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Today, Baiji China announced that China State Drug Administration Bureau (NMPA) Center for Drug Evaluation (CDE) have accepted the anti-PD-1 antibody Chak one hundred? (Tilelizumab ) is a new indication for the treatment of second- or third-line locally advanced or metastatic non-small cell lung cancer ( NSCLC ) patients who have undergone disease progression after receiving platinum-based chemotherapy .
Manage NSCLC
This sBLA is based on the interim analysis results of the RATIONALE 303 study.
BeiGene announced in November 2020 that after an independent data monitoring committee (DMC) evaluation and evaluation, the RATIONALE 303 clinical trial reached the primary endpoint of OS in a pre-planned interim analysis.
Bai Zean? (Tilelizumab injection) is a humanized lgG4 anti-programmed death receptor 1 (PD-1) monoclonal antibody, designed to minimize interaction with Fcγ receptors in macrophages Combine.
immunity
At present, tislelizumab injection has been approved for 3 indications in China, which are used to treat Hodgkin’s lymphoma , urothelial carcinoma, and squamous NSCLC.
Lymphoma
At present, there are 15 registered clinical trials of Baizhan in China and globally, including 13 phase 3 clinical trials and 2 key phase 2 clinical trials.
In January 2020, BeiGene and Novartis reached a cooperation to develop, manufacture and commercialize BeiGene in North America, Europe and Japan.
In China, the incidence of lung cancer continues to increase.
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