Brief: Beyondspring Announces Submission Of New Drug Application To U.S. FDA And China NMPA For Plinabulin And G-CSF Combination
01/04/2021 04:41
March 31 (Reuters) - Beyondspring Inc BYSI.O :
* BEYONDSPRING ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION
TO
U.S. FDA AND CHINA NMPA FOR PLINABULIN AND G-CSF COMBINATION FOR
THE PREVENTION OF CHEMOTHERAPY-INDUCED NEUTROPENIA (CIN)
* NDA SUBMISSION IS BASED ON POSITIVE DATA FROM
BEYONDSPRING'S
PROTECTIVE-2 PHASE 3 REGISTRATION STUDY
* BEYONDSPRING - STUDY MET PRIMARY ENDPOINT, WITH A
STATISTICALLY
SIGNIFICANT IMPROVEMENT IN RATE OF PREVENTION OF GRADE 4
NEUTROPENIA
* BEYONDSPRING - STUDY MET ALL KEY SECONDARY ENDPOINTS
INCLUDING
DURATION OF SEVERE NEUTROPENIA (DSN) AND ABSOLUTE NEUTROPHIL
COUNT (ANC) NADIR
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