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EUSA Pharma (UK), Ltd.: BeiGene and EUSA Pharma Announce China NMPA Approval of QARZIBA (Dinutuximab Beta) for Patients With High-Risk Neuroblastoma

BeiGene, Ltd. (NASDAQ:BGNE; HKEX:06160) and EUSA Pharma (UK), Ltd. today announced that the China National Medical Products Administration (NMPA) has granted QARZIBA(dinutuximab beta) conditional approval ....

United States , Rebecca Kerr , Gabrielle Zhou , Xiaobin Wu , Carsten Thiel , European Commission , Beigene Ltd , Exchange Commission , China National Medical Products Administration , European Medicines Agency , Pharma United Kingdom Ltd , Bristol Myers Squibb , United Kingdom , New Drugs , Urgent Clinical Need Marketed Overseas , Chief Operating Officer , General Manager , Chief Executive Officer , International Society , Paediatric Oncology Europe Neuroblastoma Group , Product Characteristics , Bristol Myers , Mirati Therapeutics , North America , Private Securities Litigation Reform Act , ஒன்றுபட்டது மாநிலங்களில் ,

BeiGene, Ltd.: BeiGene and EUSA Pharma Announce China NMPA Approval of QARZIBA (Dinutuximab Beta) for Patients with High-Risk Neuroblastoma

BeiGene, Ltd.: BeiGene and EUSA Pharma Announce China NMPA Approval of QARZIBA (Dinutuximab Beta) for Patients with High-Risk Neuroblastoma
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EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for SYLVANT® (Siltuximab for Injection) in China

Press release content from Business Wire. The AP news staff was not involved in its creation.
EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for SYLVANT® (Siltuximab for Injection) in China
January 25, 2021 GMT
HEMEL HEMPSTEAD, England & BEIJING, China & CAMBRIDGE, Mass. (BUSINESS WIRE) Jan 25, 2021
EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for SYLVANT ® (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-threatenin ....

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