U.S. FDA declines to approve two more China-tested drugs

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The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd (0013.HK) – needs to test its drug for the U.S. population in a diverse multi-regional trial.

This is the second time the U.S. regulator has declined to approve a drug that was tested mainly in China. In March, it declined to approve Eli Lilly (LLY.N) and partner Innovent Biologics Inc’s (1801.HK) lung cancer drug that had been studied only in China.

Coherus BioSciences Inc (CHRS.O) and Chinese partner Shanghai Junshi Biosciences Co Ltd said the FDA indicated their China-only trial may be sufficient for its cancer drug, toripalimab, but declined to approve it over quality processes.

Coherus said the FDA indicated the target disease, a type of nasopharyngeal carcinoma that currently has no approved treatment options in U.S., warrants flexibility with respect to the sufficiency of single-country clinical data on the drug.

For both the Hutchmed and Coherus/Shanghai Junshi treatments, the FDA flagged issues concerning 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.

The FDA’s communication – known as a Complete Response Letter – to Hutchmed said its treatment for neuroendocrine tumors requires data from a study more representative of the U.S. patient population. Hutchmed had conducted a “bridging study” in the U.S. but the FDA recommended a multi-regional clinical trial, the company 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% at $8.7 in early trading, while U.S.-listed shares of Hutchmed slumped 22% to $11.76.