Akeso’s PCSK9 MONOCLONAL ANTIBODY (EBRONUCIMAB) EARLY COMPLETION OF PATIENT ENROLLMENT IN A PHASE III CLINICAL TRIAL FOR PRIMARY HYPERCHOLESTEROLEMIA AND MIXED HYPERLIPIDEMIA

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HONG KONG, Dec. 23, 2021 /PRNewswire/ — Today, Akeso, Inc. (09926.HK) announces that Ebronucimab (PCSK9 monoclonal antibody, research and development code: AK102), jointly developed by the Company and Dawnrays Biotechnology Capital (Asia) Ltd., completed patient enrollment early in a pivotal registrational phase III clinical trial in the People’s Republic of China for the treatment of primary hypercholesterolemia and mixed hyperlipidemia.

The clinical trial is one of the three large-scale pivotal registrational clinical trials of Ebronucimab for the treatment of primary hypercholesterolemia and mixed hyperlipidemia.

The clinical trial is designed to cover the unmet clinical needs of a large number of population, aiming to evaluate the efficacy and safety of long-term administration of Ebronucimab on patients with extremely high, high and low-to-medium cardiovascular hyperlipidemia risk, and provide more basis for product launch.

Results of previous clinical trials showed that Ebronucimab demonstrated good efficacy and safety profile in treating patients with hypercholesterolemia. After 12 weeks of continuous treatment using Ebronucimab, the fasting serum level of low-density lipoprotein cholesterol (”LDL-C”) in each dose group have improved significantly compared to patients treated with placebo, demonstrating similar efficacy as the marketed products with the same target.

In particular, 450 mg once every four weeks (Q4W) can reduce LDL-C by 65.48% from baseline and 65.69% from the placebo arm; 150 mg once every two weeks (Q2W) can reduce LDL-C by 63.69% from baseline and 63.90% from the placebo arm. In the clinical trials, Ebronucimab showed similar safety profile compared with the marketed PCSK9 monoclonal antibody drugs with the same target, with drug-related adverse events greater than 5% and higher than placebo only included the injection site adverse reactions.

The Company could complete the patient enrollment for the phase III clinical trial of Ebronucimab in China early is the result of the Company’s efficient clinical operation system and innovation capability. Clinical trials have shown that Ebronucimab has a more complete inhibition of PCSK9 compared to the marketed products with the same target, and can significantly reduce cholesterol in all patients administered. The Company expects that Ebronucimab will be approved for marketing as soon as possible, providing a better choice for a large number of cardiovascular patients in China.

PCSK9 monoclonal antibody is known as the most effective lipid-lowering drug following the statin drugs. At present, two PCSK9 monoclonal antibodies, namely Evolocumab and Alirocumab, have been approved for launch globally. The global market size of PCSK9 monoclonal antibody was US$1.246 billion in 2020, and an authoritative institution forecasts that PCSK9 monoclonal antibody market in China will grow at a compound annual growth rate of 36.9% from 2023 to 2030.

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Source: Akeso, Inc.