Item 8.01. Other Events.

On January 25, 2021, EUSA Pharma (UK) Limited ("EUSA Pharma") and BeiGene, Ltd. ("BeiGene") 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 the U.S. 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. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.



(d) Exhibits.
   Exhibit No.           Description

       99.1              Press Release titled "EUSA Pharma and BeiGene Announce Acceptance of a
                         Biologics License Application for SYLVANT® (Siltuximab for Injection) in
                         China" issued on January 25, 2021.

       104               The cover page from this Current Report on Form 8-K, formatted in Inline
                         XBRL.

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses