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Transfer from | Pharmaceutical Mission Hills
On December 10th, Junshi Biotech announced that the National Medical Products Administration (NMPA) of China has accepted its self-developed anti-PD-1 monoclonal antibody drug teriprizumab combined with standard first-line chemotherapy for untreated, driver genes A new indication for the marketing of negative advanced non-small cell lung cancer (NSCLC) is the sixth listing application submitted by Teriplizumab in China
The marketing application for this new indication is based on the CHOICE-01 study (NCT03856411).
The study enrolled a total of 465 NSCLC patients in 63 centers across the country, including 220 squamous cancer subjects and 245 non-squamous cancer subjects.
According to the results of the interim analysis of the CHOICE-01 study, the Independent Data Monitoring Committee (IDMC) determined that its main research endpoint, Progression-Free Survival (PFS), reached the superiority threshold preset by the protocol
Junshi Biotech stated that it will subsequently submit further analysis results of the CHOICE-01 study OS to regulatory agencies and communicate with the US FDA about the submission of the listing application
Lung cancer is currently the world's second most common malignant tumor with the second highest mortality rate
Original title: For the first-line treatment of non-small cell lung cancer, Junshi Biologics submits a new indication for PD-1 inhibitor listing application!
