Asieris Pharmaceuticals says it has completed the first patient dose in its phase III bridging trial for Hexvix, a drug used for the diagnosis of bladder cancer.
Asieris Pharmaceuticals is a global biopharmaceutical company specializing in the discovery and development of drugs for the treatment of genitourinary tumors and other major diseases.
The study is a prospective, self-controlled, multicenter phase Ⅲ trial aimed at investigating the additional detection rate and safety of Hexvix and blue light cystoscopy (BLC) versus white light cystoscopy in patients with non-muscle invasive bladder cancer (NMIBC).
This study will be led by Peking Union Medical College Hospital and the Chinese Academy of Medical Sciences. Li Hanzhong, head of the Department of Surgery at Peking Union Medical College Hospital, will serve as the principal investigator to carry out this study.
License agreement between Asieris Pharmaceuticals and Photocure ASA
The company plans to file a new drug application with the National Medical Products Administration (NMPA) in the future pending clinical trial progress and meaningful data.
In January 2021, Asieris Pharmaceuticals entered into a license agreement with Photocure ASA, a bladder cancer specialty company based in Oslo, Norway, to obtain the exclusive registration and commercialization rights of Hexvix in China and Taiwan.
In December 2021, Hexvix was put into pilot use in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province and the first prescription in China was issued at Hainan General Hospital, with the first patient operated on successfully. It received approval from the NMPA for phase III clinical trials in the first quarter of 2022 and was included in the real-world clinical data pilot program.