On June 5, SDA announced that Donepezil hydrochloride tablet (10mg), commissioned by Zhejiang Hisun Pharmaceutical Co., LTD. (Changsha Central Hospital is in charge of clinical research), was approved for the first time in China. This is also the fourth variety approved for production by Duzheng Biotechnology since July 22 (currently the company has 22 projects pending approval).
Donepezil hydrochloride is a second-generation specific reversible central acetylcholinesterase (AChE) inhibitor, suitable for the treatment of mild, moderate or severe Alzheimer's disease. In 2018, Donepezil achieved revenue of 854 million yuan in public hospitals. According to the data, CDE has received 22 applications for Donepezil hydrochloride so far, and the competition is very fierce.
The clinical study of Donepezil hydrochloride project is difficult to be carried out due to the serious clinical adverse reactions and the high difficulty of subject management. Company r & D team in-depth study of the project literature, through the reasonable judgment of the existing data, successful pre-test design, accurate estimation of the number of formal test cases, for the sponsor greatly save costs. At the same time, the company's "one-stop" platform, from recruitment, clinical, analysis, data, each link seamless, the whole process of information management mode, to ensure that the study of high quality and efficient completion!
The company will continue to uphold the mission of "let the people take the rest assured medicine", "customer-centered" service concept, to provide clinical research "one-stop" service for domestic and foreign pharmaceutical enterprises, help partners out of the tight encircling, curve overtaking!