AstraZeneca's Complement C5 Inhibitor Eculizumab Receives New Indication Approval in China

On June 12, AstraZeneca's complement C5 inhibitor Eculizumab (Soliris) received approval from the National Medical Products Administration for a new indication, presumed to be for the treatment of generalized myasthenia gravis (gMG).

Eculizumab is the world's first approved complement inhibitor, which inhibits the uncontrolled activation of the immune system by inhibiting terminal complement. Eculizumab was first approved for marketing in China on August 23, 2018, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

Mechanism of Action of Eculizumab

Eculizumab was initially developed by Alexion. On December 12, 2020, AstraZeneca acquired Alexion for $39 billion, gaining access to Eculizumab and another key long-acting complement C5 inhibitor, Ultomiris (Ravulizumab), the two most important marketed products. According to AstraZeneca's financial report, in 2022, the global sales of Soliris and Ultomiris reached $3.762 billion and $1.965 billion, respectively.

AstraZeneca has made a comprehensive layout in the complement field. In addition to Soliris and Ultomiris, the company's first-in-class oral Factor D inhibitor danicopan, as an add-on therapy to C5 inhibitors, achieved great success in Phase III studies for the treatment of PNH (see details: ).

In addition, AstraZeneca's globally first-in-class C5/albumin bispecific antibody ALXN1720 has advanced to Phase III clinical trials. ALXN1720 is a third-generation C5 inhibitor, a mini-bispecific antibody (25kD), comprising only the heavy chain variable region (VH) of an antibody targeting C5 and an antibody fragment that specifically binds to albumin. Its smaller molecular weight offers improved tissue penetration, and its binding to albumin extends its half-life. ALXN1720 is expected to become a once-weekly subcutaneous injection therapy that can be administered at home. ALXN1720 has completed Phase II studies for generalized myasthenia gravis (gMG).

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account backend or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.