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News & Alerts

China clears Mprosevir, its first AI-assisted Class 1 drug

NMPA clears Westlake's Mprosevir, China's first AI-assisted Class 1 drug.

MedSpark Staff
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msadmin
MedSpark Staff
Bymsadmin
Medical, Healthcare, & Biotech/Pharma AI News
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Published: September 5, 2026
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China has conditionally approved an AI-assisted COVID-19 treatment called Mprosevir. The drug, meant for adults with mild to moderate illness, came out of a three-way Westlake project spanning Westlake University, Westlake Laboratory and Westlake Pharmaceuticals. University officials say the clearance makes it the first Class 1 medicine in the country built with an AI-assisted program.

The Class 1 tag is reserved for genuinely new medicines in China’s filing system. Anything holding it has never gone on sale at home or abroad and must clear the bar on structure, mechanism and patient benefit. Westlake says the program moved from hit to finished trials in about 42 months.

Its DNA-encoded library carried roughly 49 billion compounds, and the first screening pass surfaced more than 100 leads. An AI model then trimmed that shortlist to nine within days, and six of the nine showed real activity in tests. The approval makes Mprosevir the first small-molecule drug born of a DEL screen to reach any market, more than three decades after the concept first appeared.

Regulators stopped short of a full clearance. Still, the case shows how virtual screening can compress the slowest stretch of early drug discovery, and it gives China a homegrown proof point for AI-guided development at a moment when regulators worldwide are watching how fast such programs move.

TAGGED:AI Drug DiscoveryDNA-encoded librarydrug approvalMprosevirNMPAWestlake Pharmaceuticals
SOURCES:Global TimesAnadolu Agency
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