Shanghai, China, November 12, 2024 β Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, announced that the international multicenter phase III clinical study data of its non-surgical treatment for cervical High-Grade Squamous Intraepithelial Lesion (HSIL) product APL-1702 has been published by the 2024 International Papillomavirus Conference (IPVC) as a poster, focusing on the analysis data of HPV clearance rate for different HPV types and different follow-up times.
This study is a prospective, randomized, double blind, placebo controlled, multicenter phase β ’ clinical study, which has reached its primary efficacy endpoint and exhibited good safety.
Furthermore, this study found that the baseline HPV clearance rate and the HPV16/18 clearance rate in the APL-1702 group at the 6th month were significantly better than those in the placebo group, as detailed below:
| Subgroup Analysis | APL-1702 Group | PBO Group | P Value |
| Baseline HPV Clearance | 29.4% | 18.9% | 0.04 |
| HPV16/18-Positive Clearance Rate | 31.4% | 15.4% | 0.01 |
At 3 and 6months, the positive rates of different subgroups of HPV in the APL-1702 group were lower than those in the placebo group, suggesting that the APL-1702 group had a faster rate of HPV clearance and that the HPV clearance persisted at 12 months after merely 1-2 treatments, as shown in the below:
The new drug application for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024. The review process is progressing smoothly.
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 patientβs 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.
