JP2024530152A - 皮下単位剤形 - Google Patents

皮下単位剤形 Download PDF

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Publication number
JP2024530152A
JP2024530152A JP2024506201A JP2024506201A JP2024530152A JP 2024530152 A JP2024530152 A JP 2024530152A JP 2024506201 A JP2024506201 A JP 2024506201A JP 2024506201 A JP2024506201 A JP 2024506201A JP 2024530152 A JP2024530152 A JP 2024530152A
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JP
Japan
Prior art keywords
biologic
unit dosage
dosage form
fcrn
efgartigimod
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2024506201A
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English (en)
Japanese (ja)
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JP2024530152A5 (https=
Inventor
ジャコバ マリア ヴァン ブラフト アントワネッタ
ウルリッツ ピーター
ホフマン エリック
ヴェルヘーセン ピーター
Original Assignee
アルジェニクス ビーブイ
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Application filed by アルジェニクス ビーブイ filed Critical アルジェニクス ビーブイ
Publication of JP2024530152A publication Critical patent/JP2024530152A/ja
Publication of JP2024530152A5 publication Critical patent/JP2024530152A5/ja
Pending legal-status Critical Current

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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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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
    • C07K16/283—Immunoglobulins [IG], 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 against Fc-receptors, e.g. CD16, CD32, CD64
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2024506201A 2021-08-02 2022-08-02 皮下単位剤形 Pending JP2024530152A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163203856P 2021-08-02 2021-08-02
US63/203,856 2021-08-02
PCT/IB2022/000443 WO2023012515A2 (en) 2021-08-02 2022-08-02 Subcutaneous unit dosage forms

Publications (2)

Publication Number Publication Date
JP2024530152A true JP2024530152A (ja) 2024-08-16
JP2024530152A5 JP2024530152A5 (https=) 2025-08-13

Family

ID=83192179

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024506201A Pending JP2024530152A (ja) 2021-08-02 2022-08-02 皮下単位剤形

Country Status (11)

Country Link
US (1) US20240325528A1 (https=)
EP (1) EP4380618A2 (https=)
JP (1) JP2024530152A (https=)
KR (1) KR20240040104A (https=)
CN (1) CN117897172A (https=)
AU (1) AU2022322077A1 (https=)
CA (1) CA3228105A1 (https=)
IL (1) IL310608A (https=)
MX (1) MX2024001631A (https=)
TW (1) TW202320849A (https=)
WO (1) WO2023012515A2 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3081144A1 (en) 2017-12-08 2019-06-13 Argenx Bvba Use of fcrn antagonists for treatment of generalized myasthenia gravis
US12202900B2 (en) 2018-06-08 2025-01-21 argenx BV Compositions and methods for treating immune thrombocytopenia
JP2023509195A (ja) 2020-01-08 2023-03-07 アルジェニクス ビーブイ 天疱瘡症を治療する方法
CN119365209A (zh) * 2022-04-26 2025-01-24 阿根思有限公司 用于使用fcrn拮抗剂治疗大疱性类天疱疮的方法
CN119698429A (zh) 2022-06-15 2025-03-25 阿根思有限公司 Fcrn结合分子及使用方法
WO2025233684A1 (en) * 2024-05-10 2025-11-13 argenx BV Subcutaneous formulations, pre-filled syringes and methods of use thereof

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7871607B2 (en) 2003-03-05 2011-01-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases
NZ542873A (en) 2003-03-05 2008-07-31 Halozyme Inc Soluble, neutral-active hyaluronidase activity glycoprotein (sHASEGP) that is produced with high yield in a mammalian expression system by introducing nucleic acids that lack a narrow region encoding amino acids in the carboxy terminus of the human PH20 cDNA
SI4269578T1 (sl) 2008-03-06 2024-07-31 Halozyme, Inc. Sestava topne hialuronidaze
EA022752B1 (ru) 2008-12-09 2016-02-29 Галозим, Инк. Длинные растворимые полипептиды рн20 и их использование
HUE028832T2 (en) * 2009-09-17 2017-01-30 Baxalta Inc Stable co-formulation of hyaluronidase and immunoglobulin, as well as a process for its preparation
WO2013102144A2 (en) 2011-12-30 2013-07-04 Halozyme, Inc. Ph20 polypeptede variants, formulations and uses thereof
CA3081144A1 (en) * 2017-12-08 2019-06-13 Argenx Bvba Use of fcrn antagonists for treatment of generalized myasthenia gravis
MX2020009824A (es) 2018-07-25 2021-01-15 Alteogen Inc Nuevas variantes de hialuronidasa y composicion farmaceutica que comprende la misma.
KR102650991B1 (ko) 2019-03-25 2024-03-27 (주)알테오젠 인간 히알루로니다제 ph20의 변이체와 약물을 포함하는 피하투여용 약학 조성물
JP2023509195A (ja) * 2020-01-08 2023-03-07 アルジェニクス ビーブイ 天疱瘡症を治療する方法

Also Published As

Publication number Publication date
WO2023012515A2 (en) 2023-02-09
IL310608A (en) 2024-04-01
WO2023012515A3 (en) 2023-04-06
CN117897172A (zh) 2024-04-16
KR20240040104A (ko) 2024-03-27
US20240325528A1 (en) 2024-10-03
TW202320849A (zh) 2023-06-01
AU2022322077A1 (en) 2024-02-08
CA3228105A1 (en) 2023-02-09
MX2024001631A (es) 2024-04-19
EP4380618A2 (en) 2024-06-12

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