Clinical application of global heavyweight first-line innovative drugs valued at 15 billion by GST was accepted

Yesterday evening, guangshengtang announced that its company submitted clinical registration application to the State Drug Administration on January 14, 2019, and recently received the acceptance notice The clinical application of gst-hg151 non-alcoholic fatty liver disease and liver fibrosis reversible global innovative drug was accepted, which is a milestone in the three-year professional research of the project, and the company is also in the process of creation In the new drug field, another important progress has been made after the approval of gst-hg161 new targeted drug for liver cancer According to the announcement, no drugs have been approved for the treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in the world According to the data and prediction of nature reviews drug discovery, once the relevant patented drugs for NASH indications are approved for marketing, the drug market will exceed 15 billion US dollars by 2025, with huge market space Gst-hg151, a new drug of guangshengtang, is a global innovative drug developed by gst-hg151 in cooperation with Shanghai yaomingkant new drug development Co., Ltd Preclinical research has shown the effect of improving liver function and remarkable anti fibrosis effect, which is expected to fill the gap in the field of anti fibrosis in the world and overcome the irreversible world problems of liver fibrosis and cirrhosis The company will actively carry out clinical preparation work, and in the future, superimpose the priority policies of the state for the 13th five year plan major new drug creation support and innovative drug review, so that gst-hg151 project is expected to become the latest global non-alcoholic fatty liver disease treatment and the realization of liver fibrosis reversible global heavyweight first-line innovative drugs Main contents of the notice of acceptance of basic information of drugs 1 Drug name: gst-hg151 acceptance No.: cxhl1900079 country 2 Dosage form: API application matters: new drug application: Chemicals: Class 1 application stage: clinical applicant: Fujian guangshengtang Pharmaceutical Co., Ltd conclusion: after examination, it is decided to accept 3、 Drug name: GST-HG151 tablet Acceptance Number: CXHL1900080, CXHL1900081 dosage form: tablet application item: new drug application: chemical drug: Class 1 application stage: clinical applicant: Fujian guangshengtang Pharmaceutical Co., Ltd conclusion: after examination, it is decided to accept NAFLD is a kind of metabolic stress liver injury closely related to insulin resistance and genetic susceptibility Nash is a serious pathological type of NAFLD NAFLD is the most common chronic liver disease in the world The prevalence of NAFLD in general adults is 6.3% - 45%, of which 10% - 30% is Nash The prevalence of NAFLD in most Asian countries, including China, is in the upper middle level (> 25%) With the prevalence of obesity and MetS, NAFLD has become the first major cause of liver biochemical index abnormality in chronic liver disease and health examination in China If NAFLD is not treated, it can progress from simple fatty liver to Nash, and gradually to liver fibroplasia, and even to fatty liver cirrhosis, and finally to liver cell carcinoma (HCC) More and more people with chronic HBV infection combine NAFLD, seriously endangering people's life and health Despite the urgency of medical treatment, no drugs have been approved for the treatment of NAFLD and Nash worldwide New drug research and development gst-hg151 is a global innovative drug for the treatment of NASH The company has global intellectual property rights and has applied for two PCT international patents for this project Gst-hg151 can prevent the activation of JNK (c-Jun amino terminal kinase) and p38MAPK (mitogen activated protein kinase) pathways downstream of the target site through specific binding with the corresponding target, so as to reduce the occurrence of apoptosis and fibrosis Gst-hg151 has the characteristics of good target selectivity, strong drug-making, significant drug effect and high safety It is used to evaluate Nash or liver fibrosis animal models before clinical application Type B showed the effect of improving liver function and statistically significant anti fibrosis effect At present, there is no effective treatment for NASH The development of gst-hg151 project is expected to fill the gap in the field of global liver fibrosis and overcome the world's irreversible problems of liver fibrosis and cirrhosis The company will actively carry out the clinical registration and application of FDA in the United States, and choose the opportunity to solely finance overseas interests and seek overseas cooperative development partners.