Application for marketing of diclofenac, the original diabetes drug of microchip biology, was accepted

Shenzhen September 19, 2019 / Meitong news agency / -- in September 19, 2019, the application for listing (NDA) of class 1 original new drug, chiglitazar sodium (trade name: shuangluoping ® / bilessglu ®), independently developed by Shenzhen micro chip Biotechnology Co., Ltd (Shanghai Stock Exchange Stock Code: 688321), was accepted (accepted) by the drug review center of the State Drug Administration Cxhs1900032) Diabetes is the highest chronic disease in the world China has become the country with the largest number of diabetes patients, with 110 million patients, more than 90% of whom are type 2 diabetes Insulin resistance is one of the core pathological mechanisms of the occurrence and development of diabetes About 10% of diabetic patients have severe insulin resistance, and nearly 60% of them have metabolic syndrome The treatment effect of conventional drugs is poor, and there are significant unmet clinical needs Xiglitaza sodium is a nuclear receptor peroxisome proliferator receptor (PPAR) full activator independently developed by Shenzhen micro core Bio Technology Co., Ltd., which has obtained the global compound invention patent It belongs to a new mechanism of insulin sensitizer, and is used for the treatment of type 2 diabetes As the first PPAR agonist to complete confirmatory phase III clinical trials in the world, ciglitazidine sodium has shown significant and lasting hypoglycemic effect, significant insulin sensitization and lipid regulation in a series of clinical studies, and has potential liver protection effect, which is expected to bring more clinical benefits to patients with diabetes and metabolic syndrome As a whole agonist of PPAR, ciglitazone sodium has been widely concerned in the international and domestic fields since it entered clinical phase III In 2017, the international academic journal Nature endocrinology reviews reviewed the research progress in PPAR field, and paid special attention to and looked forward to the progress of phase III clinical trials of ciglitazidine sodium On June 7, 2019, at the annual meeting of the American Diabetes Association (ADA) held in San Francisco, the United States, Professor Ji Linong of the people's Hospital of Peking University and Professor Jia Weiping of the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, as the main researchers of two phase III clinical trials of cigreta sodium, introduced the phase III clinical trials of cigreta sodium to doctors and scholars in the field of global diabetes treatment Research results This is also the first time for Chinese scholars to show the results of the confirmatory clinical trials of Chinese original metabolic diseases in the international academic arena It has been 15 years since sieglitazone sodium submitted its ind application in 2004 It is a special subject of "major new drug creation" in the 15th, 11th and 12th Five Year Plan of China As for microchip biology, a leading enterprise in the field of biomedicine founded in 2001 by a senior returned team in the United States, specializing in the research and development of original small molecule drugs, with complete capabilities from drug target research to clinical candidate drug development and industrialization, and with a team of technology, management and intellectual property specializing in the research and development of original new drugs With the core competitiveness of "integrated drug discovery and early evaluation platform based on chemical genomics" and the goal of "original, safe and effective", microchip is committed to providing patients with affordable innovative mechanism therapy drugs Many breakthroughs have been made in the development of innovative small molecule drugs for major diseases, global patent protection and unique clinical effects The company is also one of the first batch of "innovative drug incubation bases" for major national science and technology projects, independently undertaking a number of national "863" and major new drug creation and technology projects, and won the first prize of national science and Technology Progress Award in 2013 In 2017, xidaban won the gold medal of invention patent issued by the State Intellectual Property Office Source: This article of Shenzhen micro core Biotechnology Co., Ltd 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 our website message, we will delete the content in the first time.