Shanghai, China, October 10, 2025 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, 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 have been published online in Med, a flagship medical journal from Cell Press. As a top-tier journal, Med is ranked in the Q1 quadrant of Journal Citation Reports (JCR) and as a Top tier journal in the Chinese Academy of Sciences classification.
Cervical cancer ranks as the fourth most common cancer in women globally. According to the 2020 Global Cancer Statistics, there were approximately 604,127 new cases and 341,831 deaths worldwide. In China, it is the second most prevalent cancer among women, with the 2024 National Cancer Report indicating 150,700 new cases and 55,700 deaths in 2022.
The APRICITY study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. The study is led by Dr. Jinghe Lang, an academician at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. A total of 402 eligible patients from various countries including China, Germany, the Netherlands et al. The study met its primary endpoint, together with a robust safety profile.
Previous I/II studies in Germany and Norway showed high response rates of 71%–95% in patients with CIN2 and CIN3. Subsequent global Phase III results in China and Europe demonstrated that at 6 months after initial treatment, the pathological regression rate (histopathological response rate, defined as the proportion of subjects with histopathological regression to CIN1 or normal) was significantly higher in the APL-1702 group than in the placebo group (47.0% vs. 29.5%, p < 0.001). The histopathological improvement rate (defined as CIN2 regressing to CIN1 or normal, or CIN3 regressing to CIN2, CIN1, or normal) was 53.8% in the APL-1702 group versus 36.4% in the placebo group (p = 0.001). The high-risk HPV clearance rate was 28.0% in the APL-1702 group compared to 19.8% in the placebo group (p = 0.086). For the most carcinogenic HPV16/18 subtypes, the clearance rate increased by 103.90% in the APL-1702 group compared to the control group (31.4% vs. 15.4%, p = 0.011). Subgroup analyses by age, HPV status, region, and lesion area showed consistently better response, histopathological regression, and HPV clearance rates in the APL-1702 group. The incidence of Treatment-Related Adverse Events (TRAEs) for APL-1702 showed no difference compared to the placebo group, demonstrating a favorable safety profile.
Additionally, the study found that APL-1702 demonstrated sustained long-term efficacy at the extended endpoint, with an overall response rate of 44.4% at 12 months.
APL-1702 is currently regulatory review by the Center for Drug Evaluation (CDE). The company team will maintain proactive communication with the CDE to expedite the New Drug Application (NDA) review process.
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. To learn more, please visit https://asieris.com/ .