Syneos Health: Early China Inclusion

Global biotech sponsors should embed China in their clinical development strategy from the earliest planning phases, according to Syneos Health. This proactive approach can compress timelines, improve data robustness, and enhance cost-efficiency compared to treating China as a late-stage commercial market.

George Li, Managing Director, China, Clinical Development at Syneos Health, notes that many companies only consider China after key development decisions are locked in. "Sponsors are better positioned to capture far greater value when China is embedded within the global strategy early on, rather than added as a last-minute operational consideration," Li stated. Drawing on over 25 years of experience, he highlighted several critical factors for success.

A Changing Regulatory Landscape

China's regulatory environment has evolved significantly since joining the International Council for Harmonisation (ICH) in 2017. Reforms have shortened study start-up times and aligned local requirements with global standards.

Key policy shifts include an implied Investigational New Drug (IND) pathway introduced in 2018, allowing sponsors to proceed if no major objections are raised within 60 working days. More recently, an accelerated 30-working-day review pathway was established for certain innovative therapies. These changes enable China to participate earlier in global programs, allowing for parallel enrollment strategies and potentially eliminating the need for costly, standalone bridging studies.

Leveraging Patient Pools and Site Quality

China offers access to one of the world's largest patient populations across major therapeutic areas like oncology, cardiometabolic disease, and immunology. The country records approximately 5 million new cancer cases annually, presenting significant recruitment opportunities.

However, raw patient volume does not automatically guarantee fast enrollment. Syneos Health emphasizes that high-performing programs must prioritize site quality over sheer quantity. Selecting experienced investigators and sites with proven patient access, strong infrastructure, and operational capabilities is critical. Early investment in feasibility assessments and site selection is needed to keep recruitment on track.

Building Global Confidence in Data

China's clinical research ecosystem has matured rapidly. A growing number of leading Chinese investigators now have extensive experience in Multi-Regional Clinical Trials (MRCTs), and China's adoption of ICH E17 principles supports the prospective inclusion of Chinese cohorts in global studies.

Increased experience with international regulatory expectations and sponsor quality standards has contributed to improved confidence in data reliability. To ensure China-generated data can be fully leveraged in global submissions, sponsors must align statistical plans, clinical endpoints, and cross-regional trial frameworks during the design stage. This prevents costly protocol rework later.

Unlocking Operational Efficiency with Local Expertise

For resource-constrained biotechs, execution costs remain a key consideration. Relative to sites in the U.S. and Western Europe, China can deliver meaningful savings in site expenditures and gains in enrollment velocity, depending on the therapeutic area and study complexity.

Yet these cost advantages can diminish without a clear understanding of local requirements. Sponsors must account for China-specific rules related to ethics approvals, the Human Genetic Resources Administration of China (HGRAC), data privacy, contracting, and site activation. True operational savings stem from navigating these local rules efficiently while maintaining consistent global quality and governance benchmarks.

Successful strategies balance deep local expertise with strong global governance. Local teams provide critical knowledge of country-specific processes, while global teams safeguard consistency in protocol execution and quality standards. A well-defined governance framework connects these capabilities through clear accountability and centralized performance metrics. This allows sponsors to benefit from China's operational strengths without compromising the requirements of global development programs.