EQRx Price Disruptor Business Model Faces The Costly Reality Of FDA Drug Development Standards

An innovative start-up company that aims to disrupt biopharma’s traditional pricing model with “radically” lower priced me-too drugs is facing potentially significant challenges from the US Food and Drug Administration right out of the gate.

The FDA's concerns over the fact that the pivotal clinical trial for Eli Lilly/Innovent's PD-1 inhibitor sintilimab was based primarily on data from China has blocked progress on the application and has ramifications for other companies developing drugs with Chinese-only trials, including EQRx