Benzinga | Jan 25, 2021 07:02AM EST

EUSA Pharma And BeiGene Announce Acceptance Of A Biologics License Application For SYLVANT In China

EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160))))) today announced that the Biologics License Application (BLA) for SYLVANT(r) (siltuximab for injection) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. Siltuximab is a monoclonal antibody approved by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD). iMCD is a rare, life-threatening and debilitating condition of the lymph nodes and related tissues. Siltuximab is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.