BR112017006112A2 - formulação de proteína de fusão recombinante - Google Patents

formulação de proteína de fusão recombinante

Info

Publication number
BR112017006112A2
BR112017006112A2 BR112017006112A BR112017006112A BR112017006112A2 BR 112017006112 A2 BR112017006112 A2 BR 112017006112A2 BR 112017006112 A BR112017006112 A BR 112017006112A BR 112017006112 A BR112017006112 A BR 112017006112A BR 112017006112 A2 BR112017006112 A2 BR 112017006112A2
Authority
BR
Brazil
Prior art keywords
recombinant fusion
fusion protein
protein formulation
stabilizer
surfactant
Prior art date
Application number
BR112017006112A
Other languages
English (en)
Other versions
BR112017006112B1 (pt
Inventor
Li Junfeng
Huang Xiaole
Wang Yinjue
Original Assignee
Innovent Biologics 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
Application filed by Innovent Biologics Inc filed Critical Innovent Biologics Inc
Publication of BR112017006112A2 publication Critical patent/BR112017006112A2/pt
Publication of BR112017006112B1 publication Critical patent/BR112017006112B1/pt

Links

Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/711—Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K9/0012—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere

Abstract

trata-se de uma formulação líquida que permite o armazenamento estável de proteínas de fusão recombinantes, que compreende uma proteína de fusão recombinante, um sal de tampão, um estabilizador e um tensoativo.
BR112017006112-0A 2014-09-25 2015-09-25 Formulação de proteína de fusão recombinante BR112017006112B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2014104979374 2014-09-25
CN201410497937.4A CN105435222B (zh) 2014-09-25 2014-09-25 重组融合蛋白制剂
PCT/CN2015/090777 WO2016045626A1 (zh) 2014-09-25 2015-09-25 重组融合蛋白制剂

Publications (2)

Publication Number Publication Date
BR112017006112A2 true BR112017006112A2 (pt) 2017-12-19
BR112017006112B1 BR112017006112B1 (pt) 2023-12-26

Family

ID=55546140

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017006112-0A BR112017006112B1 (pt) 2014-09-25 2015-09-25 Formulação de proteína de fusão recombinante

Country Status (10)

Country Link
US (1) US10293045B2 (pt)
EP (1) EP3199179B1 (pt)
JP (1) JP6196419B1 (pt)
CN (1) CN105435222B (pt)
AU (1) AU2015320084B2 (pt)
BR (1) BR112017006112B1 (pt)
CA (1) CA2962480C (pt)
DK (1) DK3199179T3 (pt)
ES (1) ES2905614T3 (pt)
WO (1) WO2016045626A1 (pt)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9840553B2 (en) 2014-06-28 2017-12-12 Kodiak Sciences Inc. Dual PDGF/VEGF antagonists
KR20180104635A (ko) 2015-12-30 2018-09-21 코디악 사이언시스 인코포레이티드 항체 및 이의 접합체
WO2019099965A1 (en) * 2017-11-20 2019-05-23 Just Biotherapeutics, Inc. Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof
CN107988292B (zh) * 2018-01-18 2023-12-26 江苏江山聚源生物技术有限公司 提高重组人源胶原蛋白稳定性的发酵工艺
CN108671229B (zh) * 2018-05-08 2022-03-25 华博生物医药技术（上海）有限公司 一种重组人血管内皮生长因子受体-抗体融合蛋白的药物组合制剂
WO2019217927A1 (en) 2018-05-10 2019-11-14 Regeneron Pharmaceuticals, Inc. High concentration vegf receptor fusion protein containing formulations
EP3878461A4 (en) * 2018-11-09 2022-08-17 Jiangsu Hengrui Medicine Co., Ltd. PHARMACEUTICAL COMPOSITION OF TGF-BETA RECEPTOR FUSION PROTEIN AND USE THEREOF
CN114786731A (zh) 2019-10-10 2022-07-22 科达制药股份有限公司 治疗眼部病症的方法
JP2023509880A (ja) * 2019-12-24 2023-03-10 イノベント バイオロジクス（スーチョウ）カンパニー，リミティド 加齢黄斑変性の治療における融合タンパク質の使用
WO2022017468A1 (zh) * 2020-07-23 2022-01-27 信达生物制药(苏州)有限公司 Pd-l1/lag-3双特异性抗体制剂及其制备方法和用途

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK1861116T3 (en) * 2005-03-25 2015-11-09 Regeneron Pharma VEGF antagonist formulations
JP2009516692A (ja) 2005-11-22 2009-04-23 ワイス 免疫グロブリン融合タンパク質製剤
CN101664378B (zh) * 2008-09-06 2012-11-21 浙江我武生物科技股份有限公司 一种重组人血清白蛋白与干扰素α融合蛋白的药物组合物
CN102380096B (zh) * 2010-08-31 2014-04-30 成都康弘生物科技有限公司 一种含有抑制血管增生的融合蛋白的药物组合物及用途
CA2857168C (en) * 2011-12-01 2020-10-27 Protevobio, Inc. Protein inhibitors to complement and vegf pathways and methods of use thereof
CN107115294B (zh) * 2012-01-19 2019-10-18 北京康弘生物医药有限公司 一种含有vegf拮抗剂的滴眼液
CN104940926B (zh) 2014-09-25 2017-09-22 信达生物制药(苏州)有限公司 重组融合蛋白制剂

Also Published As

Publication number Publication date
ES2905614T3 (es) 2022-04-11
DK3199179T3 (da) 2022-02-07
US20190038746A1 (en) 2019-02-07
JP2017535557A (ja) 2017-11-30
CA2962480A1 (en) 2016-03-31
CA2962480C (en) 2019-06-04
BR112017006112B1 (pt) 2023-12-26
CN105435222A (zh) 2016-03-30
WO2016045626A1 (zh) 2016-03-31
EP3199179A4 (en) 2017-11-29
EP3199179B1 (en) 2021-12-01
AU2015320084B2 (en) 2018-01-25
AU2015320084A1 (en) 2017-04-20
JP6196419B1 (ja) 2017-09-13
CN105435222B (zh) 2018-05-29
EP3199179A1 (en) 2017-08-02
US10293045B2 (en) 2019-05-21

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/09/2015, OBSERVADAS AS CONDICOES LEGAIS