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作 者:王颖 刘璐瑶 张婵娟 李伟 杨依晗 黄堃 胡骏 WANG Ying;LIU Luyao;ZHANG Chanjuan;LI Wei;YANG Yihan;HUANG Kun;HU Jun(Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring,Shanghai 200040,China;China National Pharmaceutical Industry Information Center,Shanghai 200002,China)
机构地区:[1]上海市药品和医疗器械不良反应监测中心,上海200040 [2]中国医药工业信息中心,上海200002
出 处:《上海医药》2025年第1期14-19,共6页Shanghai Medical & Pharmaceutical Journal
摘 要:目的:了解2023年全球药品研发数据,展望未来全球药品研发格局。方法:介绍2023年全球药品研发情况,并从研发阶段和研发区域两个方面进行分析。结果:在药品研发阶段方面,2023年全球开展临床试验的药品总数仍保持上升趋势;在开展临床试验和申报上市的药品方面,中国超越美国成为新药临床试验和申报上市的首选国家;在原研企业分布方面,超过半数开展新药临床试验和申报上市的原研企业总部设在中美两国;在许可交易方面,中国医药企业许可交易的活跃度仅次于美国,许可引进仍是中国成熟医药企业开发新业务的重要模式。结论:2023年医药行业的研发活动已恢复到新冠疫情前水平,未来医药行业将处于平稳发展状态。Objective:To understand the data of global drug R&D in 2023 and look forward to the future global R&D pattern.Methods:The global drug R&D in 2023 was introduced,and the data were analyzed from two aspects:drug R&D stage and drug R&D region.Results:In the R&D stage,the total number of drugs in clinical trials in 2023 still maintained an upward trend.China has surpassed the United States to become the first choice for clinical trials and listing of new drugs.In terms of the distribution of original research enterprises,more than half of the original research enterprises that carry out clinical trials of new drugs and apply for listing of new drugs were headquartered in China and the United States;in terms of the distribution of licensed enterprises,the activity of licensing transactions of pharmaceutical enterprises in China is second only to that of the United States,and licensing was still an important mode for mature pharmaceutical companies in China to develop new business.Conclusion:In 2023,the R&D activities of pharmaceutical industry have recovered to the pre-epidemic level,and pharmaceutical industry will be in a steady development state in the future.
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