Shanghai, China, October 22, 2026 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, announced that two clinical study data sets on its product APL-1702 in cervical intraepithelial neoplasia grade 2 (CIN2) have been selected for the 38th International Papillomavirus Conference (IPVC) 2026 and will be presented as an e-poster and a poster, respectively. One is the AEGIS study, a multicenter, prospective clinical study designed to explore the efficacy and safety of different APL-1702 treatment frequencies and intervals in patients with CIN2. Interim results will be presented at the conference, providing preliminary evidence for further optimization of the treatment regimen. The other is a post hoc exploratory analysis of the APRICITY study, which explored the relationship between baseline HPV genotype and age and response to APL-1702, aiming to identify subgroups with higher response and provide evidence for understanding differences in treatment response across patient characteristics. Interim AEGIS results showed a week-24 histological regression rate of 93.3% (14/15) in the Q3W × 3 group. The APRICITY post hoc exploratory analysis showed a month-6 histological regression rate of 72.2% (39/54) in the APL-1702 group among patients with baseline non-HPV16/18 infection, and 80% (20/25) among patients aged <30 years with non-HPV16/18 infection.
The AEGIS study is an investigator-initiated, multicenter, prospective clinical study designed to explore the efficacy and safety of different treatment frequencies and treatment intervals of APL-1702 in patients with CIN2. The interim results of this study will be presented at this conference, providing preliminary evidence for further optimization of the APL-1702 treatment regimen.
This study enrolled a total of 118 high-risk HPV (hr-HPV)-positive patients with CIN2 confirmed by colposcopic biopsy. Patients were divided into six groups according to treatment interval (once every 1 week, every 2 weeks, or every 3 weeks) and number of treatments (3 or 6). The primary endpoint was the histopathological regression rate at week 24 after the first treatment, defined as histopathological results changing from CIN2 to normal or CIN1; the histological regression rate at week 36, hr-HPV clearance rate, and safety during the study period were also assessed. As of September 16, 2026, based on the available assessed data, the histological regression rates at week 24 and week 36 were 81.6% (80/98) and 91.5% (43/47), respectively, and the hr-HPV clearance rates were 39.6% (40/101) and 57.6% (38/66), respectively. Among them, the group treated once every 3 weeks for a total of 3 treatments (Q3W × 3) had histological regression rates of 93.3% (14/15) at week 24 and 100% (4/4) at week 36. In terms of safety, the incidence of treatment-related adverse events was 32.2% (38/118). All adverse events during treatment were mild or moderate; no permanent discontinuation due to adverse events was observed, and no new safety signals were identified. The data disclosed herein are interim results; final study results await complete follow-up and further analysis.
The post hoc exploratory analysis of the APRICITY study was based on CIN2 patient data from the APRICITY study and explored the relationship between baseline HPV genotype, age, and lesion area and histological response after APL-1702 treatment. The analysis endpoint was the histological regression rate at 6 months after treatment. Among the CIN2 patients included in the analysis, the histological regression rates at month 6 in the CEVIRA group and the placebo group were 57.5% (69/120) and 30.6% (19/62), respectively. By baseline HPV genotype, in the non-HPV16/18 infection subgroup, the histological regression rates in the CEVIRA group and the placebo group were 72.2% (39/54) and 34.5% (10/29), respectively. Among CIN2 patients aged <30 years with non-HPV16/18 infection, the histological regression rate in the APL-1702 group was 80% (20/25). The above results are from a post hoc exploratory analysis, and the related findings require further study for validation.
APL-1702 (trade name: CEVIRA®) was approved by China’s National Medical Products Administration (NMPA) in March 2026. It is the world’s first and currently only approved non-invasive therapeutic product for the CIN2 indication [1], filling the clinical gap in this treatment area. In February 2026, the European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for CEVIRA® for the treatment of patients with high-grade squamous intraepithelial lesions (HSIL).
Ms. Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals, said: “CEVIRA® is a first-in-class photodynamic therapy product that treats cervical precancerous lesions through a non-surgical drug-device combination approach. The data presented at the IPVC conference further validate the highly promising clinical profile of CEVIRA®. We believe that this innovative drug will bring greater benefits to patients with cervical precancerous lesions. We will actively advance related research and look forward to benefiting more patients.”
[1] Insight Database
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 women’s health. 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.
Through proprietary R&D and strategic collaborations, the company is committed to developing first-in-class drugs and other innovative technologies and products that address significant unmet medical needs, building a robust portfolio spanning from disease diagnosis to treatment within its focused therapeutic areas. Driven by patient needs, we are comprehensively advancing Commercialization 2.0 to improve the accessibility and affordability of innovative products, thereby benefiting more patients in China and globally.