Controversies

Clinical-study anticancer drug entered market; sales staff forged documents to obtain it

Akeso's cadonilimab, labeled "for clinical research use only," was found to have entered the market for patient use. The Chongqing Medical Products Administration reported that Akeso sales staff forged hospital research project approvals, ethics approvals, and prescriptions to obtain the drug; two patients received 59 and 78 vials respectively. The involved clinic, doctor, and pharmacy were penalized, and clues on Akeso project management were transferred to drug regulatory authorities. The case exposed loopholes in clinical drug management for innovative drugs, and the stock price suffered.