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PHARMACEUTICAL COMPOSITIONS CONTAINING ANTIBODIES TO HUMAN PCSK9
专利权人:
САНОФИ (FR)
发明人:
АНОТЭН Коринн (FR),БЕССАК Лоранс (FR),ЧАУДХАРИ Умеш (US)
申请号:
RU2013139736/15
公开号:
RU2013139736A
申请日:
2012.01.27
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A pharmaceutical composition comprising an antibody or antigen-binding fragment thereof that specifically binds a human subtilisin / kexin type 9 convertase protein (hPCSK9) in an amount of from about 40 mg to about 500 mg per dose, together with a pharmaceutically acceptable excipient or carrier. . The pharmaceutical composition according to claim 1, containing approximately 50 mg, approximately 100 mg, approximately 150 mg, approximately 200 mg, approximately 250 mg, approximately 300 mg, approximately 350 mg, approximately 400 mg, approximately 450 mg, or approximately 500 mg of the antibody or antigen binding fragment. 3. The pharmaceutical composition according to claim 1, containing an effective dose of an antibody or antigen-binding fragment thereof that specifically binds hPCSK9, where such a dose is sufficient to sustainably lower levels of low density lipoproteins (LDL-C) for at least 14 days, at least 15 days at least 16 days, at least 17 days, at least 18 days, at least 19 days, at least 20 days, at least 21 days, at least 22 days, at least 23 days, or at least 28 days after administration. 4. The pharmaceutical composition of claim 1, wherein the antibody or antigen binding fragment thereof is characterized by one or more of the following: a. a decrease in the levels of low density lipoproteins (LDL-C) by at least about 25% to about 40%, compared with the level before the dose, with a steady decrease over the period of at least 14 days after the individual dose, approximately equal to 50 mg, in the regimen of administration once every two1. Фармацевтическая композиция, содержащая антитело или его антигенсвязывающий фрагмент, который специфически связывает пропротеин конвертазы субтилизина/кексина типа 9 человека (hPCSK9), в количестве от приблизительно 40 мг до приблизительно 500 мг на одну дозу, вместе с фармацевтически приемлемым эксципиентом или носителем.2. Фармацевтическая композиция по п.1, содержащая приблизительно 50 мг, приблизительно 100 мг
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