Completion of First Subject Enrollment in Phase III Clinical Trial of lutetium Lu 177 dotatate

Company News

The first subject in the phase III clinical trial of lutetium Lu 177 dotatate, the first targeted therapeutic radiopharmaceutical developed independently by Sinotau, was successfully randomized on September 22, 2022 at the First Medical Center of the Chinese PLA General Hospital which is the group leader unit, and successfully completed dosing on September 24, marking another milestone for this project.


About Lutetium Lu 177 Dotatate

Lutetium Lu 177 dotatate, the first nuclide therapeutic drug developed independently and put into clinical research by Sinotau , is also the first PRRT therapeutic drug in China, opening up a precedent of nuclide therapeutic drug in China. Its future launch will help prolong the progression-free survival of patients and address the treatment needs of domestic neuroendocrine tumor patients. At the same time, it will further strengthen Sinotau' s industry leadership in the field of nuclide therapeutic drug. This study adopts a multi-center, randomized, open, parallel-controlled clinical trial design, aiming to compare the safety and efficacy of lutetium Lu 177 dotatate with long-acting oxytetracycline in patients with gastroenteropancreatic neuroendocrine tumors, and to provide a basis for the approval of it’s marketing in China. The study was approved by the National Medical Products Administration (NMPA) for clinical trials in March 2022, and after nearly half a year's effort, it is now confirmed to be conducted in 22 centers nationwide. The Chinese PLA General Hospital which is the group leader unit, has successfully started and completed the first subject enrollment, and other sub-centers have also started the process such as the establishment of each center in parallel.