Essex Bio-Technology Limited is pleased to announce that a Biologics License Application (“BLA”) for EB12-20145P (HLX04-O), a recombinant anti-VEGF humanized monoclonal antibody injection, has recently been accepted by the Centre for Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”) in China. The product is jointly developed by the Group and Shanghai Henlius Biotech, Inc. (“Henlius”, Stock Code: 2696.HK) for the treatment of wet age-related macular degeneration (“wet-AMD”) in China.

The phase 3 clinical trial of EB12-20145P (HLX04-O) among Chinese patients (“AURA-1”) has successfully reached the primary endpoint in April this year. AURA-1 is a multi-centre, randomised, double-blind, active-controlled, and non-inferiority phase 3 clinical trial which aimed to compare the efficacy and safety of EB12-20145P (HLX04-O) with that of ranibizumab administered by intravitreal injection (“IVT”) in newly diagnosed wet-AMD patients.

In addition to AURA-1, the BLA of which has been validated by the NMPA, an international, multi-centre phase 3 clinical study of EB12-20145P (HLX04-O) in patients with wet-AMD is ongoing successively in several European countries, Australia, the United States, and China (“AURA-2”) with last patient last visit completed by January 2025. Moving forward, Essex will continue to strive for excellence by embracing innovation to develop first-in-class and best-in-class products, providing solutions for Tomorrow’s healthcare problems.