On October 10, 2025, Yahong Pharma (Stock Code: 688176.SH), a global innovative drug company focused on urogenital tumors and women's health, announced that the results of its international multicenter Phase III clinical trial of APL-1702 for the treatment of high-grade squamous intraepithelial lesion (HSIL) of the cervix have been published online in Med, a journal under Cell Press. Med, founded by Cell Press, is a flagship medical journal launched by Cell Press following Cell and Chem. It is a TOP journal in Journal Citation Reports (JCR) Q1 and a dual first-class journal of the Chinese Academy of Sciences.

According to the 2020 Global Cancer Statistics Report, the number of new cases of cervical cancer in women worldwide in 2020 was 604,127, and the number of deaths was 341,831, ranking fourth among female malignant tumors. The incidence rate of cervical cancer ranks second among female malignant tumors in China. According to the 2024 National Cancer Report released by the National Cancer Center, there were 150,700 new cases of cervical cancer in China in 2022, and 55,700 deaths from cervical cancer.

The APRICITY study is a prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of APL-1702 for cervical high-grade squamous intraepithelial lesion (HSIL). The study was led by Academician Lang Jinghe from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, as the principal investigator, and enrolled 402 eligible patients from multiple countries including China, Germany, and the Netherlands. Completed statistical analysis results show that the study achieved its primary efficacy endpoint with a favorable safety profile.

In previous Phase I/II studies in Germany and Norway, APL-1702 demonstrated high response rates of 71%-95% in patients with CIN2 and CIN3. Subsequently, results from the global Phase III study in China and Europe showed that at 6 months after the first treatment, the histopathological regression rate (i.e., 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 control group (47.0% vs. 29.5%, p < 0.001). At 6 months after the first treatment, the histopathological improvement rates (defined as regression from CIN2 to CIN1 or normal, or from CIN3 to CIN2, CIN1 or normal) were 53.8% in the APL-1702 group and 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 in the APL-1702 group was 103.90% higher than that in the control group (31.4% vs. 15.4%, p = 0.011). In stratified analyses by age, HPV status, region, and lesion coverage area, the APL-1702 group also showed better response rates, histopathological regression rates, and HPV clearance rates than the control group. There was no difference in the incidence of treatment-related adverse events (TRAEs) between the APL-1702 group and the placebo group, indicating good safety.

Furthermore, this study found that APL-1702 also demonstrated stable long-term efficacy at the extended endpoint: at 12 months, the overall response rate in the APL-1702 group reached 44.4%.

APL-1702 is currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company team will continue to maintain active communication with the CDE to complete the new drug approval process as soon as possible.