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ESSEX BIO-TECH Bevacizumab (HLX04-O) Ophthalmic Indication Phase III Clinical Trial Meets Study Primary Endpoint
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ESSEX BIO-TECH (01061.HK) announced that the multi-centre phase 3 clinical trial of EB12-20145P (HLX04-O), a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the Group and HENLIUS (02696.HK), in patients with wet age-related macular degeneration (wet-AMD) (AURA-2), has met the study primary endpoint. Together with the global phase 3 clinical study conducted in China (AURA-1), these results will constitute a pivotal data package to support the Group in advancing marketing authorisation applications in overseas markets, including the United States. Previously, the Biologics License Application (BLA) for EB12-20145P (HLX04-O) in wet-AMD has been accepted by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Auto-translated by AI This article was automatically translated by AI, the original language version should be considered the authoritative version. AASTOCKS.com Limited does not guarantee its accuracy or completeness and accepts no liability for any damages or losses arising from the use of this translation. More Details
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