全球创新药研发趋势与重点研发领域 |
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引用本文: | 张磊,王艳霞. 全球创新药研发趋势与重点研发领域[J]. 中国药业, 2014, 0(2): 1-4 |
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作者姓名: | 张磊 王艳霞 |
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作者单位: | [1]西安杨森制药有限公司注册事务部,北京100025 [2]沈阳药科大学工商管理学院,辽宁沈阳110016 |
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摘 要: | 采用文献研究、比较研究方法,介绍了全球创新药研发趋势与重点研发领域。医药市场欧美继续保持领导地位,同时新兴市场崛起;新药投入产出比降低,临床试验复杂性增加;传统活跃领域仍是研发的侧重点,但罕见药受到重视,个体化研发时代到来。制药企业应目标明确,关注热点领域,才能维持企业的不断创新。
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关 键 词: | 创新药物 研发趋势 药物研发 |
Targeted inhibition of inflammation in cardiovascular disease |
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Affiliation: | LI Dazhu;HE Shaolin;Institute of Cardiology,Union Hospital,Huazhong University of Science and Technology; |
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Abstract: | Inflammation plays a fundamental role in atherosclerosis.Yet,whether direct inhibition of inflammation will reduce the occurrence of adverse cardiovascular outcomes is unkown.Low-dose methotrexate(LDM),or canakinumab(a monoclonal antihuman IL-1β antibody)could reduce several inflammatory biomarkers without substantive effects on lipid levels,hemostasis,and platelet function.CANTOS and CIRT trails will enroll more than 25,000 patients worldwide.Each trial uses an event-driven protocol to address whether IL-1inhibition with canakinumab(CANTOS)or LDM(CIRT)can reduce rates of recurrent myocardial infarction,stroke,and cardiovascular death as compared to placebo in stable coronary artery disease patients with a persistent pro-inflammatory response(in CIRT using the additional entry criteria of the presence of either diabetes or metabolic syndrome and in CANTOS using the additional entry criteria of hs-CRP 2mg/L).Together,both trials would support the inflammatory hypothesis of atherosclerosis and serve as catalyst for the development of novel therapeutic agents focused specifically on vascular inflammation. |
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Keywords: | atherosclerosis inflammation CANTOS CIRT |
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