Asieris Releases Phase III Clinical Study and Real-World Research Data for APL-1706, a Bladder Cancer Diagnosis and Management Drug, at the 2024 ASCO-GU

SHANGHAI, Jan. 29, 2024 /PRNewswire/ — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the release of Phase III clinical trial data and real-world study data for APL-1706 (compound name: Hexaminolevulinate Hydrochloride for Intravesical Solution), a bladder cancer diagnosis and management drug , at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in the form of a poster presentation (Abstract No. 593).

The study included 158 patients enrolled in a randomized controlled trial (RCT), with 37 patients in the training group and 6 patients randomly assigned to the non-Blue Light Cystoscopy (BLC) group, one patient withdrew. A total of 114 patients were in the full analysis set. Nineteen patients were included in the real-world study (RWS). Among patients diagnosed with Ta, T1, or CIS, 42 out of 97 patients (43.3%) in the RCT and 4 out of 12 patients (33.3%) in the RWS had at least one lesion detected by BLC but not by white light cystoscopy (WLC) (p<0.0001). In the RCT, 11 out of 114 (9.6%) CIS patients, and in the RWS, 1 out of 14 (7.1%) CIS patients had additional CIS lesions detected under BLC that were not found by WLC. The BLC detection rates for PUNLMP, CIS, Ta, T1, and T2 ~ T4 tumors in the RCT were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while the WLC detection rates were NA, 42.1%, 76.1%, 91.2%, and 100%. In the RWS, the BLC detection rates for PUNLMP, CIS, Ta, T1, and T2 ~ T4 tumors were NA, 100%, 100%, 100%, and the WLC detection rates were NA, 50%, 81%, 100%, and 100%. Both the RCT and RWS confirmed that APL-1706 combined with BLC demonstrated superior detection of bladder cancer in the Chinese population compared to WLC, especially in the CIS population, with good tolerability.

The new drug application (NDA) for APL-1706 was accepted by the National Medical Products Administration (NMPA) in November 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.

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