CN116782876A - 高浓度抗c5制剂 - Google Patents

高浓度抗c5制剂 Download PDF

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Publication number
CN116782876A
CN116782876A CN202080069383.1A CN202080069383A CN116782876A CN 116782876 A CN116782876 A CN 116782876A CN 202080069383 A CN202080069383 A CN 202080069383A CN 116782876 A CN116782876 A CN 116782876A
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CN
China
Prior art keywords
approximately
water
arginine
histidine
sucrose
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
CN202080069383.1A
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English (en)
Chinese (zh)
Inventor
玛丽·克莱普
马扬克·帕特尔
汤晓林
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Regeneron Pharmaceuticals Inc
Original Assignee
Regeneron Pharmaceuticals Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=72560889&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN116782876(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of CN116782876A publication Critical patent/CN116782876A/zh
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08—Solutions
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
CN202080069383.1A 2019-08-16 2020-08-14 高浓度抗c5制剂 Pending CN116782876A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962888086P 2019-08-16 2019-08-16
US62/888,086 2019-08-16
PCT/US2020/046314 WO2021034639A1 (en) 2019-08-16 2020-08-14 High concentration anti-c5 formulations

Publications (1)

Publication Number Publication Date
CN116782876A true CN116782876A (zh) 2023-09-19

Family

ID=72560889

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080069383.1A Pending CN116782876A (zh) 2019-08-16 2020-08-14 高浓度抗c5制剂

Country Status (15)

Country Link
US (1) US20210046182A1 (cg-RX-API-DMAC10.html)
EP (1) EP4013784A1 (cg-RX-API-DMAC10.html)
JP (2) JP7813222B2 (cg-RX-API-DMAC10.html)
KR (1) KR20220047826A (cg-RX-API-DMAC10.html)
CN (1) CN116782876A (cg-RX-API-DMAC10.html)
AU (1) AU2020334880A1 (cg-RX-API-DMAC10.html)
BR (1) BR112022002831A2 (cg-RX-API-DMAC10.html)
CA (1) CA3145621A1 (cg-RX-API-DMAC10.html)
CL (1) CL2022000340A1 (cg-RX-API-DMAC10.html)
CO (1) CO2022001097A2 (cg-RX-API-DMAC10.html)
IL (1) IL290034A (cg-RX-API-DMAC10.html)
JO (1) JOP20220030A1 (cg-RX-API-DMAC10.html)
MX (1) MX2022001896A (cg-RX-API-DMAC10.html)
PH (1) PH12022550167A1 (cg-RX-API-DMAC10.html)
WO (1) WO2021034639A1 (cg-RX-API-DMAC10.html)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119454939A (zh) * 2024-11-28 2025-02-18 北海康成(苏州)生物制药有限公司 一种欧莫扑拜单抗原液及其制备方法
WO2026011779A1 (zh) * 2024-07-10 2026-01-15 凯莱英医药集团（天津）股份有限公司 制备Cemdisiran的方法

Families Citing this family (14)

* Cited by examiner, † Cited by third party
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PT2970974T (pt) 2013-03-14 2017-11-29 Alnylam Pharmaceuticals Inc Composições de irna de componente do complemento c5 e métodos para a sua utilização
CN112545886A (zh) 2015-03-10 2021-03-26 里珍纳龙药品有限公司 无菌刺穿系统和方法
IL263481B2 (en) 2016-06-14 2024-06-01 Regeneron Pharma Anti-c5 antibodies and uses thereof
CA3055583A1 (en) 2017-05-05 2018-11-08 Regeneron Pharmaceuticals, Inc. Auto-injector
AU2018383751B2 (en) 2017-12-13 2025-05-08 Regeneron Pharmaceuticals, Inc. Anti-C5 antibody combinations and uses thereof
EP4423271A2 (en) 2021-10-28 2024-09-04 Regeneron Pharmaceuticals, Inc. Crispr/cas-related methods and compositions for knocking out c5
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector
AR130041A1 (es) * 2022-07-27 2024-10-30 Cephalon Llc Formulaciones de anticuerpos anti-tl1a
CN119894931A (zh) * 2022-07-27 2025-04-25 赛福伦有限责任公司 用于治疗溃疡性结肠炎和克罗恩病的抗tl1a抗体
JP2025536552A (ja) * 2022-10-28 2025-11-07 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗Ｃ５抗体／Ｃ５ ｉＲＮＡ合剤および併用療法
WO2024259313A1 (en) 2023-06-16 2024-12-19 Regeneron Pharamceuticals, Inc. Medical device packaging and related methods
CN116712390B (zh) * 2023-08-04 2023-11-14 上海览屹医药科技有限公司 一种高浓度高稳定性的抗体制剂及其制备方法
TW202529831A (zh) 2023-10-02 2025-08-01 美商再生元醫藥公司 藥物遞輸裝置安全系統
US20260221053A1 (en) 2025-01-29 2026-07-30 Regeneron Pharmaceuticals, Inc. Drug delivery devices, safety systems, training devices, and methods of use thereof

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US20080071063A1 (en) * 2006-02-03 2008-03-20 Medimmune, Inc. Protein Formulations
US20170355757A1 (en) * 2016-06-14 2017-12-14 Regeneron Pharmaceuticals, Inc. Anti-c5 antibodies and uses thereof
WO2019023564A1 (en) * 2017-07-27 2019-01-31 Alexion Pharmaceutical, Inc. ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5981501A (en) 1995-06-07 1999-11-09 Inex Pharmaceuticals Corp. Methods for encapsulating plasmids in lipid bilayers
CA2289702C (en) 1997-05-14 2008-02-19 Inex Pharmaceuticals Corp. High efficiency encapsulation of charged therapeutic agents in lipid vesicles
CA2489174C (en) 2002-07-10 2013-02-05 Thomas Tuschl Rna-interference by single-stranded rna molecules
ITMI20021527A1 (it) 2002-07-11 2004-01-12 Consiglio Nazionale Ricerche Anticorpi anti componente c5 del complemento e loro uso
JP5419709B2 (ja) 2007-01-09 2014-02-19 ワイス・エルエルシー 抗ｉｌ−１３抗体製剤およびその使用
EP2279254B1 (en) 2008-04-15 2017-07-05 Protiva Biotherapeutics Inc. Novel lipid formulations for nucleic acid delivery
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
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KR20220038506A (ko) 2009-06-10 2022-03-28 알닐람 파마슈티칼스 인코포레이티드 향상된 지질 조성물
PT2970974T (pt) 2013-03-14 2017-11-29 Alnylam Pharmaceuticals Inc Composições de irna de componente do complemento c5 e métodos para a sua utilização
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US20080071063A1 (en) * 2006-02-03 2008-03-20 Medimmune, Inc. Protein Formulations
US20170355757A1 (en) * 2016-06-14 2017-12-14 Regeneron Pharmaceuticals, Inc. Anti-c5 antibodies and uses thereof
WO2019023564A1 (en) * 2017-07-27 2019-01-31 Alexion Pharmaceutical, Inc. ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION

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SHUJING WANG，ET AL: "Viscosity-Lowering Effect of Amino Acids and Salts on Highly Concentrated Solutions of Two IgG1 Monoclonal Antibodies", MOLECULAR PHARMACEUTICS, vol. 12, no. 12, 3 November 2015 (2015-11-03), pages 1 - 3 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026011779A1 (zh) * 2024-07-10 2026-01-15 凯莱英医药集团（天津）股份有限公司 制备Cemdisiran的方法
CN119454939A (zh) * 2024-11-28 2025-02-18 北海康成(苏州)生物制药有限公司 一种欧莫扑拜单抗原液及其制备方法

Also Published As

Publication number Publication date
CA3145621A1 (en) 2021-02-25
US20210046182A1 (en) 2021-02-18
AU2020334880A1 (en) 2022-03-24
JP7813222B2 (ja) 2026-02-12
BR112022002831A2 (pt) 2022-06-28
WO2021034639A4 (en) 2021-04-15
CO2022001097A2 (es) 2022-03-08
JOP20220030A1 (ar) 2023-01-30
JP2022544589A (ja) 2022-10-19
EP4013784A1 (en) 2022-06-22
JP2026003133A (ja) 2026-01-09
PH12022550167A1 (en) 2023-05-08
WO2021034639A1 (en) 2021-02-25
CL2022000340A1 (es) 2022-10-07
MX2022001896A (es) 2022-06-02
IL290034A (en) 2022-03-01
KR20220047826A (ko) 2022-04-19

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