Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab BLA
– The CRL requests a quality process change Junshi Biosciences and Coherus believe is readily addressable – – BLA resubmission anticipated by mid-summer 2022 with expected six month FDA review timeline – – Onsite inspections in China, impeded to date by COVID-19-related travel restrictions, are required for FDA’s completion of BLA review – – Toripalimab