The R & D and industrialization project of the original new drug eprazole of Lizhu group won the first prize of Guangdong science and technology progress

The results of the research on desion of solafeni were published by ornix pharmaceutical company, a subsidiary of Bayer and Amgen, which announced that the positive data of the critical phase III desion test of solafeni (dogimer) had been published in the lancet recently These data support the FDA's approval in November 2013 for the treatment of refractory local recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) patients with radioiodine (RAI) Sorafenib has also been submitted to the European Drug Administration (EMA) for approval of this indication In November 2013, sorafenib was awarded the rare disease drug qualification by the European Commission for the treatment of follicular and papillary thyroid cancer "As the first phase III study to be reported in patients with Rai - refractory differentiated thyroid cancer, these positive results are important progress for patients with this disease who have no standard treatment options at present." According to Martin Schlumberger, M.D of staf roussey Institute (villerev, France) and co lead researcher of decisio n experiment In patients with refractory (RAI refractory) differentiated thyroid cancer (DTC) treated with radioiodine, sorafenib significantly prolonged progression free survival compared with placebo Based on the results of the study, dorgime was approved for Rai - refractory DTC in the United States; meanwhile, it submitted an application in the European Union (Yiyao) iprazole industrialization project won the first prize of provincial science and technology progress award at the just held 2013 Guangdong science and technology award conference It is understood that the R & D and industrialization project of liprazole, the original new drug of Lizhu group, selects the molecular entity with the strongest activity from more than 10000 compounds, adopts patent technology to synthesize, online monitoring production, establishes strict central control index and national quality standard, solves the problem of drug stability with targeted release technology, and is the first in China to fully complete the pharmaceutical generation and characteristics Special toxicity study: independently designed and implemented phase I-IV clinical trials and genotype analysis of all phase III 500 cases Zero defect was successfully listed through the on-site verification of the State Administration Lizhu group, together with the United States and South Korea, signed the agreement of "eprazole global pharmacovigilance alliance" to reevaluate the safety of 4000 patients after being put on the market Through the research of gastric pH real-time monitoring technology and metabolism in vivo, it was found that eprazole has quick effect, long action time, and the efficacy is 4 times stronger than that of similar drugs without individual difference It has become the first-line drug for the treatment of acid diseases (Liu Xibin)