The final BIOSECURE Act: which Chinese firms are under threat?

We have compiled a list of Chinese firms whose U.S. operations may be at risk.

Written by Tom Campbell and Dirk van der Kley

Key points

• The US accounts for ~45% of global pharma sales. It is potentially a very powerful form of leverage for the US.

• We count 16 Chinese firms at immediate risk of being cut off from the US biotech ecosystem (list at end of article).

• The Act is designed to reduce data and economic security risks, but it also has the potential to be deployed in broader US-China economic stoushes.

• The power of BIOSECURE relies on inflated US drug pricing. Trump is simultaneously trying to reduce US drug prices.

BIOSECURE passes as part of a bigger bill

After years of vacillation, the US government signed a version of the BIOSECURE Act into law on December 18, 2025, as part of the National Defense Authorisation Act (NDAA) for Fiscal Year 2026.

The NDAA FY26 folds in an updated version of the BIOSECURE Act in Sec. 851 (it is no longer formally called this but the name has stuck around as a convention). The broader Act contains 17 provisions relating to biotechnology. Many of these have a heavy domestic focus, empowering the Department of Defense to fund bioindustrial research and commercialisation facilities.

Differences between the new version and the original

The BIOSECURE Act (H.R. 8333) was first introduced in May 2024 as a security measure to prohibit entities that receive federal funds from procuring or obtaining ‘any biotechnology equipment or services produced or provided by a biotechnology company of concern’

The updated act does two new things:

1. It removes the five explicitly named companies in the original version. This gives the US government wiggle room in implementation.

2. Biotechnology companies that are already on Department of Defense’s (DoD) existing 1260H List will automatically deemed companies of concern. 1260H List identifies Chinese companies that have military links and operate in the US, updated annually by the DoD. .

In the original BIOSECURE Act, two Chinese contract development and manufacturing organisations (CDMOs) - WuXi AppTec and WuXi Biologics - and three Chinese genomics firms - BGI, MGI, and Complete Genomics were directly named as companies of concern.

This pattern reveals two distinct motivations for US policymakers. The first is a matter of economic security. The US does not want its biopharma sector to be dependent on Chinese CDMOs or on Chinese manufacturing of cutting-edge equipment. An extra motivation against genomics firms is to protect US genomic data from being used to develop new biotech products.

Beyond the two obvious motivations, the Act creates a way to block almost any Chinese biotech company from accessing the US ecosystem which could be deployed for broader geopolitical purposes. Because the US market is more profitable than any other in the world, losing access to it is a major blow for firms — effectively creating a global bottleneck, similar to US control over finance or China’s control over critical mineral refining.

There is no indication that the Trump administration intends to use it more broadly. But the tool is there.

Which Chinese companies are under threat (there is a list at end of article)

The 1260H list covers a lot of ground from telecoms to aviation to facial recognition software, and the majority of the companies are not biotech-relevant. Of the original named five, BGI and affiliate MGI both appear on the 1260H list. So we know that they will automatically be included on the company of concern list, alongside forensic DNA testing service FGI (another BGI subsidiary) and the cell bank network Origincell.

The 1260H list is updated annually (most recently in Jan 2025), and an imminent update will be important to watch. According to Bloomberg, Deputy Defense Secretary Stephen Feinberg informed Congress in an October 7 letter that the department should add WuXi AppTec to the 1260H list. This makes WuXi Biologics a likely contender as well.

Additionally, in a March 2024 letter from the Select Committee on the Chinese Communist Party to the DoD several biotech companies are listed as warranting inclusion on the 1260H list. The same committee has had a continued interest in Genscript and its affiliates Bestzyme, Legend Biotech, and ProBio. Requests to the ODNI and the FBI for an investigation into these companies’ government links were made in May 2024 and July 2025.

We have collated this information in a table at the bottom of the article. It is our best guess at what Chinese biotech companies may be at risk of a ‘biotechnology company of concern designation’.

Chinese CDMOs will be hit hardest…and US small capital biopharma will stomach the cost

US biopharma is coupled to Chinese drug services firms. Drug development involves the synthesis of hundreds of thousands of drug candidates, which is done by manual stepwise synthesis. This is prohibitively expensive to staff in the US.

China has become the major destination for this work - an oft-cited Biotechnology Innovation Organisation survey in May 2024 highlighted that 79% of their members relied on at least one contract with a Chinese research or manufacturing partner. Large CROs such as WuXi AppTec have over 38,000 employees and synthesise over 500,000 compounds annually.

Curiously, the threat of the BIOSECURE Act over the past few years has not seen real change in the extent to which these services are being contracted. Both WuXi AppTec and WuXi Biologics’ share of revenue from US customers has remained consistent (shown below). Additionally, WuXi AppTec backlog of orders increased 41.2% year-over-year in Q3 2025. This could indicate companies rushing to sign contracts in the looming shadow of BIOSECURE.

At the same time, there are anecdotal examples that US firms are trying to de-link their manufacturing from China. We have spoken to Chinese bioreactor suppliers that claim US firms are skittish about buying their equipment.

Small-capital US biopharma firms will rightly complain that they are being locked out of the cheapest research ecosystem.

It seems then, that small-capital US biopharma firms are stuck between two pitfalls. Continuing to do business with Chinese CDMOs is a risk that private investors will be unwilling to take on. But many innovative biopharma firms are outsourcing to China because it is significantly cheaper than the rest of the world. Increased demand for non-China manufacturing will simply drive up prices elsewhere and lead to longer wait times in drug development.

The effect for the genomics firms is smaller because they typically have less concentrated revenue streams - only a very small fraction of MGI and BGI’s business comes from the US. So, it is less of an economic security concern and more of a data security concern.

Regardless, the wording of the bill seems to imply that BGI and MGI equipment being used for any work done will be prohibited. This could mean that contracting a CDMO that has a BGI genome sequencer is no longer fair game. Even if it isn’t explicitly stated, companies might start to self-censor.

How will Chinese firms (and the CCP) respond?

When the BIOSECURE Act was first being discussed in 2024, there was dismay among Chinese firms. BGI and MGI both released statements arguing against their inclusion, while Complete Genomics set up a website to protest the act.

Denials aside, companies that see themselves at threat of a ‘biotechnology company of concern’ designation will seek to ‘de-China’ their operations. We are already seeing this manifest in a few ways.

1. Chinese companies set up a subsidiary in the US that operates separately from their operation in China. This may be enough to avoid restrictions. Complete Genomics made progress towards its localisation strategy; establishing a manufacturing facility in San Jose, CA to produce low-to-mid range sequencers

2. Chinese companies sell their overseas operations. BIOSECURE has been shown to reduce market valuations of Chinese firms, meaning they can be bought at a discount. Even the threat of the BioSECURE Act has been enough to drive action - in early 2025 WuXi AppTec sold UK and US based operations of its subsidiary Advanced Therapies to the NY based firm Altaris and its US based medical device testing services to NAMSA.

The Chinese government also has options:

1. It can retaliate in the bio space. Gene-sequencer producer Illumina was placed on the Ministry of Commerce’s Unreliable Entities List in early 2025. Illumina remains the only life sciences company on the UEL, and therefore this may be a unique case (Illumina lobbied for the BIOSECURE Act).
   
   Although the export ban on Illumina has been lifted, it remains on the UEL and thus purchases require government approval. Given this, it will likely be excluded from Chinese research institutes procurement - Matt Marlowe notes an interviewee who claimed “Even if Illumina performs well, it’s no longer worth the operational uncertainty.”

2. It can choose to use tools outside of bio (no indication that it is planning to do so). China has many tools to potetially punish the US, athough it appears not willing to do so for pharmaceutical CDMOs.

The takeaway is that even without formal sanctions, we could end up with geographic siloing of sequencing technologies. This will further drive down Illumina’s China business: their Q4 25 financial presentation indicates a year-on-year decrease in Chinese revenue by 30%.

‘Most-favoured nation’ pricing is inconsistent with BIOSECURE ambitions

The bite of BIOSECURE relies on the fact that the US accounts for ~45% of global pharma sales despite having only 4% of the population. Firms’ pathway to profit is the US. This is particularly the case for name-brand drugs, where Americans pay 4.22 times more than consumers in other OECD countries.

But if the US market becomes less valuable, and thereby less crucial to drug manufacturers, the US government loses bargaining power.

This leverage could be lost because of Trump’s executive order to pursue a ‘most-favoured nation’ (MFN) pricing policy for drug sales. It aims to tie the price of prescription drugs to the lowest price available in an OECD country.

The loss of the US premium would change the calculus for pharma. Companies will migrate to more economically viable locations where they can access cheap development costs and market revenue. This may preclude innovation or manufacturing in the US. Rather, companies might look to Europe for research, Australia for early clinical trials, and India for manufacturing. So while BIOSECURE aims for de-Chinfying bio supply chains, MFN doesn’t necessarily favour reshoring them.

Ultimately, if the overarching ambition for the Trump administration is to make biotech American again, then the US might be shooting themselves in the foot.

List of companies who are at threat of a biotechnology company of concern designation