Rising US scrutiny on clinical trials could threaten China’s biotech advantage: analysts

China’s edge in fast, cost-effective early clinical trials has propelled its emergence as a global biopharmaceutical powerhouse, but there is a risk that the United…

China’s edge in fast, cost-effective early clinical trials has propelled its emergence as a global biopharmaceutical powerhouse, but there is a risk that the United States could take steps to curb that advantage, according to analysts.

US lawmakers and officials at the Food and Drug Administration (FDA) have raised the alarm about American pharmaceutical companies’ growing reliance on conducting early clinical trials in China, flagging the opaqueness of the process and the need to keep medical innovations on shore.

While large multinational corporations’ compliance teams have been “on high alert for quite a while”, the recent ratcheting up of such rhetoric in Washington could prompt firms to “double click a lot more when evaluating China-origin target assets”, said Xianfeng Morgan Xu, a partner at US law firm Foley Hoag based in Washington.