With R & D investment of 238 million, Haizheng's new drug application for primary hypercholesterolemia was accepted

On January 14, Haizheng pharmaceutical released a notice that the company's application for the listing of new drugs of Haize mAb and Haize mAb tablets was accepted At present, the company has invested about 238 million yuan in the project In October 2013, Haizheng pharmaceutical submitted to Zhejiang food and drug administration an application for phase II / III clinical trial of Haize Mabu (hs-25), which was intended to be used for the treatment of primary hypercholesterolemia In September 2018, According to the summary report of clinical research, the two clinical phase III trials were all up to the preset standard The curative effect of haizemab in the treatment of primary hypercholesterolemia is definite, which can reduce LDL-C, TCH, non-HDL-C and apo B Level, 2 weeks effect, fast and stable effect, long-term use of this product, low incidence of adverse reactions, high safety, good tolerance For hypercholesterolemia patients with atherosclerotic cardiovascular disease and other critical diseases who are often treated with statins but still fail to reach the target value, the effect of adding haizemab to reduce blood lipid is better than that of increasing the dose of statins, and the frequency of adverse events and adverse reactions is lower At present, the same target drug on the market in foreign countries is ezemeb (trade name "zetia"), which is mainly used for the treatment of primary hypercholesterolemia, homozygous familial hypercholesterolemia (hofh) and homozygous sitosteronemia (or phytosterosteroemia) It was approved to be on the market in China in 2006 In 2017, zetia's global sales volume was about US $3.49 billion, and the sales volume in China was about US $10 million Up to now, Haizheng pharmaceutical has invested about 238 million yuan in the research and development project of Haize Mabu According to Haizheng pharmaceutical, the "multi center, randomized, double-blind, double simulation and controlled observation" of two doses of haizemab (hs-25) developed by the combination of haizemab and atorvastatin ）The clinical study on the efficacy and safety of combination with atorvastatin in the treatment of hypercholesterolemia is still in progress The efficacy and safety of combination of haizemab and atorvastatin in the treatment of hypercholesterolemia will be further evaluated Disclaimer: This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprinting is to transmit more information and does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact with this website message, we will delete the content in the first time!