China’s value proposition in first-in-human trials: Back to School 2026

Over the past decade, China has built a compelling value proposition as a venue for running first-in-human trials: large numbers of patients concentrated at major academic medical centers, lower research costs, and regulatory and institutional processes that can move in parallel rather than sequentially. For cell and gene therapies, an investigator-initiated trial (IIT) pathway has provided an additional — if controversial — way to generate early evidence in patients quickly and inexpensively.

These advantages have helped fuel a sharp rise in early-stage trial activity and the growth of China’s biotech ecosystem. And BioCentury’s conversations with biotechs, investors, and other stakeholders indicate that more U.S. companies are considering conducting FIH trials in China, a country that only a few years ago was barely on the radar of early development strategies...