New drug 1.1 of enwaside Pharmaceutical Co., Ltd. is applied for production again

According to the information on the website of CFDA on December 9, the application and production of class 1.1 new drug etakalin hydrochloride raw materials and tablets of Jiangsu Enhua saide Pharmaceutical Co., Ltd., a subsidiary of Enhua pharmaceutical, was accepted It is worth mentioning that this is the second time that Enhua pharmaceutical has applied for the production approval document of etakalin hydrochloride Previously, after the application for production of this product, it was required to conduct additional clinical trials The company said that the application is to report again after the completion of the clinical trial From the process point of view, it will follow the new drug application process However, he also pointed out that since etakalin hydrochloride is a new drug of category 1.1, the company hopes that the product can enter the major special review channel, which can speed up the product review process Etakalin hydrochloride is a new generation of antihypertensive drug with independent intellectual property rights, which is used to treat pulmonary hypertension In 2001, Enhua Pharmaceutical Co., Ltd cooperated with Chinese Academy of Military Medical Sciences and Beijing sedvikang Research Institute to develop the drug, and completed clinical research in 2008 Later, because of the defects of the clinical trial scheme, etacalin hydrochloride was asked to do additional clinical trials in June 2010 According to information on CFDA website, at present, there is no domestic manufacturer of etakalin hydrochloride, and only Enhua pharmaceutical is applying for production According to the Research Report of Guojin securities, the antihypertensive effect of etakalin hydrochloride is good and lasts for a long time It has a clear protective effect on the brain and kidney damage caused by hypertension The adverse reactions of etakalin hydrochloride are only 5.1% and have a bright future Enhua Pharmaceutical Co., Ltd is a leading enterprise in the field of central nervous drugs in China Its leading products include three categories: anesthetics, psychotropic drugs and neurodrugs At present, the company has few high blood pressure products, and it is expected to establish a high blood pressure product line for promotion after the listing of etakalin hydrochloride.