BYSI - BeyondSpring files plinabulin + G-CSF application in U.S. and China

BeyondSpring (BYSI) has submitted a New Drug Application ((NDA)) to the FDA and the China National Medical Products Administration for use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia ((CIN)). The NDA is based on positive data from PROTECTIVE-2 Phase 3 study which showed that plinabulin in combination with pegfilgrastim demonstrated superior CIN prevention benefit, compared to pegfilgrastim alone.Plinabulin is a selective immune-modulating microtubule-binding agent. It triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects, a durable anticancer benefit and early-onset action in CIN prevention after chemotherapy by boosting hematopoietic stem/progenitor cells.

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BeyondSpring files plinabulin + G-CSF application in U.S. and China