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| 我国已上市治疗用生物制品整体情况分析 |
| Overall situation analysis of biological products for therapeutic use in China |
| 投稿时间：2019-08-01 修订日期：2019-08-20 |
| DOI： |
| 中文关键词: 生物制品 注册管理制度 已上市药品信息 创新性分析 发展历程 |
| 英文关键词: biological products registration management marketed products innovative analysis development history |
| 基金项目: |
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| 中文摘要: |
| 生物医药技术及产品在全球医药领域中已成为重要的支撑元素，也逐步成为行业及国家竞争力的核心要素之一。与发达国家相比，我国治疗用生物制品的研发和产业化相对较晚，市场规模较为有限，但增速显著高于全球水平。本文通过梳理整合我国已批准治疗用生物制品信息，从批准上市产品的发展历程、创新程度、技术类别等不同维度进行了全方位深入分析，旨在摸清我国已上市治疗用生物制品的整体情况，提炼出存在的问题，为业界提供参考信息，同时为完善我国治疗用生物制品注册管理制度体系提供数据支持。 |
| 英文摘要: |
| Biomedical technology and biotechnological drugs have become an important supporting element in the global pharmaceutical field, and have gradually become one of the core elements of industry and national competitiveness. Compared with developed countries, the research and industrialization of therapeutic biological products in China are relatively late, with the market size limited, but the growth rate is significantly higher than the global level. This paper analyzes and integrates the information on biological products approved for treatment in China, and conducts comprehensive and in-depth analysis from different dimensions such as the development history, innovation degree and technology category of approved products, aiming to find out the overall situation of the listed therapeutic biological products in China, to extract existing problems, provide reference information for the industry and data support for improving the registration management system of therapeutic biological products in China. |
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