Two child deaths in Chinese gene-therapy trials raise oversight concerns

September 8, 2026 at 10:45 AM2 min

This digest was compiled by AI from multiple sources — links to the originals are below.

Two children died in separate gene-therapy trials in China, one announced by HuidaGene Therapeutics on August 5 and another revealed in July involving a six-year-old girl. The deaths raise serious questions about oversight of investigator-initiated trials and could damage the credibility of Chinese biomedical institutions. The Chinese government increased oversight of such trials in May and may strengthen regulations further.

Key Facts

HuidaGene Therapeutics announced on August 5 that a young boy died during one of its gene-therapy trials in 2025.
A six-year-old girl died in March 2025 after receiving an experimental gene therapy in a trial led by Zilong Qiu and Yongguo Yu at Xinhua Hospital in Shanghai.
Shanghai Jiao Tong University announced an investigation into the trial and a related preclinical study on July 26.
At least a dozen people have died in gene-therapy clinical trials in the United States, Europe, and Russia over the past three decades.
The Chinese government increased oversight of investigator-initiated trials in May 2025.

Trial Deaths and Investigations

HuidaGene Therapeutics, a Shanghai-based gene-editing company, announced on August 5 that a young boy had died during one of its trials in 2025. In July, an investigation by Science and Retraction Watch revealed that a six-year-old girl had died in March 2025 after receiving a different experimental gene therapy. That trial was pioneered by neuroscientist Zilong Qiu at Shanghai Jiao Tong University and clinician Yongguo Yu at Xinhua Hospital in Shanghai. On July 26, Shanghai Jiao Tong University announced an investigation into the trial and a related preclinical study the researchers had published in Nature.

Oversight and Regulatory Response

The trials put a spotlight on China's fast-track clinical trials, called investigator-initiated trials, which allow researchers to test therapies quickly without supervision from the country's drug regulator. The Chinese government increased oversight of these trials in May 2025. Regulations for gene-therapy trials will probably be strengthened in response to the deaths, according to Jiayou Shi, a lawyer at the National Research Center for Civil and Commercial Law at Renmin University of China in Beijing. Sociologist Joy Zhang of the University of Kent said the deaths will do or have done great damage to the credibility of Chinese institutions.

Ethics and Historical Context

Researchers say the two trials in China involved breaches of ethics and lacked transparency. When Chinese biophysicist He Jiankui produced gene-edited babies in 2018, the government strengthened laws around this kind of editing and He was sentenced to three years in prison. Unlike He, who is considered a rogue scientist, Qiu is a successful scientist and an influential science communicator, according to Zhang. According to Science and Retraction Watch, the girl in Qiu's trial had a defect in a gene called CHD3.