组态视角下基于MAH制度的CXO企业绩效提升路径

Research on CXO enterprise performance improvement path based on MAH system from the perspective of configuration

目的基于药品上市许可持有人(marketing authorization holder,MAH)制度的颁布实施,从组态视角探究国内医药外包服务(contracted executive officer,CXO)企业的绩效提升路径。方法以15家国内CXO企业为研究对象,运用模糊集定性比较分析方法,构建CXO企业绩效提升能力模型。结果单一能力要素并不构成企业高绩效的必要条件,但生产研发能力在实现高绩效中发挥着较重要的作用。组态分析显示:实现企业高绩效共有3条牵引路径,分别为刚性能力主导型、刚性能力主导柔性能力辅助型与刚柔并济型,生产研发能力、内部管理水平、制度建设、员工能力与政策关注度5种前因条件多重并发,以“殊途同归”的方式驱动实现高绩效;刚性能力缺失或核心条件缺失均导致非高绩效出现,这与企业高绩效的驱动路径存在非对称关系。结论针对性提出CXO企业应敏锐捕捉MAH制度实施带来的政策契机,基于内部特性提升技术实力、管理水平等刚性能力,关注制度建设、政策敏感度等柔性能力,以构建高绩效实现路径。本文不仅丰富了医药外包行业绩效提升的理论依据,更为该行业拓展国内市场提供了有益借鉴及实践启示。

Objective To explore the path for enhancing the performance of contracted executive officer(CXO)enterprises from a configurational perspective based on the promulgation and implementation of the marketing authorization holder(MAH)system.Methods Taking 15 domestic CXO companies as the research subjects,a fuzzy-set qualitative comparative analysis was employed to construct a model of CXO firms'capabilities for performance enhancement.Results The analysis revealed that single capability factors did not constitute necessary conditions for achieving high enterprise performance,but production and research&development(R&D)capabilities played a crucial role in attaining such performance.The configurational analysis identified three distinct pathways towards high enterprise performance:a rigid capability-driven path,a rigid capability-led path with the support of flexible capabilities,and a balanced approach integrating both rigid and flexible capabilities.Multiple concurrent antecedent conditions including production and research and development capabilities,internal control management level,system construction,employee capabilities,and policy attention drived the achievement of high performance in a"divergent paths converging to the same goal"manner.However,the absence of rigid capabilities or core conditions led to non-high performance,indicating an asymmetric relationship with the drivers of high enterprise performance.Conclusion This study explored the intricate antecedent factors contributing to the achievement of high performance by CXO enterprises.It proposes that CXO enterprises should be astute in seizing the policy opportunities arising from the implementation of the MAH(Marketing Authorization Holder)system.Based on internal characteristics,they should enhance rigid capabilities such as technological prowess and management standards,and also pay attention to flexible capabilities including system development and policy sensitivity,in order to construct a pathway to high performance.The conclusions of this study not only enrich the theoretical foundation for performance enhancement in the pharmaceutical outsourcing industry but also provide valuable references and practical insights for the industry's expansion strategies in the domestic market.