BeyondSpring’s plinabulin gets Breakthrough Therapy Designation from FDA in Chemotherapy-Induced Neutropenia

The Company expects to report the full PROTECTIVE-2 Phase 3 topline data in 4Q-2020 and file an NDA with the FDA by the end of 2020. The Company has already submitted an NDA for Plinabulin for the CIN indication to the NMPA on a rolling basis in Q1 2020. 

These results were further strengthened by the Company’s other CIN studies that have confirmed Plinabulin’s early onset action in Week 1 with protecting neutrophils in various cancer types and various chemotherapies, which is complementary to Week 2 neutrophil protection with G-CSFs.