China clears AI-assisted drug in pharmaceutical milestone

Chinese regulators have conditionally approved a COVID-19 treatment described by state media as the country’s first Class 1 innovative drug developed with the assistance of artificial intelligence.

The National Medical Products Administration cleared Mprosevir for adults with mild to moderate COVID-19, according to the state-run Global Times. The medicine was jointly developed by Westlake University, Westlake Laboratory and Westlake Pharmaceuticals.

The approval came about three and a half years after researchers first identified a potential drug candidate, with the medicine subsequently progressing through development and clinical trials.

Researchers combined AI with DNA-encoded library, or DEL, technology to search a collection of roughly 49 billion compounds for molecules that could be developed further.

The first stage produced more than 100 possible compounds, after which AI-assisted analysis reduced the field to nine in a matter of days. Subsequent testing found strong activity in six of them.

Researchers then evaluated the candidates for toxicity, metabolism and other characteristics before selecting a molecule identified as WLU6937. The team spent around two years refining the compound as it moved through laboratory and animal studies toward clinical testing.

China classifies Class 1 medicines as innovative drugs that have not previously been marketed domestically or overseas. Global Times also reported that Mprosevir was the world’s first small-molecule innovative drug approved using DEL technology.

The conditional approval provides a closely watched example of how AI can be incorporated into pharmaceutical research to help identify promising compounds from extremely large datasets. The authorization covers Mprosevir specifically for treating mild to moderate COVID-19 in adults.

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