Clinical approval of yizhemeb tablets

Approval document for clinical trials of drugs (SH: 600422): Announcement on obtaining the approval document for clinical trials of yizheimai tablets Recently, kunyao Group Co., Ltd (hereinafter referred to as "kunyao group" and "the company") received the approval document for clinical trials of drugs approved and issued by the State Food and Drug Administration (hereinafter referred to as "the State Food and Drug Administration"), and now the relevant information is announced as follows: 1 Basic information of clinical approval document 1) drug name: yizheymaibu tablet 2) dosage form: tablet 3) Approval No.: 2016l06717 4) specification: 10mg 5) application items: domestic drug registration 6) Applicant: Kunming Pharmaceutical Group Co., Ltd 7) acceptance No.: cyhs1501141 Yunnan 8) registration classification: original chemical category 6 9) Examination and approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration, and agrees to carry out human bioequivalence (be) test The applicant shall complete the corresponding research work as required before the be test, during the be test and when applying for listing 2、 Other information of drug research on July 1, 2015, the company first submitted an application for production application to the State Food and Drug Administration for yizheymaibu tablets, which was accepted On July 27, 2016, the State Food and Drug Administration approved the company to conduct human bioequivalence (be) test on the drug, and the company received the official approval document on August 11, 2016 At present, the company has invested about 3 million yuan in R & D expenses The indications of ezem tablets developed by the company: primary hypercholesterolemia, homozygous familial hypercholesterolemia (hofh), homozygous sitosteronemia (or phytosteroemia) Cardiovascular disease is one of the most common and serious diseases endangering human health (especially the middle-aged and old people) Dyslipidemia is an important risk factor of atherosclerosis, coronary heart disease and other cardiovascular and cerebrovascular diseases Lipid regulating drugs can reduce the incidence and mortality of these diseases, and have a positive effect and profound influence on the prevention and treatment of cardiovascular diseases Currently, half of the country incidence of cholesterol lowering drugs is the statins, which are the mainstream of lipid regulating drugs market But as a combination of statins and their products, the market share of them is very steady With the rapid improvement of the living standard of the people, the incidence rate of hyperlipidemic patients is increasing linearly The incidence rate of cardiovascular diseases represented by dyslipidemia is obviously improved, and the domestic market is also increasing It will continue to expand Statins are widely used in our country, but the combination of ezemeb and statins has achieved good curative effect and good tolerance With the wide application of the combination, ezemeb will have a better market development prospect Foreign countries are preparing to market the compound preparation of ezemeb and statins, so it also provides an objective basis for the combination of ezemeb and statins in domestic clinic Relying on the huge market foundation of statins, the clinical space of ezemeb will be broad Yizheyi cereal (yishichun) was developed by Merck and Schering plough in cooperation It was approved by FDA in 2002, and then successively listed in European countries, Australia, Japan, South Korea and other countries On April 6, 2006, China approved the listing of imported yizhezi cereal in China Since its listing, it has been widely concerned and the sales prospect is very promising.