Pharma Focus Asia

Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab

Tuesday, April 11, 2023

Shanghai Junshi Biosciences announced the acceptance of the supplemental new drug application for toripalimab in combination with chemotherapy as perioperative treatment and toripalimab monotherapy as consolidation therapy after adjuvant therapy for the treatment of resectable stage III non-small cell lung cancer (“NSCLC”) by the National Medical Products Administration (“NMPA”).

This newly applied indication for operable NSCLC patients will open the door to the clinical application of toripalimab in the early stages of the disease.

This supplemental new drug application is based on the Neotorch study (NCT04158440), a randomised, double-blind, placebo-controlled, multi-centre phase III clinical study led by Professor Shun LU of Shanghai Chest Hospital as the principal investigator. The study was conducted in 56 centres nationwide.

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalisation (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumour cells.

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