Ahong Pharmaceutical (688176.SH): APL-1702 international multicenter Phase III clinical trial has reached the primary efficacy endpoint with good safety.

Yahong Pharmaceuticals (688176.SH) announced that the results of the prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial of the company's product APL-1702 for the treatment of High-Grade Squamous Intraepithelial Lesion (HSIL) have been selected for presentation at the 2024 International Papillomavirus Conference (IPVC) and will be published in the form of a poster presentation, including data analysis on HPV clearance rates for different HPV types and different follow-up times. This study is a prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial aimed at evaluating the efficacy and safety of APL-1702 for treating HSIL. The study is led by Academician Lang Jinghe of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, with 402 eligible patients from China, Germany, the Netherlands, and other countries randomized and enrolled in the study. The completed statistical analysis results show that the study has met its primary efficacy endpoint and has shown good safety profile. The primary endpoint of the study is the proportion of responders at 6 months after the initial treatment. Response is defined as the cervical epithelial tissue pathology returning to normal, or the pathology converting to Low-Grade Squamous Intraepithelial Lesion (LSIL) along with HPV clearance. From November 2020 to July 2022, 402 eligible subjects were randomized and enrolled in the study. The primary efficacy endpoint showed that the response rate in the APL-1702 group was significantly higher than in the placebo group (41.1% vs. 21.7%, p=0.0001), demonstrating a significant efficacy of APL-1702. Additionally, the study found that the overall HPV clearance rate and HPV16/18 clearance rate in the APL-1702 group at 6 months were significantly better than those in the placebo group. At 3 months and 6 months, the HPV positivity rates in different subgroups of the APL-1702 group were lower than in the placebo group, indicating a faster HPV clearance rate in the APL-1702 group, which was still ongoing at 12 months post-treatment.