GENE ONLINE|News &
BIOSECURE Act Absent in Key U.S. Defense Bill—Slim Chance of Passing December 20 Resolution
The BIOSECURE Act, targeting the dissociation of the U.S. pharmaceutical industry from select Chinese firms by 2032, has strong bipartisan backing. Image: Shutterstock.
The future of the BIOSECURE Act became more uncertain recently after United States senators excluded it from a key defense spending bill. The omission means the legislation, which aims to block certain Chinese biotech firms and manufacturers from accessing U.S. funding and collaborating with U.S. pharma companies using federal resources, will likely be delayed until the incoming Trump administration. As Congress heads into its holiday recess, the BIOSECURE Act may miss its chance to pass this year.
BIOSECURE Act Absent from U.S. Defense Bill—A Win for China Biopharma
Nearly a year after the U.S. House of Representatives introduced the BIOSECURE Act, its potential impact on the U.S. pharmaceutical and biotechnology industries is becoming clear. The legislation seeks to end federal contracts with five Chinese life sciences companies—WuXi AppTec, WuXi Biologics, BGI Group, MGI, and Complete Genomics—due to national security concerns. However, the act failed to secure inclusion in the 2025 National Defense Authorization Act (NDAA), a key legislative vehicle for passage.
The annual defense bill had been viewed as the most viable path to enact the BIOSECURE Act after the House overwhelmingly passed it in September. The omission leaves the Act, aimed at blocking these Chinese biotechs from accessing U.S. federal funding and collaborating with U.S. pharma companies, unlikely to pass this year as Congress approaches its holiday recess.
Under the proposed legislation, U.S. drugmakers would have until 2032 to dissociate from these Chinese companies. Despite the extended timeline, some companies are already seeking alternatives. Many are turning to Indian drug service firms, which are preparing for increased demand. Additionally, others are exploring partnerships with European or North American contract development and manufacturing organizations (CDMOs).
BIOSECURE Act Excluded, but Biotech Security Stays on U.S. Agenda for 2025, with Focus on Securing Critical Supply Chains
The BIOSECURE Act names five Chinese biotechs, including WuXi AppTec, WuXi Biologics, BGI Group, and its subsidiaries MGI Tech and Complete Genomics. Following recent developments, WuXi AppTec’s shares rose over 10% after this development, compared to the previous market close. The Hong Kong-listed company currently holds a market capitalization of $185.4 billion.
A WuXi AppTec spokesperson acknowledged the act’s exclusion from the FY2025 National Defense Authorization Act (NDAA). They stated the company remains committed to sharing facts with lawmakers and federal agencies about their operations and the global services they provide, including to U.S. customers.
BIOSECURE Act Faces Slim Chance of Passing This Year with December 20 Resolution
While the five Chinese companies named in the BIOSECURE Act may be breathing a sigh of relief, there’s still a slim chance the bill could pass Congress this year. A continuing resolution, scheduled for December 20, could allow federal operations to continue while the final terms of the defense bill are negotiated.
Since its introduction in January by former Republican Congressman Mike Gallagher, the BIOSECURE Act has gone through several revisions. The bill gained significant bipartisan support when the U.S. House of Representatives passed it in September with a 306-81 vote. However, concerns have arisen about the impact the bill could have on U.S. pharmaceutical R&D and manufacturing, given the industry’s heavy reliance on Chinese companies like WuXi, which operates one of the largest biologics manufacturing networks globally.
While the bill passed the House, many Democrats opposed it, and several high-ranking lawmakers have since expressed their opposition. Biopharmaceutical companies such as MSD, Gilead Sciences, and Vertex Pharmaceuticals have warned that the BIOSECURE Act could increase costs, delay clinical trials, FDA regulatory submissions, and drug launches. According to GlobalData, over 120 U.S. biopharmaceutical drugs with Chinese biotech involvement could be impacted, with 60% of these in late clinical-stage trials.
Both WuXi and BGI have voiced strong objections to the bill. WuXi called the designation “pre-emptive and unjustified,” while BGI described it as containing “falsehoods and baseless allegations,” arguing it would only strengthen monopolies in the U.S. Analysts are also skeptical. A recent CPHI Milan industry survey of 280 drugmakers found that 38% of respondents saw the BIOSECURE Act as a “politically motivated issue,” and just 19% viewed China-based CDMOs as a threat that should be removed from Western supply chains.
U.S. Companies Grapple with Balancing Security Concerns and Dependence on Chinese Biotech Services
The U.S. biopharma industry relies on Chinese CDMOs for low costs and skilled workforce. WuXi AppTec employs over 20,000 chemists. BIO’s survey shows 79% of U.S. biotech firms contract with at least one Chinese company. AlphaSense reports 60 U.S. companies linked to those named in the BIOSECURE Act. Shifting to non-Chinese CDMOs is complex and long-term. Despite growth, WuXi AppTec’s Advanced Therapies revenue declined by 17%, blaming the BIOSECURE Act.
Despite growing opposition and concerns from the U.S. biopharma industry, the BIOSECURE Act remains a contentious issue in Congress. Its exclusion from the 2025 National Defense Authorization Act leaves its future uncertain, but ongoing national security debates will keep it on the political agenda. For now, U.S. companies continue to navigate the complexities of balancing security concerns with reliance on Chinese biotech services.
Author
LATEST
