Suoyuan bio obtained the global authorization of phase III antitumor drug enzastaurin from Lilly

----Denovo US San Diego location -------------- denovo China Hangzhou location this is the first time for a Chinese pharmaceutical company to obtain a global license for clinical phase III innovative drugs from an international pharmaceutical company After more than two years of contact, Suoyuan's model of developing innovative drugs with biomarkers finally moved the American giant Lilly is a world pharmaceutical giant founded in 1876 It set up an office in Shanghai in 1918 and now has a wholly-owned company in Suzhou Lilly has conducted a series of clinical studies on a variety of tumors with enzastaurin, including phase II and phase III clinical trials of diffuse large B-cell lymphoma (DLBCL) Enzastaurin achieved encouraging clinical results in the phase II trial of DLBCL induction therapy, but failed to achieve the expected results in the phase III maintenance therapy trial Through the detailed analysis of clinical data, Suoyuan biomedical found that there was a significant improvement in progression free survival of patients in one subgroup after taking enzastaurin Suoyuan plans to find biomarkers related to drug efficacy through the reverse full gene scanning technology pioneered by the company, and use the biomarkers found to screen patients, so as to carry out new clinical trials for drug sensitive patients, so as to improve the efficacy of the drug and lay the foundation for the final approval of the drug on the market Due to the long time (more than 10 years), high cost (more than US $1 billion) and high risk characteristics of innovative drug research and development, most Chinese pharmaceutical companies have been afraid of the way, while the vast majority of innovative drugs in the global market are monopolized by European and American pharmaceutical companies, because innovative drugs have far higher market returns than generic drugs "The agreement with Lilly marks a new milestone in the development of Suoyuan." Dr Fang Xiangming, chairman of Suoyuan, said, "the smooth cooperation means that Suoyuan can use its own technical advantages to explore a new path for Chinese pharmaceutical enterprises to develop a class of innovative drugs with international advanced level more quickly and economically." According to Dr Luo Wen, general manager of Suoyuan, Lilly's new drug has been tested in more than 3000 cancer patients, accumulating a large number of high-quality clinical data and samples, which is more helpful for Suoyuan to develop relevant biomarkers It is understood that in addition to this lymphoma project, Suoyuan already has a late clinical lung cancer innovative drug At present, Suoyuan is still negotiating with several international pharmaceutical companies to purchase phase III innovative drugs with similar clinical effects in the unselected patients, and will use its biomarker platform technology in the same way to develop personalized innovative drugs News extension > > Suoyuan biomedical (Hangzhou) Co., Ltd., which is approved to engage in personalized new drug research and development, announced on September 16 in Beijing that its wholly-owned subsidiary, denovo biopharma, obtained the global authorization of clinical phase III anti-tumor drug enzastaurin from Lilly According to the terms of the agreement, Suoyuan biomedical will have all rights to the global development, production and sale of the medicine, including all intellectual property rights and other relevant rights and data This is the first time that a Chinese pharmaceutical company has obtained the global authorization of clinical phase III innovative drugs from a large international pharmaceutical company Its significance lies in the recognition of the international pharmaceutical company for the development of innovative drug models by using biomarkers of Suoyuan bio The cooperation between Suoyuan bio and Lilly is based on its original biomarker platform technology Enzastaurin (db102, formerly known as ly317615 HCl) is a small molecule serine / threonine kinase inhibitor initiated by Lilly company Its target is PKC - β and Akt signaling pathway The clinical efficacy of enzastaurin has been tested in more than 3000 tumor patients, including a variety of solid tumors and blood tumors The incidence rate of diffuse large B cell lymphoma in the United States is about 25000 per year, and Enzastaurin has been certified by orphan drug FDA and EMA in the United States Lilly has carried out a series of clinical studies on a variety of tumors with enzastaurin, including phase II and phase III clinical trials of diffuse large B-cell lymphoma (DLBCL) Enzastaurin achieved encouraging clinical results in the phase II trial of DLBCL induction therapy, but failed to achieve the expected results in the phase III maintenance therapy trial Through the detailed analysis of clinical data, Suoyuan biomedical found that there was a significant improvement in progression free survival of patients in one subgroup after taking enzastaurin Suoyuan bio introduced new drugs which were proved to be safe and effective for some patients through phase II and phase III clinical trials from the international pharmaceutical factory Using its unique and exclusive biomarker platform technology, we found biomarkers that can predict the efficacy of drugs in the remaining clinical samples Through the use of 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 drugs, and finally achieve the goal of developing a batch of innovative drugs with lower cost and faster time Suoyuan biological plans to find biomarkers related to drug efficacy through the company's pioneering reverse full gene scanning technology, and use the biomarkers found to screen patients, so as to carry out new clinical trials for drug sensitive patients, so as to improve the therapeutic effect of the drug and lay a foundation for the final approval of the drug on the market "The agreement with Lilly marks a new milestone in the development of Suoyuan." Dr Fang Xiangming, chairman of Suoyuan biology, said, "the smooth cooperation means that Suoyuan can use its own technical advantages to explore a new path for Chinese pharmaceutical enterprises to develop a class of innovative drugs with international advanced level more quickly and economically." Because of its original reverse full gene scanning technology, Suoyuan biology is positioning itself as a "personalized innovative drug company with unique business model", and using this technology to introduce the most cutting-edge personalized treatment into China Dr Rowan, general manager of Suoyuan biology, said: "the high-quality clinical data and a large number of clinical samples made by Lilly company for the research and development of enzastaurin help Suoyuan develop relevant biomarkers The reverse full gene scanning platform of Suoyuan biology is relatively mature It only takes a short time to find biomarkers with this platform Combined with the existing data and data of Lilly company, we hope to launch a new clinical trial of personalized treatment of DLBCL to verify the efficacy of our biomarkers and enzastaurin in the selected patients It is understood that in addition to the lymphoma project, Suoyuan bio has a late clinical innovative drug for lung cancer, and is currently negotiating with several international pharmaceutical companies to purchase the innovative drugs of phase III with similar clinical effect in the unselected patients, and will use its biomarker platform technology in the same way to develop personalized innovative drugs.