Research & Development
Biologics License Application Accepted in China for Sylvant
26 January 2021 - - The Biologics License Application for Sylvant (siltuximab for injection) was accepted by the China National Medical Products Administration and granted priority review, UK-based Eusa Pharma Ltd. and China-based BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) said.

Siltuximab is a monoclonal antibody approved by the European Medicines Agency and Food and Drug Administration for the treatment of adult patients with multicentric Castleman's disease who are human immunodeficiency virus negative and human herpesvirus-8 (HHV-8) negative, also known as idiopathic MCD.

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.

Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions.

Siltuximab (Sylvant) is currently approved by the US Food and Drug Administration and the European Commission, as well as regulatory authorities in several other jurisdictions worldwide, for the treatment of adult patients with Multicentric Castleman Disease who are human immunodeficiency virus negative and human herpesvirus-8 (HHV-8) negative. 

Indications and Usage See EMA Summary of Product Characteristics and FDA Prescribing Information for additional information.

Founded in March 2015, Eusa Pharma is a biopharmaceutical company focused on oncology and rare disease.

The company is headquartered in Hemel Hempstead, England, and has extensive commercial operations in the United States and Europe, alongside a direct presence in selected other markets across the globe.

BeiGene is a global, commercial-stage biotechnology company.
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