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Junshi Biosciences’ sNDA for Toripalimab/Bevacizumab Combo Accepted in China for HCC

Jul 17, 2024

On 17 July 2024, Junshi Biosciences announced that China’s National Medical Products Administration has accepted for review its supplemental new drug application (sNDA) for Tuoyi® (toripalimab) combined with bevacizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).  Toripalimab has previously been approved for a number of cancer indications in China.

In January 2024, Coherus launched Loqtorzi® (toripalimab-tpzi) in the US after it was approved by the FDA on 27 October 2023 in combination with cisplatin and gemcitabine for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

Pursuant to an agreement entered in February 2021, toripalimab is co-developed by Junshi and Coherus, with Coherus responsible for commercialisation of the drug in the US and Canada.