美国又一轮生物安全法案,中企如何应对?
Hu Xiu·2025-10-19 04:03

Core Viewpoint - The U.S. Senate passed the 2026 Fiscal Year National Defense Authorization Act (NDAA) on October 9, 2025, which includes a new version of the Biosecurity Act (S.A.3841) as an amendment, significantly impacting the global biopharmaceutical industry [1][2]. Legislative Path and Evolution - The 1.0 version of the Biosecurity Act was introduced in May 2024 but failed to pass due to high Senate thresholds and the impending congressional turnover [3][4]. - The 2.0 version was introduced in 2025 and successfully attached to the NDAA, significantly increasing its chances of passing due to the NDAA's mandatory nature [5][4]. Sanction Logic and Scope - The new legislation follows a "Huawei-style sanction" logic, identifying Chinese biotech companies as threats to U.S. national security, thus prohibiting U.S. federal agencies from procuring their products or services [6]. - The sanction list will include entities identified by the Department of Defense and other agencies, with a 90-day appeal period for those listed [7]. Transition Period and Exemption Rules - The 2.0 version includes a transition period of 2-3 years before sanctions are implemented, allowing time for strategic adjustments [8][9]. - Existing contracts signed before the legislation may not be retroactively exempt, which could impact companies' operational strategies [8]. Strategic Adjustments for Chinese Companies - Companies with overseas production or R&D bases should strengthen local barriers and consider relocating core projects to non-China sites [11][12]. - Companies without overseas bases should develop tiered strategies, focusing on localizing key markets and diversifying customer bases to mitigate risks associated with U.S. federal clients [14]. Industry-Wide Actions - The industry should unify efforts to create a defensive network in critical areas where China holds a monopoly, particularly in active pharmaceutical ingredients (APIs) [15]. - China's dominance in the global supply chain for APIs presents a strategic advantage that can be leveraged against unilateral restrictions [15][17].