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.
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 phase III 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.
Read Asieris’ full media release here: https://asieris.com/hexvix-a-diagnostic-drug-for-bladder-cancer-of-asieris-has-completed-the-phase-iii-bridging-trial-enrollment/
Source: Photocure: The Bladder Cancer Company, July 6, 2023, Photocure Partner Asieris announces completion of enrollment for Hexvix Phase III clinical trial in China, [Press Release] https://www.photocure.com/news/photocure-partner-asieris-announces-completion-of-enrollment-for-hexvix-phase-iii-clinical-trial-in-china-4583554