BR112018005349A2 - preparação farmacêutica de anticorpo anti-pd-1 estável e sua aplicação em medicamentos - Google Patents

preparação farmacêutica de anticorpo anti-pd-1 estável e sua aplicação em medicamentos

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Publication number
BR112018005349A2
BR112018005349A2 BR112018005349-0A BR112018005349A BR112018005349A2 BR 112018005349 A2 BR112018005349 A2 BR 112018005349A2 BR 112018005349 A BR112018005349 A BR 112018005349A BR 112018005349 A2 BR112018005349 A2 BR 112018005349A2
Authority
BR
Brazil
Prior art keywords
antibody
application
medicine
antibody preparation
pharmaceutical preparation
Prior art date
Application number
BR112018005349-0A
Other languages
English (en)
Chinese (zh)
Inventor
Li Jie
Yan Zhen
Wang Pingping
Fang Yan
Tao Weikang
Zhang Lianshan
Sun Piaoyang
Original Assignee
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Jiangsu Hengrui Medicine Co.,Ltd.
Shanghai Hengrui Pharmaceutical Co., Ltd.
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 Suzhou Suncadia Biopharmaceuticals Co., Ltd., Jiangsu Hengrui Medicine Co.,Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd. filed Critical Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Publication of BR112018005349A2 publication Critical patent/BR112018005349A2/pt

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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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/12—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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • 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

Abstract

a presente invenção refere-se a uma preparação farmacêutica de anticorpo anti-pd-1 estável e uma aplicação desta em um medicamento. a preparação farmacêutica de anticorpo anti-pd-1 compreende um anticorpo anti-pd-1, um tampão e pode ainda compreender pelo menos um tipo de estabilizante, e opcionalmente pode ainda compreender um surfactante. a preparação farmacêutica de anticorpo anti-pd-1 da presente invenção pode efetivamente suprimir a agregação e a desamidação de anticorpos, evitando assim a degradação de um produto de anticorpo, obtendo uma preparação farmacêutica injetada estável.
BR112018005349-0A 2015-09-28 2016-09-14 preparação farmacêutica de anticorpo anti-pd-1 estável e sua aplicação em medicamentos BR112018005349A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201510629020 2015-09-28
CN201510629020.X 2015-09-28
PCT/CN2016/098982 WO2017054646A1 (zh) 2015-09-28 2016-09-14 一种抗pd-1抗体制剂及其在医药上的应用

Publications (1)

Publication Number Publication Date
BR112018005349A2 true BR112018005349A2 (pt) 2018-10-09

Family

ID=58422670

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018005349-0A BR112018005349A2 (pt) 2015-09-28 2016-09-14 preparação farmacêutica de anticorpo anti-pd-1 estável e sua aplicação em medicamentos

Country Status (13)

Country Link
US (2) US10786567B2 (pt)
EP (1) EP3357508A4 (pt)
JP (1) JP6921062B2 (pt)
KR (1) KR20180054791A (pt)
CN (1) CN106999591B (pt)
AU (1) AU2016329960A1 (pt)
BR (1) BR112018005349A2 (pt)
CA (1) CA2999079A1 (pt)
MX (1) MX2018003306A (pt)
RU (1) RU2731418C2 (pt)
TW (1) TWI721020B (pt)
UA (1) UA124259C2 (pt)
WO (1) WO2017054646A1 (pt)

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Also Published As

Publication number Publication date
JP6921062B2 (ja) 2021-08-18
RU2018110333A3 (pt) 2019-12-30
CA2999079A1 (en) 2017-04-06
US10786567B2 (en) 2020-09-29
TW201711699A (zh) 2017-04-01
RU2731418C2 (ru) 2020-09-02
CN106999591A (zh) 2017-08-01
RU2018110333A (ru) 2019-10-28
EP3357508A4 (en) 2019-04-24
TWI721020B (zh) 2021-03-11
UA124259C2 (uk) 2021-08-18
MX2018003306A (es) 2018-05-16
KR20180054791A (ko) 2018-05-24
WO2017054646A1 (zh) 2017-04-06
JP2018532730A (ja) 2018-11-08
AU2016329960A1 (en) 2018-04-26
US20210000954A1 (en) 2021-01-07
CN106999591B (zh) 2021-02-23
EP3357508A1 (en) 2018-08-08
US20180339045A1 (en) 2018-11-29

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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.

B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]