BeiGene tislelizumab for the treatment of esophageal squamous cell carcinoma has been accepted by the FDA, and 4 PD-1 models have been listed in the United States in China

Today (September 13), BeiGene announced that the U.
S.
Food and Drug Administration (FDA) has accepted a new drug listing application (BLA) for its anti-PD-1 antibody drug tislelizumab injection for treatment Patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment
.

It is reported that BeiGene's listing application is based on the results of a randomized, open, multi-center global phase 3 clinical trial RATIONALE 302 (NCT03430843), which aims to evaluate the comparative study of tislelizumab injection The effectiveness and safety of the chemotherapy selected by the patient for the second-line treatment of patients with advanced or metastatic ESCC
.
The test results have been announced on ASCO 2021

The primary endpoint of the RATIONALE 302 trial is the overall survival (OS) of the intention-to-treat (ITT) population; the key secondary endpoint is the OS of patients with high PD-L1 expression (defined as a visually estimated comprehensive positive score [vCPS] ≥10%) , Other secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety
.
A total of 512 patients from 11 countries or regions in Asia, Europe and North America were enrolled in the trial, and they were randomly assigned to the tislelizumab group or chemotherapy group at 1:1

At present, there are 8 PD-1 models on the market in China.
2 of them are imported, and the remaining 6 models are self-developed domestically.
Except for the newly approved Yuheng Pharmaceutical/Wuxi Biologics products, the other 5 models are from Junshi Bio, Cinda Bio, Hengrui Pharmaceutical, BeiGene and Kangfang Bio; there are also two imported PD-L1.

It is worth noting that BeiGene has previously sold this PD-1 in the US, Canada, Mexico, EU member states, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan for US$2.
2 billion.
The price authorized by Novartis
.
Of course, in addition to BeiGene, other domestic PD-1 pharmaceutical companies are also actively seeking overseas partners to explore overseas market opportunities

At present, 4 of the PD-1s on the market in China have submitted their marketing applications to the FDA
.
The other three companies are: Junshi’s tereprizumab was the first to be submitted.