WuXi Biologics Removed from US Unverified List Amid Ongoing Restrictions

The US Commerce Department’s Bureau of Industry and Security (BIS) has updated its Unverified List (UVL), removing WuXi Biologics (HKG: 2269), a contract research organization (CRO) based in Wuxi, China. However, the US authorities have added 31 additional Chinese companies and universities to the list, including Shanghai Tech University, University of Chinese Academy of Sciences, and University of Shanghai for Science and Technology.

Understanding the UVL and Its Implications
The UVL is an administrative measure, reflecting the US government’s inability to verify the “bona fides” of foreign entities importing US goods. Entities on the list face restrictions, requiring US companies to conduct additional due diligence or seek specific license exceptions before exporting certain goods. WuXi Biologics was first added to the UVL in February 2022 due to COVID-19 related restrictions that impacted inspections. In July this year, the company revealed that inspections had been completed at its Wuxi facility, and it anticipated removal from the list.

Next Steps for WuXi Biologics
A company spokeswoman, as quoted by Reuters, stated that WuXi Biologics now looks forward to scheduling an inspection of its Shanghai subsidiary, which was also placed on the UVL in February. The removal of WuXi Biologics from the UVL marks a significant development, though the addition of other Chinese entities highlights ongoing regulatory scrutiny by US authorities.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry