Asieris Pharmaceuticals announced that the Phase III bridging clinical trial of Hexvix(R) for bladder cancer diagnosis met the primary endpoint. 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. The study is a prospective, self-controlled, multicenter Phase trial aimed at investigating the additional detection rate and safety of Hexvix(R) and blue light cystoscopy (BLC) versus white light cystoscopy in patients with non-muscle invasive bladder cancer (NMIBC) including tumors with stage carcinoma in situ (CIS), Ta, and T1.

A total of 158 patients were enrolled in this study. The completed statistical analysis results indicate that the study has been successfully conducted and has achieved the primary endpoint. The results of the study will be presented at upcoming academic conferences.

In January 2021, Asieris entered into a license agreement with Photocure ASA (Photocure, OSE:PHO), a bladder cancer specialty company based in Oslo, Norway, to obtain the exclusive registration and commercialization rights of Hexvix(R) in mainland China and Taiwan.