China Approves Aipusiwei, Its First AI-Assisted Class 1 Innovative Drug
China's National Medical Products Administration (NMPA) has conditionally approved Aipusiwei, a Class 1 innovative drug for treating mild to moderate COVID-19 in adults. Jointly developed by Westlake University, Westlake Laboratory, and Westlake Therapeutics, it is China's first approved AI-assisted drug and completed development from initial discovery to clinical trials in just 3.5 years. This milestone marks the world's first approved small-molecule drug developed using DNA-Encoded Chemical Library (DEL) technology, validating a 34-year-old concept. It demonstrates how integrating AI and DEL can drastically accelerate pharmaceutical R&D, shortening traditional decade-long drug discovery timelines. Classified as a Class 1 innovative drug in China, Aipusiwei features a completely novel chemical structure and mechanism of action. The oral drug (Esteveir hydrochloride) was granted conditional market approval specifically for treating adult COVID-19 patients.
## BACKGROUND
DNA-encoded chemical libraries (DEL) allow researchers to synthesize and screen vast collections of small molecules linked to unique DNA tags, enabling rapid target binding identification. In China's pharmaceutical classification, a 'Class 1 innovative drug' represents the highest tier of original innovation, requiring entirely new active structures and distinct clinical value.