创新前行与全球拓展：中国临床试验发展的新篇章

Foreword: This report summarizes the key strategic trends of clinical development in China, and can •Over the past decade, China’s clinical development landscape has undergone a remarkable transformation. The markethas expanded rapidly, fueled by favorable policy reforms and sustained R&D investment frompharmas. This evolution haslaid a strong foundation for the next phase of growth, one characterized by deeper innovation, greater global integration of •This report, produced in collaboration withPharmaDJ, provides a comprehensive overview of the strategic trends shapingChina’s clinical trial ecosystem today. It highlights not only the progress made in innovation, globalization and AI/smarter •Supported by a comprehensive survey of pharmaceutical companies and contract research organizations (CROs), thisreport serves as a starting point for multinational corporation (MNC)pharmas, Chinesebiopharmasandbiotechs, and Executive summary: Three strategic trends are shaping the future of China’s clinical trial landscape China has established a strong foundation for clinical trial growth, underpinned by its large patient base, favorable policies and sustained R&Dinvestment frompharmas. Trial volume in China has risen rapidly from roughly one-third of the U.S. and one-half of the European levels in 2019 to approximately 0.8×and 1.1×respectively by 2024, positioning China as a major global player in clinical development. As the sector entersits next phase of growth, three strategic trends are expected to shape the future of China’s clinical trial landscape: •Development of more innovative and differentiated therapies:Chinesebiopharmasandbiotechsare increasing investment in first-in-class and best-in-class assets, next-generation modalities, and new technology platforms, gaining stronger global recognition. The surge in Phase II and III trials highlights China’s growing capability to advance innovations from early to late stages, creating risingopportunities forclinical development industry participants. While homogeneous competition persists, companies are driving differentiation through early •Continued globalization of Chinese innovation:Globalization remains a strategic imperative for Chinesebiopharmas/biotechs,with risingChina-to-global trials and licensing deals reaching record highs. This creates expanding opportunities for MNCpharmasto accessdifferentiated, early-stage Chinese assets that enhance global portfolios, and for CROs equipped with global-standard quality systems, •Adoption ofAI and smarter clinical trial tools: AI is emerging as a transformative enabler across the drug R&D life cycle. Within clinicaldevelopment, industry participants show growing interest in adopting AI, with the highest near-term potential in data analysis andmanagement.Pharmasand CROs need to proactively integrate AI into their clinical development capabilities to enhance efficiency and Agenda •Context of clinical trial development in China•Future strategic trends of clinical trial development in China China has a strong foundation for healthcare market growth, based on the key economic and China has and will continue to have the largest patient pool with better affordability, though facing China clinical trial volume has returned to growth after a dip in 2022, with Chinesepharmas’ in-Chinatrials accounting for ~75% oftotal new trial starts In-China trial volume has risen rapidly compared to U.S. and Europe, positioning China as a major Favorable policy Accelerated innovation Continuous R&D investment Rapid rise in early-phase and FIC trials shows China isclosing the gap with global innovation leaders Growing R&D spend and patent output; China now hasfour of the top 25 pharma companies by pipeline size China’s government has launched a series of policies toboost innovative drugs, emphasizing full-chain integration Favorable policy: Healthcare industry has benefited from stronger government policy support and a Accelerated innovative drug development: China has built a strong foundation in early-phase clinical •The rapid growth of Phase II and III trials in China demonstrates Chinesepharmas’ strong willingness and capability to advance innovations from early-to late-stage clinical development •Phase II and III now account for over 50% of total trials, indicating rising opportunities for the clinical development ecosystem participants Continuous R&D investment: RobustpharmaR&Dexpenditure among Chinesepharmashas also •Under encouraging policy,Chinesepharmasare devotingmore efforts to drug development, supported by rising top •Continuous R&D investment has driven steady patentgrowth for Chinesepharmas,with their share of publishedpharma PCT (Patent Cooperation Treaty) applications rising Looking forward, ~80% of survey respondents show a positive attitude toward future trial number Growth drivers •Continued Chinese governmentsupporting policy towardinnovative drugR&D and commercialization•Chinesebiopharma