Juhew Biotech Announces Interim Unblinding of Multicenter Cervical Cancer Methylation Screening Study with 10,000+ Participants and Submits IPO Prospectus

On July 3, 2021, the 6th Xiangya Forum on Hot Topics in Gynecology and the 2021 National Symposium on Innovation in Fertility Preservation and Restoration were grandly held in Changsha, Hunan Province. Hosted by the Department of Gynecology of the Third Xiangya Hospital of Central South University, the conference brought together top obstetrics and gynecology experts from across China. Participants engaged in extensive and in-depth discussions on key and challenging issues in gynecology, including early screening and diagnosis of gynecologic tumors such as cervical cancer, ovarian cancer, and endometrial cancer; the latest advances in their diagnosis and treatment; the management and recurrence of endometriosis; robotic gynecologic surgery and its complications; and issues related to the application of HPV vaccines in adult women. The conference also provided incisive explanations of the latest perspectives and progress in the diagnosis and treatment of gynecologic diseases.

Shenzhen CisPolyHe Biotechnology Co., Ltd. (hereinafter referred to as “CisPolyHe”) shared insights on methylation detection-based(Brand Name: Hegongkang)Research Progress in Cervical Cancer Screening (abbreviated as METHY3, ClinicalTrials.gov Identifier: NCT04646954), a MulticenterUnblinding of Nearly 10,000 Clinical Cases。

Special Invitation to Academician Lang Jinghe and Professor Xu Dabao for Hosting and Commentary

Led by Peking Union Medical College Hospital and co-organized by cispoly, this study involves participating institutions including Peking University International Hospital, the Sixth and Seventh Medical Centers of the Chinese PLA General Hospital, Cangzhou Central Hospital in Hebei Province, and the People’s Hospital of Inner Mongolia Autonomous Region. It is the first multicenter prospective study on gynecological tumors based on gene methylation in China. The enrolled population consists of outpatients undergoing cervical cancer screening, with 30,000 participants recruited to date. This multicenter prospective cohort study evaluates the clinical performance metrics of Hegongkang, including clinical sensitivity, specificity, and positive/negative predictive values. In particular, clinical sensitivity and negative predictive value are critical performance indicators for early disease screening products, which must achieve high levels to be approved for market launch as screening tools. The number of subjects enrolled in the screening trial must meet statistical requirements.

Currently, cytology and HPV testing are the commonly used methods for cervical cancer screening. However, cytology has low sensitivity, while HPV testing has low specificity. Combining both tests can improve the sensitivity of cytology but does not enhance the specificity of HPV testing. To address the limitations of current cervical cancer screening strategies, this prospective clinical trial aims to resolve the following issues:

1. To identify a more objective, reproducible, and highly specific detection method that better complements HPV testing in distinguishing infections likely to progress to high-grade lesions

2. This test can overcome the limitations of cytological testing, provide highly objective clinical diagnosis and treatment plans, and is even expected to replace cytological testing.

3. This method may become a routine follow-up protocol for cervical cancer

4. There are currently no mature DNA methylation products available for cervical lesion screening, and large-scale clinical studies comparing them with current screening strategies are lacking. Therefore, prospective multicenter cohort studies are required to validate the advantages of Hegongkang as a screening approach.

Cispoly implemented a rigorous three-step strategy for Hegongkang, comprising retrospective studies, prospective studies, and multicenter cohort studies. Cispoly has completed the retrospective and prospective studies, and this meeting unveiled the data from the multicenter cohort study involving nearly 10,000 cases. With a negative predictive value (NPV) of 0.996 (compared to 1.000 for HPV testing and 0.997 for TCT), Hegongkang demonstrated a positive predictive value (PPV) significantly superior to current methodologies—three times higher than that of HPV testing and twice as high as that of TCT. In the analysis of outpatient triage to colposcopy or surgery, while maintaining comparable NPVs (Hegongkang: 0.901, TCT: 0.890, HPV: 0.917), Hegongkang’s PPV (0.635) was significantly superior to that of HPV testing (0.203) and TCT (0.256).

Through this multicenter cohort study, the participating experts have drawn the following preliminary conclusions:

1. Hegongkang exhibits extremely high specificity, while its detection sensitivity in cervical squamous cell carcinoma is comparable to that of HPV testing methods,Cervical adenocarcinoma detection rate is superior to HPV testing

2. Hegongkang Demonstrates Clinical Value in Routine Follow-up

3. Hegongkang testing is expected to replace cytology testing, and may even replace HPV testing or serve as an important objective supplementary or triage test for HPV.

HeGongKang screening for patients at risk of cervical cancer can avoid overdiagnosis, overtreatment, and excessive patient anxiety, thereby further reducing the socioeconomic burden. Therefore, HeGongKang is poised to replace cytology testing and may even replace HPV testing, or serve as an important objective adjunct or triage tool for HPV detection.

Further studies of this multicenter cohort include:

1. Follow-up of patients with negative TCT and HPV results but positive Hegongkang test results

2. Follow-up with Hegongkang testing after cervical cancer surgery

3. Monitoring for residual disease after conization or hysterectomy

4. Follow-up of patients who tested positive for Hegongkang but did not undergo surgery, despite having other abnormalities (such as abnormal TCT or HPV results)

Currently, there are no mature DNA methylation products available for cervical lesion screening, and there is a lack of large-scale clinical studies comparing them with current screening strategies. It is understood that the vast majority of cancer screening products currently on the market in China have only completed retrospective studies. However, the results of retrospective studies can only serve as references during product development. To obtain marketing approval and become a screening-grade product suitable for use in the general population, multi-center, large-cohort prospective trials are required. This multi-center, large-cohort prospective study validating the use of DNA methylation for cervical lesion screening has demonstrated the advantages of DNA methylation as a screening approach, providing stronger evidence to support its market entry as a method for cervical cancer screening.

Shenzhen Cispoly Biotechnology Co., Ltd. is a high-tech enterprise dedicated to innovative biotechnology and women's health. Committed to becoming a leader in the early diagnosis of gynecological tumors, Cispoly has developed early diagnostic products for cervical cancer, ovarian cancer, and endometrial cancer, leveraging its proprietary technologies and patented biomarkers, thereby filling a gap in this field.

Founded in 2020, Cispoly boasts a 900-square-meter GMP-compliant production facility and an 800-square-meter R&D laboratory. Located in the Daxing Biomedical Industry Base, the company focuses on the research and development, manufacturing, and sales of early diagnostic products for gynecological cancers as well as related automated testing equipment. Cispoly holds intellectual property rights for its leading methylation detection technology and multiple biomarkers, and is committed to exploring further possibilities in the future.