AstraZeneca's Long-Acting Complement C5 Inhibitor Ravulizumab Granted Clinical Trial Approval in China for Use in Chronic Kidney Disease Patients Undergoing Cardiopulmonary Bypass

Intelligent Finance APP learned on March 23 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that ravulizumab injection, submitted by Alexion under AstraZeneca (AZN.US), has been approved for clinical trials. The proposed indication is: to prevent severe renal adverse events in patients with chronic kidney disease during extracorporeal cardiopulmonary circulation. Public data shows that ravulizumab is a long-acting complement C5 protein inhibitor developed by Alexion and has been approved by the U.S. FDA for the treatment of various autoimmune diseases.

Complement protein C5 is at the terminal end of the complement cascade, so targeting this protein can regulate complement signals activated by all three different pathways. In various complement-mediated immune diseases, the complement-mediated immune response attacks the patient's own healthy tissues and cells, leading to damage in different tissues and organs. Inhibiting the activity of C5 can suppress autoimmune attacks, thereby alleviating disease symptoms.

Ravulizumab is a long-acting C5 monoclonal antibody developed by Alexion. Its unique design provides it with a longer half-life compared to first-generation C5 inhibitors. When treating patients with paroxysmal nocturnal hemoglobinuria, it effectively controls hemolysis with just once every 8 weeks of intravenous administration. In 2020, AstraZeneca acquired Alexion for approximately $39 billion, gaining this marketed product.