中国医药研发趋势 本地化发展的机遇与影响.docxVIP

Opportunity and Influence for Localized Development Pharmaceutical RD Trends in China As China’s government continues to face gaps in the quality of and access to healthcare—in addition to the growing burdens of population size, ageing and utilization on the existing system—one strategy will be continued support for the local RD industry. The primary directives of this strategy are to develop innovative capabilities and upgrade applicable technologies as well as attract, develop and retain a strong talent base. This strategy will have strong implications for multinational pharmaceutical companies, who must adopt more localized RD approaches to address new opportunities and challenges. A shifting landscape — key implications The Chinese government has made significant multi-pronged investments to grow the local RD industry. The aggregate result is increased local RD output, a more innovative RD pipeline (Fig 1) and China’s growing importance in support of global and regional study submissions. Fig 1: RD pipeline growth (2011-2014) China Chemical Drugs Applications Structure 2014 2011 4% 1% 21% 31% 32% Innovators Generics 43% 35% Label changes 33% Others 5,877 Applications 7,829 Applications Source: Center for Drug Evaluation at China Food and Drug Administration The growing local RD industry is already challenging traditional, global-centric RD models with increased RD competition and regulatory complexities. Despite the long-term promise of accelerated time-to-market for more innovative products, large uncertainties still remain in timing and the extent of impacts. Opportunities do exist, however, for MNC pharma to adopt a more localized and integrated RD strategy in China. This strategy would leverage increased local RD capabilities in order to accelerate development of local, and in the longer-term, global products.  Great flux in RD regulatory reform Launching local clinical studies for overseas clinical programs have traditionally been challenged by two main b