China Approves Mprosevir, the World's First AI- and DEL-Discovered COVID-19 Drug
核心洞察
China's National Medical Products Administration (搜索) granted conditional marketing approval to Mprosevir, the country's first AI-assisted "Class 1" innovative drug, for treating mild to moderate COVID-19 (搜索) in adults.
The drug was jointly developed by Westlake University (搜索), Westlake Laboratory (搜索), and Westlake Pharmaceuticals (搜索), advancing from candidate discovery to completed clinical trials in just three and a half years.
Mprosevir is the world's first small-molecule innovative drug approved based on DNA-encoded library (DEL) technology, marking a milestone 34 years after the DEL concept was first proposed.
China's National Medical Products Administration (搜索) (NMPA) has granted conditional marketing approval to Mprosevir, the country's first AI-assisted "Class 1" innovative drug, for the treatment of mild to moderate COVID-19 (搜索) infections in adults. The approval was announced by Westlake University (搜索) on Wednesday, marking a historic milestone in AI-driven drug discovery.
The drug was jointly developed by Westlake University (搜索), Westlake Laboratory (搜索), and Westlake Pharmaceuticals (搜索). According to Xinhua News Agency, "Class 1" medications refer to innovative drugs that have not previously been marketed in China or abroad, representing the highest category in China's drug registration classification system. This designation requires a completely new chemical structure, a novel mechanism of action, and clear clinical value.
A Breakthrough in AI-Assisted Drug Discovery
Mprosevir has drawn significant attention across the industry as the world's first small-molecule innovative drug successfully approved based on DNA-encoded library (DEL) technology. The milestone represents a historic breakthrough, arriving 34 years after the concept of DEL technology was first proposed, as reported by Tide News.
The development timeline is notably compressed: the drug advanced from initial discovery of the drug candidate to the completion of its clinical trials in just three and a half years.
Dual-Screening Strategy Combining AI and DEL
The scientists designed a dual-screening strategy combining artificial intelligence and DEL technology from the outset. AI was employed for virtual screening to eliminate various "false positives" and identify candidates with genuine potential to become drugs.
The DEL library selected to search for Mprosevir contained as many as 49 billion compounds. DEL technology initially screened out more than 100 "promising candidates," which were then examined one by one. Traditionally, testing more than 100 molecules individually would have required substantial manpower and resources. However, an AI model narrowed the candidates to just nine in a matter of days.
Activity testing of the nine molecules showed that six of them demonstrated superior activity, indicating a very high predicted hit rate. After a series of toxicity, metabolism, and other drug-development assessments, the team ultimately selected the WLU6937 (搜索) molecule as the lead candidate.
Optimization and Clinical Development
Over the following two years, the team carried out a comprehensive drug optimization process centered on the WLU6937 (搜索) molecule, including enhancing its activity, improving its drug-like properties, reducing toxicity, and advancing it from in vitro cell experiments and mouse studies through clinical trials. AI also played a key role throughout this stage.
According to the R&D team, Mprosevir has demonstrated that genuine AI-assisted drug development is currently both efficient and feasible.