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中国药品许可趋势:从引进到走向全球。

Trends of drug licensing in China: From bring-in to go-global.

作者信息

Jiang Yale, Zhao Guo, Jia Linlin, Li Cheng, Wang Xin, Cai Jing, Huang Huiyao, Wang Shuhang, Li Ning

机构信息

Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Pharmcube (Beijing) Co., Ltd., Beijing, China.

出版信息

Pharmacol Res. 2024 Dec;210:107488. doi: 10.1016/j.phrs.2024.107488. Epub 2024 Nov 1.

Abstract

Global medicine R&D has shown a stabilized trend after fleeting prosperity lately. Despite of discouraging whole picture, the role of China in cross-border out-licensing activities of medical therapeutics keeps rising, which started since 2020 and further boosted in 2023. A holistic analysis of drug and technology licensing, involving Chinese enterprises from 2019 to 2023, revealed 807 license-in deals and 401 license-out deals. In-licensing showed a decreasing trend, while out-licensing was the opposite. Increasing ingenuity of Chinese products has led to a shift from an import-oriented to an export-oriented situation, such as antibody-drug-conjugates, and cell/gene therapies. With supportive policies of Chinese government, southeast Asia is becoming an important downstream market for out-licensed drugs. Biotech innovators are emerging as a dominant force with core innovation capacity. China is embracing international collaboration by showing favorable markets and high-level innovative products.

摘要

全球医药研发在经历了短暂的繁荣之后,近来呈现出稳定的趋势。尽管整体形势不容乐观,但中国在医疗疗法跨境许可活动中的作用不断上升,这一趋势自2020年开始,在2023年进一步增强。对2019年至2023年涉及中国企业的药品和技术许可进行的全面分析显示,有807笔引进交易和401笔许可转让交易。引进许可呈下降趋势,而许可转让则相反。中国产品的创新性不断提高,导致了从进口导向型向出口导向型的转变,如抗体药物偶联物和细胞/基因疗法。在中国政府的支持政策下,东南亚正成为许可转让药物的重要下游市场。生物技术创新者正成为具有核心创新能力的主导力量。中国通过展示良好的市场和高水平的创新产品,正在积极开展国际合作。

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