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| 我国已上市治疗用单抗类产品分析 |
| Analysis of mono-antibody products for therapeutic use in China |
| 投稿时间：2019-08-01 修订日期：2019-08-09 |
| DOI： |
| 中文关键词: 生物制品 单抗类产品 上市分析 代次分析 |
| 英文关键词: biological products mono-antibody products listing analysis generations analysis |
| 基金项目: |
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| 中文摘要: |
| 单克隆抗体药物凭借其高靶向性可直达病变细胞,具有疗效明确、正常细胞受损小、副作用低的独特优势,已广泛应用于各种临床治疗领域。单抗类药物在生物技术制药中占有重要地位,并逐渐成为生物医药领域发展的主要方向。本文从我国单抗类药物的发展历程、上市时间、批准品种以及我国已批准上市的单抗类药物与FDA单抗类药物的批准情况进行对比梳理,分析我国单抗药物存在的差距,明确努力方向。 |
| 英文摘要: |
| With high targeting, monoclonal antibody drugs can directly reach diseased cells, which have the unique advantages of clear curative effect, small normal cell damage and low side effect and have been widely used in various clinical treatment fields. Monoclonal drugs play an important role in biological products and gradually become the main direction of biomedical field. This paper compares the development history of monoclonal antibody drugs, time to market, approved varieties, and the approved monoclonal antibody drugs in China with the approval status of monoclonal antibody drugs in FDA, and analyze the shortcomings of the monoclonal antibody drugs in China and clarify the direction of efforts. |
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