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Beijing, December 10, 2021/PRNewswire/ - Junshi Bio (1877.
Lung cancer is currently the world’s second most common malignant tumor with the second highest incidence and the highest mortality rate [1], and it also ranks first in China in terms of morbidity and mortality [2]
The marketing application for this new indication is based on the CHOICE-01 study (NCT03856411), which is the first domestic patient to include both advanced squamous cell carcinoma and non-squamous cell carcinoma NSCLC histological types at the same time, and anti-PD-1 monoclonal antibody combined with chemotherapy as the first line The randomized, double-blind, placebo-controlled, multi-center phase III clinical study of the treatment was conducted by Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences as the main investigator
According to the results of the interim analysis of the CHOICE-01 study, the Independent Data Monitoring Committee (IDMC) determined that its main study endpoint, Progression-Free Survival (PFS), reached the superiority threshold preset by the protocol
Junshi Bio will subsequently submit further analysis results of the CHOICE-01 study OS to regulatory agencies on a rolling basis, and communicate with the U.
About Teriplizumab Injection (Tuoyi®)
As the first domestically-made monoclonal antibody drug targeting PD-1 that was approved for marketing in China, Teriplizumab Injection (Tuoyi®) has been supported by a major national science and technology project
In March 2021, teriprizumab for the first-line treatment of advanced mucosal melanoma was included in the breakthrough therapy program by the State Food and Drug Administration
Teriplizumab has been in clinical research and development since the beginning of 2016.
About Junshi Bio
Junshi Bio (688180.
Relying on the protein engineering core platform technology, Junshi Bio is at the forefront of international macromolecular drug research and development, and has obtained the first domestic anti-PD-1 monoclonal antibody NMPA approval, the domestic anti-PCSK9 monoclonal antibody NMPA clinical application approval, and the world's first treatment The tumor anti-BTLA blocking antibody was approved in the clinical application of China NMPA and the US FDA, and the phase I clinical study was conducted in China and the United States
[1] https://gco.
[2] https://gco.
[3] https://gco.
[4] Rosell R, Karachaliou N.
Source: Junshi Bio
