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WuXi AppTec Faces Biosecure Act Implications Following U.S. Listing

COMPANY PROFILE
  • The U.S. Department of Defense has added WuXi AppTec to its list of Chinese military companies, a designation that may affect the company’s eligibility under provisions linked to the Biosecure Act.
  • WuXi AppTec disputes the designation and says it will pursue available remedies while continuing normal operations and customer programs.

WuXi AppTec has been added to the U.S. Department of Defense’s list of Chinese military companies, a designation that places the contract development and manufacturing organization (CDMO) within the scope of provisions associated with the Biosecure Act. The company said the designation was made in error and stated that it does not meet the statutory criteria for inclusion on the list.

According to the Department of Defense, WuXi AppTec was included on the updated roster based on alleged indirect affiliations with Chinese state and military-linked entities. The designation means the company is considered a biotechnology company of concern under the Biosecure Act, which restricts certain U.S. federal procurement and grant activities involving listed companies.

WuXi AppTec rejected the designation and said it is not owned, controlled by, or affiliated with any military or government entity in China. The company stated that it has never been placed on a government sanctions list and noted that it passed more than 50 regulatory inspections and hundreds of customer audits in 2025 without critical findings. “We do not meet the statutory criteria for designation as a ‘Chinese military company,’” a company spokesperson said.

The company also emphasized that ongoing customer programs will continue without interruption and that its manufacturing facilities remain operational. WuXi AppTec said it plans to pursue available avenues to challenge the designation and seek removal from the list through due process.

Despite the development, the company continues to advance its U.S. manufacturing strategy, including a manufacturing campus in Delaware expected to become operational by the end of 2026, with additional expansions planned for 2027. WuXi AppTec is forecasting total revenue of 51.3 billion to 53 billion yuan in 2026, following reported revenue growth of 28% in the first quarter of the year.

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