Is China’s biotech boom at risk? Fear of policy backlash after death in gene-editing trial

The death of a six-year-old girl after receiving an experimental gene-editing therapy has been described by scientists as a tragedy that highlights the need to improve trial safeguards.

But some in the biotechnology industry fear Chinese policymakers may curtail the regulatory flexibility that scientists have long enjoyed in initiating clinical trials – a key mechanism behind China’s competitive edge in frontier treatments.

“I hope this tragedy does not have a lasting negative impact on China’s investigator-initiated clinical-research system, but there is a real risk of a regulatory backlash,” said Wang Haoran, chief executive of Neoland Biosciences, based in Shandong province.

“China has advanced rapidly in several frontier areas, partly because the mechanism has provided greater flexibility for carefully supervised early clinical exploration. That speed has increased the sense of urgency across the biotechnology industries in the United States and Europe.