China reportedly approves first AI-assisted innovative drug for marketing

China’s National Medical Products Administration (NMPA) granted conditional marketing approval to Mprosevir, described in media reports as the country’s first AI-assisted Class 1 innovative drug.

Mprosevir, also reported as iscartrelvir hydrochloride tablets (艾普司韦), is an oral treatment for mild-to-moderate COVID-19 in adults.

It was jointly developed by Westlake University, Westlake Laboratory and Westlake Pharmaceuticals.

Westlake University said the program took about three and a half years from candidate discovery to completing clinical trials; reports attribute part of the accelerated development process to AI assistance.

The drug is also reported to be the first approved original small-molecule drug based on DNA-encoded library (DEL) technology. In China, a Class 1 innovative drug is a new drug not previously marketed domestically or abroad.

The approval is conditional, meaning the sponsor may need to provide further post-marketing evidence and meet additional regulatory requirements.