The Board of Essex Bio-Technology Limited announced that the phase 1/2 clinical study for recombinant anti-vascular endothelial growth factor (?anti-VEGF?) humanised monoclonal antibody ophthalmic injection HLX04-O for the treatment of wet-AMD has recently shown its safety and tolerability and demonstrated preliminary efficacy. The phase 1/2 clinical study is a single-arm, open-label and multi-centre study that consists of two parts, which aims to evaluate the safety and preliminary efficacy of HLX04-O via intravitreal injection (?IVT?) in patients with active wet-AMD. Part 1 of the study is a safety run-in stage and 6 patients were enrolled, and part 2 of the study is a single-arm, open-label and multi-centre phase 2 study and 20 patients (including 6 patients from part 1) were enrolled.

All patients received HLX04-O IVT (1.25 mg/0.05 mL) every four weeks until death, withdrawal of informed consent, loss to follow-up, termination of study by sponsor or completion of one-year treatment. For part 1, the primary endpoint is the safety event related to HLX04-O that occurred within four weeks after the first dose of HLX04-O, and secondary endpoints are the systemic pharmacokinetic characteristics of HLX04-O after the first and fourth IVT administration. For part 2, the primary endpoint is the mean change of letters from baseline in bestcorrected visual acuity (BCVA) at week 12, and secondary endpoints include other efficacy measures, safety, immunogenicity and systemic pharmacokinetic characteristics.

The results show that HLX04-O is safe and well tolerated in wet-AMD patients, and preliminary efficacy was observed. ABOUT HLX04-O: HLX04-O is a new ophthalmic preparation product developed based on HANBEITAI® (bevacizumab injection) independently developed by Henlius, through optimising the prescription, specifications and production processes of HANBEITAI® (bevacizumab injection) according to the requirements of ophthalmic drugs, without changing the active ingredients, and is intended to be used for the treatment of wet-AMD. In November 2021, the first patient had been dosed in a phase 3 clinical study for HLX04-O for the treatment of wet-AMD in the PRC.

So far, the first patient had been dosed in an international multi-centre phase 3 clinical study for HLX04-O in patients with wet-AMD in countries such as Latvia (a European Union country), Australia and the United States successively.