FDA flags issues at Coherus partner's China plant for cancer drug

[June 01, 2023]  (Reuters) -Coherus BioSciences Inc 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. 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.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

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.

(Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Rashmi Aich and Pooja Desai)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.