The Food & Drug Administration has denied approval of two proposed new cancer drugs which were developed in China.  The FDA issued a letter to Hong Kong-based Hutchmed Ltd. denying permission to market the drug ufatinib, which is approved in the Chinese market to treat pancreatic and neuroendocrine tumors.  It also notified China-based Shanghai Junshi Biosciences Co. and its U.S.-based partner Coherus BioSciences Inc. that it denied its application to sell the drug toripalimab, which treats nasopharyngeal cancer.  The FDA asked the companies to change their quality-related processes at which time the FDA will reexamine the applications.  However, the FDA did note that two clinical trials Hutchmed conducted in China for ufatinib didn’t support approval so that company may have to go back to the drawing board on clinical trials as well.  FDA officials have commented publicly recently that they were not happy with the quality of drug studies conducted in China and that it was unclear whether the results would be applicable to U.S. patients.

 

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