Biopharma deal-making is shifting, with Chinese companies now accounting for 30% of global licensing deals as of 2024. While Western markets face uncertainty, China’s rapid growth in first-in-class therapeutics presents attractive acquisition opportunities for U.S. and EU buyers. However, key risks—such as differences in regulatory standards, quality systems, and data integrity—must be carefully assessed.
This white paper outlines a structured approach to CMC due diligence, including data review, risk assessment, and strategic recommendations. Three case studies illustrate common challenges in transitioning China-manufactured biologics for Western clinical trials. As interest in earlier-stage Chinese assets grows, robust due diligence is essential to ensure regulatory compliance and commercial viability.
