Suoyuan bio will start the international phase III clinical trials of antitumor drugs

[China Pharmaceutical network enterprise news] on February 15, Suoyuan biology, a leading medical enterprise, successfully discovered the biomarker dgm1 of the new antitumor drug db102, and plans to launch the international multicenter phase III clinical trial for the treatment of diffuse large B-cell lymphoma this year The clinical trial will screen the patients of db102 through dgm1 The application of the clinical trial guided by medical treatment has been accepted by the State Food and drug administration (picture source: Baidu picture) db102 (enzastaurin) is a kind of first in class small molecule serine / threonine kinase inhibitor Its target is PKC β, PI3K, Akt and other key carcinogenic factors Db102 was initially developed by Lilly company, and a series of clinical studies were carried out for a variety of tumors, including phase II and phase III clinical trials of DLBCL Db102 showed a certain effect in the phase II clinical trial of DLBCL first-line treatment, but it did not achieve the expected effect in the phase III clinical trial of maintenance treatment After a detailed analysis of the clinical results of db102, Suoyuan biology found that some of the patients benefited from the treatment of db102 Suoyuan then acquired the db102 project as a whole from Lilly company, which has the full right to develop, produce and sell the drug globally After the handover of db102 project, Suoyuan biology completed large-scale genomic analysis of phase III clinical trial samples of db102 by using its reverse whole gene scanning platform technology, and calculated big data in combination with clinical indicators, thus found a group of new biomarkers dgm1, and the survival period of dgm1 positive patients after taking db102 had a very significant improvement Similarly, a retrospective analysis of the phase II trial of db102 in the first-line treatment of DLBCL showed that the efficacy of dgm1 positive patients was significantly better than that of dgm1 negative patients Diffuse large B cell lymphoma is a high incidence rate in non Hodgkin lymphoma (NHL), accounting for about half of the total number of 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 Suoyuan biological found that the overall survival rate of high-risk patients with dgm1 positive treated with R-CHOP and db102 was much higher than that of patients only using R-CHOP Based on the encouraging analysis results, Suoyuan biological plan launched an international multicenter randomized, double-blind, placebo-controlled, phase III clinical study on the first-line treatment of diffuse large B-cell lymphoma in 2017, and has successfully submitted an international multicenter clinical trial application for class I new drug to CFDA drug review center in January 2017, which will be conducted in China and the United States Dr Luo Wen, chairman of Suoyuan biology, said: "the successful discovery of dgm1 biomarkers is a major breakthrough of Suoyuan and another successful verification of Suoyuan reverse full gene scanning platform Db102 has a unique anticancer mechanism, and there is no drug targeting its target in the world Suoyuan's unique medical technology and business model give Chinese companies the opportunity to develop first in class innovative drugs around the world, and it is expected to enable Chinese patients with high-risk diffuse large B-cell lymphoma to use this global innovative therapy as soon as possible As a first-line drug, if the db102 clinical trial is successful, its global sales volume is expected to exceed US $1 billion, which is expected to become a blockbuster anti-cancer drug developed by Chinese pharmaceutical companies " Han Yingying, director of clinical operation of Suoyuan biology in China, said: "Lilly company has carried out a series of high-quality clinical studies on the research and development of enzastaurin, including the international multi center phase III clinical trials participated by China, which has created a large number of favorable conditions for Suoyuan's clinical application this time China will play a key role in Suoyuan biological's international multi center clinical trials and in the future For this reason, we established a Chinese clinical operation center in the core area of Beijing at the end of 2016, and began to form an experienced clinical team to more effectively support the company's international clinical trials " About Suoyuan biopharmaceutical (Hangzhou) Co., Ltd is a new type of medical leading enterprise that develops a new type of new drugs in a fast and effective mode It is located in Hangzhou Economic and Technological Development Zone, China Its clinical operation center is located in Beijing, and has a wholly-owned subsidiary 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 international pharmaceutical plants Using its biomarker platform technology, we can 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, Suoyuan biology also has the global rights and interests of the innovative drug db103 which has been developed to the late clinical stage Db103 is also a global first-class drug for the treatment of schizophrenia 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.