AD Pharmaceuticals Co., Ltd. announced that patient enrollment has been completed ahead of schedule for the key registered Phase III clinical trial of the anti-PCSK9 monoclonal antibody Ebronucimab (R&D code: AK102), in the treatment of primary hypercholesterolemia and mixed hyperlipidemia.

This clinical trial is one of three large pivotal clinical trials of Ebronucimab in the treatment of primary hypercholesterolemia and mixed hyperlipidemia. This trial was designed to cover the unmet clinical needs of a wide range of population, and aimed to evaluate the lipid-lowering efficacy and safety of Ebronucimab under long-term administration in hyperlipidemia patients at extremely high risk, high risk, medium，andlow risk for cardiovascular disease so as to provide a greater basis for supporting the product’s launch.

Previous clinical studies have demonstrated the favorable efficacy and safety of Ebronucimab in the treatment of hypercholesterolemia: after 12 weeks of continuous treatment with Ebronucimab, fasting serum low-density lipoprotein-cholesterol (LDL-C) levels were significantly improved compared with a placebo in all dose groups, with similar efficacy as marketed products with the same target. Of these, 450 mg of Q4W reduced LDL-C by 65.48% from the baseline and 65.69% from the placebo-combined group; and 150 mg of Q2W reduced LDL-C by 63.69% from the baseline and 63.90% from the placebo-combined group. In clinical studies, Ebronucimab shows similar safety levels as the marketed PCSK-9 monoclonal antibody with the same target, and drug-related adverse events with an incidence rate > 5% and higher than the placebo only involve adverse reactions at the injection site.

Dr. Xia Yu, general manager of AD Pharmaceuticals said, "We are very pleased to enroll the patients ahead of schedule for the Phase III clinical study of Ebronucimab in China, which is a positive result of the Company's efficient clinical operation system and innovative strength. This clinical study has shown that compared to drugs with the same target, Ebronucimab can inhibit PCSK9 in a complete manner and may significantly reduce cholesterol in all patients after administration. The Company is looking forward to early approval of Ebronucimab so as to offer a better choice for a large number of patients with cardiovascular diseases in China."

The PCSK9 monoclonal antibody is known as the most effective lipid-lowering drug after statins. At present, two PCSK9 monoclonal antibodies, namely Evolocumab and Alirocumab, have been approved worldwide. The global market size of the PCSK9 monoclonal antibody in 2020 reached USD 1.246 billion. The authorities predict that the compound annual growth rate of the PCSK9 monoclonal antibody market in China will be as high as 36.9% from 2023 to 2030.