The BIOSECURE Act was passed with a large bipartisan majority in the House in 2024 and now awaits action in the Senate in 2025. Passage of the Act would be a significant first step in protecting Americans and American companies from malicious foreign influence in biotechnology, especially from China. The problem is we needed a first step years ago.
American Biotechnology Is Compromised
Chinese companies have long been accused of pirating American-developed IP and data, and it is frequently reported that Chinese researchers have abused the openness of Western university labs. Chinese contractors have become essential elements of our medical supply chain, making it easier to funnel trade secrets back to Beijing. This has all had negative effects on American companies, but Chinese interference in biotechnology also presents national security risks for the United States as a whole.
The Senate has an opportunity in 2025 not just to pass The BIOSECURE Act but to strengthen it. Congress should amend The BIOSECURE Act to be more stringent, with stronger enforcement and more named Chinese companies of concern than just the original five in the bill that was passed by the House (BGI, Complete Genomics, MGI, WuXi AppTec, and WuXi Biologics).
The Current BIOSECURE Act Is a Good Start But Has Major Limitations
There are many worthy initiatives in the current version of The BIOSECURE Act. Enacting prohibitions on the most malign Chinese companies is a no-brainer. The Act would also expand export control regulations for the most sensitive biotechnologies, mandate greater transparency of funding sources for joint U.S.-Chinese business ventures, and establish a new inter-agency oversight body that reviews foreign investments in American biotech.
However, the Act in its current form does not properly address the sophisticated and multifaceted tactics employed by Chinese state-linked firms to steal IP and potentially weaponize the biotechnology supply chain against the United States. Notable limitations to The BIOSECURE Act include:
Insufficient Focus on Covert Espionage and Indirect Investment
The current Act strengthens America's hand against the most overt Chinese tactics, but it lacks robust provisions to counter more covert espionage like cyber hacks, data exfiltration, and hiring former biotech employees to steal IP. The current Act regulates direct foreign investments but fails to address indirect investments made through intermediaries adequately.
Ignoring the Academic Backdoor
BIOSECURE has strong provisions regulating corporate partnerships but leaves the backdoor open for China to continue to exploit academic research collaborations. This has been a major source of technology transfer—the Chinese Communist Party eagerly uses our values of academic openness and collaboration against us to steal IP and recruit top scientists.
Failure to Address Financial Coercion
The Act does not directly address the pressing issue of economic coercion or intimidation tactics used by Chinese firms and government-linked entities to influence U.S. companies. Chinese investors have been known to take equity stakes in American companies and have used threats of cutting off market access or supply chains to pressure U.S. companies into transferring technology or altering business decisions.
Lack of International Coordination
BIOSECURE does not establish a framework for international coordination with allied countries facing similar threats. We are all safer when we work together in a united front against these attacks.
Lack of Clear Enforcement Framework
The Act would benefit from a clearer and more actionable enforcement framework to ensure effective compliance. Without a robust enforcement framework, there is a risk that prohibited activities could go unchecked, highlighting the need for clear oversight and stringent compliance measures.
Expanding the Scope of the BIOSECURE Act
The existing BIOSECURE Act establishes a workable structure for combatting Chinese biotechnology theft. The Senate Committee on Homeland Security and Governmental Affairs should amend the bill to go further. Here are six ways the Senate can add teeth to the bill without overhauling its language:
Shorten the Timeline for Compliance
The bill passed by the House includes a misguided grandfather clause that waters down enforcement. Much has been made of what a disruption the Act would be to American biotech companies, who have come to rely on relatively cheap Chinese contractors and suppliers. However, the grandfather clause added by the House gives American companies until 2031 to disengage from Chinese companies of concern.
That means 5+ more years for American companies to keep doing business as usual with Chinese firms that Congress has identified as national security risks. We should not wait until the next decade and the next presidential term to start safeguarding critical biotechnologies. The Senate should amend the bill to ensure American companies cut ties with the riskiest Chinese firms by 2028 at the latest.
Support American Companies Under Fire
Numerous innovative American companies face malevolent financial pressures from Chinese backers and partners. It is easy for an ambitious startup to fall prey to predatory Chinese investment, but very difficult to get out of the trap. The Committee on Foreign Investment in the United States (CFIUS) does excellent work blocking some of these deals, but its purview is limited to a handful of cases. The BIOSECURE Act should provide for additional financial, legal, and diplomatic assistance for American companies under the thumb of Chinese investors.
Close the Academic Backdoor
Current provisions on corporate partnerships are a model for additional measures to monitor and regulate international academic exchanges and talent recruitment. BIOSECURE should include enhanced oversight of U.S.-funded research involving foreign nationals.
Improve Cybersecurity Resilience and Financial Oversight
To address potential risks of covert espionage, such as the theft of biological data, the Act could mandate enhanced cybersecurity measures. Additionally, establishing a framework for monitoring access to sensitive data within U.S. companies would strengthen protections. Enhanced oversight of indirect investments, including more rigorous due diligence requirements for VC firms receiving foreign funds, could provide greater transparency and mitigate potential vulnerabilities.
Build Strength in Numbers with Allies
The Act should establish a means for coordinating with our allies. Intelligence sharing and joint strategic planning are needed to address better the global nature of predatory investments and technology transfer.
Include a Broader Range of Chinese Companies of Concern
The House version of The BIOSECURE Act named five Chinese "companies of concern" that have come under scrutiny for their business practices: BGI, Complete Genomics, MGI, WuXi AppTec, and WuXi Biologics. This only scratches the surface. Congress should send a stronger message to China by doing its homework and naming a wider range of Chinese firms as companies of concern.
Naming specific companies gets results. Even though the Act hasn't passed yet, the inclusion of two WuXi entities in the bill text has already had real-world effects. Seeing the writing on the wall, WuXi chose to sell off its cell and gene therapy manufacturing units in December 2024 to an American firm. Other Chinese firms might be pressured to do the same if Congress shined a spotlight on them with the BIOSECURE Act.
Zeroing in on More Chinese Companies of Concern
BGI, Complete Genomics, MGI, WuXi AppTec, and WuXi Biologics are obvious targets for The BIOSECURE Act. It is well known that WuXi entities have become dangerously entwined with American biotech. BGI Group's genomic data collection and ties to the Chinese military have alarmed national security observers for years.
However, the focus on these initial companies obscures other potential nefarious actors operating in the shadows. The Senate could add numerous other companies to the concern list. These four are good starting points to consider:
GenScript Biotech
GenScript offers gene synthesis and biologics development with no shortage of U.S. partners in industry and government. Its subsidiaries include Legend Biotech, Bestzyme, and ProBio. In 2024, the House Committee on China asked the FBI for a briefing on GenScript's potential ties to the Chinese Communist Party. There is widespread concern that these entities may be stealing IP to strengthen Chinese biotech at America's expense.
BeiGene
AbbVie recently filed a lawsuit against this Chinese oncology brand, alleging theft of trade secrets tied to a former AbbVie employee who may have disclosed confidential information to support BeiGene's own drug programs.
China Grand Pharmaceutical (Grand Pharma)
China Grand Enterprises, through its many subsidiaries such as China Grand Pharmaceutical (GCP), has major equity stakes in American medical companies like Sirtex, which manufactures radioactive beads, and a troubling history of anti-competitive business manipulation. China Grand's leader, billionaire Hu Kaijun, has a checkered past of using shell companies to undervalue assets and enrich himself at the expense of partners and patients.
Conclusion: A Stronger BIOSECURE Act in 2025
The United States has already waited too long to counter Chinese interference in American biotech. Our nation needs a long-term strategy to protect our companies and their IP and to protect everyday Americans from the risks of bioweapons and supply chain manipulation.
The House version of BIOSECURE is a worthwhile start but lacks the teeth to counter China's vast, opaque espionage apparatus effectively. The ball is now in the Senate's court. Lawmakers have a golden opportunity to strengthen the current version of The BIOSECURE Act to more fully address the threats facing our nation and our biotechnology industry.
