A U.S. congressional investigation launched last month to examine the status of global pharmaceutical companies’ clinical trials in China is set to conclude this week.
Some observers say the United States could accelerate efforts to counter China in the biotechnology sector based on the findings, raising attention over how the trend could affect South Korean companies.
According to foreign media reports including Reuters on July 14, the U.S. House Select Committee on the Chinese Communist Party requested five pharmaceutical companies — Merck & Co., AbbVie, Eli Lilly, Pfizer and Bristol Myers Squibb — submit information on their clinical trials in China by July 17.
The requested information includes each company’s clinical trial site inspection procedures in China, data protection systems and ethical standards. The review aims to determine whether U.S. advanced technologies and intellectual property may have been transferred to the Chinese government or military during clinical trials conducted in China, as well as whether there were any human rights concerns involving trial participants.
The U.S. Congress is paying particular attention to clinical trials conducted in China’s Xinjiang region and at Chinese military hospitals. In a letter, lawmakers described Xinjiang as the “origin of China’s genocide targeting ethnic minorities, including Uyghurs, and religious groups.” The investigation appears to focus on concerns that Chinese research institutions may have collected DNA and other biological information from ethnic minorities without proper consent.
Congress also warned that “conducting clinical research at Chinese military hospitals creates a potential risk of transferring advanced biotechnology intellectual property from U.S. companies to the Chinese military.”
Industry observers widely expect the investigation to go beyond a simple fact-finding exercise. If the United States establishes additional guidelines for clinical trials conducted in China based on the results, global pharmaceutical companies’ research and development strategies could face inevitable changes.
The United States has recently classified biotechnology as a key national security industry alongside semiconductors and artificial intelligence, while pushing policies aimed at reducing dependence on China. Washington has been seeking to lower China’s role across the supply chain, including raw materials, biopharmaceutical production, clinical trials and research and development.
Meanwhile, China has rapidly grown into a global clinical trial hub by leveraging its large patient population, faster trial timelines and lower costs. Multinational pharmaceutical companies have also actively used clinical trials in China to shorten drug development timelines.
According to the U.S. Congress, Merck has sponsored or collaborated on 224 clinical studies in China since 2005, including at least 31 studies conducted in Xinjiang and 40 at Chinese military-related medical institutions. AbbVie has been involved in more than 100 clinical studies in China since 2007, including at least 17 in Xinjiang and 16 at military-related institutions.
There are mixed views on how intensifying U.S.-China biotechnology competition could affect South Korea. If the United States strengthens restrictions on Chinese biotech companies, South Korean firms with advanced medical capabilities, strong hospital infrastructure and clinical trial expertise could emerge as alternative partners.
However, concerns remain that South Korean companies may face greater diplomatic pressure when pursuing cooperation with China. Many domestic biotech companies are conducting joint research and development, technology transfers and clinical trials with Chinese biotechnology firms, meaning expanded U.S. regulations could require companies to reassess their business strategies.
Experts believe the United States is likely to follow up with measures such as restrictions on cooperation with Chinese clinical research institutions and stricter standards for the use of clinical data based on the investigation results. However, replacing China’s role with other countries in the global drug development process in the short term appears difficult, given its continued influence.
Hwang Ju-ri, head of external cooperation at the Korea Biotechnology Association, said, “This investigation is not simply a review of individual companies but will serve as a signal of the direction of the U.S. strategy toward China’s biotechnology sector.” She added, “However, since this remains an issue between the United States and China, even after the results are released, the direct impact on Korean companies is unlikely to be significant.”
She added, “While the United States and China are strengthening biotechnology competition on the surface, there are also signs that cooperation between the two countries is increasing behind the scenes compared with the past,” adding that Korean companies are closely monitoring changes in the global biotechnology market while considering areas where they can strategically expand.
