China approves first AI-assisted 'Class 1' innovative drug

China's National Medical Products Administration has granted conditional marketing approval to Mprosevir for treating mild to moderate COVID-19 infections in adults, making it the first Class 1 innovative drug developed with artificial intelligence assistance to enter the Chinese market, according to the Global Times.

Accelerated development timeline

The drug was jointly developed by Westlake University, Westlake Laboratory and Westlake Pharmaceuticals — institutions based in Hangzhou — and took approximately three and a half years to advance from initial candidate discovery through clinical trial completion. Researchers said the compressed timeline resulted from integrating artificial intelligence with DNA-encoded library screening throughout the development pipeline.

AI-powered compound screening

Scientists utilized AI to evaluate a database containing roughly 49 billion compounds, initially identifying more than 100 potential candidates before an algorithm narrowed the selection to nine molecules within days. Six of these compounds demonstrated strong activity in subsequent testing, leading the team to select WLU6937 as the lead candidate following toxicity and metabolism assessments, with AI guiding the subsequent two-year optimization process from laboratory studies through clinical preparation, according to the report.

Regulatory classification

China designates Class 1 medicines as innovative drugs not previously marketed domestically or internationally. Mprosevir also represents the first small-molecule innovative drug approved globally using DEL technology, the state-run newspaper noted.