Zhitong Financial App News, Donui Pharmaceutical (02348) announced that the company has been informed by Congrong Oriental that one of the key registered III clinical trials of PCSK9 McAb (AK102) in the treatment of primary hypercholesterolemia and mixed hyperlipidemia in China has been completed ahead of schedule.
This clinical trial is one of three large-scale key registered clinical trials of inuximab in the treatment of primary hypercholesterolemia and mixed hyperlipidemia. The clinical trial is designed to cover the unmet clinical needs of a wide range of people, and is designed to evaluate the lipid-lowering efficacy and safety of inuximab in patients with cardiovascular very high-risk, high-risk and medium-low risk hyperlipidemia for a long time. To provide more basis for supporting the launch of products.
Previous clinical studies have shown that inuximab shows good efficacy and safety in the treatment of patients with hypercholesterolemia. After continuous treatment with inucizumab for 12 weeks fasting serum low density lipoprotein cholesterol (LDL-C) levels in all dose groups were significantly improved compared with placebo showing similar efficacy to the products already on the market at the same target. Among them, 450mg once every four weeks (Q4W) decreased LDL-C by 65.48% relative to the baseline and 65.69% compared with the placebo group. 150mg once every two weeks (Q2W) reduced LDL-C by 63.69% relative to the baseline and 63.90% compared with the placebo group. In clinical studies, inuximab showed similar safety characteristics to PCSK9 McAb drugs with the same target, and drug-related adverse events with an incidence of more than 5% and higher than placebo included only injection site adverse reactions.
It is the result of efficient clinical operation system and innovative strength that Congrong Oriental was able to complete the phase III clinical study of inuximab in China ahead of time. Clinical studies have shown that inuximab can more completely inhibit PCSK9 than the target products, and can significantly reduce cholesterol in all patients. The company expects that inuximab will be approved and put on the market as soon as possible to provide more choices for a large number of cardiovascular patients in China.
In addition, PCSK9 monoclonal antibody is regarded as the most effective lipid-lowering drug after statins. At present, two types of PCSK9 McAbs (Evolocumab and Alirocumab) have been approved and put on the market all over the world. The global market size of PCSK9 McAbs in 2020 is US $1.246 billion, and authorities predict that the compound annual growth rate of China's PCSK9 McAb market will be as high as 36.9% from 2023 to 2030.