Photocure Partner Asieris announces First Patient treated in Hexvix Real-world Evidence study in Hainan, China
Oslo, Norway, December 12, 2022: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has communicated today on the first patient treatment which took place in a Hexvix® real-world evidence clinical study at Hainan General Hospital Lecheng Branch.
Real-world evidence (RWE) plays an increasingly important role in clinical development and regulatory application. The present RWE study will provide complementary data in addition to the Hexvix Phase III randomized controlled study for which patient enrollment also began last month in China (see release from November 4: https://photocure.com/news/photocure-partner-asieris-announces-1st-patient-enrolled-in-hexvix-phase-iii-trial-in-china-4392430). 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 Asieris’ announcement of the first patient dosed in the RWE study, Dr. Zhuang Chengfeng, Chief Operating Officer of Asieris Pharmaceuticals, states Asieris’ expectations of real-world evidence data accelerating the approval process of Hexvix in China: "Thanks to the policies introduced by the Hainan Provincial Government and the Bo'ao Lecheng Pilot Zone of International Medical Tourism, we successfully completed dosing of Hexvix for the first patient in our real-world clinical study. By taking advantage of the beneficial policy associated with real-world studies in Hainan, we hope to accelerate the approval of the innovative product Hexvix in China to meet the growing medical needs of bladder cancer patients."
Read Asieris’ full media release here: https://asieris.com/asierisbladder-cancer-diagnostic-drug-hexvix-completed-dosing-of-first-patient-in-real-world-clinical-study/