CN117858722A - 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 - Google Patents
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 Download PDFInfo
- Publication number
- CN117858722A CN117858722A CN202280054611.7A CN202280054611A CN117858722A CN 117858722 A CN117858722 A CN 117858722A CN 202280054611 A CN202280054611 A CN 202280054611A CN 117858722 A CN117858722 A CN 117858722A
- Authority
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- China
- Prior art keywords
- antibody
- formulation
- arginine hydrochloride
- polysorbate
- injection
- 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
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title claims abstract description 20
- 108090001005 Interleukin-6 Proteins 0.000 title claims abstract description 18
- 201000010099 disease Diseases 0.000 title claims abstract description 15
- 239000012669 liquid formulation Substances 0.000 title abstract description 7
- 239000000203 mixture Substances 0.000 claims abstract description 175
- 238000009472 formulation Methods 0.000 claims abstract description 170
- 238000010254 subcutaneous injection Methods 0.000 claims abstract description 10
- 239000007929 subcutaneous injection Substances 0.000 claims abstract description 10
- 239000000872 buffer Substances 0.000 claims description 71
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical group OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims description 66
- 229960003589 arginine hydrochloride Drugs 0.000 claims description 66
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 58
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 58
- 229920000053 polysorbate 80 Polymers 0.000 claims description 58
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- 229930006000 Sucrose Natural products 0.000 claims description 46
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 46
- 239000005720 sucrose Substances 0.000 claims description 46
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims description 43
- 229930182817 methionine Natural products 0.000 claims description 43
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 43
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- DPVHGFAJLZWDOC-PVXXTIHASA-N (2r,3s,4s,5r,6r)-2-(hydroxymethyl)-6-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-3,4,5-triol;dihydrate Chemical compound O.O.O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 DPVHGFAJLZWDOC-PVXXTIHASA-N 0.000 claims description 10
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- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims description 3
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- 125000000487 histidyl group Chemical class [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 11
- 208000002267 Anti-neutrophil cytoplasmic antibody-associated vasculitis Diseases 0.000 claims 1
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- 239000003708 ampul Substances 0.000 claims 1
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- 102000005962 receptors Human genes 0.000 description 36
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- 150000002411 histidines Chemical class 0.000 description 29
- 150000003839 salts Chemical class 0.000 description 26
- 229940100601 interleukin-6 Drugs 0.000 description 19
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 15
- 210000004027 cell Anatomy 0.000 description 15
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 14
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 14
- 229960002885 histidine Drugs 0.000 description 14
- 239000004475 Arginine Substances 0.000 description 11
- 229960003121 arginine Drugs 0.000 description 11
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 11
- 239000007974 sodium acetate buffer Substances 0.000 description 11
- 102000004889 Interleukin-6 Human genes 0.000 description 10
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- 108090000623 proteins and genes Proteins 0.000 description 8
- 238000012216 screening Methods 0.000 description 8
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 description 8
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 7
- 102000004169 proteins and genes Human genes 0.000 description 7
- 239000000523 sample Substances 0.000 description 7
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 6
- 238000012375 Ion exchange chromatography - high performance liquid chromatography Methods 0.000 description 6
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 6
- 239000003513 alkali Substances 0.000 description 6
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
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- 239000000178 monomer Substances 0.000 description 5
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- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 4
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- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 4
- 238000010257 thawing Methods 0.000 description 4
- QZNNVYOVQUKYSC-JEDNCBNOSA-N (2s)-2-amino-3-(1h-imidazol-5-yl)propanoic acid;hydron;chloride Chemical compound Cl.OC(=O)[C@@H](N)CC1=CN=CN1 QZNNVYOVQUKYSC-JEDNCBNOSA-N 0.000 description 3
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- 102000010781 Interleukin-6 Receptors Human genes 0.000 description 2
- 108010038501 Interleukin-6 Receptors Proteins 0.000 description 2
- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-Proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 description 2
- BVHLGVCQOALMSV-JEDNCBNOSA-N L-lysine hydrochloride Chemical compound Cl.NCCCC[C@H](N)C(O)=O BVHLGVCQOALMSV-JEDNCBNOSA-N 0.000 description 2
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 description 2
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- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 description 2
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- 241000894006 Bacteria Species 0.000 description 1
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- 102100037792 Interleukin-6 receptor subunit alpha Human genes 0.000 description 1
- 208000000770 Non-ST Elevated Myocardial Infarction Diseases 0.000 description 1
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- 125000000637 arginyl group Chemical group N[C@@H](CCCNC(N)=N)C(=O)* 0.000 description 1
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- PXEDJBXQKAGXNJ-QTNFYWBSSA-L disodium L-glutamate Chemical compound [Na+].[Na+].[O-]C(=O)[C@@H](N)CCC([O-])=O PXEDJBXQKAGXNJ-QTNFYWBSSA-L 0.000 description 1
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- 238000000703 high-speed centrifugation Methods 0.000 description 1
- 230000016784 immunoglobulin production Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 108040006858 interleukin-6 receptor activity proteins Proteins 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
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- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 1
- 229910000404 tripotassium phosphate Inorganic materials 0.000 description 1
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Classifications
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
- C07K16/248—IL-6
-
- 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
- C07K2317/90—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)
- Organic Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Rheumatology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Medicinal Preparation (AREA)
- Physical Education & Sports Medicine (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNPCT/CN2021/113273 | 2021-08-18 | ||
| CN2021113273 | 2021-08-18 | ||
| CNPCT/CN2022/077411 | 2022-02-23 | ||
| CN2022077411 | 2022-02-23 | ||
| PCT/CN2022/113202 WO2023020563A1 (fr) | 2021-08-18 | 2022-08-18 | Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à l'il-6 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117858722A true CN117858722A (zh) | 2024-04-09 |
Family
ID=85240061
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202280054611.7A Pending CN117858722A (zh) | 2021-08-18 | 2022-08-18 | 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 |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN117858722A (fr) |
| WO (1) | WO2023020563A1 (fr) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| TWI505838B (zh) * | 2010-01-20 | 2015-11-01 | Chugai Pharmaceutical Co Ltd | Stabilized antibody solution containing |
| CR20180465A (es) * | 2016-03-07 | 2019-03-04 | Sanofi Biotechnology | Composiciones y métodos para tratar artritis reumatoide |
| JP2021504482A (ja) * | 2017-11-30 | 2021-02-15 | バイオ−テラ ソリュ−ションズ，エルティーディー． | Ｉｌ‐６関連疾患を治療するためのヒト化抗体の液体製剤 |
| WO2022037606A1 (fr) * | 2020-08-19 | 2022-02-24 | Bio-Thera Solutions, Ltd. | Formulations liquides comprenant des anticorps humanisés à concentrations élevées pour le traitement de maladies liées à il-6 |
-
2022
- 2022-08-18 WO PCT/CN2022/113202 patent/WO2023020563A1/fr active Application Filing
- 2022-08-18 CN CN202280054611.7A patent/CN117858722A/zh active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| WO2023020563A1 (fr) | 2023-02-23 |
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