China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company’s co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has disclosed in its Q1 2023 financial report that the FDA plans to conduct the required inspection of the toripalimab manufacturing facility in China in May 2023.
Historical Context and Recent Developments
Junshi’s toripalimab was the first domestically developed PD-1 inhibitor to gain approval in China in December 2018 and initiated the approval filing process in the US with a rolling Biologics License Application (BLA) submission in March 2021. The drug was filed for the first indication of recurrent or metastatic nasopharyngeal carcinoma (NPC) but encountered a setback in July 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.
NPC as a Rare Disease and Potential for FDA Approval
NPC is classified as a rare disease in the US, which could influence the FDA to consider China-derived clinical trial data in support of an approval filing, a distinction from other China-sourced PD-1 inhibitors such as Innovent Biologics/Eli Lilly’s sintilimab. The US FDA has granted orphan drug designation (ODD) to toripalimab for five indications, including NPC, mucosal melanoma, soft tissue sarcoma, esophageal cancer, and small-cell lung cancer.-Fineline Info & Tech
