Asieris to Unveil First-ever Results of the Phase III Clinical Study for APL-1706, an Imaging Drug for Diagnosis or Surgery of Bladder Cancer, at the 2023 SIU Annual Meeting

Shanghai, China, October 7, 2023 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, has announced that the results of Phase III clinical study of APL-1706 (Hexvix®) for bladder cancer diagnosis or surgery has been selected for Late-breaking Abstract (LBA) at the 2023 Annual Meeting of the Society of International Urology (SIU). The clinical study data will be presented for the first time in the form of an Oral ePoster.

The study is a prospective, self-controlled, multicenter Phase Ⅲ trial aimed at comparing the detection rate and safety of Hexvix® and blue light cystoscopy (BLC) versus white light cystoscopy (WLC) in patients with non-muscle invasive bladder cancer (NMIBC). Primary endpoint was set for additional detection rate of one or more lesions including tumors with stages of carcinoma in situ (CIS), Ta, and T1 by APL-1706 BLC compared to WLC. The study reached its primary endpoint in August 2023.

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.