La FDA Acaba de Otorgar el Status de Medicamento Huérfano ( OD ) a HANSIZHUANG ( Serplulimab ) Para el Tratamiento del Cáncer de Pulmón de Células Pequeñas ( SCLC ) ... Los Resultados de Fase III son Espectaculares y en China Será Revisado con Prioridad ..

Henlius' Serplulimab Granted Orphan-Drug Designation in the United States for Small Cell Lung Cancer  .

SHANGHAI, April 7, 2022 /PRNewswire .

 Shanghai Henlius Biotech, Inc. (2696.HK) Announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG ( Serplulimab ) for the Treatment of Small Cell Lung Cancer ( SCLC ). 

This is the First Such Designation Granted to HANSIZHUANG. 

The ODD Granted by the FDA is Beneficial for the Continuous Development of HANSIZHUANG and the Enjoyment of Certain Policy Support in Terms of Registration and Commercialization in the United States. 

The Company Plans to File its NDA in China and MAA in the EU in 2022, Making HANSIZHUANG Potentially to be the World's first PD-1 Inhibitor for the First-Line Treatment of SCLC. ...