The development model of biopersonalized innovative medicine of so-yuan is recognized.
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Last Update: 2020-05-13
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Source: Internet
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Author: User
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original title: Soyuan Biopersonalized Innovation Drug Development Model Is Recognized
Biotechnology Siono Biopharmaceuticals (Hangzhou) Co., Ltd engaged in personalized new drug research and development, announced in Beijing on September 16th that its wholly-owned subsidiary, Denovo Biopharma, obtained a global license for the clinical phase III anti-tumor drug Enzataurin from Lilly Under the terms of the agreement, Soyuan Biopharmaceuticals will have all rights to the global development, production and sale of the drug, including all intellectual property rights and other related rights and data This is the first time that China's pharmaceutical companies from the international large pharmaceutical companies to obtain a clinical phase III innovative drug global authorization, its significance lies in the international pharmaceutical companies to the bio-marker bio-marker development of innovative drug model, Soyuan bio-bio-based cooperation is its original biomarker platform technology Enzataurin (DB102, formerly known as LY317615 HCl) is Lilly's first small molecule serine/sucine kinase inhibitor sontos, targeting PKC-beta and AKT signaling pathways Enzataurin's clinical efficacy has been tested in more than 3,000 tumor patients, including a variety of solid and blood tumors The drug's preferred indication-based diffuse large B-cell lymphoma is in the United States with an incidence of about 25,000 people per year, and Enzataurin has been certified by the FDA and the European EMA Orphan Drug Lilly has conducted a series of clinical studies with Enzataurin on a variety of tumors, including phase II and Phase III clinical trials of diffuse large B-cell lymphoma (DLBCL) Enzataurin achieved encouraging clinical results in clinical Phase II trials of DLBCL-induced therapy, but did not achieve the desired results in Phase III maintenance therapy trials Through detailed analysis of clinical data, soyuan biopharmaceuticalfound found that one of the subgroups of patients after taking Enzataurin, their non-progressive survival significantly improved new drugs proven safe and effective in some patients by clinical II, Phase III trials, and biomarkers that predict the efficacy of the drug in residual clinical samples were found in the remaining clinical samples By using these newly discovered biomarkers as an accompanying diagnosis to screen patients, the bio-biowas can re-conduct clinical trials in sensitive patients, optimizing efficacy, safety and tolerability, improving the success rate of new drugs, and ultimately developing a number of innovative drugs at a lower cost and in a faster time metabiotic program to identify biomarkers associated with the efficacy of the drug through the company's pioneering reverse all-gene scanning technology and to screen patients with the biomarkers found to conduct new clinical trials for drug-sensitive patients to improve the drug's efficacy and lay the groundwork for the drug's eventual market approval "This agreement with Lilly marks a new milestone in the development of soyuan "The smooth cooperation means that Soyuan can use its own technological advantages to explore a new path for Chinese pharmaceutical companies to develop a class of innovative drugs with international advanced level in a fast and better way." "Because of its original reverse all-gene scanning technology, Soyuan Bio is positioning itself as a "personalized innovative pharmaceutical company with a unique business model" and using it to bring the most advanced personalized treatments to the country today "The high-quality clinical data and a large number of clinical samples from Lilly for Enzataurin's research and development contribute to the development of biomarkers related to Soyuan," said Dr Rowan, General Manager of Soyuan Biology The reverse all-gene scanning platform of Soyuan Bio has matured, and with the discovery of biomarkers in a short time, combined with data and data already available from Lilly, we hope to launch a new clinical trial of personalized treatment DLBCL to verify the efficacy of our biomarkers and Enzataurin in screened patients it is understood that, in addition to this lymphoma project, Soyuan Bio already has a clinical advanced lung cancer innovation drug, and is currently in negotiations with a number of international pharmaceutical companies to acquire similar clinical effects in the unscreened patients in the efficacy of phase III innovative drugs, and will use its biomarker platform technology in the same way for individual innovation drug research and development (Source: Science daily)
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