China Surprises With First CRISPR Trial Despite Regulatory Lag, Concerns
The lack of a comprehensive regulatory pathway has not hindered Chinese researchers from forging ahead with the world's first human clinical study using CRISPR-Cas9 gene editing technology, which will be used to treat advanced lung cancer.
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Plagued by a scandal which gained global attention a few years go, the gene therapy sector has recovered and is now thriving in China. But a drive for innovation, combined with ready cash for aspiring start-ups, may not translate into leaps and bounds in the field due to challenges unique to these latest treatments, including manufacturing, durability and coverage.
CRISPR Therapeutics and Vertex initiated the first human study of CRISPR gene-editing technology with an industry sponsor, following an investigator-sponsored study initiated in China two years ago. These are not the first gene-editing trials, but they're important milestones for the CRISPR field.
China is aggressively driving up life sciences innovations, leading the charge in technologies including gene editing and genome testing, prompting executives to take a fresh approach.