JP7032412B2 - 抗ceacam6抗体及び使用方法 - Google Patents
抗ceacam6抗体及び使用方法 Download PDFInfo
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- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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- 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
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- 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
- A61K47/6415—Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
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- 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
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- 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
- A61K47/6851—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 the antibody targeting a determinant of a tumour cell
- A61K47/6857—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 the antibody targeting a determinant of a tumour cell the tumour determinant being from lung cancer cell
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
- A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
- A61K51/04—Organic compounds
- A61K51/08—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
- A61K51/10—Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody
- A61K51/1045—Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants
- A61K51/1048—Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants the tumor cell determinant being a carcino embryonic antigen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3023—Lung
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/44—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57473—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving carcinoembryonic antigen, i.e. CEA
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- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- 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
- A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
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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
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/705—Assays involving receptors, cell surface antigens or cell surface determinants
- G01N2333/70503—Immunoglobulin superfamily, e.g. VCAMs, PECAM, LFA-3
Description
本出願は、その内容全体があらゆる目的のために参照により本明細書に援用される、2016年10月10日に出願されたシンガポール出願番号第10201608481W号の優先権の利益を主張する。
以下は、本発明の記載を理解するのに役立ち得るいくつかの定義である。これらは一般的な定義として意図されており、本発明の範囲を決してそれらの用語だけに限定するべきではないが、以下の記載をよりよく理解するために述べられている。
Claims (31)
- (i)アミノ酸配列GNTFTSYVMH(配列番号3)を有するVHCDR1、アミノ酸配列YINPYNDGTKYNEKFKG(配列番号4)を有するVHCDR2、及びアミノ酸配列STARATPYFYAMDY(配列番号5)を有するVHCDR3を含む重鎖可変ドメインと、(ii)アミノ酸配列KSSQSLLWSVNQNSYLS(配列番号6)を有するVLCDR1、アミノ酸配列GASIRES(配列番号7)を有するVLCDR2、及びアミノ酸配列QHNHGSFLPYT(配列番号8)を有するVLCDR3を含む軽鎖可変ドメインとを含む抗原結合タンパク質又はその抗原結合断片であって、CEACAM6に結合する、抗原結合タンパク質又はその抗原結合断片。
- 重鎖可変領域が、配列番号1に記載のアミノ酸配列SGPELVKPGASVKMSCKASGNTFTSYVMHWVKQKPGQGLEWIGYINPYNDGTKYNEKFKGKATLTSDKSSSTAYMELSSLTSEDSAVYYCARSTARATPYFYAMDYWGQGTSVTVSSを含む、請求項1に記載の抗原結合タンパク質又はその抗原結合断片。
- 軽鎖可変領域が、配列番号2に記載のアミノ酸配列DILMTQSPSSLAVTAGEKVTMRCKSSQSLLWSVNQNSYLSWYQLKQGQPPKLLLYGASIRESWVPDRFTGSGSGTDFTLTISNVHVEDLAVYYCQHNHGSFLPYTFGGGTKLEIKを含む、請求項1に記載の抗原結合タンパク質又はその抗原結合断片。
- 抗原結合タンパク質が、モノクローナル、組み換え、ポリクローナル、キメラ、ヒト化、二重特異性及びヘテロコンジュゲート抗体;キメラ抗原受容体(CAR)、抗原結合断片、免疫学的に有効な断片、単鎖Fv、ヒンジ領域を欠く一価抗体、ミニボディ、ダイアボディ、並びにTandabs(商標)からなる群から選択される、請求項1から3のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片。
- 結合タンパク質がモノクローナル抗体である、請求項4に記載の抗原結合タンパク質又はその抗原結合断片。
- モノクローナル抗体がヒト化されている、請求項5に記載の抗原結合タンパク質又はその抗原結合断片。
- モノクローナル抗体がキメラである、請求項5に記載の抗原結合タンパク質又はその抗原結合断片。
- 抗原結合タンパク質又はその抗原結合断片が、CEACAM6上のグリカンに結合する、請求項1から7のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片。
- 抗原結合タンパク質又はその抗原結合断片が、CEACAM6上のN-結合グリカンに結合する、請求項8に記載の抗原結合タンパク質又はその抗原結合断片。
- コンジュゲートした放射性同位体又は細胞毒素を含む、請求項1から9のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片。
- 抗体が、モノメチルアウリスタチンE(MMAE)、メルタンシン(DM-1)、サポリン、ゲムシタビン、イリノテカン、エトポシド、ビンブラスチン、ペメトレキセド、ドセタキセル、パクリタキセル、白金製剤、ビノレルビン、カペシタビン、ミトキサントロン、イクサベピロン、エリブリン、5-フルオロウラシル、トリフルリジン及びチピラシルからなる群から選択される細胞毒素とコンジュゲートされている、請求項10に記載の抗原結合タンパク質又はその抗原結合断片。
- 抗原結合タンパク質又は抗原結合断片が、CEACAM6に結合した際に細胞中に内部移行する、請求項1から11のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片。
- 抗原結合タンパク質又は抗原結合断片が、CEACAM6に結合した際に細胞中に内部移行しない、請求項1から11のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片。
- 抗原結合タンパク質又は抗原結合断片が、ゲフィチニブ耐性の肺がん細胞、非小細胞性肺がん細胞、乳がん細胞、結腸直腸がん細胞に選択的に結合する、請求項1から13のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片。
- 生理学的に許容される担体、及び治療有効量の、請求項1から14のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片を含む組成物。
- 1つ又は複数のさらなる治療化合物を含む、請求項15に記載の組成物。
- がんを治療又は予防するための医薬の製造における、請求項1から14のいずれか一項に記載の抗原結合タンパク質若しくはその抗原結合断片、又は請求項15若しくは請求項16に記載の組成物の使用。
- がんが、ゲフィチニブ耐性の肺がん、非小細胞性肺がん、乳がん、胃がん、小腸がん、食道がん及び結腸直腸がんからなる群から選択される、請求項17に記載の使用。
- 医薬が、1つ又は複数のさらなる活性医薬成分とともに投与される、請求項17又は請求項18に記載の使用。
- 医薬が、化学療法が実施される際に投与される、請求項17又は請求項18に記載の使用。
- 1つ若しくは複数のさらなる活性医薬成分が、前記医薬と別々に、同時に若しくは逐次的に投与され、又は、化学療法が、前記医薬と別々に、同時に若しくは逐次的に実施される、請求項19又は20に記載の使用。
- 対象においてがんを検出するための方法であって、前記対象から得られる試料を、請求項1から14のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片とin vitroで接触させるステップ;前記試料中の前記抗原結合タンパク質又はその抗原結合断片の結合を検出するステップ;前記結合を対照試料中の結合レベルと相関させて、前記試料中の結合レベルを決定するステップを含み、前記対照試料と比較した前記試料中の結合レベルの増加が、がんであることを示す、方法。
- がんに罹患しやすい対象を特定するための方法であって、前記対象から得られる試料を、請求項1から14のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片とin vitroで接触させるステップ;前記試料中の前記抗原結合タンパク質又はその抗原結合断片の結合を検出するステップ;前記結合を対照試料中の結合レベルと相関させて、前記試料中の結合レベルを決定するステップを含み、前記対照試料と比較した前記試料中の結合レベルの増加が、前記対象ががんに罹患しやすいことを示す、方法。
- 対照試料が、同じ対象由来のものである、請求項22又は23に記載の方法。
- 対照試料が、異なる対象由来のものである、請求項22又は23に記載の方法。
- 抗原結合タンパク質又はその抗原結合断片が、検出可能な標識を含む、請求項22から25のいずれか一項に記載の方法。
- 検出可能な標識が、蛍光標識、化学発光標識、酵素標識及び放射性核種標識からなる群から選択される、請求項26に記載の方法。
- 検出可能な標識が、ビオチン、アルカリホスファターゼ、ホースラディッシュペルオキシダーゼ、FITC、PE及びCy色素からなる群から選択される、請求項26又は請求項27に記載の方法。
- 検出可能な標識が、フローサイトメトリー、組織切片、免疫蛍光法、免疫細胞化学法又は免疫組織化学法から選択されるアッセイにおいて検出される、請求項26から28のいずれか一項に記載の方法。
- がんが、ゲフィチニブ耐性の肺がん、非小細胞性肺がん、乳がん、胃がん、小腸がん、食道がん及び結腸直腸がんからなる群から選択される、請求項22から29のいずれか一項に記載の方法。
- 請求項22から30のいずれか一項に記載の方法において使用するときのキットであって、使用説明書と一緒に、請求項1から14のいずれか一項に記載の抗原結合タンパク質又はその抗原結合断片を含むキット。
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Application Number | Priority Date | Filing Date | Title |
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SG10201608481W | 2016-10-10 | ||
SG10201608481W | 2016-10-10 | ||
PCT/SG2017/050509 WO2018070936A1 (en) | 2016-10-10 | 2017-10-10 | Anti-ceacam6 antibodies and methods of use |
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JP2020510631A JP2020510631A (ja) | 2020-04-09 |
JP7032412B2 true JP7032412B2 (ja) | 2022-03-08 |
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US (2) | US11236160B2 (ja) |
EP (1) | EP3523333B1 (ja) |
JP (1) | JP7032412B2 (ja) |
KR (1) | KR102580319B1 (ja) |
CN (1) | CN110139874B (ja) |
AU (1) | AU2017343377A1 (ja) |
BR (1) | BR112019007272A2 (ja) |
CA (1) | CA3039886A1 (ja) |
ES (1) | ES2968264T3 (ja) |
SG (1) | SG11201903178QA (ja) |
WO (1) | WO2018070936A1 (ja) |
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CN116621980A (zh) * | 2020-10-21 | 2023-08-22 | 北京纽安博生物技术有限公司 | 抗ceacam6单域抗体及其融合蛋白和应用 |
BR112023024141A2 (pt) * | 2021-05-21 | 2024-01-30 | Agency Science Tech & Res | Moléculas de ligação ao antígeno anti-ceacam5/6 e métodos de tratamento das mesmas |
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CN110139874A (zh) | 2019-08-16 |
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US11820821B2 (en) | 2023-11-21 |
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EP3523333C0 (en) | 2023-12-13 |
WO2018070936A1 (en) | 2018-04-19 |
KR102580319B1 (ko) | 2023-09-19 |
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AU2017343377A1 (en) | 2019-05-02 |
EP3523333A1 (en) | 2019-08-14 |
US20220213189A1 (en) | 2022-07-07 |
CN110139874B (zh) | 2023-04-14 |
US11236160B2 (en) | 2022-02-01 |
EP3523333B1 (en) | 2023-12-13 |
SG11201903178QA (en) | 2019-05-30 |
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