Biosecure Act Signed, Heightening Tensions in the Bio Industry

With U.S. President Donald Trump's signing of the Biosecure Act in December 2025, U.S. biopharmaceutical companies face strict regulatory compliance obligations in their collaborations with Chinese supply chains. The 2026 BIO International Convention witnessed significant concerns and tensions regarding these comprehensive restrictions on transactions with China. Warnings have been raised that regulatory uncertainty could hinder startups' fundraising and M&A activities, potentially stifling the innovation ecosystem. Venture capitalists and entrepreneurs widely express critical views, suggesting that the expansion of regulations without clear guidelines will freeze investment sentiment.

Pfizer and BMS Announce Major Licensing Agreements in China

Despite the strong regulatory push from the U.S., global pharmaceutical companies continue to acquire innovative assets from China. Recently, Pfizer (PFE) signed a large-scale oncology and antibody-drug conjugate (ADC) co-development agreement with Innovent Biologics, valued at $10.5 billion (approximately 14 trillion KRW). Bristol Myers Squibb (BMY) also announced a global licensing agreement with Hengrui Pharmaceuticals for 13 pipeline assets, totaling up to $15.2 billion (approximately 21 trillion KRW). This demonstrates that, despite U.S.-China tensions, Chinese innovative drug assets have become a core strategic pipeline for U.S. Big Pharma.

U.S. Policy to Expedite Clinical Trials and Incentivize Domestic Development

Instead of solely relying on regulations ('stick'), the U.S. Department of Health and Human Services (HHS) has announced a policy to accelerate early-stage clinical research within the U.S. ('carrot'). This includes clarifying data requirements before submitting Investigational New Drug (IND) applications and providing rapid feedback through the Food and Drug Administration (FDA)'s Rolling Submission platform. This aims to bring clinical development and contract manufacturing organization (CMO) infrastructure, which had been reliant on China, back to the U.S., and to increase the potential for early returns for venture capital, thereby strengthening U.S. biosecurity. However, industry experts point out that conducting global clinical trials remains essential for acquiring data quickly.

Securing Patient Access Through U.S.-China Cooperation

The Chinese government is also introducing new incentive schemes to encourage domestic pharmaceutical companies to focus on the domestic market and patient treatment. Nevertheless, companies affiliated with Biocom, a California-based biotechnology organization, continue to seek collaborations with pipeline developers in Shanghai and Shenzhen. Experts express concern that regulatory protectionism, which closes borders, may have the unintended consequence of hindering access to innovative life-saving technologies. Ultimately, a balanced policy approach is needed that protects national security while allowing global capital and talent to combine and solve intractable diseases.