Innovent Biologics’ PD-1 bispecific antibody is again granted FDA Fast Track Qualification
February 18, 2025
Source: drugdu
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On February 17, Innovent Biologics announced that its PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 was granted Fast Track Qualification (FTD) by the US FDA, with the proposed indication being locally advanced or metastatic squamous non-small cell lung cancer that has progressed after anti-PD-(L)1 immune checkpoint inhibitors and platinum-containing chemotherapy. This is the second time that IBI363 has been granted FDA Fast Track Qualification after melanoma.
According to the data, IBI363 is the world's first PD-1/IL-2 bispecific fusion protein independently developed by Innovent Biologics, which has the functions of blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. IBI363 has shown positive efficacy and safety signals in a variety of advanced solid tumors. Innovent Biologics is currently conducting Phase 1/2 clinical studies of IBI363 in China and the United States.
https://finance.eastmoney.com/a/202502183321598760.html
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