AstraZeneca Launches Phase 3 Clinical Trials in China for Two C5 Complement Inhibitors: Ravulizumab and Gefurulimab

Intelligent Finance APP learned on September 7 that the official website of China's Drug Clinical Trial Registration and Information Disclosure Platform announced: AstraZeneca (AZN.US) has registered in China to initiate Phase 3 international multicenter clinical trials for two new drugs. Both of these new drugs were acquired through its approximately $39 billion acquisition of Alexion in 2020, namely: 1) Ravulizumab injection, a long-acting C5 complement inhibitor, targeting the indication of preventing severe renal adverse events in chronic kidney disease patients during extracorporeal cardiopulmonary circulation; 2) Gefurulimab (ALXN1720) injection, a third-generation C5 complement inhibitor, targeting the indication of generalized myasthenia gravis.

Public information shows that ravulizumab has been approved by the U.S. FDA for multiple autoimmune diseases (brand name: Ultomiris), including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome (aHUS), myasthenia gravis, etc. The drug also achieved positive results in a Phase 3 clinical trial for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

AstraZeneca has launched a Phase 3, randomized, double-blind, placebo-controlled, multicenter ARTEMIS study in China. This study aims to evaluate the efficacy of ravulizumab in preventing cardiac surgery-associated acute kidney injury (CSA-AKI) and subsequent major adverse kidney events (MAKE) in patients with chronic kidney disease (CKD). The principal investigator for this study in China is Chief Physician Wang Chunsheng from Zhongshan Hospital, Fudan University.