Amid growing U.S. anxiety over China’s rapid rise as a biotech powerhouse, a fast regulatory pathway for early development of novel cell and gene therapies has become a recent focal point. Through investigator-initiated trials (IITs), Chinese academics and hospitals can launch early-stage, in-human studies faster with fewer requirements than the standard drug review process permits in both the U.S. and China. But two undisclosed deaths tied to gene-therapy IIT studies have raised questions about the role of this pathway. In the first case, reported by the jornal Science along with the blog Retraction Watch, a 6-year-old girl with a rare—but nonfatal—neurodevelopmental disorder died last year from a severe immune response just days after receiving an experimental base-editing therapy funded in part by her parents.

Full report : The two deaths happened before China’s government introduced a new regulation to establish more standardized frameworks and tighter requirements for conducting IITs.