Considerations on Clinical Development and Regulatory of the Oversea License-in Anti-tumor Drugs

随着我国创新药产业的蓬勃发展，授权许可引进逐渐成为创新药企的重要研发模式。不同研发阶段引进的药物，在中国的研发策略有所不同。企业需全面整理药物已产生的境外临床数据，对临床药理学、安全性、有效性和种族敏感性进行详细的分析。应基于上述数据和分析的结果制定合理的临床研发策略。我们鼓励引进中国境内真正未满足临床需求的优质药物，尽可能在研发的早期阶段引进，以实现国内外的同步研发。新药引进后的临床研发策略对于药物能否顺利上市尤为重要，企业应遵循国家药品监督管理局已发布的指导原则和相应的临床指南进行临床试验设计，积极与监管部门进行沟通。 With the boom of China's innovative pharmaceutical industry, licensing-in model has gradually become an important research and development model for innovative pharmaceutical companies. The in-licensed drugs at different stages need different research and development (R&D) strategy in China. The pharmaceutical companies take the responsibility to comprehensively collate the oversea clinical data and conduct a detailed analysis of clinical pharmacology, safety, efficacy and ethnic sensitivity. Clinical R&D strategy should be made based on the results of the above data and analysis. We encourage high-quality drugs which fill unmet clinical needs licensed in, and as early as possible, so as to conduct multi-regional clinical trials (MRCTs). The clinica