The first clinical trial of Tianjin original chemicals in Australia

Recently, act001, a new anticancer drug developed by Tianjin Suntech Pharmaceutical Co., Ltd., welcomed the first clinical trial patient who took it voluntarily in Epworth hospital, Melbourne, Australia At present, the patient has completed the first and several days of medication, no side effects were found This indicates that act001 has become the first chemical in Tianjin to conduct clinical trials of new drugs in developed countries The R & D of act001 has lasted for 8 years, with an investment of nearly 40 million yuan In addition to the support from the national "major new drug creation" major science and technology projects, Tianjin Science and technology support plan, and Tianjin major anti-cancer science and technology projects, act001 has also attracted more than 100 million yuan of social investment At the end of 2015, act001 applied for approval of clinical trials of new drugs in China and Australia respectively On March 1, 2016, act001 obtained approval of clinical trials of new drugs in Australia (including Australia and New Zealand), and the approval of clinical trials in China is currently under approval Up to now, Suntech Pharma has applied for 16 related invention patents for act001, 12 of which have been authorized by China Patent Office, and one has been authorized by 17 European countries, the United States, Japan and other developed countries The indication of act001 is preferably recurrent glioblastoma The treatment of glioblastoma is a worldwide medical problem, and its recurrence is almost inevitable The median survival time (half of the survival time) is about 14.6 months, and the 5-year long-term survival rate is close to 0% It is difficult to treat because of the strong dryness and infiltration of cancer cells It is difficult to distinguish cancer tissue from normal tissue, which makes it difficult to clean up operation and radiotherapy However, most anticancer drugs are difficult to enter the brain At present, the concentration of temozolomide in the brain is 40% of that in the blood, which can only prolong the median survival time by 20% The concentration of act001 in the brain is about 1.8 times of that in the blood, which has good efficacy and excellent safety in animal model experiment Act001 can be prepared from feverfew and Magnolia The content of steviolide in Magnolia officinalis root bark is about 60 times of that in feverfew Magnolia officinalis is a widely planted medicinal / green tree in China, which provides a very rich source of raw materials for act001 production and significantly reduces the production cost
Dr Chen Yue, the winner of the national and Tianjin "thousand talents plan", Professor of Nankai University, director of Suntech pharmaceutical company and the first inventor of act001, said: "act001 has a strong originality in the treatment of brain glioblastoma Compared with the glioblastoma drugs in the market and clinical trials, it has a significant innovation in structure, mechanism and concept If it can be observed in the clinic To the curative effect, it will bring new means for the treatment of glioblastoma, and it is expected to make breakthrough progress, and it is expected to achieve the status of "orphan drug" to be listed in developed countries such as Europe, America and Australia, and we urgently await the results of clinical trials