How Verta supports U.S. biotech in acquiring Chinese molecules and advancing clinical trials

U.S.-based pharmaceutical and biotech companies are increasingly seeking U.S. and ex-China rights to innovative molecules developed by Chinese companies. The trend reflects both the growing strength of China’s biotech ecosystem and global demand for novel therapeutics.

Over the past year, Verta has supported four such partnerships, helping clients navigate the scientific, regulatory, and operational complexities involved in bringing these molecules into Western clinical development.

Starting with CMC due diligence

Verta’s work begins with comprehensive due diligence. We partner with clients to evaluate critical Chemistry, Manufacturing, and Controls components so the sponsor understands what can be relied upon, what needs clarification, and what must be remediated before clinical advancement.

• Cell line development and product understanding
• Manufacturing processes and process-control strategy
• Analytical methods and method-transfer readiness
• Stability data and shelf-life assumptions
• Supply chain robustness and clinical-supply feasibility

This assessment helps identify potential risks and gaps that must be addressed before a product can move confidently into U.S. and EU clinical trials.

Translating source data into submission-ready packages

Building on due diligence, Verta leverages data provided by the originating Chinese companies to prepare high-quality regulatory documentation. This includes authoring Module 3 sections and Overall Quality Summaries for IND and IMPD submissions, with an emphasis on FDA and EMA expectations.

The work is not simply translation. It is the conversion of technical evidence into a regulatory story that Western agencies can review efficiently and trust.

Supporting tech transfer and clinical supply

Beyond documentation, Verta provides hands-on operational support. Our team facilitates technology transfer for clinical packaging and supports the supply of investigational materials required for clinical trials in both the United States and European Union.

Bridging U.S. and Chinese biotech teams

With deep expertise and Chinese-speaking regulatory and quality consultants, Verta is positioned to bridge the gap between U.S. and Chinese biotech companies. Whether supporting inbound licensing or enabling global clinical development, we help clients move forward with confidence.

For organizations exploring opportunities to acquire or develop China-originated molecules, Verta provides the due diligence, regulatory, quality, and operational expertise needed to accelerate the path to the clinic.

For help applying this expertise to your program, contact Verta.