Lilly's FGFR3 Inhibitor LOXO-435 Receives CDE Acceptance for Clinical Trial Application in China

On September 18, the CDE website showed that the clinical trial application for Eli Lilly's FGFR3 inhibitor LOXO-435 tablet had been accepted.

LOXO-435 is an effective and highly subtype-selective FGFR3 inhibitor with activity against FGFR3 gatekeeper resistance mutations. LOXO-435 can avoid dose-limiting toxicities caused by the inhibition of FGFR1 and FGFR2, such as hyperphosphatemia and other chronic intolerance-related adverse events.

Currently, the product is undergoing a Phase I clinical trial for urothelial cancer abroad, and globally, no FGFR3 inhibitor has been approved for marketing. In China, drugs targeting the same point that have entered clinical trials include Recifercept (recombinant FGFR3, Pfizer) and SAR442501 (FGFR3 monoclonal antibody, Sanofi).

Among them, the Phase I clinical trial of Recifercept was voluntarily terminated in February this year, and SAR442501 was approved for clinical trials in China for the first time in July this year.

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