US-based Coherus Biosciences Inc., (NASDAQ: CHRS) has disclosed that the US FDA has recently completed the long-awaited pre-licensing inspection of its partner Junshi Biosciences Ltd’s (HKG: 1877, SHA: 688180) manufacturing site for toripalimab in China. The inspection resulted in “three observations” from the FDA, which Coherus described as “readily addressable.”
Submission of Response and Confidence in US Launch
Coherus’s statement indicated that the company, in collaboration with Junshi, plans to submit a response to the FDA in early June. Despite the minor setbacks, the firm remains confident about eventually securing the commercial launch of Junshi’s programmed death-1 (PD-1) inhibitor in the United States. However, both Coherus’ and Junshi’s share prices have experienced a dip of around 8% following the news.
Historical Context and FDA Designations
Junshi’s toripalimab was the first domestically developed PD-1 inhibitor to gain approval in China in December 2018 and was the first to initiate the approval filing process in the US with a rolling Biologics License Application (BLA) submission in March 2021. The companies are seeking a first indication approval for the drug in recurrent or metastatic nasopharyngeal carcinoma (NPC). They faced a setback in May 2022 when the FDA issued a complete response letter (CRL) requesting a change in the manufacturing process. The BLA was refiled but faced further delays in December 2022, attributed to COVID-related disruptions that prevented the FDA from inspecting Junshi’s manufacturing plant for toripalimab. The US FDA has awarded toripalimab orphan drug designation (ODD) for five indications, including NPC, mucosal melanoma, soft tissue sarcoma, esophageal cancer, and small-cell lung cancer.-Fineline Info & Tech
