It's been a long road for PD-1 partners Coherus BioSciences and Junshi Biosciences since their FDA rejection for cancer drug toripalimab more than a year ago, but the companies appear to be nearing the regulatory finish line in the U.S.
Wednesday, Coherus said in a Securities and Exchange Commission filing that the U.S. FDA "successfully completed the required pre-licensing inspection" of Junshi's manufacturing site in China. The FDA made three observations about plant deficiencies, but Coherus believes those are "readily addressable."
The partners plan to submit their response to the FDA in the coming weeks. Coherus says it's planning to launch toripalimab in the U.S. after a potential FDA approval.
The inspection comes after multiple regulatory delays. In May 2022, the FDA rejected the drug and requested a quality process change. At the time, the companies noted that a resubmission would take about six months because plant inspections had been delayed by travel restrictions.
After the partners made the change and resubmitted their application, the agency set a new target action date in late December 2022. But the review was stalled again because FDA staffers couldn’t conduct a timely inspection.
Then in March 2023, Coherus said the FDA's plant inspection for Junshi had finally been scheduled for the second quarter of the year.
Toripalimab is approved in China in six indications. In the U.S., Coherus and Junshi are targeting an FDA nod in recurrent or metastatic nasopharyngeal carcinoma, a rare type of head and neck cancer. If approved, the drug would be the first in the PD-1 class for this use.
Coherus and Junshi were not the only companies with drug applications that were affected by COVID-related travel restrictions in recent years. Other companies to face similar setbacks include partners Novartis and BeiGene plus Spectrum Pharmaceuticals, the now-bankrupt Zosano and GSK.