FDA flags issues at Coherus partner’s China plant for cancer drug
May 31 (Reuters) – Coherus BioSciences Inc. (CHRS.O) said on Wednesday the U.S. Food and Drug Administration (FDA) had flagged three observations at its partner’s manufacturing site in China when the agency was conducting inspections related to its experimental cancer drug.
However, the company said those observations, raised in Form 483, were “easily addressable”, adding that it planned to submit its response to the FDA in early June.
“The fact that observations were noted does not mean that a facility re-inspection is required or that there will be delays in approval,” Chief Financial Officer McDavid Stilwell said in an emailed statement to Reuters.
The FDA had delayed its decision on the drug in December, as its team had been unable to travel to China to conduct the required site inspection.
The company is developing the drug with its partner Shanghai Junshi Biosciences Co. Ltd. (688180.SS). Coherus’ shares closed down 1.5% at $4.09 on Wednesday.
The companies had received the U.S. health regulator’s complete response letter over quality issues last year.
The company is seeking approval for the drug toripalimab for patients with nasopharyngeal carcinoma, an aggressive type of head and neck cancer that currently has no approved treatment options in the U.S.
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