CN106999581A - 含有高浓度抗vegf抗体的稳定蛋白质溶液剂型 - Google Patents

含有高浓度抗vegf抗体的稳定蛋白质溶液剂型 Download PDF

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Publication number
CN106999581A
CN106999581A CN201580060665.4A CN201580060665A CN106999581A CN 106999581 A CN106999581 A CN 106999581A CN 201580060665 A CN201580060665 A CN 201580060665A CN 106999581 A CN106999581 A CN 106999581A
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pharmaceutical composition
aqueous pharmaceutical
concentration
sucrose
buffer
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CN201580060665.4A
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Chinese (zh)
Inventor
张惠湘
C·博灵
A·库尔诗瑞施塔
曾宇红
万里
L·埃兰尼
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Novartis AG
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Novartis AG
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Application filed by Novartis AG filed Critical Novartis AG
Priority to CN202511153148.3A priority Critical patent/CN120938921A/zh
Publication of CN106999581A publication Critical patent/CN106999581A/zh
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/12—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for looking at the eye fundus, e.g. ophthalmoscopes
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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    • 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
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    • 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
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    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • A—HUMAN NECESSITIES
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    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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    • C07K2317/522—CH1 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/567—Framework region [FR]
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
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    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
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    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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CN201580060665.4A 2014-11-07 2015-11-06 含有高浓度抗vegf抗体的稳定蛋白质溶液剂型 Pending CN106999581A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202511153148.3A CN120938921A (zh) 2014-11-07 2015-11-06 含有高浓度抗vegf抗体的稳定蛋白质溶液剂型

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201462076770P 2014-11-07 2014-11-07
US62/076,770 2014-11-07
US201462088061P 2014-12-05 2014-12-05
US62/088,061 2014-12-05
PCT/US2015/059571 WO2016073915A1 (en) 2014-11-07 2015-11-06 Stable protein solution formulation containing high concentration of an anti-vegf antibody

Related Child Applications (1)

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CN202511153148.3A Division CN120938921A (zh) 2014-11-07 2015-11-06 含有高浓度抗vegf抗体的稳定蛋白质溶液剂型

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CN106999581A true CN106999581A (zh) 2017-08-01

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CN201580060665.4A Pending CN106999581A (zh) 2014-11-07 2015-11-06 含有高浓度抗vegf抗体的稳定蛋白质溶液剂型
CN201580060416.5A Pending CN107635580A (zh) 2014-11-07 2015-11-06 治疗眼病的方法
CN202111376360.8A Pending CN114081951A (zh) 2014-11-07 2015-11-06 治疗眼病的方法
CN202511153148.3A Pending CN120938921A (zh) 2014-11-07 2015-11-06 含有高浓度抗vegf抗体的稳定蛋白质溶液剂型

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CN201580060416.5A Pending CN107635580A (zh) 2014-11-07 2015-11-06 治疗眼病的方法
CN202111376360.8A Pending CN114081951A (zh) 2014-11-07 2015-11-06 治疗眼病的方法
CN202511153148.3A Pending CN120938921A (zh) 2014-11-07 2015-11-06 含有高浓度抗vegf抗体的稳定蛋白质溶液剂型

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US (5) US10689438B2 (enExample)
EP (3) EP3215122B1 (enExample)
JP (6) JP6753848B2 (enExample)
KR (4) KR20170082526A (enExample)
CN (4) CN106999581A (enExample)
AU (6) AU2015342818B2 (enExample)
BR (2) BR112017008093A2 (enExample)
CA (1) CA2966646A1 (enExample)
CL (2) CL2017001115A1 (enExample)
CO (1) CO2017004596A2 (enExample)
EA (1) EA201790989A1 (enExample)
EC (1) ECSP17034829A (enExample)
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PH (3) PH12021550147A1 (enExample)
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CN111433223A (zh) * 2017-11-29 2020-07-17 普罗塞纳生物科学有限公司 抗甲状腺素运载蛋白单克隆抗体的冻干制剂
CN111699004A (zh) * 2018-02-06 2020-09-22 豪夫迈·罗氏有限公司 眼科疾病的治疗
CN111867631A (zh) * 2018-03-16 2020-10-30 诺华股份有限公司 治疗眼部疾病的方法
CN112004827A (zh) * 2018-03-23 2020-11-27 艾伯维德国有限责任两合公司 稳定的水性抗tau抗体调配物
CN112839683A (zh) * 2018-10-10 2021-05-25 安斯泰来制药株式会社 含有标记部-抗人抗体Fab片段复合物的药物组合物
CN113194993A (zh) * 2018-12-18 2021-07-30 诺华股份有限公司 含高浓度抗vegf抗体的蛋白质溶液配制品
WO2021233408A1 (zh) * 2020-05-21 2021-11-25 迈威(上海)生物科技股份有限公司 抗α-溶血素的抗体及其稳定制剂
CN113940997A (zh) * 2021-12-21 2022-01-18 迈威(上海)生物科技股份有限公司 一种双特异性抗体的稳定制剂
WO2024056058A1 (zh) * 2022-09-16 2024-03-21 齐鲁制药有限公司 一种稳定的高浓度自缓冲药物组合物

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RU2653753C1 (ru) 2008-06-25 2018-05-14 ИЭсБиЭйТЕК, ЭН АЛЬКОН БАЙОМЕДИКАЛ РИСЕРЧ ЮНИТ ЭлЭлСи СТАБИЛЬНЫЕ И РАСТВОРИМЫЕ АНТИТЕЛА, ИНГИБИРУЮЩИЕ TNFα
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CN104039351A (zh) 2011-10-13 2014-09-10 阿尔皮奥治疗学股份有限公司 用于治疗血管渗漏综合征和癌症的方法
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TWI761959B (zh) 2014-11-07 2022-04-21 瑞士商諾華公司 治療眼部疾病之方法
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IL259576B (en) 2015-12-04 2022-09-01 Novartis Ag grna molecule containing tracr and crrna, pharmaceutical composition containing it and method for preparing cells for immunotherapy
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AU2017324983B2 (en) * 2016-09-07 2025-03-20 Saksin Lifesciences Pvt Ltd Synthetic antibodies against VEGF and their uses
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