Shanghai, China, September 17, 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 HSIL(High-Grade Squamous Intraepithelial Lesion) product APL-1702 has been accepted for oral presentation by the International Photodynamic Therapy & Photodiagnosis (PDT&PD) update conference in Germany in September 2024, focusing on the efficacy data related to the regression of the histological grade of cervical precancerous lesions.
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.
Additionally, the study found that at 6 months after the first treatment, the regression rate (RR) in the APL-1702 group was significantly higher than that in the placebo (PBO) group (47.0% vs. 29.5%, p < 0.01). Subgroup analysis data showed that in all HPV-negative, HPV16-positive, and HPV18/others-positive subgroups, the APL-1702 group demonstrated favorable rates of histological regression comparing to PBO (64.7% vs. 25.0%, 37% vs. 25.4%, 60.0% vs. 36%). At 6 months after first treatment, improvement rate (IR) of the two groups were 54% and 36%, respectively (p ＜ 0.01). Among them, 38% of the subjects had cervical tissue restored to normal tissue at 6 months in APL-1702 group, while only 19% were in PBO group. In the APL-1702 group, 79.1% of subjects had no disease progression, while in the placebo group, that is 67.4% (p = 0.0171). Further information includes:
| Subgroup Analysis | APL-1702 Group | PBO Group | P Value | |
| regression Rate | Total Patients | 47.0% | 29.5% | p < 0.01 |
| HPV-Negative | 64.7% | 25.0% | / | |
| HPV16-Positive | 37% | 25.4% | / | |
| HPV18/others-Positive | 60.0% | 36% | / | |
| Improvement Rate | 54% | 36% | p < 0.01 | |
| Cervical Tissue Restored to Normal Tissue | 38% | 19% | / | |
| No Disease Progression | 79.1% | 67.4% | p = 0.0171 | |
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.
