Juhe Bio Launches China's First Prospective Multicenter Study on DNA Methylation for Gynecological Cancer Early Screening
In recent years, early cancer screening has become a focal point for multiple stakeholders. During the 2021 Two Sessions, Li Weimin, President of West China Hospital of Sichuan University and a deputy to the National People’s Congress (NPC), proposed including low-dose spiral CT for lung cancer screening in the national medical insurance reimbursement coverage. Gu Jin, President of Peking University Shougang Hospital and also an NPC deputy, suggested formulating a National Cancer Control Action Plan and linking key cancer prevention and control indicators with local government performance evaluations.
In the industry, numerous Chinese enterprises and clinical practitioners are also making significant contributions to the cause of early cancer screening and diagnosis. On March 6, 2021,"A Prospective Multicenter Cohort Study on DNA Methylation for Cervical Lesion Screening"Officially launched in Beijing. Led by Peking Union Medical College Hospital, this study involves participation from Peking University Third Hospital, Peking University International Hospital, Peking University Cancer 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, with Shenzhen Shunshi Juhe Biotechnology Co., Ltd. (hereinafter referred to as “Juhe Bio”) serving as a co-organizer.
This study isChina's First Multicenter Prospective Study on Gene Methylation in Gynecologic Tumors, with strong research evidence, rigorous design, and minimal bias; the enrolled population consisted of outpatients undergoing cervical cancer screening.To date, 12,000 cases have been enrolled, with a projected cumulative total of 20,000 cases for the prospective study.
Early screening and diagnosis of gynecological tumors are effective measures to reduce the incidence and mortality of gynecological cancers. Gene methylation, as an independent biomarker for early tumor screening, holds significant application value. It is foreseeable that this study will greatly promote the development of the early screening and diagnosis industry for gynecological tumors in China.
The registration of cancer early screening products requires rigorous retrospective and prospective studies, in which the results of retrospective trials serve only as a reference during the product development process.To achieve market approval as a screening-grade product for use in the general population, it is necessary to complete prospective trials involving large cohorts across multiple centers.
Conducting multicenter prospective studies is a major challenge for the cancer early screening industry. Such studies for cancer early screening products involve large-scale cohorts, extended follow-up periods, and high costs, imposing stringent demands on companies’ cash reserves and financing capabilities. For example, GRAIL’s research initiatives have enrolled at least several thousand participants, with its STRIVE study reaching an enrollment scale of hundreds of thousands. These studies also require long-term follow-up of participants, necessitating substantial investments of both time and capital.
The substantial investment of time and capital has deterred many companies focused on early cancer screening from undertaking multicenter prospective studies. It is understood that the vast majority of cancer screening products currently marketed in China have only completed retrospective studies.
Juhe Bio places great emphasis on multicenter prospective studies for its cancer early screening products and is actively advancing its strategic layout. Dr. Liu Pei, founder of Juhe Bio, stated: “Data from small-scale studies are highly prone to bias in real-world applications; therefore, cancer early screening products require thorough validation in real-world settings.”
Juhe Biotechnology adopts“Retrospective Study–Prospective Study–Multicenter Cohort Study”A Three-Step Strategy. Within less than a year of its establishment, Juhe Biology has completed both retrospective and prospective studies on products for the early screening and diagnosis of gynecological tumors. Meanwhile, a prospective, multicenter cohort study on the use of DNA methylation for cervical lesion screening has also been launched. Dr. Liu Pei stated, “We expect to complete the prospective, multicenter cohort study this year, and we are confident that the final data will provide sufficient evidence to promote the application of methylation detection technology in the early screening and diagnosis of gynecological tumors.”
Juhe Bio is dedicated to empowering the women's health management market with innovative biotechnologies. Centered on proprietary technologies and patent-protected biomarkers, the company is strategically positioning itself in the field of early screening and diagnosis of gynecological tumors over the short to medium term.Dr. Liu Pei, the founder, previously conducted research in molecular genetics at the Chinese Academy of Sciences and served as General Manager of Sinomedic. He spearheaded the regulatory approval processes for multiple innovative Class III medical devices, demonstrating profound insights into industry innovation trends, market dynamics, and clinical needs.
According to Dr. Liu Pei, there is substantial demand in China for early screening and diagnosis of gynecological tumors. The latest global cancer statistics for 2020 indicate that in China, there were 420,000 new cases of breast cancer, 110,000 new cases of cervical cancer, 80,000 new cases of endometrial cancer, and 60,000 new cases of ovarian cancer among women. The steadily rising incidence of these cancers has imposed a significant disease burden on Chinese women.
At present, screening methods for gynecological tumors such as cervical cancer, endometrial cancer, and ovarian cancer all have certain limitations. Taking cervical cancer as an example, ThinPrep Cytologic Test (TCT) and HPV testing are currently the most commonly used screening methods. Although TCT is relatively low-cost, it is highly susceptible to subjective human factors, which can easily lead to misdiagnosis and missed diagnosis, resulting in poor accuracy. HPV testing offers high sensitivity; however, since most HPV infections are transient, the specificity of HPV testing is relatively low. As for ovarian cancer and endometrial cancer, there is currently a lack of effective screening methods. There is an urgent need for new innovative biotechnologies to address the shortcomings of traditional screening methods or even fill existing gaps.
ctDNA methylation is closely associated with early tumorigenesis and exhibits cancer-type specificity, offering significant advantages in early cancer screening.Leveraging ctDNA methylation as its core technology, Juhe Bio has developed early screening and diagnostic products for cervical, ovarian, and endometrial cancers based on blood and exfoliated cervical cell samples. With user-friendly operation, affordable pricing at the hundred-yuan level, and superior performance, the company is driving improvements in the coverage and accessibility of gynecologic oncology screening in China.
Currently, Juhe Bio is advancing the research and development and regulatory registration of its related products. As women pay increasing attention to their own health, the female health market holds significant promise. In addition to its product line for early screening and diagnosis of gynecological tumors, Juhe Bio will establish more product pipelines related to women’s health, aiming to become a leading, technology-driven innovator in the female health market.