Hexvix®, A Diagnostic Drug for Bladder Cancer of Asieris has Completed the Phase III bridging trial Enrollment

SHANGHAI,July 6,2023 -- Asieris Pharmaceuticals (688176),a global biopharma company specializing in discovering,developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases,announced the completion of patient enrollment for its Phase III bridging clinical trial of Hexvix®,a drug used for the diagnosis of bladder cancer.

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) including tumors with stage carcinoma in situ (CIS),Ta,and T1.

This study is 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,serves 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 will closely track the subsequent progress of this clinical trial.

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.

"Completing patient enrollment for the Phase III bridging clinical trial of Hexvix®marks a significant milestone for Asieris Pharmaceuticals." said Dr. Linda Wu,Chief Development Officer of Asieris," We are thrilled to have reached this stage in the development of a drug that has the potential to revolutionize the diagnosis of bladder cancer. Our goal is to provide healthcare professionals with a more effective and reliable way for patient with bladder cancer."

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 to preserve patient's dignity. 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.