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Junshi Bio-Treplimumab submits its fifth listing application

 Last Update: 2021-09-05
 Source: Internet
 Author: User

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On July 29, Junshi Biotech announced that the National Food and Drug Administration (NMPA) of China has accepted its self-developed anti-PD-1 monoclonal antibody drug teriprizumab combined with platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic esophageal scales The application for new indications for cancer, this is also the fifth application for the listing of Teriplizumab in China
.

The marketing application for this new indication is based on the JUPITER-06 study, which is a randomized, double-blind, placebo-controlled, multi-center phase 3 clinical study.
Professor Xu Ruihua from the Cancer Hospital of Sun Yat-sen University serves as the main investigator.
To compare the effectiveness and safety of teriprizumab combined with paclitaxel/cisplatin and placebo combined with paclitaxel/cisplatin in the first-line treatment of advanced esophageal squamous cell carcinoma
.
The main research endpoints of the study were progression-free survival (PFS) and overall survival (OS) assessed by the blinded independent review committee (BICR)

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