JP7579888B2 - 治療用固形製剤 - Google Patents

治療用固形製剤 Download PDF

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Publication number
JP7579888B2
JP7579888B2 JP2022574098A JP2022574098A JP7579888B2 JP 7579888 B2 JP7579888 B2 JP 7579888B2 JP 2022574098 A JP2022574098 A JP 2022574098A JP 2022574098 A JP2022574098 A JP 2022574098A JP 7579888 B2 JP7579888 B2 JP 7579888B2
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Prior art keywords
dimethyltryptamine
solid formulation
compounds
disorder
solid
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JP2022574098A
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English (en)
Japanese (ja)
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JP2023527575A (ja
JPWO2021244831A5 (https=
JP2023527575A5 (https=
Inventor
ランズ，ピーター
ベンウェイ，ティファニー
ジョエル，ゼラ
レイゼル，マリー
ジェイムズ，エレン
Original Assignee
サイビン ユーケー リミテッド
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Priority claimed from PCT/EP2020/065244 external-priority patent/WO2020245133A1/en
Priority claimed from US17/108,938 external-priority patent/US20220169606A1/en
Priority claimed from GBGB2018950.2A external-priority patent/GB202018950D0/en
Priority claimed from US17/108,679 external-priority patent/US20220168274A1/en
Priority claimed from GBGB2018955.1A external-priority patent/GB202018955D0/en
Priority claimed from US17/208,583 external-priority patent/US11773062B2/en
Priority claimed from GB2103981.3A external-priority patent/GB2605144A/en
Application filed by サイビン ユーケー リミテッド filed Critical サイビン ユーケー リミテッド
Publication of JP2023527575A publication Critical patent/JP2023527575A/ja
Publication of JP2023527575A5 publication Critical patent/JP2023527575A5/ja
Publication of JPWO2021244831A5 publication Critical patent/JPWO2021244831A5/ja
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
    • C07D209/04—Indoles; Hydrogenated indoles
    • C07D209/10—Indoles; Hydrogenated indoles with substituted hydrocarbon radicals attached to carbon atoms of the hetero ring
    • C07D209/14—Radicals substituted by nitrogen atoms, not forming part of a nitro radical
    • C07D209/16—Tryptamines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B59/00—Introduction of isotopes of elements into organic compounds ; Labelled organic compounds per se
    • C07B59/002—Heterocyclic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/05—Isotopically modified compounds, e.g. labelled

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2022574098A 2020-06-02 2021-05-13 治療用固形製剤 Active JP7579888B2 (ja)

Applications Claiming Priority (21)

Application Number Priority Date Filing Date Title
PCT/EP2020/065244 WO2020245133A1 (en) 2019-06-03 2020-06-02 Therapeutic compositions comprising deuterated or partially deuterated n,n-dimethyltryptamine compounds
GB2008303.6 2020-06-02
EPPCT/EP2020/065244 2020-06-02
GB2008303.6A GB2585978B (en) 2019-06-03 2020-06-02 Therapeutic compositions
US16/890,664 US11771681B2 (en) 2019-06-03 2020-06-02 Therapeutic compounds
US16/890,664 2020-06-02
GBGB2018950.2A GB202018950D0 (en) 2020-12-01 2020-12-01 Parenteral formulation
GBGB2018955.1A GB202018955D0 (en) 2020-12-01 2020-12-01 Compositions and compounds for bioanalysis
US17/108,679 2020-12-01
US17/108,938 2020-12-01
US17/108,938 US20220169606A1 (en) 2020-12-01 2020-12-01 Compositions and compounds for bioanalysis
GB2018955.1 2020-12-01
GB2018950.2 2020-12-01
US17/108,679 US20220168274A1 (en) 2020-12-01 2020-12-01 Parenteral Formulation
US17/208,583 US11773062B2 (en) 2021-03-22 2021-03-22 Deuterated compounds
US17/208,583 2021-03-22
GB2103981.3A GB2605144A (en) 2021-03-22 2021-03-22 Deuterated compounds
GB2103981.3 2021-03-22
EPPCT/EP2021/060750 2021-04-23
PCT/EP2021/060750 WO2021116503A2 (en) 2020-06-02 2021-04-23 Deuterated compounds
PCT/EP2021/062794 WO2021244831A1 (en) 2020-06-02 2021-05-13 Therapeutic solid dosage forms

Publications (4)

Publication Number Publication Date
JP2023527575A JP2023527575A (ja) 2023-06-29
JPWO2021244831A5 JPWO2021244831A5 (https=) 2024-04-16
JP2023527575A5 JP2023527575A5 (https=) 2024-04-16
JP7579888B2 true JP7579888B2 (ja) 2024-11-08

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JP2022574098A Active JP7579888B2 (ja) 2020-06-02 2021-05-13 治療用固形製剤

Country Status (8)

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EP (3) EP3902541B1 (https=)
JP (1) JP7579888B2 (https=)
CN (1) CN115996713A (https=)
AU (1) AU2021284861A1 (https=)
CA (1) CA3118556A1 (https=)
GB (1) GB2595776B (https=)
IL (1) IL298542B2 (https=)
WO (2) WO2021116503A2 (https=)

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GB201907871D0 (en) 2019-06-03 2019-07-17 Small Pharma Ltd Therapeutic compositions
JP7422473B2 (ja) 2019-11-07 2024-01-26 サイビン ユーケー リミテッド 合成方法
MX2022009528A (es) 2020-02-04 2022-11-14 Mindset Pharma Inc Derivados de 3-pirrolidina-indol como agentes psicodélicos serotoninérgicos para el tratamiento de trastornos del snc.
PH12022551981A1 (en) 2020-02-04 2023-10-16 Mindset Pharma Inc Psilocin derivatives as serotonergic psychedelic agents for the treatment of cns disorders
AU2021268204A1 (en) 2020-05-08 2022-12-08 Psilera Inc. Novel compositions of matter and pharmaceutical compositions
KR20240096817A (ko) 2020-05-19 2024-06-26 사이빈 아이알엘 리미티드 중수소화된 트립타민 유도체 및 사용 방법
US11773062B2 (en) 2021-03-22 2023-10-03 Small Pharma Ltd Deuterated compounds
US12042564B2 (en) 2020-06-02 2024-07-23 Cybin Uk Ltd Therapeutic solid dosage forms
CA3146880C (en) * 2020-07-29 2023-07-18 Gregory Ellis Delivery system for ayahuasca-like substances
US12122741B2 (en) 2020-08-18 2024-10-22 Cybin Irl Limited Therapeutic phenethylamine compositions and methods of use
US11406619B2 (en) 2020-08-28 2022-08-09 Small Pharma Ltd Injectable formulations
US11660289B2 (en) 2020-12-01 2023-05-30 Small Pharma Ltd. Deuterated or partially deuterated N,N-dimethyltryptamine compounds
WO2022117640A1 (en) 2020-12-01 2022-06-09 Small Pharma Ltd Inhalable formulations
IL303288A (en) * 2020-12-01 2023-07-01 Small Pharma Ltd N,N-Dimethyltryptamine compounds partially or fully deuterated
US12521370B2 (en) 2020-12-01 2026-01-13 Cybin Uk Ltd Inhalable formulations
WO2022120181A1 (en) * 2020-12-03 2022-06-09 Mydecine Innovations Group Inc. Novel psilocin analog compositions and methods of synthesizing the same
IL308816A (en) 2021-05-25 2024-01-01 Atai Therapeutics Inc New n,n-dimethyltryptamine salts and crystalline salt forms
MX2023014620A (es) 2021-06-09 2024-01-30 Atai Therapeutics Inc Nuevos profarmacos y conjugados de dimetiltriptamina.
US11697638B2 (en) 2021-09-08 2023-07-11 Small Pharma Ltd 5-methoxy-N,N-dimethyltryptamine crystalline forms
EP4159201A1 (en) 2021-09-30 2023-04-05 Biomind Labs Inc Encapsulated microparticles and nanoparticles of dimethyltriptamines
US12318477B2 (en) 2021-11-18 2025-06-03 Cybin Uk Ltd Injectable and inhalable formulations
MX2024005955A (es) 2021-11-18 2024-06-11 Cybin Uk Ltd Formulaciones inyectables e inhalables.
JP2024545787A (ja) * 2021-12-30 2024-12-11 アタイ セラピューティクス， インコーポレイテッド 一酸化窒素送達剤としてのジメチルトリプタミン類似体
US20250051279A1 (en) * 2022-01-14 2025-02-13 Cybin Irl Limited Tryptamine compositions and methods
WO2023168023A1 (en) 2022-03-04 2023-09-07 Reset Pharmaceuticals, Inc. Co-crystals or salts comprising psilocin
AU2023242469A1 (en) * 2022-03-31 2024-09-05 Cybin Irl Limited Combination of nitrous oxide and 5-ht2a receptor agonists
EP4522167A1 (en) 2022-05-10 2025-03-19 Mydecine Innovations Group Inc. Novel psilocin prodrug compounds and methods of synthesizing the same
EP4618981A1 (en) 2022-11-17 2025-09-24 Remedi, Inc. Combinations of monoamine oxidase inhibitors and serotonin receptor agonists and their therapeutic use

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JP2011016835A (ja) 2001-06-21 2011-01-27 Sigma Tau Ind Farmaceut Riunite Spa ５−ｈｔ６および／または５−ｈｔ７セロトニン受容体のリガンドとして使用される５−ハロ−トリプタミン誘導体
JP2015117185A (ja) 2013-12-17 2015-06-25 コンサート ファーマシューティカルズ インコーポレイテッド ルキソリチニブの重水素化誘導体
WO2019081764A1 (en) 2017-10-26 2019-05-02 Consejo Superior De Investigaciones Científicas (Csic) ASSOCIATION PRODUCT FOR THE TREATMENT OF NEUROLOGICAL AND / OR PSYCHIATRIC DISORDERS

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JP7422473B2 (ja) * 2019-11-07 2024-01-26 サイビン ユーケー リミテッド 合成方法

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JP2011016835A (ja) 2001-06-21 2011-01-27 Sigma Tau Ind Farmaceut Riunite Spa ５−ｈｔ６および／または５−ｈｔ７セロトニン受容体のリガンドとして使用される５−ハロ−トリプタミン誘導体
JP2015117185A (ja) 2013-12-17 2015-06-25 コンサート ファーマシューティカルズ インコーポレイテッド ルキソリチニブの重水素化誘導体
WO2019081764A1 (en) 2017-10-26 2019-05-02 Consejo Superior De Investigaciones Científicas (Csic) ASSOCIATION PRODUCT FOR THE TREATMENT OF NEUROLOGICAL AND / OR PSYCHIATRIC DISORDERS

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Biochem Pharmacology，1986年，Vol.35, No.17，p.2893-2896
Frontiers in Neuroscience，2018年，Vol.12, Article 536，p.1-17
MORRIS; ET AL，INDOLEALKYLAMINE METABOLISM: SYNTHESIS OF DEUTERATED INDOLEAKYLAMINES AS METABOLIC PROBES，JOURNAL OF LABELLED COMPOUNDS AND RADIOPHARMACEUTICALS，1993年，VOL:33, NO:6，PAGE(S):455 - 465，http://dx.doi.org/10.1002/jlcr.2580330603
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SIMON D BRANDT; ET AL，MICROWAVE-ACCELERATED SYNTHESIS OF PSYCHOACTIVE DEUTERATED N , 以下備考，JOURNAL OF LABELLED COMPOUNDS AND RADIOPHARMACEUTICALS，英国，2008年11月，VOL:51, NO:14，PAGE(S):423 - 429，http://dx.doi.org/10.1002/jlcr.1557，N -DIALKYLATED-[ [ALPHA] , [ALPHA] , [BETA] , [BETA]-D 4 ]-TRYPTAMINES

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EP4149460B1 (en) 2024-11-27
WO2021116503A2 (en) 2021-06-17
CA3118556A1 (en) 2021-12-02
WO2021116503A3 (en) 2023-09-28
EP3902541B1 (en) 2022-09-14
EP4494703A3 (en) 2025-04-02
EP4494703A2 (en) 2025-01-22
IL298542B2 (en) 2025-02-01
WO2021244831A1 (en) 2021-12-09
EP4149460B8 (en) 2025-01-08
EP4149460A1 (en) 2023-03-22
GB202106881D0 (en) 2021-06-30
IL298542A (en) 2023-01-01
GB2595776B (en) 2023-05-24
AU2021284861A1 (en) 2023-01-05
GB2595776A (en) 2021-12-08
IL298542B1 (en) 2024-10-01
WO2021116503A8 (en) 2021-08-12
JP2023527575A (ja) 2023-06-29
EP3902541A2 (en) 2021-11-03
EP4149460C0 (en) 2024-11-27
CN115996713A (zh) 2023-04-21

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