Shots:

• The designation is based on P-III PROTECTIVE-2 evaluating Plinabulin + Neulasta vs Neulasta alone for the treatment of CIN
• In the protocol-specified interim analysis- combination regimen was better than Neulasta alone in achieving the 1EPs with p<0.01 and have a well-tolerated safety profile with fewer Grade 4 AEs
• The company plans to report full results of the P-III PROTECTIVE-2 study in Q4’20 and file an NDA with the FDA by the end of 2020. The company has submitted an NDA to the NMPA on a rolling basis in Q1’20

 ­ Ref: GlobeNewswire | Image: Beyond Spring Pharma