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Stock Code: 688176
Stock Name: Yahong Pharmaceuticals
Announcement No.: 2024-059
Jiangsu Yahong Pharmaceutical Technology Co., Ltd.
Voluntary Disclosure Regarding the Presentation of Data from the APL-1702 International Multicenter Phase III Clinical Trial at the 2024 International Photodynamic Therapy & Photodiagnosis Conference
The board of directors of the company guarantees that the content of this announcement contains no false records, misleading statements, or material omissions, and assumes legal responsibility for the truthfulness, accuracy, and completeness of its contents.
Key Highlights:
- Recently, the results of the international multicenter phase III clinical trial of Jiangsu Yahong Pharmaceutical Technology Co., Ltd.'s (hereinafter referred to as “the company”) product APL-1702 for the treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) were presented at the 2024 International Photodynamic Therapy & Photodiagnosis Conference (PDT&PD). The data on the efficacy in reducing the histopathological grade of cervical precancerous lesions was shared in an oral presentation at the conference.
- The marketing application for the product has been accepted by the National Medical Products Administration (NMPA) but still needs to go through review, clinical trial site inspections, production site inspections, and approval. Whether the product will be successfully marketed and when it will be available remains uncertain. There is also some uncertainty about whether the product will achieve its commercial goals after approval. The acceptance of this product’s marketing application will not have a significant impact on the company’s short-term performance. Investors are advised to make cautious decisions and be aware of potential investment risks. The company will fulfill its information disclosure obligations in a timely manner according to relevant regulations regarding the development of the project.
1. Product Information and Disease Area Overview
APL-1702 is a photodynamic therapy product that combines a drug and device, used as a localized, non-surgical treatment for HSIL. The product consists of APL-1702 ointment (active ingredient: 5% HAL·HCl) and the APL-1702 CL7 device (a cervical photodynamic treatment cup for use inside the vagina, with an LED red light therapy source).
According to the 2020 Global Cancer Statistics, there were 604,127 new cases of cervical cancer worldwide in 2020, with 341,831 deaths, ranking it as the fourth most common malignancy in women. Cervical cancer is the second most common malignant tumor in women in China. The 2024 National Cancer Report issued by the National Cancer Center indicates that in 2022, there were 150,700 new cases of cervical cancer and 55,700 deaths in China.
The primary cause of cervical cancer is persistent infection with the Human Papillomavirus (HPV), which can lead to precancerous lesions of the cervix. Approximately 25% of HSIL patients may progress to invasive cervical cancer within 10 years. In China, there are approximately 2.1 million HSIL patients aged 18 and over, a number that is expected to continue growing over the next decade. Initial market research shows that by 2023, over 700,000 patients had been diagnosed with HSIL nationwide through tissue pathology (colposcopic biopsy), and the number of patients diagnosed with LSIL is three times higher than those diagnosed with HSIL, with about 10% of patients requiring active management.
Despite government efforts to promote HPV vaccination, the vaccination rate for girls aged 9-14 remains in the single digits. Although it is expected to increase rapidly in the coming years, the impact on HSIL incidence will not be seen for another 10 years. Additionally, the protection rate of the HPV vaccine for women over 26 is limited (20%-40%), meaning the vaccine’s impact on the number of HSIL patients will remain limited in the next 10 years. According to third-party research by IQVIA, with increased cervical cancer screening, the number of confirmed HSIL cases is expected to reach 1 million by 2030, and the number of LSIL cases will exceed 3 million.
Currently, the treatment of high-grade cervical lesions is primarily through invasive cervical excision surgery. The Expert Consensus on Cervical Cancer Screening and Management of Abnormal Findings in China recommends surgical treatment for non-pregnant HSIL patients, with the most common procedures being cervical excision surgeries such as LEEP and cold knife conization (CKC). However, there is significant unmet clinical demand among women with precancerous cervical lesions for non-surgical therapies.
For years, progress in drug treatment for cervical precancerous lesions has been slow, with no non-surgical products confirmed to have clinical efficacy for HSIL through phase III trials being approved globally.
APL-1702 is expected to redefine the treatment goal for cervical precancerous lesions, shifting from a one-time surgical approach to focusing on long-term disease management, aiming for the optimal balance between treatment risk and benefit.
2. Conference Data Presentation
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 in treating HSIL. The trial was led by Academician Lang Jinghe of Peking Union Medical College Hospital, with 402 eligible patients from China, Germany, the Netherlands, and other countries randomly enrolled in the study. The completed statistical analysis shows that the study has achieved its primary efficacy endpoint with good safety.
The primary endpoint of the study was the proportion of responders at six months after the first treatment. Responders were defined as those whose cervical epithelial histopathology results reverted to normal or who downgraded to LSIL while clearing HPV.
From November 2020 to July 2022, 402 eligible patients were randomized and enrolled in the study. The response rate in the APL-1702 group was 89.4% higher than the placebo group (41.1% vs. 21.7%, p = 0.0001), showing significant efficacy.
Additionally, at six months post-treatment, the pathological remission rate (defined as the proportion of subjects whose histopathology reverted to CIN1 or normal) in the APL-1702 group was significantly higher than in the placebo group (47.0% vs. 29.5%, p < 0.01). Subgroup analysis based on HPV status revealed that APL-1702 had a better remission rate than the placebo group across HPV-negative, HPV16-positive, and HPV18/other-positive subgroups. Six months after the first treatment, the histopathological improvement rate (defined as CIN2 reverting to CIN1 or normal, and CIN3 reverting to CIN2, CIN1, or normal) was 54% for the APL-1702 group and 36% for the placebo group (p < 0.01). Of these, 38% of the APL-1702 group’s subjects had their cervical tissue return to normal, compared to 19% in the placebo group. Moreover, 79.1% of subjects in the APL-1702 group had no disease progression, compared to 67.4% in the placebo group (p = 0.0171).
Study Results Summary:
| Item |
APL-1702 Group |
Placebo Group |
P Value |
| Histopathological Remission Rate |
47.0% |
29.5% |
p < 0.01 |
| HPV Negative |
64.7% |
25.0% |
/ |
| HPV16 Positive |
37% |
25.4% |
/ |
| HPV18/Other Positive |
60.0% |
36% |
/ |
| Histopathological Improvement Rate |
54% |
36% |
p < 0.01 |
| Return to Normal Tissue |
38% |
19% |
/ |
| No Disease Progression Rate |
79.1% |
67.4% |
p = 0.0171 |
These results were presented at the 2024 International Photodynamic Therapy & Photodiagnosis Conference in the form of an oral report.
3. Risk Warning
Pharmaceutical products are characterized by high technology, high risk, and high added value. The research and development process, from product development and clinical trial applications to production, is long and subject to various factors, including technology, approvals, and policies. There are uncertainties regarding the progress and outcomes of clinical trials, future market competition, and whether the product will ultimately support a market application. The release of these clinical trial data will not have a significant impact on the company’s short-term performance. Investors are advised to be aware of potential investment risks.
The company will actively promote the research and development of this project and strictly fulfill its information disclosure obligations in accordance with relevant regulations, disclosing updates on the Shanghai Stock Exchange website and designated media.
Jiangsu Yahong Pharmaceutical Technology Co., Ltd.
Board of Directors
September 18, 2024
江苏亚虹医药科技股份有限公司自愿披露关于在2024年国际光动力与光诊断大会上发布APL-1702国际多中心Ⅲ期临床试验相关数据的公告 (asieris.cn)
