Pharma Focus Asia

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

Wednesday, July 12, 2023

Shanghai Junshi Biosciences (Junshi Biosciences) has announced the submission of a supplemental new drug application for toripalimab, their anti-PD-1 monoclonal antibody, in combination with axitinib, for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (RCC).

The application is based primarily on the results of the RENOTORCH study (NCT04394975), which is the first pivotal Phase 3 study of immunotherapy for advanced RCC conducted in China.

The RENOTORCH study is a multi-centre, randomised, open-label, active-controlled trial designed to assess the efficacy and safety of combining toripalimab with axitinib compared to sunitinib monotherapy as a first-line treatment for patients with intermediate to high-risk unresectable or metastatic RCC.

The results of the study indicate that the combination of toripalimab and axitinib significantly reduced the risk of disease progression or death compared to sunitinib monotherapy in patients with advanced RCC.

Toripalimab is an anti-PD-1 monoclonal antibody specifically developed to block the interactions between PD-1 and its ligands, PD-L1 and PD-L2. By inhibiting these interactions, toripalimab enhances the immune system's ability to recognise and attack tumour cells.

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