Shanghai Junshi Biosciences and Coherus BioSciences, Inc. (NASDAQ:CHRS) received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC).
The complete response letter requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable.
FDA has communicated in the CRL that the review timeline for the BLA resubmission would be six months, as required onsite inspections that have been affected by travel restrictions related to the COVID-19 pandemic in China.
Denny Lanfear, CEO of Coherus, stated, ”We will continue to work closely with our partner, Junshi Biosciences, to facilitate the completion of the FDA's review of the toripalimab BLA. In late April, we responded quickly to an FDA request for a quality process change and implemented required actions.”
The companies plan to meet with the FDA panel directly and anticipated to resubmit the Biologics License Application (BLA) by mid-summer 2022.
Coherus BioSciences is trading down at $8.92 in the regular trading session.
