On May 2, the U.S. Food & Drug Administration (FDA) denied approval for two cancer treatments developed in China.
Hutchmed’s pancreatic cancer treatment was turned back due to worries about single-country trials. In addition, Junshi Biosciences and Coherus BioSciences’ throat cancer drug was held up because of quality processes.
Hong Kong-based Hutchmed received a Complete Response Letter from FDA. In the letter, the FDA urged Hutchmed to complete a “multi-region” trial in pancreatic and extra-pancreatic neuroendocrine tumors. After that, the agency will approve surufatinib.
Separately, Shanghai-based Junshi Biosciences and its American partner Coherus revealed that its cancer drug, toripalimab, had also been denied. The reason given was issue with the manufacturing of the drug- specifically a request for a quality process adjustment.
According to Reuters, this is the second time the U.S. authority has turned down approval for a drug tested primarily in China.