CN102378635A - 重组人白蛋白-人粒细胞集落刺激因子融合蛋白的新稳定制剂 - Google Patents

重组人白蛋白-人粒细胞集落刺激因子融合蛋白的新稳定制剂 Download PDF

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Publication number
CN102378635A
CN102378635A CN2010800127233A CN201080012723A CN102378635A CN 102378635 A CN102378635 A CN 102378635A CN 2010800127233 A CN2010800127233 A CN 2010800127233A CN 201080012723 A CN201080012723 A CN 201080012723A CN 102378635 A CN102378635 A CN 102378635A
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neug
neutropenia
subject
dose
chemotherapy
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CN2010800127233A
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Chinese (zh)
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J·B·博克
A·C·贝尔
J·赫普斯特
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Teva Pharmaceutical Industries Ltd
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Teva Pharmaceutical Industries Ltd
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    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38—Albumins
    • A61K38/385—Serum albumin
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38—Albumins
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/643—Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN2010800127233A 2009-01-16 2010-01-15 重组人白蛋白-人粒细胞集落刺激因子融合蛋白的新稳定制剂 Pending CN102378635A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US14544009P 2009-01-16 2009-01-16
US14543609P 2009-01-16 2009-01-16
US61/145,440 2009-01-16
US61/145,436 2009-01-16
PCT/US2010/021241 WO2010083439A2 (en) 2009-01-16 2010-01-15 Recombinant human albumin-human granulocyte colony stimulating factor for the prevention of neutropenia

Publications (1)

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CN102378635A true CN102378635A (zh) 2012-03-14

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CN2010800127233A Pending CN102378635A (zh) 2009-01-16 2010-01-15 重组人白蛋白-人粒细胞集落刺激因子融合蛋白的新稳定制剂
CN201080012749.8A Expired - Fee Related CN102395379B (zh) 2009-01-16 2010-01-15 重组人白蛋白-人粒细胞集落刺激因子融合蛋白的新稳定制剂

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US (4) US20100227818A1 (enExample)
EP (2) EP2387420A2 (enExample)
JP (2) JP2012515222A (enExample)
KR (2) KR20110132327A (enExample)
CN (2) CN102378635A (enExample)
AU (2) AU2010204552B2 (enExample)
BR (2) BRPI1004940A2 (enExample)
CA (2) CA2749786A1 (enExample)
EA (2) EA023344B1 (enExample)
IL (2) IL214052A0 (enExample)
MX (2) MX2011007583A (enExample)
NZ (2) NZ594055A (enExample)
SG (3) SG172941A1 (enExample)
UA (2) UA105201C2 (enExample)
WO (2) WO2010083439A2 (enExample)
ZA (1) ZA201105171B (enExample)

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CN107206053A (zh) * 2014-11-03 2017-09-26 华鸿新药公司 用于治疗血细胞减少症或减少血细胞减少症的持续时间的佛波醇酯组合物和方法
CN111383745A (zh) * 2018-12-29 2020-07-07 医渡云（北京）技术有限公司 计算机数据处理方法、装置、存储介质及设备
CN112105363A (zh) * 2018-02-01 2020-12-18 大连万春布林医药有限公司 用于通过施用普那布林和g-csf剂来减少化学疗法诱导的嗜中性白血球减少症的组合物和方法
CN114364393A (zh) * 2019-05-31 2022-04-15 光谱制药有限公司 使用g-csf蛋白质复合物治疗的方法
CN114746104A (zh) * 2019-12-05 2022-07-12 韩美药品株式会社 治疗由化疗或放疗引起的中性粒细胞减少症的方法

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CN102628869B (zh) * 2012-04-19 2014-04-02 上海蓝怡科技有限公司 提高甲胎蛋白抗体冻干稳定性的制剂
EP2945703A4 (en) * 2013-01-15 2016-08-31 Teva Pharma ALBU-BCHE FORMULATIONS, PREPARATION THEREOF AND USES THEREOF
US20140271538A1 (en) 2013-03-15 2014-09-18 Teva Pharmaceutical Industries Ltd. Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor for the Prevention of Neutropenia in Pediatric Patients
HK1249052A1 (zh) 2015-03-06 2018-10-26 BeyondSpring Pharmaceuticals Inc. 治疗与ras突变相关的癌症的方法
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JP2018522030A (ja) * 2015-07-30 2018-08-09 エンドール テクノロジーズ, エス.エレ.Endor Technologies, S.L. 膵癌又は大腸癌の治療用コロニー刺激因子
US10912748B2 (en) 2016-02-08 2021-02-09 Beyondspring Pharmaceuticals, Inc. Compositions containing tucaresol or its analogs
CN109475524A (zh) 2016-06-06 2019-03-15 万春药业公司 用于减少中性粒细胞减少症的组合物和方法
CN106222221A (zh) * 2016-08-05 2016-12-14 山东科兴生物制品有限公司 制备重组人粒细胞刺激因子原液的纯化方法
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WO2018187786A1 (en) * 2017-04-07 2018-10-11 La Jolla Institute For Allergy And Immunology Unipotent neutrophil progenitor cells, methods of preparation, and uses thereof
CN109420159A (zh) * 2017-08-23 2019-03-05 江苏泰康生物医药有限公司 一种重组蛋白药物的新型稳定制剂
WO2019147615A1 (en) 2018-01-24 2019-08-01 Beyondspring Pharmaceuticals, Inc. Composition and method for reducing thrombocytopenia via the administration of plinabulin
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US11684655B2 (en) * 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
CN112316120A (zh) * 2019-08-05 2021-02-05 天津派格生物技术有限公司 使用低动员型g-csf有效且安全治疗粒细胞减少症的方法
KR102485892B1 (ko) * 2020-04-09 2023-01-09 주식회사 에이프릴바이오 고양이 과립구 집락 자극인자 및 혈청 알부민에 대한 항원 결합 단편을 포함하는 융합 단백질 및 이의 용도
BR112022020256A2 (pt) 2020-04-09 2023-01-03 Aprilbio Co Ltd “anticorpo monoclonal ou um fragmento de ligação ao antígeno do mesmo, ácido nucleico, vetor de expressão, célula, composição, uso da composição e uso do anticorpo monoclonal ou fragmento de ligação ao antígeno do mesmo
CN111751552B (zh) * 2020-06-18 2022-09-16 广州市伊川生物科技有限公司 一种缺血修饰白蛋白测定试剂盒及其使用方法
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107206053A (zh) * 2014-11-03 2017-09-26 华鸿新药公司 用于治疗血细胞减少症或减少血细胞减少症的持续时间的佛波醇酯组合物和方法
CN112105363A (zh) * 2018-02-01 2020-12-18 大连万春布林医药有限公司 用于通过施用普那布林和g-csf剂来减少化学疗法诱导的嗜中性白血球减少症的组合物和方法
CN111383745A (zh) * 2018-12-29 2020-07-07 医渡云（北京）技术有限公司 计算机数据处理方法、装置、存储介质及设备
CN114364393A (zh) * 2019-05-31 2022-04-15 光谱制药有限公司 使用g-csf蛋白质复合物治疗的方法
CN114746104A (zh) * 2019-12-05 2022-07-12 韩美药品株式会社 治疗由化疗或放疗引起的中性粒细胞减少症的方法

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US20100297062A1 (en) 2010-11-25
US8993519B2 (en) 2015-03-31
SG196821A1 (en) 2014-02-13
EP2387420A2 (en) 2011-11-23
IL214051A0 (en) 2011-08-31
KR20110132326A (ko) 2011-12-07
WO2010083434A3 (en) 2010-09-10
MX2011007582A (es) 2011-12-14
WO2010083439A2 (en) 2010-07-22
EA023344B1 (ru) 2016-05-31
BRPI1004940A2 (pt) 2018-06-19
JP2012515222A (ja) 2012-07-05
CN102395379A (zh) 2012-03-28
BRPI1005159A2 (pt) 2018-04-03
WO2010083439A3 (en) 2010-09-10
JP5753095B2 (ja) 2015-07-22
US8323634B2 (en) 2012-12-04
IL214052A0 (en) 2011-08-31
AU2010204547B2 (en) 2014-01-23
UA105201C2 (uk) 2014-04-25
US20150202268A1 (en) 2015-07-23
NZ594055A (en) 2013-03-28
US20130129669A1 (en) 2013-05-23
US20100227818A1 (en) 2010-09-09
AU2010204552B2 (en) 2014-05-01
SG172941A1 (en) 2011-08-29
KR20110132327A (ko) 2011-12-07
ZA201105171B (en) 2015-12-23
AU2010204547A1 (en) 2011-07-28
EP2387419A2 (en) 2011-11-23
WO2010083434A2 (en) 2010-07-22
SG172940A1 (en) 2011-08-29
JP2012515221A (ja) 2012-07-05
CA2749802C (en) 2016-08-23
MX2011007583A (es) 2011-12-14
NZ594056A (en) 2013-03-28
CN102395379B (zh) 2015-07-22
CA2749802A1 (en) 2010-07-22
EA201190080A1 (ru) 2014-03-31
UA103221C2 (uk) 2013-09-25
CA2749786A1 (en) 2010-07-22
EA201190079A1 (ru) 2013-02-28
AU2010204552A1 (en) 2011-08-04

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Application publication date: 20120314