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New indication alert: NMPA approves Innovent Biologics/Eli Lilly’s TYVYT® (sintilimab) for EGFR-mutated Non-squamous NSCLC

May 9, 2023

Innovent Biologics and Eli Lilly announced that the Chinese NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) in patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) who progressed after EGFR tyrosine kinase inhibitor therapy.  TYVYT® is globally the first approved PD-1 inhibitor for this indication.  This is the seventh NMPA-approved indication of TYVYT®.

This comes a day after Innovent Biologics announced dosing of the first participant in its phase III study of IBI311 (Anti-IGF-1R Monoclonal Antibody).