Hexvix®, A Diagnostic Drug for Bladder Cancer of Asieris, Completed the First Patient Dose in Phase III Trial

SHANGHAI,Nov. 7,2022 -- Asieris Pharmaceuticals,a global biopharmaceutical company specializing in the discovery and development of innovative drugs for the treatment of genitourinary tumors and other major diseases,announced that Hexvix®,a drug used for the diagnosis for bladder cancer,completed the first patient dose in Phase III bridging trial.

The study is a prospective,self-controlled,multicenter Phase Ⅲ trial aimed at investigating the additional detection rate and safety of Hexvix® and blue light cystoscopy (BLC) versus white light cystoscopy in patients with non-muscle invasive bladder cancer (NMIBC) (CIS,Ta,T1).

This study will be 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,will serve as the Principal Investigator to lead a team of top experts in the field of bladder cancer in China to carry out this study. The company plans to file a new drug application with the NMPA in the future pending clinical trial progress and meaningful data.

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® in mainland China and Taiwan.

In December 2021,Hexvix® was put into pilot use in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province and the first prescription in China was issued at Hainan General Hospital,with the first patient operated successfully. It received approval from the National Medical Products Administration (NMPA) for phase III clinical trials in the first quarter of 2022 and was included in the real-world clinical data pilot program.

About Asieris

Asieris Pharmaceuticals(688176.SH),founded in March 2010,is a global biopharma company specializing in discovering,developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D,manufacturing and commercialization in our areas of focus,as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.

The company has been developing its proprietary R&D platform and core technologies,exploring new mechanisms of action,and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development,Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.

Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships,while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs,and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

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