Junshi Biosciences Submitted MAA to EMA for Toripalimab for NPC and ESCC

Junshi Biosciences (Chinese：君实生物) announced today that it had submitted the marketing authorization application (MAA) to the European Medicines Agency (EMA) for toripalimab as the first-line treatment for nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). The toripalimab’s commercialization destination is extending to Europe after China and the United States.

Toripalimab is an anti-PD-1 monoclonal antibody independently developed by Junshi Biosciences, an innovation-driven biopharmaceutical company founded in 2012.

The indications submitted for MAA were as the first-line treatment for patients with advanced recurrent or metastatic NPC in combination with cisplatin and gemcitabine and as the first-line treatment for patients with unresectable locally advanced/recurrent or distant metastatic ESCC in combination with paclitaxel and cisplatin.

There are currently no approved drugs for NPC in the United States and Europe, and the indications for immunotherapy treatments that have been approved for ESCC are limited to a minority of patients. As a result, new drugs and treatment options are urgently needed to extend the survival of patients. Toripalimab has demonstrated solid efficacy in the treatment of NPC and ESCC, as well as an excellent safety profile in treating a variety of tumors, which will benefit global patients.

In 2021, the National Medical Products Administration (NMPA) approved toripalimab for two NPC indications. Additionally, the United States Food and Drug Administration (FDA) has granted two breakthrough therapy designations and one orphan-drug designation for toripalimab for NPC. In May 2022, the supplement new drug application (NDA) for toripalimab for ESCC was approved by NMPA. In addition, toripalimab has also received orphan-drug designation for ESCC from FDA.