It's Years Later And We Still Disagree: Free WuXi From The BIOSECURE Act

By Louis Garguilo, Chief Editor, Outsourced Pharma

Through more than a dozen editorials starting in February of 2024, I have disputed that a most reliable, trusted, and thus utilized global CDMO deserves to be tagged as off-limits to U.S. drug sponsors.

Here we are again:

WuXi AppTec is included in the Pentagon’s new list of companies said to have ties to the Chinese government and military.

Specifically, the CDMO is included under Sec­tion 1260H of the US Na­tion­al De­fense Au­tho­riza­tion Act, and again part of the BIOSECURE Act re­strict­ing fed­er­al con­tracts with certain for­eign sup­pli­ers.

WuXi’s Reply

In the editorials mentioned above, I've interviewed WuXi Apptec executives, and provided space for the organization's reactions. I’ll do that again:

“We note that the U.S. Department of Defense incorrectly included WuXi AppTec in its updated Section 1260H list of designated “Chinese military companies.” The designation of WuXi AppTec on this updated list – along with the alleged basis for the designation – was clearly a mistake, and we will take immediate actions to correct this erroneous designation.

“We do not meet the statutory criteria for designation as a ‘Chinese military company.’ The allegation basis for our 1260H list designation is factually incorrect: we are not owned or controlled by or affiliated with any PRC military or government entity; we do not provide services to the PRC military; and we are not associated with the PRC’s defense industrial base or military-civil fusion programs.

“WuXi AppTec is an independent, publicly traded company serving thousands of partners across 30+ countries to develop life-saving medicines for patients around the world. We have earned the trust of customers over 25 years through our commitment to excellence, security, and innovation. The integrity of our global operations is demonstrated by our track record, including more than 50 successful inspections by U.S., EU, and other regulators in 2025 alone, along with hundreds of customer audits.”

Where The Threat Actually Originates

We have here a level of existential threat to a member of our outsourcing community. However, this is not a defense specific to a particular company.

Rather, it is a call for transparency, due process, and our industry's agency to make outsourcing decisions based on demonstrated performance. 

Should WuXi be unable to extradite itself from this list, it faces a potential steep decline in new contracts from the U.S. customers who provide the lion’s share of its annual revenues.

So how does WuXi get out from under these accusations?  

We’d like to think cooler heads may still end up ruling the day (again). But here’s what I wrote in an editorial the first time WuXi Apptec had this stigma removed:

“The CDMO assuredly knows many of its supporters who helped persuade the U.S. Senate to reverse course and not include WuXi AppTec in The BIOSECURE Act … I would not be surprised if this global, China-based CDMO is reaching out to the many customers – and some organizations – that have not stopped registering support.”

Outsourced Pharma was one of those organizations. Yet also over the years editorially we have been balanced – and adamant the Chinese Communist Party and the underhanded ways the CCP and its organs work against our innovators, needs to be dealt with.

But with WuXi, the U.S. government appears to be barking up the wrong tree.

Many (but not every) bio/pharma industry professionals (and not all our Editorial Board members) I have spoken with over the years agrees with that analysis.

Not disputable, perhaps, is this planned action by the U.S. government impacts options well beyond just WuXi AppTec.

Innovators around the world who would like sell their drugs commercially in the U.S. would, theoretically at least, be at additional risk if they work with any Chinese-based or originated CDMO.

This then, is a global conundrum, and the entire drug industry should raise its voice.

The bio/pharma industry thrives on freely outsourcing to the external development and manufacturing organizations it selects as the best fit – and that includes culturally – and most capable on a project by project basis.

With WuXi, I’ve been told repeatedly, those individual projects lead to long-term relationships based on reliability and confirmed trust.

You Are Here (Again) 

In December of this year, the BIOSECURE Act become law as part of the U.S. de­fense pack­age – without WuXi AppTec or WuXi Biologics included.  

Now, should this re-inclusion stand, WuXi AppTec customers will be required to unwind manufacturing or other relationships with the CDMO within five years.

Again, to review the specific allegations here, the US DOD considers WuXi connected with the As­sets Su­per­vi­sion and Ad­min­is­tra­tion Com­mis­sion of the State Coun­cil (SASAC) un­der the State Coun­cil of Chi­na; the CDMO’s China headquarters is alleged to be nefariously related to the State Ad­min­is­tra­tion of Sci­ence, Tech­nol­o­gy and In­dus­try for Na­tion­al De­fense and the Peo­ple’s Lib­er­a­tion Army, the Pen­ta­gon said.

WuXi dealt with these allegation directly,and convincingly the first go-round.

If Washington wants to restrict access to one of the world's most utilized CDMOs, it owes this industry more than allegations. It owes the public evidence.

For now, WuXi AppTec must again spend time, money, and energy to defend itself – and frankly, the entire global drug development and manufacturing outsourcing ecosystem our industry thrives within.