When it comes to global contract research, development and manufacturing organizations (CRDMOs), China-headquartered WuXi AppTec and WuXi Biologics are some of the world’s largest and most influential companies in the sector. Given their respective sizes and growth trajectories, it’s not surprising that these two CRDMO powerhouses found themselves in the crosshairs of geopolitical tensions between China and the United States.

With U.S. biotechnology leadership at risk due to growing competition from Chinese companies, members of Congress in 2024 aggressively targeted both WuXi AppTec and WuXi Biologics, urging the Secretaries of the Departments of Commerce, Defense, and Treasury in a letter to investigate the two CRDMOs.

WuXi AppTec and WuXi Biologics are “rapidly becoming a global pharmaceutical and research-services giant that threatens U.S. intellectual property and national security,” the congressional letter stated, while claiming that both companies “have close ties” to the Chinese Communist Party and “have worked at its behest, in multiple instances.”

In December 2025, a separate letter was sent by nine Republican congressional leaders to the Department of Defense (DoD) requesting the addition of WuXi AppTec and Wuxi Biologics to the Pentagon’s 1260H List of “Chinese military companies” operating in the U.S. However, when DoD released its updated 1260H List earlier this month, WuXi AppTec was added to the document but WuXi Biologics was not included.

It begs the question: Why did WuXi Biologics escape inclusion on the Pentagon’s blacklist while WuXi AppTec did not?

1260H List, BIOSECURE Act and OMB

Law firm Ropes & Gray noted in an alert that WuXi Biologics was not named to DoD’s updated 1260H List because it did not meet the ownership/affiliation thresholds, adding that the CRDMO “does not appear to be implicated by the naming of WuXi AppTec because it is not a subsidiary, parent, or successor of WuXi AppTec.”

Although WuXi AppTec and Wuxi Biologics might operate as separate entities with distinct business focuses, they have both been painted as threats to U.S. national security. A 2024 report alleges WuXi Biologics is a “sprawling enterprise in its own right that raises major national security concerns and has a significant U.S. presence,” while detailing how WuXi AppTec has so far “attracted the lion’s share of outside attention.”

Among the report’s allegations: WuXi Biologics actively engages in Chinese Communist Party (CCP) activities and is an active participant in the “Biopharmaceuticals Union of Party Committees” which promotes cooperation between CCP and industry companies — making its subsidiaries and investor/shareholder relationships “worthy of additional congressional scrutiny.”

Around the same time, initial drafts of the BIOSECURE Act — restricting federal contracts with companies deemed to pose U.S. national security risks — targeted WuXi AppTec and WuXi Biologics, labeling them as “biotechnology companies of concern” due to their alleged ties to the Chinese government.

Both companies were subsequently removed from the bill before the BIOSECURE Act was passed by Congress and signed into law by President Trump in December 2025 as part of the Fiscal Year 2026 National Defense Authorization Act.

However, a lawsuit filed this month by WuXi AppTec against DoD claims harm caused to it has been “compounded” by the BIOSECURE Act, as the “designation under Section 1260H automatically results in designation of [WuXi AppTec] as a biotechnology company of concern (BCC) under the BIOSECURE Act.”

“WuXi AppTec is not a Chinese military company — not based on an objective review of the facts, and not under the statutory designation criteria for the Section 1260H List under U.S. law,” the CRDMO said in a statement. “We are not owned or controlled by or affiliated with any government or military organization; we do not provide services to the PRC military; and we are not associated with any defense industrial base or military-civil fusion programs in any country.”

The potential problem for WuXi Biologics is that the Office of Management and Budget (OMB) may publish a separate list of additional BCCs meeting statutory criteria related to foreign adversary control and national security risk, according to the law firm Hyman, Phelps & McNamara. As a result, OMB’s publication of the formal BCC list — due no later than December 2026 — could potentially include WuXi Biologics.

“The U.S. government may designate a company that is not on the 1260H List as a BCC, if it determines the company is controlled by the government of a foreign adversary and poses a national security risk,” law firm Arnold & Porter said in an advisory.

All of this comes as a biotechnology competitiveness scorecard this week found that China has achieved “manufacturing dominance” over the U.S. with CRDMO capacity called out as a “structural” advantage. Among the top threats to America’s biotech leadership are China’s supply chain capacity and manufacturing scale, according to the report.