Ice Miller partners TaeSoo Sean Kim and Mai Zymaris were featured in THE BIO article, "U.S. Legal Professionals’ View on the BIOSECURE Act: Chinese CDMO Shakes Up, Focus Shifts to Korea."

The article included:

Mai Zymaris, a partner at Ice Miller, was optimistic about the potential passage of the BIOSECURE Act this year. She specifically predicted that the newly inaugurated Trump administration would adopt a tougher approach toward China, with a focus on reducing reliance on Chinese manufacturing and limiting cooperation between the U.S. and China in the biotechnology sector.

“The BIOSECURE Act did not pass last year due to the Senate’s tight schedule, including negotiations to avoid a government shutdown,” Zymaris said. “With Republicans in control of Congress, there is a chance that the U.S. administration will bring back this bill to push back against China’s influence.”

Another perspective is that if the bill is enacted, Korean companies could become important “alternative manufacturing partners” for U.S. firms. With Chinese manufacturers facing restrictions in the U.S., Korean CDMO companies like Samsung Biologics could step in as substitute manufacturing hubs. In addition, Korean companies may have the opportunity to take over the production volumes previously handled by Wuxi BioLogics, a major Chinese CDMO company.

TaeSoo Sean Kim, a partner attorney at Ice Miller, stated, “Due to this bill, many CDMO companies are broadening their manufacturing operations beyond China and ramping up production in the U.S.”

“For CDMOs, there is an increasing trend of ‘integrated collaboration’ with clinical research organizations (CROs) to enhance the supply chain and mitigate geopolitical risks,” Kim further explained. “Major pharmaceutical companies are also restructuring their CDMO operations by boosting investments in manufacturing facilities across the U.S., the European Union (EU), and the Americas.”

Click here to read the full article.