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施樱子, 赵杨. 本土企业创新药中美双报的优势及挑战[J]. 药学进展, 2019, 43(12): 900-907.
引用本文: 施樱子, 赵杨. 本土企业创新药中美双报的优势及挑战[J]. 药学进展, 2019, 43(12): 900-907.
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SHI Yingzi, ZHAO Yang. Advantages and Challenges of China's Enterprises Conducting Clinical Trials of Innovative Drugs in both China and US[J]. Progress in Pharmaceutical Sciences, 2019, 43(12): 900-907.
Citation: SHI Yingzi, ZHAO Yang. Advantages and Challenges of China's Enterprises Conducting Clinical Trials of Innovative Drugs in both China and US[J]. Progress in Pharmaceutical Sciences, 2019, 43(12): 900-907.
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本土企业创新药中美双报的优势及挑战

Advantages and Challenges of China's Enterprises Conducting Clinical Trials of Innovative Drugs in both China and US

    摘要
  • 摘要: 越来越多中国创新药研发企业选择在中国和美国两地同时开展临床研究，并寻求在海外市场上市。截至2019年6月，从公开渠道可以收集到的中美双报产品已达85个。重点分析中美双报产品的特点以及中国公司在两国开展临床研究的优势及挑战。

     

    Abstract: Increasing number of domestic pharmaceutical companies choose to conduct clinical trials of innovative drugs in both China and US and seek to launch in overseas markets. As of June 2019, 85 products under investigational new drug (IND) application have been approved both in China and US. This paper analyzes the characteristics of these products as well as the advantages and challenges of China's enterprises conducting clinical trials of innovative drugs in both China and US.

     

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