In October 2020, Henlius entered into a co-development and exclusive license agreement with Essex. With this collaboration, Henlius and Essex plan to conduct global multi-centre clinical trials of HLX04-O in China, Australia, the European Union(EU) and the United States(US), and apply marketing authorization in different countries and regions around the globe based on the research results. As of now, HLX04-O has received clinical approvals in China, Australia, the US, Singapore and EU countries including Latvia, Hungary and Spain with global multi-centre clinical trials gathering pace.
HLX04-O is a new ophthalmic preparation product developed based on HLX04, a bevacizumab biosimilar independently developed by the Company, through optimizing the prescription, specifications and production processes of HLX04 according to the requirements of ophthalmic drugs, without changing the active ingredients, and is intended to be used for the treatment of wAMD. By means of comparability studies, it shows that changes in production processes and prescriptions of the preparation have no adverse impact on the quality, safety and efficacy of the pharmaceutical preparation. HLX04-O can inhibit VEGF’s binding to its receptor Flt-1(VEGFR-1) and KDR(VEGFR-2) on endothelial cells to inhibit the activation of its tyrosine kinase signaling pathway, inhibit endothelial cell proliferation and reduce angiogenesis, thereby treating eye diseases associated with angiogenesis.
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