The FDA rejected Hong Kong-based Hutchmed’s application to market its drug surufatinib in the U.S. as a treatment for pancreatic and neuroendocrine tumors. The two clinical trials Hutchmed performed in China don’t support approval at this time, the agency told the drugmaker.
In a separate move, the FDA also turned down an application from Shanghai Junshi Biosciences and its California-based partner Coherus BioSciences for the nasopharyngeal cancer drug, toripalimab. The agency requested the drugmakers change a quality-related process, which the companies said is easily addressable, according to the Journal. They plan to refile their approval application this summer.
The FDA declined the Journal’s request to comment on the rejections, which coincide with agency concerns over the quality of clinical trials evaluating medications developed in China.
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