Asieris(SH:688176) Shang Hai Zheng Quan Bao·2025-10-10 18:56Core Viewpoint - Jiangsu Yahon Pharmaceutical Technology Co., Ltd. announced the publication of clinical trial results for its product APL-1702 in the international journal "Med," which is a flagship journal in the medical field under Cell Press [2][8]. Group 1: Product and Disease Information - APL-1702 is a photodynamic therapy product that combines drug and device for the treatment of High-Grade Squamous Intraepithelial Lesion (HSIL) [3]. - According to the 2020 Global Cancer Statistics, there were 604,127 new cases of cervical cancer globally, with 341,831 deaths, making it the fourth most common malignancy among women [3]. - In China, cervical cancer ranks second among female malignancies, with 150,700 new cases and 55,700 deaths reported in 2022 [3]. Group 2: Clinical Trial Results - The international multicenter phase III clinical trial was randomized, double-blind, and placebo-controlled, involving 402 eligible patients from multiple countries [6]. - The primary efficacy endpoint was achieved, with the APL-1702 group showing an 89.4% higher response rate compared to the placebo group (41.1% vs. 21.7%, p = 0.0001) [6]. - The pathological regression rate for the APL-1702 group was significantly higher than that of the placebo group (47.0% vs. 29.5%, p < 0.001) [7]. - APL-1702 demonstrated a 103.90% increase in the clearance rate of high-risk HPV types 16/18 compared to the placebo group (31.4% vs. 15.4%, p = 0.011) [7]. - The overall response rate for the APL-1702 group reached 44.4% at the 12-month follow-up [7]. Group 3: Market Potential and Clinical Need - There is a significant unmet clinical need for non-surgical therapies for cervical precancerous lesions, as current treatments primarily involve invasive cervical excision [5]. - The treatment landscape for cervical precancerous lesions has seen slow progress, with no non-surgical products approved for HSIL based on phase III clinical trial efficacy [5]. - The number of diagnosed HSIL patients in China is expected to reach 1 million by 2030, indicating a growing market potential for APL-1702 [4].