Apg-115, an original and new target precise antitumor drug of AXA pharmaceutical, was approved to enter the US clinical practice

June 2, 2016 - on June 1, according to the information from FDA, apg-115, a precision anti-tumor drug with global intellectual property rights and acting on the new target MDM2-p53 independently designed and developed by AXA pharmaceutical, was approved to enter the US clinic The project is the fifth product in the Yasheng pharmaceutical product pipeline entering the clinical stage, and the second product in the US "In the early stage of design and development, all the research scheme design and experiment implementation are carried out in strict accordance with the highest international technical standards, so as to effectively ensure the quality of research work of apg-115 During the ind technical review of the project, FDA only communicated the relevant technical issues once, and it took less than 30 working days since asun pharmaceutical submitted the ind application of apg-115 to FDA for approval of clinical practice on April 30, 2016 " Dr Yang Dajun, chairman of AXA pharmaceutical and a special expert of the national thousand talents plan, said At the same time, Dr Yang Dajun briefly introduced the current situation of MDM2-p53 target drug research and development in the world: "at present, there are only four drugs targeted at MDM2-p53 in the clinical research and development stage in the world, all of which are the top ten multinational pharmaceutical enterprises in the world, and the fastest progress is only in the phase IIa clinical stage However, there are no other reports on the drugs under research in this target field in China except apg-115 At present, the enterprise is applying for the Chinese clinical trial of apg-115 to the State Food and drug administration The successful development of the drug will fill the gap in MDM2-p53 target field in China, and it also has the potential of best in class original drugs " Dr Guo Ming, general manager of AXA pharma and special expert of national thousand talents plan, said: "all pharmaceutical research work of apg-115 is completed by the scientific research team of the enterprise in accordance with GMP standards in the domestic production base, including chemical synthesis, pre prescription, preparation process, analysis and quality standards and clinical research drug production It is the consistent style of AXA to carry out pharmaceutical research in accordance with international standards " "The preclinical research of apg-115, including the design of clinical experiment scheme, was independently completed by Yasheng pharmaceutical research team, and these two pieces are exactly what FDA pays most attention to in the process of ind technology review." "All CMC production of apg-115, including clinical drug use under GMP conditions in the United States, preclinical GLP toxicology test and clinical scheme design, was completed by AXA pharmaceutical team in China," Dr Yang Dajun told the Bio Valley editor! This is a real sense of domestic nce drugs into the United States, one-time FDA approved clinical ind in the United States to carry out clinical phase I! " (Bio Valley bio Com) about apg-115 apg-115 is a small molecular inhibitor that is effective orally and highly selective for targeting MDM2-p53 protein binding The data of preclinical research shows that apg-115 can effectively inhibit sarcomas, primary liver cancer, primary gastric cancer and other tumors, and the tumor tissue can be completely disappeared by animal test administration Another study showed that apg-115 had a significant therapeutic effect on dry macular disease in the elderly In the later stage, Yasheng pharmaceutical will speed up the clinical research progress of apg-115 and strive to put the project into the market as soon as possible, so as to provide more efficient and safe new treatment drugs for clinical malignant tumors and dry senile macular diseases About AXA Pharma, AXA Pharma is a global biomedical research and development company based in China Yasheng pharmaceutical mainly aims at the research and development hotspot and development trend of international new small molecule targeted anti-tumor drugs, designs, optimizes and develops a series of original small molecule targeted anti-tumor drugs with global independent intellectual property rights, which are used to treat tumors, hepatitis B and anti-aging diseases Yasheng pharmaceutical has formed a number of core technologies in the field of drug design and Optimization Based on target protein structure, with nearly 80 international invention patents Up to now, AXA has 5 products in clinical phase I-II in the United States, Australia and China Yasheng medicine focuses on the cancer target that has been clinically verified Its R & D product pipeline is an inhibitor of the key protein of apoptosis pathway, which can inhibit IAP, bcl-2/ BCL XL and MDM2-p53, etc., restart the apoptosis process of tumor cells; the second and third generation of inhibitors for kinase mutants in cancer treatment; the inhibitors closely related to the epigenetic target of tumor treatment, etc.