GOOD NEWS丨Yeedozencom assisted Laiduo in the approval of ursodeoxycholic acid capsule for marketing

Congratulations to Shaoxing Laiduo Technology Co., Ltd. (hereinafter referred to as " Laiduo ") on the approval of Ursodeoxycholic Acid Capsule and thanks to Laido for their trust in Yeedozencom!

About UDCA

Ursodeoxycholic acid (UDCA) is a kind of hydrophilic cholic acid that has been widely used since the 1950s in the treatment of diseases such as cholelithiasis and cholestasis. Although it is present in human bile, the concentration is very low, not exceeding about 4% of the total bile acids. Among carnivores, it has been found to be highest in the bile of black bears and is the main component of cholic acid in bile. The first use of UDCA by herbalists and traditional Chinese medicine practitioners for the treatment of liver diseases dates back more than a thousand years. Before it was discovered to have the ability to dissolve gallstones, its main use was as a liver tonic.

About Ursodeoxycholic Acid Capsule

Ursodeoxycholic Acid Capsules (trade name: Ursofalk®) was approved for marketing in Germany and China in 1978 and 1994, respectively, and are now mainly used for the treatment of cholesterol gallbladder stones, cholestatic liver disease, and cholestatic reflux gastritis in which the gallbladder has normal systolic function and the stones can be penetrated by X-rays.

Yeedozencom provided full-process services in terms of trial protocol design, project management, clinical monitoring, quality assurance and summary report in undertaking the BE trial of Ursodeoxycholic Acid Capsules. After obtaining ethical approval on 30 July 2021, the project initiated the fasting trial and postprandial trial in September and November of the same year respectively, and completed all clinical trials in early March 2022, and completed the delivery of application materials in April 2022. As for the questions raised by the CDE about the various aspects of the clinical trial, we actively cooperated with them to give replies and submit supplementary materials, and finally assisted Laiduo in getting the approval of Ursodeoxycholic Acid Capsule for marketing.