China’s Gene Therapy Regulations Under Scrutiny After 6‑Year‑Old’s Fatal Trial

In March 2025, a Shanghai hospital administered the nation’s first human trial of a CRISPR‑based gene edit to a six‑year‑old girl diagnosed with Snijders Blok‑Campeau syndrome. The case has become a flashpoint for gene therapy regulations China. The child, identified only as “Mei” by her parents, died a week after receiving the viral vector injection.

Gene therapy regulations China: the regulatory vacuum

The experimental protocol was led by neuroscientist Zilong Qiu of Shanghai Jiao Tong University’s brain centre. Qiu’s company, Lanqi Xintu Gene Technology, proposed a base‑editing approach that would replace a single DNA letter in neurons. The plan required ↓ $860,000 from the parents, who were told the fee covered development, testing and the procedure itself—an arrangement that contravenes Chinese law prohibiting charges for unapproved therapies.

Animal studies revealed alarming toxicity: four monkeys developed moderate to severe liver injury and one suffered kidney damage. Yet the hospital’s ethics board approved the human injection without reviewing these findings.

“The data were presented, but no one expressed alarm,” a senior researcher recalled.

On March 24, 2025, Dr Yongguo Yu delivered the virus‑laden solution into Mei’s spinal fluid after a single steroid dose. Within days she exhibited fever, anuria and a precipitous drop in platelets, culminating in thrombotic microangiopathy and death.

The hospital was later fined ↓ $3,600 for procedural lapses and failure to register the trial as a commercial study. The incident has drawn scrutiny from international media, including Reuters, and reignited debate over the legacy of the 2018 CRISPR‑baby scandal.

Mei’s parents have petitioned the university for a retraction of the team’s Nature paper and called for a full investigation. Their appeal highlights the need for transparent oversight, especially as China expands its biotech sector in the post‑pandemic era.

Reported by Elena Rostova (Socio-Economic Trends Analyst).