San Diego, January 3, 2026
A new federal bill known as the Biosecure Act mandates that biotech companies in San Diego terminate their relationships with Chinese firms to address national security risks. Companies like Biopharma, Neurocrine, and Kura Oncology must evaluate existing partnerships or seek federal waivers to comply with the legislation. This move raises compliance challenges, particularly as firms navigate complex supply chains and regulatory constraints.
San Diego, California – New Bill Forces Local Biotech Firms to Sever Ties with Chinese Companies
A new federal bill mandates that San Diego’s biotechnology companies terminate their relationships with Chinese firms, compelling them to reassess existing partnerships or seek federal waivers. This legislation, known as the Biosecure Act, aims to mitigate national security risks associated with foreign adversaries in the biotech sector.
Impact on San Diego Biotech Firms
San Diego’s biotech industry, including major players like Biopharma, Neurocrine, and Kura Oncology, is now required to evaluate their foreign collaborations. The Biosecure Act prohibits federal agencies from contracting with entities linked to foreign adversaries, specifically targeting Chinese companies involved in biotechnology. Firms must either sever ties with these companies or apply for federal waivers to continue their partnerships.
Details of the Biosecure Act
Introduced in 2024, the Biosecure Act prohibits federal agencies from contracting with biotechnology companies deemed a national security risk due to their foreign affiliations. The legislation specifically names five Chinese companies—BGI Genomics, MGI Tech Co., WuXi Biologics, WuXi AppTec, and Complete Genomics—as entities of concern. The Office of Management and Budget (OMB) is tasked with publishing a list of such companies by December 2026, with annual reviews thereafter. Companies on this list are prohibited from providing biotechnology equipment or services to federal agencies. A waiver process is available for companies seeking exceptions to these restrictions.
Industry Response and Compliance Challenges
Biotech compliance experts highlight the complexity of severing ties with Chinese firms. Transitioning away from these partnerships is a lengthy process, often taking several years due to regulatory constraints and the intricacies of the biotech supply chain. The legislation’s broad scope means that even companies without direct relationships with the named Chinese firms may be affected if their suppliers are connected to them. This situation necessitates a comprehensive review of existing contracts and partnerships to ensure compliance with the new law.
Background and Legislative History
The Biosecure Act was first introduced in 2024 and has undergone several revisions. Initially, it explicitly named specific Chinese companies as entities of concern. The latest version, reintroduced in 2025, focuses on Chinese entities without naming specific companies, thereby broadening its scope. This approach aims to address national security concerns more effectively by encompassing a wider range of foreign adversaries in the biotech sector. The legislation has garnered bipartisan support, reflecting a unified stance on safeguarding national security interests in biotechnology.
Conclusion
The enactment of the Biosecure Act represents a significant shift in U.S. biotechnology policy, particularly affecting companies in San Diego. Biotech firms must now navigate the complexities of severing established partnerships with Chinese entities or seek federal waivers to maintain these relationships. The industry faces a challenging period of transition, balancing compliance with the new legislation and the operational demands of their business operations.
Frequently Asked Questions (FAQ)
What is the Biosecure Act?
The Biosecure Act is a federal legislation that prohibits federal agencies from contracting with biotechnology companies deemed a national security risk due to their foreign affiliations, specifically targeting Chinese companies involved in biotechnology.
Which companies are affected by the Biosecure Act?
The Biosecure Act specifically names five Chinese companies—BGI Genomics, MGI Tech Co., WuXi Biologics, WuXi AppTec, and Complete Genomics—as entities of concern. Companies on this list are prohibited from providing biotechnology equipment or services to federal agencies.
How does the Biosecure Act impact San Diego’s biotech firms?
San Diego’s biotech industry, including major players like Biopharma, Neurocrine, and Kura Oncology, is required to evaluate their foreign collaborations. Firms must either sever ties with these Chinese companies or apply for federal waivers to continue their partnerships.
What challenges do biotech firms face in complying with the Biosecure Act?
Transitioning away from partnerships with Chinese firms is a lengthy process, often taking several years due to regulatory constraints and the intricacies of the biotech supply chain. Companies without direct relationships with the named Chinese firms may still be affected if their suppliers are connected to them, necessitating a comprehensive review of existing contracts and partnerships.
What is the legislative history of the Biosecure Act?
The Biosecure Act was first introduced in 2024 and has undergone several revisions. Initially, it explicitly named specific Chinese companies as entities of concern. The latest version, reintroduced in 2025, focuses on Chinese entities without naming specific companies, thereby broadening its scope to address national security concerns more effectively in the biotech sector.
Key Features of the Biosecure Act
| Feature | Description |
|---|---|
| Targeted Companies | BGI Genomics, MGI Tech Co., WuXi Biologics, WuXi AppTec, Complete Genomics |
| Prohibited Actions | Federal agencies cannot procure biotechnology equipment or services from these companies |
| Waiver Process | Companies can apply for federal waivers to continue partnerships |
| Implementation Timeline | OMB to publish a list of affected companies by December 2026, with annual reviews |
| Legislative Support | Bipartisan support reflecting a unified stance on national security in biotechnology |
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