- The U.S. House’s BIOSECURE Act amendment exempts WuXi AppTec and other Chinese CDMOs from national security scrutiny until 2032.
- Biopharma industry welcomes the eight-year transition period to reduce reliance on China-based biomanufacturing.
The U.S. House of Representatives has amended the BIOSECURE Act, providing a significant reprieve to WuXi AppTec and other Chinese contract manufacturing organizations (CDMOs). The revised bill now includes an eight-year period of immunity, allowing existing contracts with these entities to continue without national security interference until January 1, 2032.
This legislative update has been met with approval from the biopharma industry. John Crowley, CEO of the Biotechnology Innovation Organization, lauded the bill for offering “a reasonable timeframe for companies to decouple their reliance on China-based biomanufacturing.” He emphasized the importance of this period in ensuring that “important biomedical research will not be slowed and that patients will have unimpeded access to life-saving medicines.”
Introduced by a bipartisan group of lawmakers, the House bill aims to prevent “biotechnology companies of concern” from receiving federal funding indirectly through their biopharma customers. To maintain eligibility for Medicare and Medicaid, drugmakers are required to sever ties with the specified Chinese contractors.
While WuXi AppTec and genome sequencing firms such as BGI, MGI, and Complete Genomics were initially targeted, the U.S. government retains the authority to identify additional “foreign adversary biotech companies of U.S. national security concern” for future inclusion.
Despite the lack of transparency in the selection process for potential new targets, the biopharma industry has begun distancing itself from Chinese CDMOs. Novartis CFO Henry Kirsch stated that the company is proactively developing plans to end its relationships with Chinese contractors.
Overview of outsourcing trends 
