Suoyuan bio's world first anti-tumor new drug international multicenter clinical trial (Engine Research) approved

Source: from October 10, 2017 to October 10, 2017, Suoyuan biology, the leading enterprise of precision medicine, announced that its in-process drug db102 (enzastaurin) International multi center phase III clinical trial (engine study) had obtained the approval document of drug clinical trial issued by the State Food and Drug Administration (CFDA) Engineering research is a first-line clinical trial of high-risk diffuse large B-cell lymphoma (DLBCL) initiated by Suoyuan biology under the guidance of precision medicine, which will be carried out simultaneously in China and the United States Introduction to db102 - the world's first new drug db102 is a class of first in class small molecule serine / threonine kinase inhibitors, which acts on key tumor targets in the field of PKC β, PI3K and Akt, and has direct effects on inducing tumor cell death and inhibiting tumor cell proliferation, as well as indirect effects on inhibiting tumor induced angiogenesis Db102 was initially developed by Lilly company, which has carried out more than 60 clinical trials, and more than 3000 subjects have been treated with the drug, which shows that db102 has good safety The clinical trials of db102 cover many tumor fields (including blood tumor and solid tumor), especially DLBCL and gliomas, both of which have obtained Orphan Drug Certification in the United States and Europe Suoyuan acquired the db102 project from Lilly as a whole, and now has all the rights to develop, produce and sell the drug globally DB102's advantage - new biomarkers, high risk DLBCL first-line treatment DLBCL is the highest incidence rate in non Hodgkin's lymphoma (NHL), accounting for about half of the total cases At present, the international standard therapy R-CHOP has excellent effect on low-risk patients, but it is not ideal for high-risk patients Through its unique whole gene scanning platform technology, Suoyuan biology used the remaining clinical samples and combined with the clinical data for big data analysis, and found a new biomarker (dgm1tm) highly related to the efficacy of db102 The overall survival rate of high-risk dgm1tm positive patients treated with db102 combined with R-CHOP was much higher than that of patients only using R-CHOP Research purpose: precision medicine, new treatment and new hope based on the current status of DLBCL treatment and existing research and analysis data, Suoyuan biology will redevelop db102 based on the new biomarker dgm1tm, bringing new hope for the treatment of high-risk dcbcl patients Dr Luo Wen, founder and chairman of Suoyuan biology, said: "patients with high-risk DLBCL have been lack of effective treatment methods The approval of engine research has brought new solutions for this unmet clinical needs, and the db102 innovative drug guided by dgm1tm has brought more hope to patients Suoyuan bio's new new drug R & D mode, guided by precision medicine, has also opened a new path for Chinese pharmaceutical companies to develop the world's leading innovative drugs more quickly and economically " Han Yingying, executive director of clinical operation of Suoyuan biology in China, said: "the successful approval of engine research in China fully demonstrates China's recognition and full support for the innovative model of drug research and development Suoyuan biology has started the quick start procedure of the trial, and will work with researchers of various research centers to give Chinese high-risk DLBCL patients the opportunity to participate in it as soon as possible, and successfully complete the pioneering international multi center phase III clinical trial " About Suoyuan bio Suoyuan biomedical (Hangzhou) Co., Ltd is a new, rapid and effective model to develop a new type of precision medicine leading enterprise, registered in Hangzhou Economic and Technological Development Zone, China clinical operation center is located in Beijing, and has a wholly-owned subsidiary, denovo biopharma LLC, in San Diego, California, USA Suoyuan bio introduced new drugs which were proved to be safe and effective for some patients through late clinical trials from the international pharmaceutical factory The original biomarker platform technology was used to find biomarkers that can predict the efficacy of drugs in the remaining clinical samples Through these newly found biomarkers as a companion diagnosis to screen patients, Suoyuan bio can conduct clinical trials again in sensitive patients, so as to optimize the efficacy, safety and tolerance, improve the success rate of new drug development, so as to achieve the purpose of developing innovative drugs at a lower cost and in a shorter time In addition to db102 (enzastaurin), Suoyuan biology also has the global rights and interests of innovative drugs db103 and db104 that have also been developed to the late clinical stage, both of which are global first-class drugs Db103 (pomaglumetad) develops products for Lilly for the treatment of schizophrenia Db104 (liafensine) is an antidepressant drug obtained from armI / BMS At present, Suoyuan biology has negotiated with many international pharmaceutical companies to purchase similar late clinical innovative drugs, and will use its biomarker platform technology in the same way to develop personalized innovative drugs.