CN110831627A - 用于治疗慢性炎症性脱髓鞘性多发性神经病的免疫球蛋白产品 - Google Patents
用于治疗慢性炎症性脱髓鞘性多发性神经病的免疫球蛋白产品 Download PDFInfo
- Publication number
- CN110831627A CN110831627A CN201880025896.5A CN201880025896A CN110831627A CN 110831627 A CN110831627 A CN 110831627A CN 201880025896 A CN201880025896 A CN 201880025896A CN 110831627 A CN110831627 A CN 110831627A
- Authority
- CN
- China
- Prior art keywords
- immunoglobulin product
- immunoglobulin
- administered
- product
- dose
- 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
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Classifications
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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
- A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- 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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- 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
- A61K47/16—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
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Public Health (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762488219P | 2017-04-21 | 2017-04-21 | |
| US62/488,219 | 2017-04-21 | ||
| EP17177134 | 2017-06-21 | ||
| EP17177134.8 | 2017-06-21 | ||
| US201762571812P | 2017-10-13 | 2017-10-13 | |
| US62/571,812 | 2017-10-13 | ||
| PCT/EP2018/060158 WO2018193078A1 (en) | 2017-04-21 | 2018-04-20 | Immunoglobulin products for use in the treatment of chronic inflammatory demyelinating polyneuropathy |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN110831627A true CN110831627A (zh) | 2020-02-21 |
Family
ID=62063037
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201880025896.5A Pending CN110831627A (zh) | 2017-04-21 | 2018-04-20 | 用于治疗慢性炎症性脱髓鞘性多发性神经病的免疫球蛋白产品 |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US20200055922A1 (https=) |
| EP (1) | EP3612221A1 (https=) |
| JP (2) | JP7275044B2 (https=) |
| CN (1) | CN110831627A (https=) |
| AU (2) | AU2018253931A1 (https=) |
| CA (1) | CA3060169A1 (https=) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100074885A1 (en) * | 2008-03-17 | 2010-03-25 | Richard Schiff | Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase |
| US20110066111A1 (en) * | 2009-09-17 | 2011-03-17 | Wolfgang Teschner | Stable co-formulation of hyaluronidase and immunoglobulin, and methods of use thereof |
| CN103080129A (zh) * | 2010-04-08 | 2013-05-01 | 巴塞尔大学医院 | 用于治疗和预防免疫重建炎症综合征(iris)的血浆衍生的免疫球蛋白 |
| CN103118705A (zh) * | 2010-07-19 | 2013-05-22 | 分馏及生物技术法国实验室 | 浓缩人免疫球蛋白组合物 |
| CN104958761A (zh) * | 2010-05-26 | 2015-10-07 | 巴克斯特国际公司 | 从血浆制备富含IgG的组合物的方法 |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019224304A1 (en) * | 2018-05-23 | 2019-11-28 | Csl Behring Ag | Treatment of cidp |
-
2018
- 2018-04-20 EP EP18720203.1A patent/EP3612221A1/en active Pending
- 2018-04-20 CA CA3060169A patent/CA3060169A1/en active Pending
- 2018-04-20 AU AU2018253931A patent/AU2018253931A1/en not_active Abandoned
- 2018-04-20 US US16/606,605 patent/US20200055922A1/en active Pending
- 2018-04-20 CN CN201880025896.5A patent/CN110831627A/zh active Pending
- 2018-04-20 JP JP2019556864A patent/JP7275044B2/ja active Active
-
2023
- 2023-05-01 JP JP2023075372A patent/JP7621411B2/ja active Active
-
2025
- 2025-04-02 AU AU2025202358A patent/AU2025202358A1/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100074885A1 (en) * | 2008-03-17 | 2010-03-25 | Richard Schiff | Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase |
| US20110066111A1 (en) * | 2009-09-17 | 2011-03-17 | Wolfgang Teschner | Stable co-formulation of hyaluronidase and immunoglobulin, and methods of use thereof |
| CN103080129A (zh) * | 2010-04-08 | 2013-05-01 | 巴塞尔大学医院 | 用于治疗和预防免疫重建炎症综合征(iris)的血浆衍生的免疫球蛋白 |
| CN104958761A (zh) * | 2010-05-26 | 2015-10-07 | 巴克斯特国际公司 | 从血浆制备富含IgG的组合物的方法 |
| CN103118705A (zh) * | 2010-07-19 | 2013-05-22 | 分馏及生物技术法国实验室 | 浓缩人免疫球蛋白组合物 |
Non-Patent Citations (4)
| Title |
|---|
| CSL BEHRING: "Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)(NCT01545076)" * |
| L. H. MARKVARDSEN: "Subcutaneous immunoglobulin as first-line therapy in treatment-naive patients with chronic inflammatory demyelinating polyneuropathy: randomized controlled trial study" * |
| 马培奇;: "美FDA批准延长皮下注射用人免疫球蛋白制剂Hizentra的保质期至24个月" * |
| 马培奇;: "美FDA批准第一种免疫球蛋白皮下输注剂Hizentra用作原发性免疫缺陷患者替代治疗" * |
Also Published As
| Publication number | Publication date |
|---|---|
| JP7275044B2 (ja) | 2023-05-17 |
| JP7621411B2 (ja) | 2025-01-24 |
| US20200055922A1 (en) | 2020-02-20 |
| EP3612221A1 (en) | 2020-02-26 |
| AU2025202358A1 (en) | 2025-04-24 |
| CA3060169A1 (en) | 2018-10-25 |
| JP2020517636A (ja) | 2020-06-18 |
| AU2018253931A1 (en) | 2019-11-21 |
| JP2023099143A (ja) | 2023-07-11 |
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| Date | Code | Title | Description |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |