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Innovent/Lilly PD-1 Rejected by US FDA Panel; Lilly Says Price 40% Below Competition

publication date: Feb 10, 2022

As predicted, a US FDA oncology advisory panel rejected the NDA submitted by Innovent and Lilly for their partnered anti-PD-1 antibody. Before the panel met, Lilly tried to influence the panel to approve the drug, sintilimab (Tyvyt), by announcing it would offer the drug at a wholesale price 40% lower than the US competition. The last-minute strategy didn't work: the panel voted 14-1 against approval. Yesterday, it seemed the main problem was the Phase III trial, which included only people with China genomes. But there were other issues as well. More details....

Stock Symbols: (HK: 01801) (NYSE: LLY) 


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