On May 14, the State Food and Drug Administration announced that Tiandi Hengyi Pharmaceutical Co., LTD. Citrate tofa cloth tablets were approved successfully!
The clinical study of this variety was completed by Duzheng Biology "One-stop" (nanning Second People's Hospital, a cooperative co-construction unit, was responsible for the clinical study, Xutong Intelligence was responsible for recruitment, Xianling Medicine was responsible for SMO service, and weight ke data execution data management and statistical analysis). The verification, clinical and analytical tests were exempted.
Tofacitinibis an oral small-molecule inhibitor of JAK1/JAK3 that blocks signal transduction ofa variety of inflammatory cytokines. It has a good therapeutic effect on rheumatoid arthritis, ulcerative colitis, active psoriatic arthritis (PsA), moderate and severe active ulcerative colitis (UC) and other related diseases. According to statistics, there are about 23.7 million patients with RA (rheumatoid arthritis) worldwide, and about 5 million patients in China. According to the 28 joint disease activity Score (DAS28), a national multi-center cross-sectional study showed that the remission rate of RA patients in China was 8.6% and the disability rate was 50.3%. There is a big gap between The remission rate of RA in China and western countries. After entering the belt quantity purchase, patients will be given new drug choice!
Duzheng Biology has assisted many enterprises to obtain approval successfully with efficient recruitment and management of subjects, rich clinical resources, strict quality management and risk control system, and perfect information system guarantee. In the future, Duzheng Bio will continue to provide high-quality and professional "one-stop" service for pharmaceutical and medical device clinical research for global biomedical enterprises