On January 25, 2021 EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) reported 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 (Press release, BeiGene, JAN 25, 2021, View Source [SID1234575010]). 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.
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"The BLA acceptance of siltuximab for review, an important treatment approved in more than 40 countries worldwide for iMCD, is good news for Chinese patients with this rare condition," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "We’re glad to see continued progress in our collaboration with EUSA, which was built upon our shared commitment to bringing impactful therapies to patients in China and around the world."
Lee Morley, Chief Executive Officer of EUSA Pharma, said, "The BLA acceptance of siltuximab for review in China represents another exciting step in delivering therapies to patients in need worldwide. We will continue in our close collaboration with BeiGene and the NMPA to potentially bring siltuximab to iMCD patients in China."
About Siltuximab
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 (FDA) and the European Commission (EC), as well as regulatory authorities in several other jurisdictions worldwide, for the treatment of adult patients with Multicentric Castleman Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Indications and Usage – See EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information for additional information.