China-tested drugs fail to receive FDA approval

Two cancer therapies were denied access to the U.S. markets as they were predominately tested in China.



On Monday, the United States (U.S.) Food and Drug Administration (FDA) has declined to approve two new cancer drugs which were developed in China. The FDA stated that Hutchmed Ltd. needed to test their drug on the U.S. population in a multi-regional clinical trial. "There are very few treatments approved and used in these rare diseases. We look forward to continued engagement with the FDA on developing a plan to bring surufatinib to patients in the US," stated Weiguo Su, CEO of Hutchmed. Suruatinib has been approved in China for treatment of pancreatic and extra-pancreatic neuroendocrine tumours. The regulator has also declined the approval of Coherus BioSciences Inc. and their partner Shanghai Junshi Biosciences. The FDA indicated that the drug was declined due to “quality processes.”


For both cancer treatments the regulator noted issues regarding the inspection of facilities due to deferred travel during the COVID-19 pandemic. In March the American pharmaceutical company Eli Lilly and China-based partner Innovent Biologics had their lung cancer therapy declined by the FDA, raising concerns over the lack of population diversity in single-country trials. The regulator cited concerns that the data would not be applicable to the “racial diversity” of the U.S. population. “We have nothing against drugs being developed in China,” said Richard Pazdur, the director of the FDA’s cancer-drugs division. “Our issue is, are those results generalizable to the U.S. population?” In February there were at least 25 drug applications that were submitted or planned on being submitted to the FDA, they are mainly based on data from China.