Western drugmakers are increasingly relying on China to test experimental cell and gene therapies on humans, drawn by a fast-track clinical pathway. Over the past 18 months, groups including AstraZeneca, Sana Biotechnology, and Tempest Therapeutics have pursued investigator-initiated trials (IITs) with Chinese partners. This shift signals a new stage in Western pharma's reliance on China, moving trials to earlier stages of drug development.
Despite recent patient safety concerns following two deaths, the Chinese IIT system allows rapid human testing. A record 282 IITs were launched in 2025, up from 63 a decade ago. Western companies, including those testing therapies for children with rare conditions, represent a small but growing part of these studies.
The trend highlights China's emergence as a global hub for medical research, supported by a network of academic hospitals, a booming biotechnology industry, and a large patient pool. Trials in China enrol patients two to five times faster than in the US. Principal investigators at leading hospitals have become highly experienced with large patient volumes, which is valuable for first-in-human studies testing safety and tolerability.
Tempest Therapeutics, facilitated by Hebei Senlang, is conducting a human trial for an autoimmune disease treatment. While IITs offer speed, the true number of participating biotechs is likely far larger due to underreporting.
Source: Financial Times Companies · Summarized by HeadlinesBriefing