学 | ニーマン・ピック病ｃ型を予防または治療するための医薬組成物 |
| IL272757B2 (en) | 2017-08-24 | 2024-07-01 | Sanofi Sa | Recombinant human SPHINGOMYELINASE acid for use in the treatment of abnormal bone conditions, reducing bone marrow load and/or improving bone mineral density |
| TW201925236A (zh) | 2017-10-02 | 2019-07-01 | 美商戴納立製藥公司 | 包含酶替代療法酶之融合蛋白 |
| WO2024026390A2 (en) * | 2022-07-28 | 2024-02-01 | Wylder Nation Foundation | Compositions and methods for diagnosing, treating, and preventing lysosomal storage diseases |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4082781A (en) | 1976-06-04 | 1978-04-04 | The United States Of America As Represented By The Department Of Health, Education And Welfare | Synthesis of 2-alkanoylamino-4-nitrophenyl phosphorylcholine-hydroxide |
| US4039388A (en) | 1976-06-04 | 1977-08-02 | The United States Of America As Represented By The Government | Diagnostic test for Niemann-Pick disease |
| US5773278A (en) * | 1991-05-03 | 1998-06-30 | Mount Sinai Medical Center | Acid sphingomyelinase gene |
| AR034413A1 (es) | 2000-08-25 | 2004-02-25 | Nestor Abel Chamoles | Metodo para determinar la actividad de las enzimas lisosomales |
| US7001994B2 (en) | 2001-01-18 | 2006-02-21 | Genzyme Corporation | Methods for introducing mannose 6-phosphate and other oligosaccharides onto glycoproteins |
| US7615224B2 (en) | 2004-12-02 | 2009-11-10 | Women's And Children's Hospital | Multiplex-bead complex for determination of lysosomal storage disorders |
| JP2006214731A (ja) | 2005-02-01 | 2006-08-17 | Institute Of Physical & Chemical Research | スフィンゴミエリンの検出方法 |
| AU2006333135A1 (en) | 2005-12-15 | 2007-07-12 | The Research Foundation Of State University Of New York | Enzymatic methods for measuring plasma and tissue sphingomylelin and phosphatidylcholine |
| AR059089A1 (es) * | 2006-01-20 | 2008-03-12 | Genzyme Corp | Administracion intraventricular de una enzima para enfermedades de almacenamiento lisosomal |
| US8026099B2 (en) | 2007-07-26 | 2011-09-27 | Washington University | Lipid profile as a biomarker for early detection of neurological disorders |
| US8497122B2 (en) | 2008-04-11 | 2013-07-30 | Washington University | Biomarkers for Niemann-pick C disease and related disorders |
| HUE046598T2 (hu) * | 2009-08-28 | 2020-03-30 | Icahn School Med Mount Sinai | Dóziseszkalációs enzim helyettesítõ terápia savas szfingomielináz elégtelenség kezelésére |
| JP2013002933A (ja) | 2011-06-16 | 2013-01-07 | Hitachi Plant Technologies Ltd | ３次元測位システム |
| DK2780716T3 (da) * | 2011-11-15 | 2019-10-14 | Centogene Ag | Fremgangsmåde til diagnose af Niemann-Pick sygdom |
| CA2912274A1 (en) * | 2013-05-14 | 2014-11-20 | Centogene Ag | Method for the diagnosis of niemann-pick disease |
| RS59677B1 (sr) * | 2013-06-07 | 2020-01-31 | Genzyme Corp | Marker za poremećaje povezane sa sfingomijelinazom kiselom i njegove upotrebe |
-
2014
- 2014-06-06 RS RS20191627A patent/RS59677B1/sr unknown
- 2014-06-06 CA CA2914751A patent/CA2914751C/en active Active
- 2014-06-06 AU AU2014274670A patent/AU2014274670B2/en active Active
- 2014-06-06 KR KR1020167000011A patent/KR102228367B1/ko active IP Right Grant
- 2014-06-06 BR BR112015030099A patent/BR112015030099A2/pt active Search and Examination
- 2014-06-06 IL IL298675A patent/IL298675A/en unknown
- 2014-06-06 LT LTEP14735056.5T patent/LT3004896T/lt unknown
- 2014-06-06 JP JP2016518053A patent/JP6457501B2/ja active Active
- 2014-06-06 CN CN201480043918.2A patent/CN105474017A/zh active Pending
- 2014-06-06 NZ NZ754328A patent/NZ754328A/en unknown
- 2014-06-06 SG SG11201509622WA patent/SG11201509622WA/en unknown
- 2014-06-06 US US14/895,472 patent/US10022428B2/en active Active
- 2014-06-06 WO PCT/US2014/041405 patent/WO2014197859A1/en active Application Filing
- 2014-06-06 PL PL14735056T patent/PL3004896T3/pl unknown
- 2014-06-06 KR KR1020217025969A patent/KR102434244B1/ko active IP Right Grant
- 2014-06-06 DK DK14735056.5T patent/DK3004896T3/da active
- 2014-06-06 SG SG10201709925SA patent/SG10201709925SA/en unknown
- 2014-06-06 EP EP14735056.5A patent/EP3004896B1/en active Active
- 2014-06-06 MA MA38638A patent/MA38638B1/fr unknown
- 2014-06-06 CN CN202210555370.6A patent/CN115128287A/zh active Pending
- 2014-06-06 SI SI201431434T patent/SI3004896T1/sl unknown
- 2014-06-06 HU HUE14735056A patent/HUE047863T2/hu unknown
- 2014-06-06 IL IL284102A patent/IL284102B2/en unknown
- 2014-06-06 EP EP19191053.8A patent/EP3584580A1/en active Pending
- 2014-06-06 KR KR1020217007269A patent/KR102292298B1/ko active IP Right Grant
- 2014-06-06 MY MYPI2015704368A patent/MY185990A/en unknown
- 2014-06-06 MX MX2015016844A patent/MX370570B/es active IP Right Grant
- 2014-06-06 ES ES14735056T patent/ES2762608T3/es active Active
- 2014-06-06 PT PT147350565T patent/PT3004896T/pt unknown
- 2014-06-06 EA EA201592265A patent/EA035342B1/ru not_active IP Right Cessation
- 2014-06-06 UA UAA201600158A patent/UA120591C2/uk unknown
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2015
- 2015-11-23 ZA ZA2015/08630A patent/ZA201508630B/en unknown
- 2015-12-01 PH PH12015502687A patent/PH12015502687A1/en unknown
- 2015-12-04 CL CL2015003563A patent/CL2015003563A1/es unknown
- 2015-12-04 CR CR20150638A patent/CR20150638A/es unknown
- 2015-12-06 IL IL242964A patent/IL242964B/en unknown
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2016
- 2016-05-11 HK HK16105373.8A patent/HK1217534A1/zh unknown
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2018
- 2018-02-09 AU AU2018200977A patent/AU2018200977B2/en active Active
- 2018-06-08 US US16/003,598 patent/US10888607B2/en active Active
- 2018-12-19 JP JP2018236856A patent/JP6835806B2/ja active Active
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2019
- 2019-12-13 HR HRP20192246TT patent/HRP20192246T1/hr unknown
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2020
- 2020-10-22 AU AU2020257114A patent/AU2020257114B2/en active Active
- 2020-12-11 US US17/119,035 patent/US11998592B2/en active Active
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2021
- 2021-02-03 JP JP2021015390A patent/JP7414750B2/ja active Active
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2023
- 2023-02-23 AU AU2023201062A patent/AU2023201062A1/en active Pending
- 2023-12-27 JP JP2023220385A patent/JP2024038145A/ja active Pending
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