Photocure ASA announced that its partner Asieris Pharmaceuticals has communicated that it has completed patient enrollment for the Hexvix® Phase III bridging trial. The objective of the multicenter Phase III trial is to support regulatory approval of Hexvix in Mainland China. The bridging trial is intended to confirm results from prior clinical trials regarding the safety and detection benefits of blue light cystoscopy (BLC®) with Hexvix compared to white light cystoscopy in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population.

The clinical trial follows the same protocols for registration studies in countries where Hexvix already has market authorization. This study is being led by Peking Union Medical College Hospital and the Chinese Academy of Medical Sciences. Professor Li Hanzhong, head of the Department of Surgery at Peking Union Medical College Hospital, is serving as the Principal Investigator, leading a team of top experts in the field of bladder cancer in China to carry out this study.

Asieris plans to file a new drug application with the National Medical Products Administration (NMPA) in the future, pending clinical trial progress and meaningful data.