Coherus Biosciences Inc., (NASDAQ: CHRS), a US-based biotechnology company, has provided an update on the progress of its programmed death-1 (PD-1) inhibitor, toripalimab, at the US Food and Drug Administration (FDA). Toripalimab is under license from China’s Junshi Biosciences (HKG: 1877; SHA: 688180). The FDA has completed its clinical study inspections at three sites in China, which were involved in two pivotal trials supporting the current Biologics License Application (BLA) for the drug.
FDA Inspections and Coherus’ Outlook
According to a press release, one of the sites received an FDA Form 483 with one observation noted, an issue that Coherus considers minor and easily remedied. This positive development has led to the forecast that toripalimab could gain its first approval by the end of 2023.
Torpilimab’s Journey to US Approval
Junshi’s toripalimab was the first domestically developed PD-1 inhibitor to gain approval in China in December 2018. It was also the first to initiate the approval filing process in the US with a rolling BLA submission in March 2021. Coherus and Junshi are seeking a first indication approval for the drug in recurrent or metastatic nasopharyngeal carcinoma (NPC). However, they encountered 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 delay in December 2022 due to COVID-related disruptions that prevented the FDA from inspecting Junshi’s manufacturing plant for toripalimab.
Orphan Drug Designation and Indications
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. This designation highlights the potential impact of toripalimab in treating rare diseases and underscores the importance of its approval process.-Fineline Info & Tech
