Junshi Biologics submitted the first Chinese domestic anti-PD-1 monoclonal antibody listing application to the FDA

On March 3, Junshi Bio announced that it had recently submitted a rolling submission of a biological product license (BLA) application (BLA) for the treatment of relapsed or metastatic nasopharyngeal carcinoma (NPC) with teriprizumab to the US FDA.

Teriplizumab injection (Tuoyi) is independently developed by Junshi Biologics.

In September 2020, teriplimumab was approved by the FDA for breakthrough therapy for the treatment of recurrent or metastatic nasopharyngeal carcinoma, becoming the first domestic anti-PD-1 monoclonal antibody in China to be approved by the FDA for breakthrough therapy.

Based on this, the BLA for the treatment of nasopharyngeal carcinoma with teriprizumab can be submitted to the FDA for rolling review (Rolling Review).

It is worth mentioning that in February 2021, Junshi Biotech has reached a cooperation with Coherus on the development and commercialization of tereprizumab in the United States and Canada, and Coherus is responsible for all commercial activities in the United States and Canada.