LEKPharma研发客Advancing Innovation and GlobalReach: TheNext Chapter in China'sClinicalTrial DevelopmentPharmaDJ xL.E. K. Clinical Development ReporNovember2025
Foreword: This report summarizes the key strategic trends of clinical developme nt in China, and canbe referenced by pharmaceutical companies and CROs to support their R&.D/service strategies。Overthe oast decade. China's clinicaldevelooment landscape has underaone a remarkable transformation. Themarkethas expanded rapidly, fueled byfavorable policy reforms and sustained R&D investmentfrom oharmas. This evolutionhaslaid a strong foundation for the next phase ofgrowth, one characterized by deeperinnovation. areater alobalintearation ofChinese biooharmas/biotechs and the increasing adoption of smarter tools such as artificial intelligence (Al). As the industrycontinues to mature. China is poised to emerae as a leadina hub alobally for innovation-driven clinical development.This report, produced in collaboration with PharmalD.J, provides a comprehensive overview of the strategic trends shapingChina's clinical trial ecosvstem today. It highlights not only the progress made in innovation. globalization and Al/smartercinical trial tools, but also the opportunities facing both multinational and Chinese companies. Supported by a comprehensive survey of pharmaceutical companies and contract research organizations (CROs), thisreport serves as a starting point for multinational corporation (MNC) pharmas, Chinese biopharmas and biotechs, andCROs to reassess how they can better prepare for the future of drug R&.D, by driving greater inovation, efficiency andglobal collaboration.LEK@2025LEK.Consultling
Executive summary. Three strategic trends are shaping the future of China's clinical trial landscapeChina has established a strong foundation for clinical trial growth, underpinned by its large patient base, favorable policies and sustained R&D investment from pharmas. Trial volume in China has risen rapidly fromroughly one-third ofthe U.S. and one-halfoftheEuropeanlevels in2019to approximately 0.8xand 1.1x respedively by 2024, postining China as a majorglobal player in clinical development. As the sedtor entersit's nextphase ofgrowth,threestrategic.trends are expected to shape the future ofChina's clinical trial landscane:+Developmentof moreinne:Chinase biorharmas and biotechs are increasing investment in frst-in-class and best-in-dass technoloav platforms aainina stronaer alobal recognition. The surge inPhasell and ll trialshinnovations from early to late staces. creatina rising opportunities forcinical develooment industry participarts. While homogeneous competition persists, companies are driving dfererntiation through earlycombination planning, indication ex pansion and stratecic asset orioritizationContinuedalobalizationofChineseinnovation:Globalizationremase blopharmas/biotechs, withrisingChina-to-plobal tnials and licensing deals reachina record highs. This creates expanding ...