UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has revealed plans to sell Soliris (eculizumab) in Hangzhou for the first time. The drug, originally developed by Alexion Pharmaceuticals, received conditional approval in 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and children in China. A change in the manufacturing site was approved in 2021, paving the way for AstraZeneca to launch the drug. This marks the first approval in China from Alexion’s portfolio, the rare disease specialist acquired by AstraZeneca in July 2021 for USD 39 billion.
Additional Indications and Clinical Trials
Alongside the initial approvals, China’s National Medical Products Administration (NMPA) has accepted a supplementary new drug application (sNDA) for Soliris to treat adults with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive. Clinical trials are also underway for lupus nephritis (LN), immunoglobulin A nephropathy (IgAN), and light chain (AL) amyloidosis.
Soliris Profile
Soliris is the global first-in-class C5 complement inhibitor, capable of inhibiting the C5 protein in the terminal complement cascade. The drug is used to reduce disease symptoms associated with PNH and aHUS. First approved in the United States in 2007, Soliris remains one of the most expensive therapeutics in the country, priced at around USD 16,000 per dose and approximately USD 470,000 for one year of treatment. In 2021, Soliris generated USD 1.87 billion in global sales for AstraZeneca.-Fineline Info & Tech
