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.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!