Hengrui PD-1 new indication for nasopharyngeal carcinoma will be approved soon

April 20, NMPA official website shows, Ka Ruili natalizumab single pharmaceutical in progress and previously treated with second-line chemotherapy after more than a disease or intolerable advanced nasopharyngeal carcinoma patients with indications for listing application (admissibility: CXSS2000045) The approval status is changed to "Pending Approval ".

At the 2020 ESMO conference, Hengrui announced the clinical results of the national multi-center, single-arm clinical trial CAPTAIN study

The results of the study with a median follow-up of 9.

Currently in China, Hengrui's main competitor for nasopharyngeal cancer indications is Junshi
.
Among the domestically approved PD-1s, only Hengrui and Junshi have reported on the market for nasopharyngeal cancer indications, including third-line and first-line treatments for nasopharyngeal cancer
.
Junshi is slightly faster than Hengrui, and was approved for third-line therapy on February 10 this year, and Hengrui is about to be approved now
.


Domestic PD-1 nasopharyngeal cancer indications are reported

in China.
The incidence and mortality of nasopharyngeal cancer are significantly higher than the world average.
50% of nasopharyngeal cancers worldwide occur in China
.
Radiotherapy is the main method for the treatment of early-stage nasopharyngeal carcinoma, but about 20-37% of patients will have local recurrence or distant metastasis
.
The treatment options for recurrent or metastatic nasopharyngeal carcinoma are very limited and the prognosis is poor
.

Attachment: Timeline of Carrelizumab Review (http://db.
dxy.
cn/ )