Asieris Announces Positive Phase III Bridging Trial of Hexvix®, a Diagnostic Drug for Bladder Cancer

SHANGHAI,Aug. 11,2023 --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 that the Phase III bridging clinical trial of Hexvix®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 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.

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®in mainland China and Taiwan.

"The clinical data of Hexvix® further confirms its outstanding clinical performance. We sincerely thank all the researchers and participants for their dedication and efforts in advancing this clinical study." said Dr. Linda Wu,Chief Development Officer of Asieris,"This marks a significant milestone in our company's comprehensive efforts to create an integrated diagnostic and therapeutic solution in the field of bladder cancer. We will continue to vigorously advance the follow-up work,aiming to achieve commercialization and benefit more bladder cancer patients as soon as possible."

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.