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Plinabulin + G-CSF

Prevention of Chemotherapy-Induced Neutropenia (CIN)

Phase 3Completed; NDA submitted, CRL receivedNCT03294577, NCT02504489

Key Facts

Indication
Prevention of Chemotherapy-Induced Neutropenia (CIN)
Phase
Phase 3
Status
Completed; NDA submitted, CRL received
Company

About BeyondSpring

BeyondSpring is a NASDAQ-listed biotech focused on developing plinabulin, a novel immunomodulating microtubule-binding agent, for oncology. Its primary objectives are securing approval for plinabulin to prevent chemotherapy-induced neutropenia (CIN) and demonstrating its efficacy as a combination therapy in non-small cell lung cancer (NSCLC). The company's strategy leverages a dual-mechanism platform to differentiate from standard care and targets high-value markets in the US and China. Despite a prior FDA Complete Response Letter for CIN, BeyondSpring continues to generate supportive clinical data, particularly from its Phase 3 DUBLIN-3 trial in NSCLC, to build a compelling case for global registration.

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