After the Donald Trump administration in the United States moved to rein in Chinese biotech firms under the Biosecure Act, Congress launched a sweeping investigation into U.S. drugmakers that have conducted clinical trials in China.
Seeing China as leveraging clinical data as a strategic asset to wage a contest for biotech supremacy, the aim is to comprehensively review U.S. pharmaceutical companies' dependence on and partnerships with China.
According to the Bioeconomy Research Center of the Korea Biotechnology Industry Organization on the 3rd, the U.S. House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party opened an investigation on Apr. 30 (local time) into the status of clinical trials in China by five U.S. pharmaceutical companies: Bristol Myers Squibb (BMS), Pfizer, AbbVie, Merck, and Eli Lilly and Company.
The United States has recently designated biotechnology as a core arena in its economic and national security competition with China and is stepping up scrutiny of China's biotech industry. Since last year, Congress has been pushing the Biosecure Act, which would limit Chinese biotech companies' participation in U.S. government projects, elevating bio supply chain and data security issues to matters of national security.
China, meanwhile, released its 15th five-year plan this year, setting bio innovation as a national priority. In particular, by tightening regulation of biological data and expanding the use of artificial intelligence (AI) across the bio sector, it is accelerating the race to secure clinical trial data.
Congress sees China's clinical trial system at the heart of this competition. Backed by regulatory easing and government support, China has built an environment to conduct early-stage trials, especially first-in-human (FIH) studies, quickly and cheaply. With patient enrollment reportedly three to five times faster than in the United States, many global drugmakers have conducted clinical development in China.
The U.S. side, however, voiced concern that this speed is being achieved without sufficient ethical and institutional safeguards. In Xinjiang, allegations of forced labor, forced medical experiments, organ harvesting, and human rights abuses targeting ethnic minorities such as Uyghurs have been raised consistently, and officials say whether clinical trial participants gave voluntary consent also needs verification.
In fact, BMS has conducted about 180 clinical trials in China since 2004, at least eight of which involved hospitals in Xinjiang and at least 17 of which were carried out at Chinese military hospitals or medical centers.
Pfizer has conducted more than 300 since 2000, Lilly more than 220 since 2003, Merck 224, and AbbVie more than 100 clinical trials in China, it was found.
These corporations have also recently signed large-scale technology licensing deals with Chinese biotechs.
BMS signed a deal worth up to $15.2 billion (about 23.4 trillion won) with China's Hengrui Pharma, while Pfizer reached deals with Innovent worth up to $10.5 billion (about 16.2 trillion won) and with 3SBio worth up to $6 billion (about 9.2 trillion won).
Lilly also in-licensed an oncology candidate from Innovent for up to $8.9 billion (about 13.7 trillion won). MSD and AbbVie likewise signed multi-billion-dollar license deals with Chinese corporations.
Accordingly, Chairperson John Moolenaar of the House Select Committee sent letters to each corporations' chief executive officer (CEO) on Apr. 29 (local time), requesting submission of related materials by the 17th of this month.
Congress requested submissions on the following: ▲ whether good clinical practice (GCP) standards were followed in China and Xinjiang ▲ the status of clinical trials conducted at Chinese military hospitals and Xinjiang hospitals ▲ information on contracted clinical research organizations (CROs) and contract development and manufacturing organizations (CDMOs) ▲ safeguards for sensitive clinical data and intellectual property ▲ license and joint venture agreements signed with Chinese corporations since 2020.
The U.S. government is also moving to strengthen domestic clinical capacity. The Trump administration recently said the Food and Drug Administration (FDA) is developing a phase 1 pilot program. If implemented, the process for developing new drugs in the United States and approving phase 1 trials is expected to be shortened by as much as six to 12 months.
In addition, Chairperson Moolenaar is pursuing inclusion in the fiscal 2027 FDA budget bill of a provision that would bar the FDA from accepting, reviewing, or evaluating data generated by Chinese clinical trial institutions.
Industry watchers say the probe could be more than a fact-finding effort, signaling that the United States may be set to fully embark on "de-risking from China" in the bio sector.
An industry official said, "The United States has begun to see not only Chinese biotech firms but also U.S. drugmakers' China-related operations as subject to oversight," and added, "Going forward, clinical data produced in China and histories of technology licensing or joint ventures with China could become new regulatory risks in the process of entering the U.S. market."