March 11, 2021, the State Food and Drug Administration announced that Zhejiang Hisun Pharmaceutical Co., LTD. Apixaban tablets successfully approved! The clinical study of this variety is undertaken by Duzheng Biological analysis and testing Center (duzheng Biological analysis and testing center). The inspection, analysis of testing units free inspection, fully affirmed the state food and Drug Administration is biological accreditation.
Apixaban is a novel oral anticoagulant, mainly used in adult patients undergoing elective hip or knee replacement to prevent venous thromboembolic events.
Although the domestic market size of Apixaban is still small, in recent years, the sales volume of Apixaban has grown rapidly in Chinese urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) and Chinese urban entity pharmacies. According to Data from Milanet, the sales volume of Apixaban, the terminal of urban entity drugstore in China, was 8.09 million yuan in 2019, with a year-on-year growth of 2596.89%. The sales volume is expected to be 23.89 million yuan in 2020, with a year-on-year growth of 195.35%.
As a "one-stop" service platform for clinical research, Duzheng Biological has helped many pharmaceutical companies successfully obtain approval. After July 22, the company carried out more than 200 BE/PK studies, among which pantoprazole sodium enteric-coated tablets were approved first and second in China. The first donepezil hydrochloride tablet approved in China; Solina succinate new national third approved; Escitalopram oxalate was first approved in Hunan. Outstanding clinical research achievements in innovative drugs, the company has completed more than 10 early clinical research projects, projects covering a number of professional fields.