Photocure ASA announced that its partner Asieris Pharmaceuticals has communicated that the Hexvix Phase III bridging trial in China has successfully met its primary research endpoint. The objective of this 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 (WLC) 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. A total of 158 patients were enrolled in this study. The completed statistical analysis results indicate that the study was successful and has achieved the primary research endpoint, which was defined as; the proportion of patients who have at least one tumor found by blue light but not by white light cystoscopy.

The results of the study will be submitted to the Chinese National Medical Products Administration (NMPA) for a new drug application (NDA) in the coming months. Asieris Pharmaceuticals is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. In January 2021, Asieris entered into a license agreement with Photocure ASA to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan.

In December 2021, 2021, Hexvix obtained initial clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province, when the first patient received blue light cystoscopy with Hexvix at the Hainan General Hospital. The clinical trial obtained approval from the NMPA in the first quarter of 2022 and Hexvix was subsequently included in the real-world clinical data pilot program.