Shanghai, China, September 29, 2024 – 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 will be published by the 27th Chinese Society of Clinical Oncology (CSCO) as a poster, focusing on the analysis of different age subgroups regarding the six-month pathological regression rate and HPV clearance rate.
This study is a prospective, randomized, double blind, placebo controlled, multicenter phase Ⅲ clinical study, which has reached its primary efficacy endpoint and exhibited good safety.
Furthermore, the study results indicated that the pathological regression rate (defined as the proportion of subjects with a pathological regression to CIN1 or normal tissue) at the 6th month in different age subgroups, both the “≥20 and <30 years” subgroup and the “≥30 and <40 years” subgroup showed an increase of 15% to 20% in the pathological regression rate in the APL-1702 group compared to the placebo (PBO) control group. No cervical cancer events were reported, suggesting a significant therapeutic potential of APL-1702 in the HSIL population aged 20 to 40 years. Further information includes:
| Subgroup Analysis | Age Group ≥20 and <30 | Age Group ≥30 and <40 | ||
| APL-1702 Group | PBO Group | APL-1702 Group | PBO Group | |
| Pathological Regression Rate | 52.8% | 37.7% | 37.7% | 19.2% |
Regarding HPV clearance rate, in the “≥20 and <30 years” age group, the APL-1702 group showed enhancements in the overall HPV clearance rate, HPV16-positive clearance rate, and HPV16/18-positive clearance rate compared to the placebo control group. The patients’ number in the “<20 years” and “≥40 years” age groups were limited, thus the results in these age groups requires validation study with a larger sample size. Overall, APL-1702 not only facilitates the regression from HSIL to LSIL（Low-Grade Squamous Intraepithelial Lesion） but also demonstrates the ability to induce clearance of high-risk HPV infections. Further information includes:
| Subgroup Analysis | Age Group ≥20 and <30 | Age Group ≥30 and <40 | ||
| APL-1702 Group | PBO Group | APL-1702 Group | PBO Group | |
| HPV Clearance Rate | 33.6% | 24.6% | 20.6% | 10.4% |
| HPV16 Positive Clearance Rate | 37.7% | 20% | 23.0% | 3.8% |
| HPV16/18-Positive Clearance Rate | 37.6% | 18.2% | 22.2% | 3.4% |
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 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.
