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

(Reuters) – Coherus BioSciences Inc said on Wednesday that 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.

The FDA’s observations, sent in a Form 483, were yet another setback for the company and its partner Shanghai Junshi Biosciences Co Ltd , and sent Coherus’s shares to a record low of $3.60 in afternoon trade.

The agency usually flags any potential regulatory violations found during an inspection under its Form 483 observations.

The observations at Junshi’s plant come at a time of increased scrutiny by the FDA over China-based manufacturing sites. The companies had received the U.S. health regulator’s so-called complete response letter over quality issues last year.

Coherus said on Wednesday it believes that the observations are readily addressable, adding that it plans to submit its response to the FDA in early June.

The U.S. health regulator had also 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 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)