Chinese NDA for fruquintinib and sintilimab combo accepted for review

The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for locally advanced or metastatic renal cell carcinoma patients who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA).

Fruquintinib is co-developed and co-commercialized in China by Chinese drugmaker Hutchmed (Nasdaq/AIM:HCM; HKEX:13) and US pharma major Eli Lilly (NYSE: LLY) under the brand name Elunate. It is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. 

Sintilimab, marketed as Tyvyt (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed and co-commercialized by China’s Innovent (HKG: 1801) and Lilly, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.