Deaths of two children in Chinese gene-therapy trials spark scrutiny of oversight
Two children died in separate Chinese gene-editing trials — a boy in a 2025 trial by HuidaGene Therapeutics and a six-year-old girl in March 2024 after treatment developed by researchers at Shanghai Jiao Tong University and Xinhua Hospital. Shanghai Jiao Tong University has launched an investigation into the girl's case and a related study published in Nature, while HuidaGene disclosed the boy's death publicly in August.
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The cases expose weak supervision of China's investigator-initiated trials, a fast-track pathway that lets researchers test experimental therapies with minimal regulatory oversight. Experts warn the deaths could damage international trust in Chinese biomedical research and may prompt tighter rules just as authorities were already moving in May to increase scrutiny of such trials.
- Two children died in separate Chinese gene-therapy trials in 2024 and 2025.
- Shanghai Jiao Tong University is investigating one trial and a related Nature paper.
- China's loosely supervised 'investigator-initiated trials' system faces likely regulatory tightening.
Source: nature.com — Fieldhouse, 2026-09-08
Published there as: “Two children died from gene therapies in China: where the field goes next”
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