Asieris Unveiled Results of Its Phase III Clinical Study for APL-1706, an Imaging Drug for Diagnosis or Surgery of Bladder Cancer, at the SIU 2023 Congress

Shanghai, China, October 12,2023– 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 unveiled its phase III clinical trial data for APL-1706 (Hexvix®), an imaging drug used for the diagnosis or surgery of bladder cancer, at the 43rd  Congress of the Société Internationale d’Urologie (SIU) in 2023. The study confirmed that, in the Chinese patient, APL-1706 in combination with blue light cystoscopy (BLC) outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability.

The study included a total of 158 patients, with 37 patients in the training cases group. Six patients were randomly assigned to the standard WLC control group, and one patient dropped out, leaving 114 patients in the full analysis set (FAS). Among the 97 patients diagnosed with Ta, T1, and CIS (mFAS), compared to standard WLC, a total of 42 patients (43.3%) detected one or more additional bladder cancer lesions through the combination of APL-1706 and blue light cystoscopy (p<0.0001). Among the 114 patients, 13 patients (11.4% ,13/114) had CIS lesions, and among these, 11 patients (84.6%, 11/13) had additional CIS lesions detected under BLC that were not found under WLC. The detection rates for PUNLMP, CIS, Ta, T1, and T2-T4 tumor lesions in the BLC group were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while in the WLC group, they were NA, 42.1%, 76.1%, 91.2%, and 100%, respectively. The false positive rates for BLC and WLC were 23.2% and 16.0%, respectively. A total of 95 patients reported 200 adverse events, all of which were mild to moderate, with 95.5% of them unrelated to APL-1706. There were no serious adverse events reported.

Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, “APL-1706 is currently the only approved optical imaging for assisting in the diagnosis and surgery of bladder cancer worldwide. The data presented at the SIU conference further validates the tremendous clinical value of APL-1706. We believe that this innovative drug will bring significant benefits to bladder cancer patients in the local market. We will actively advance the related regulatory submissions in China, expediting its market entry to benefit more patients as soon as possible.”

In January 2021, Asieris entered into a license agreement with Photocure ASA (Photocure, OSE:PHO), a bladder cancer specialty company based in Oslo, Norway, and obtained the exclusive registration and commercialization rights of Hexvix® in mainland China and Taiwan.

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.