First-mover advantage in China PD-1 market for Junshi, says analyst

11 August 2023

Following the approval of toripalimab, the drug is expected to get a first-mover advantage in the first-line treatment setting within the PD-1 market in RCC for China, says data and analytics company GlobalData.

The supplemental new drug application (sNDA) for toripalimab, Shanghai Junshi Biosciences’ (HKEX: 1877) anti-PD-1 monoclonal antibody, in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (RCC), has been accepted by China’s National Medical Products Administration (NMPA).

The sNDA was based on the Phase III RENOTORCH (NCT04394975) study of toripalimab in combination with axitinib for first-line treatment of RCC. Toripalimab met the primary endpoint in combination with axitinib by reducing the risk of disease progression when compared to sunitinib monotherapy and is consistent with known risks, with no new safety signals identified in the subjects.

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