US FDA declines to approve two more China-tested drugs

The US Food and Drug Administration (FDA) declined to approve two China-tested cancer treatments recently, raising concerns over the future of drugs tested in single-country trials.

The decisions could add pressure on Chinese stocks, especially biotech companies, at a time shares of several US-listed Chinese companies have been falling on the potential risk of being de-listed.

The FDA sent a so-called Complete Response Letter to Hutchmed stating its treatment for neuroendocrine tumours requires data.

Separately, the FDA also declined to approve Coherus BioSciences and Chinese partner Shanghai Junshi Biosciences Co’s cancer drug to treat a type of nasopharyngeal carcinoma, citing the need for quality process changes.

However, Coherus said the FDA indicated existing data on the drug, toripalimab, supports a re-submission of the application.

“The FDA has stated this indication warrants regulatory flexibility with respect to the sufficiency of single-country clinical data,” Denny Lanfear, Chief Executive Officer, Coherus, said in a statement.

The regulator also cited issues concerning inspection of facilities for both the treatments due to delayed travel during the COVID-19 pandemic.

The FDA in March declined to approve Eli Lilly and partner Innovent Biologics’s lung cancer drug that had been studied only in China.

It has raised concerns over lack of population diversity in single-country trials, citing the need for conducting studies applicable to the US population.

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 and Shanghai Junshi plan to meet with the FDA and re-submit their application for the drug’s approval by mid-summer 2022, the companies said.

Edits by EP News Bureau