Junshi Biosciences Announces Toripalimab’s NDA Accepted by
From GlobeNewswire:
Junshi Biosciences has announced that the Singapore Health Sciences Authority has accepted a New Drug Application for toripalimab for the treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma, making it the first Chinese oncology drug to be included in Project Orbis, an international initiative. The application has also been granted priority review designation. Toripalimab has been approved for 7 indications in China and 2 in the US, with marketing approval applications under review in other countries. Results from clinical studies show significant improvements in progression-free survival and overall survival, with a manageable safety profile. Toripalimab is an anti-PD-1 monoclonal antibody that promotes the immune system’s ability to attack and kill tumor cells.
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