JH Biotech Announces Interim Results of China's Largest Multicenter Clinical Study on Endometrial Cancer Screening

The EndoMethy project is the first and largest multicenter clinical trial on endometrial cancer screening in China., led by Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences as the coordinating research institution, with technical support from cispoly, and conducted in collaboration with 14 clinical centers (listed in alphabetical order by pinyin initials): Peking University International Hospital, Obstetrics and Gynecology Hospital of Fudan University, Gansu Provincial Maternity and Child-care Hospital, Hainan General Hospital, Cangzhou Central Hospital in Hebei Province, The Second Hospital of Jilin University, Nanjing Maternity and Child Health Care Hospital, Inner Mongolia Autonomous Region People's Hospital, Shaanxi Provincial People's Hospital, Shenzhen Luohu District People's Hospital, The Second Affiliated Hospital of Soochow University, Beijing Tiantan Hospital of Capital Medical University, and The Third Xiangya Hospital of Central South University.Aims to identify and establish minimally invasive biomarkers for early screening of endometrial cancer, explore more objective, reproducible, and highly specific detection methods for early-stage endometrial cancer or even precancerous lesions, fill the current gap in endometrial cancer screening strategies, and provide objective clinical guidance.

Currently, there is no large-scale clinical validation for endometrial cancer worldwide. This multicenter clinical study will provide global women with results from hospital-based screening of endometrial cancer in Chinese women, along with future recommendations for endometrial cancer screening.The project was launched on November 6, 2021, and has progressed for three months. To date, 2,805 samples have been enrolled. The pathological types of the enrolled samples include benign endometrial lesions, endometrial intraepithelial neoplasia (EIN), endometrial cancer, and others (predominantly leiomyomas, with a small number of ovarian cancers or other malignancies).This multicenter clinical study, under Professor Zhu Lan’s emphasis on the meticulous collection of clinical specimens and rigorous verification of results, has elevated domestic multicenter clinical research to a more refined and systematic international standard.

1. Preliminary multicenter clinical data show that, withHeke'an Cis-Endom™ detects cervical exfoliated cells with a sensitivity of 86% and a specificity of 96% for endometrial cancer., significantly outperforming the current clinical guidelines for endometrial cancer screening based on symptoms and imaging, thereby filling the gap in effective methods for early screening and diagnosis of endometrial cancer.Note: Heke’an Cis-Endom™ can serve as an independent, non-invasive screening marker for endometrial cancer in patients with suspected endometrial cancer or in outpatient women.

2、Single-center data show that the sensitivity of C1 and C4 gene methylation is 85.7%, with a specificity of 94.5%, both demonstrating high clinical performance., and demonstrates higher specificity compared to current methodologies.

3、The clinical performance of C1&C4 gene methylation was significantly superior to that of postmenopausal status (endometrial thickness ≥5 mm), CA125, and BMI (≥25).

4. Current results showCis-Endom™ by HekouanDetection of endometrial cancer with precision using non-invasive methodologies, andReducing the risk of missed endometrial cancer cases during hysteroscopy, minimizing the need for repeated hysteroscopic examinations, and achieving significant benefits in early cancer screening。