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是商业机遇还是暗藏风险:关于吉利德科学公司瑞德西韦在中国的临床试验及上市许可的观察

Were it business opportunities or hidden risks: Observations on clinical trials and marketing authorizations of Gilead Science's remdesivir in China.

作者信息

Yu Xiang, Li Na, Li Yayi

机构信息

School of Public Affairs, Fujian Jiangxia University, Beijing, China.

School of Law, Ningbo University, Research Academy of Belt and Road, Ningbo University, Ningbo, Zhejiang, China; Ningbo University, Ningbo, Zhejiang, China;, Email:

出版信息

Pharmazie. 2020 Aug 1;75(8):407-410. doi: 10.1691/ph.2020.0549.

Abstract

New drugs against the in COVID-19 pandemic are urgently needed. Gilead Science's remdesivir has been introduced to China through special approval procedures, and was directly conducting the Phase III clinical trial. As expected, the marketing authorization process was completed soon. The drug brought hope to patients as well as business opportunities to companies. However, we must pay attention to the patent competition, generic drug competition and other unfair competition that remdesivir may face in China. China also needs to strengthen the innovation ability and international cooperation ability of local pharmaceutical companies by taking advantages of the opportunity to introduce remdesivir.

摘要

在新冠疫情大流行期间,迫切需要抗新冠的新药。吉利德科学公司的瑞德西韦已通过特殊审批程序引入中国,并正在直接进行三期临床试验。不出所料,上市许可程序很快就完成了。这种药物给患者带来了希望,也给公司带来了商机。然而,我们必须关注瑞德西韦在中国可能面临的专利竞争、仿制药竞争等不公平竞争。中国还需要利用引进瑞德西韦的契机,加强本土制药企业的创新能力和国际合作能力。

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