AstraZeneca Submits Second Clinical Trial Application in China for Ravulizumab, a Long-Acting Complement C5 Inhibitor

On February 9, the clinical application of ravulizumab, a complement C5 inhibitor developed by Alexion, a leading company in the complement field acquired by AstraZeneca, was accepted by the CDE. This marks the second clinical trial application for this drug in China.

Ravulizumab is a long-acting complement C5 inhibitor, which was first approved by the FDA in December 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), marketed under the brand name Ultomiris. In September 2021, a new indication for ravulizumab was approved by the FDA for the treatment of adult and pediatric (over one month old) patients with atypical hemolytic uremic syndrome (aHUS). In April 2022, the third indication for ravulizumab was approved by the FDA for the treatment of adult generalized myasthenia gravis (gMG).

Alexion is a pioneer in complement biology research, having developed Soliris (eculizumab), the world's first complement C5 inhibitor, and Ultomiris, the first long-acting C5 complement inhibitor. On December 12, 2020, AstraZeneca acquired Alexion for $39 billion, gaining these two key marketed products. Soliris was approved for marketing by the NMPA on September 4, 2018, and has since been approved for the treatment of pediatric and adult patients with PNH and aHUS in China. Ultomiris requires only one intravenous injection every 8 weeks, reducing the annual number of doses for patients from 26 with Soliris, which is administered every 2 weeks, to just 6.

According to AstraZeneca's financial report, the global sales of Soliris and Ultomiris in 2022 were $3.762 billion and $1.965 billion, respectively.

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