Two children died in separate gene-editing trials in China, prompting investigations and raising questions about oversight of biomedical research. The deaths occurred in 2025 and 2023, during trials conducted by HuidaGene Therapeutics and a team led by Zilong Qiu at Shanghai Jiao Tong University and Yongguo Yu at Xinhua Hospital, respectively.
The Shanghai-based HuidaGene Therapeutics announced on August 5th that a young boy died during its trial in 2025. Separately, an investigation by *Science* and *Retraction Watch* revealed that a six-year-old girl died in March of last year after receiving a different experimental gene therapy. The university announced an investigation on July 26th into the trial led by Zilong Qiu and Yongguo Yu, and a related preclinical study published in *Nature*. The university has not responded to questions from *Nature* regarding the investigation.
Researchers note that gene therapies carry risks, including severe immune reactions that can be fatal, with at least a dozen deaths occurring in clinical trials in the United States, Europe, and Russia over the past three decades. Joy Zhang, a sociologist of science at the University of Kent in Canterbury, UK, stated, “This will do or has done great damage to the credibility of Chinese institutions.”
The trials have also brought attention to China’s investigator-initiated trials (IITs), which allow for rapid testing of therapies without direct oversight from the country’s drug regulator, though oversight was increased in May. Jiayou Shi, a lawyer at the National Research Center for Civil and Commercial Law at Renmin University of China in Beijing, predicts that regulations for gene-therapy trials will likely be strengthened. Zhang suggests the Chinese government might halt gene-editing research or impose stricter funding requirements, mirroring its response to biophysicist He Jiankui’s illegal gene-editing of babies in 2018, which resulted in a three-year prison sentence. However, Zhang distinguishes Qiu as a successful scientist and influential science communicator, unlike the “rogue scientist” He.
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