The federal agency’s rejection is a sign of an increasingly tough U.S stance on drugs being tested solely in China, after some drugmakers moved to save costs by conducting clinical trials only in China.
The FDA sent Complete Response Letters (CRLs) to Hutchmed Inc. and Coherus BioSciences Inc. on Monday in response to the biotechnology companies’ New Drug Applications (NDAs) to sell their drugs in the U.S. market.
The rejection marks the second time the federal agency has rejected drugs tested in China this year.
According to the Code of Federal Regulations under Title 21, the FDA “will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form.”
In Hutchmed’s case, the drugmaker developed a drug called “surufatinib” to treat pancreatic and extra-pancreatic neuroendocrine tumors. The drugmaker conducted clinical trials in China and a bridging study in the United States before applying to the FDA to market the drug in the U.S., according to the Hong Kong-based company’s May 2 statement.
However, the FDA declined Hutchmed’s application, saying in the CRL that approval of the drug “will require a [multi-regional clinical trial] that includes subjects more representative of the U.S. patient population and aligned to current U.S. medical practice.”
The decision came shortly after the federal agency declined in March to approve a lung cancer drug made by U.S. drugmaker Eli Lilly and its Chinese partner, which was only clinically tested in China.
“The patient population in ORIENT-11, as a single country trial, does not reflect the diversity of the American population, with both known and unknown differences in intrinsic and extrinsic factors,” the FDA’s Oncologic Drugs Advisory Committee said in a February hearing on Eli Lilly’s application.
Data obtained from clinical trials, which were run in only a single foreign country, do not support the “industry commitment to patient equity and inclusion of underrepresented populations,” the summary report for the hearing reads.
The FDA also sent a CRL to Coherus BioSciences Inc. and its Chinese partner Shanghai Junshi Biosciences Co. Ltd., the California-based company said in a press release.
In the CRL, the FDA rejected the drugmakers’ Biologics License Application for a cancer-treatment product, requesting a “quality process change” that Coherus and Junshi Biosciences believe is “readily addressable,” it said.
For both the Hutchmed and Coherus/Shanghai Junshi treatments, the FDA also flagged issues concerning the inspection of facilities due to delayed travel during the COVID-19 pandemic.
Coherus and Shanghai Junshi plan to re-submit their application for the drug’s approval by mid-summer 2022, the companies said.
There are at least 25 applications from China in drug development phases, planned to be submitted or already under review by the FDA, that are predominantly or solely based on trial data from China, the regulator said in February.
Coherus shares were down 2.8 percent at $8.70 in early trading, while U.S.-listed shares of Hutchmed slumped 22 percent to $11.76.
Reuters contributed to this report.