Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biotech firm, has announced the submission of a market approval filing for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), to the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK. The company is seeking approval for the checkpoint inhibitor in combination with chemotherapy as a first-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma (NPC) and unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Clinical Study Foundations
The filing for NPC is supported by the results of the JUPITER-02 study, while the filing for ESCC is based on the JUPITER-06 study. These studies have provided robust clinical data to underpin the potential of Tuoyi in combination with chemotherapy for first-line treatments.
Tuoyi’s Regulatory Milestones
Toripalimab, marketed as Tuoyi, was the first domestic PD-1 inhibitor to be approved in China in December 2018 for the second-line treatment of melanoma. Since then, it has received multiple regulatory nods. In February 2021, it was approved as a second-line treatment for NPC. Additional approvals followed in April 2021 for locally advanced or metastatic urothelial cancer (UC) in previously treated patients, in November 2021 as a first-line treatment for NPC, and in May 2022 as a first-line treatment for ESCC.
Global Regulatory Submissions
A Biologic License Application (BLA) for Tuoyi as a treatment for second-line NPC and in combination with chemotherapy for first-line NPC was accepted for review by the US FDA in July of the previous year. Furthermore, a market approval filing for the drug in combination with chemotherapy as a first-line treatment for NPC and ESCC was accepted for review by the European Medicines Agency (EMA) in December of the same year.-Fineline Info & Tech
