EP4199965A4 - Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à il-6 - Google Patents
Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à il-6Info
- Publication number
- EP4199965A4 EP4199965A4 EP21857698.1A EP21857698A EP4199965A4 EP 4199965 A4 EP4199965 A4 EP 4199965A4 EP 21857698 A EP21857698 A EP 21857698A EP 4199965 A4 EP4199965 A4 EP 4199965A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- treating
- humanized antibodies
- high concentrations
- related diseases
- liquid formulations
- 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
Links
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
- A61K9/08—Solutions
-
- 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
- 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
- A61K47/26—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
- A61K9/0012—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
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
- C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- 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
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Rheumatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Microbiology (AREA)
- Physical Education & Sports Medicine (AREA)
- Genetics & Genomics (AREA)
- Pain & Pain Management (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2020109965 | 2020-08-19 | ||
| PCT/CN2021/113241 WO2022037606A1 (fr) | 2020-08-19 | 2021-08-18 | Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à il-6 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP4199965A1 EP4199965A1 (fr) | 2023-06-28 |
| EP4199965A4 true EP4199965A4 (fr) | 2025-03-26 |
Family
ID=80322555
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP21857698.1A Pending EP4199965A4 (fr) | 2020-08-19 | 2021-08-18 | Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à il-6 |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4199965A4 (fr) |
| CN (1) | CN116261448A (fr) |
| WO (1) | WO2022037606A1 (fr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102546471B1 (ko) * | 2016-09-27 | 2023-06-21 | 프레제니우스 카비 도이치란트 게엠베하 | 액상의 약학 조성물 |
| WO2023020563A1 (fr) * | 2021-08-18 | 2023-02-23 | Bio-Thera Solutions, Ltd. | Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à l'il-6 |
| CN121240883A (zh) * | 2023-05-26 | 2025-12-30 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10022319B2 (en) * | 2010-01-20 | 2018-07-17 | Chugai Seiyaku Kabushiki Kaisha | Stabilized antibody-containing liquid formulations |
| WO2019105450A1 (fr) * | 2017-11-30 | 2019-06-06 | 百奥泰生物制药股份有限公司 | Préparation liquide d'anticorps humanisé pour le traitement d'une maladie liée à l'il-6 |
| WO2023020563A1 (fr) * | 2021-08-18 | 2023-02-23 | Bio-Thera Solutions, Ltd. | Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à l'il-6 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20160058863A1 (en) * | 2014-09-03 | 2016-03-03 | Board Of Regents, The University Of Texas System | Low viscosity concentrated protein dispersions |
| CN108718522A (zh) * | 2016-02-23 | 2018-10-30 | 赛森生物股份有限公司 | Il-6拮抗剂制剂及其用途 |
| WO2017201731A1 (fr) * | 2016-05-27 | 2017-11-30 | Beijing Vdjbio Co., Ltd. | Anticorps, composition et kits les comprenant et leurs procédés d'utilisation |
| KR102546471B1 (ko) * | 2016-09-27 | 2023-06-21 | 프레제니우스 카비 도이치란트 게엠베하 | 액상의 약학 조성물 |
| US20200140547A1 (en) * | 2017-05-26 | 2020-05-07 | The Johns Hopkins University | Multifunctional antibody-ligand traps to modulate immune tolerance |
| CN111110841A (zh) * | 2018-10-31 | 2020-05-08 | 上海君实生物医药科技股份有限公司 | 含有抗pcsk9抗体的稳定制剂 |
-
2021
- 2021-08-18 CN CN202180051028.6A patent/CN116261448A/zh active Pending
- 2021-08-18 EP EP21857698.1A patent/EP4199965A4/fr active Pending
- 2021-08-18 WO PCT/CN2021/113241 patent/WO2022037606A1/fr not_active Ceased
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10022319B2 (en) * | 2010-01-20 | 2018-07-17 | Chugai Seiyaku Kabushiki Kaisha | Stabilized antibody-containing liquid formulations |
| WO2019105450A1 (fr) * | 2017-11-30 | 2019-06-06 | 百奥泰生物制药股份有限公司 | Préparation liquide d'anticorps humanisé pour le traitement d'une maladie liée à l'il-6 |
| WO2023020563A1 (fr) * | 2021-08-18 | 2023-02-23 | Bio-Thera Solutions, Ltd. | Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à l'il-6 |
Non-Patent Citations (2)
| Title |
|---|
| KANG JICHAO ET AL: "Rapid Formulation Development for Monoclonal Antibodies", vol. 14, no. 4, 12 April 2016 (2016-04-12), pages 40, 42, 44, 46, XP009532716, ISSN: 1542-6319, Retrieved from the Internet <URL:https://bioprocessintl.com/manufacturing/formulation/rapid-formulation-development-for-monoclonal-antibodies/> * |
| See also references of WO2022037606A1 * |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2022037606A1 (fr) | 2022-02-24 |
| EP4199965A1 (fr) | 2023-06-28 |
| CN116261448A (zh) | 2023-06-13 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
|
| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
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| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE |
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| 17P | Request for examination filed |
Effective date: 20230307 |
|
| AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
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| DAV | Request for validation of the european patent (deleted) | ||
| DAX | Request for extension of the european patent (deleted) | ||
| A4 | Supplementary search report drawn up and despatched |
Effective date: 20250224 |
|
| RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61P 29/00 20060101ALI20250218BHEP Ipc: A61P 19/02 20060101ALI20250218BHEP Ipc: A61K 47/18 20170101ALI20250218BHEP Ipc: A61K 9/08 20060101ALI20250218BHEP Ipc: A61K 39/395 20060101AFI20250218BHEP |