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Junshi Biosciences Accepts Supplemental New Drug Application for Toripalimab

Thursday, July 20, 2023

Junshi Biosciences has announced that the supplemental new drug application for toripalimab, an anti-PD-1 monoclonal antibody, in combination with etoposide plus platinum, has been accepted for review by the National Medical Products Administration (NMPA).

Toripalimab, also known as TUOYI®, is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and enhance receptor internalisation. By doing so, it can help promote the immune system's ability to recognise and eliminate tumour cells.

The supplemental new drug application is based on the results of the EXTENTORCH (NCT04012606) Phase 3 clinical study. This study is randomised, double-blind, and placebo-controlled, which means it provides rigorous scientific evidence to evaluate the efficacy and safety of toripalimab in combination with etoposide plus platinum for the first-line treatment of ES-SCLC.

According to the study results, the combination of toripalimab with chemotherapy significantly extended the progression-free survival (PFS) and overall survival (OS) of patients compared to chemotherapy alone. These findings suggest that toripalimab could be a promising treatment option for patients with ES-SCLC.

Toripalimab (TUOYI®) is the first domestically developed anti-PD-1 monoclonal antibody approved for marketing in China.

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