Cispoly Secures Investment from Shenzhen Capital Group to Accelerate Regulatory Approval of Gynecological Cancer Early Screening and Diagnosis Products

Recently, women’s health technology company Cispoly announced that it has secured exclusive investment from Shenzhen Capital Group. The proceeds will be used to accelerate the regulatory approval of its early screening and diagnostic products for gynecological cancers. It is reported thatThis round constitutes cispoly's Pre-A2 financing, with an investment amount of tens of millions of RMB., the company previously completed a Pre-A financing round of nearly RMB 100 million in June this year, led by Shanlan Capital.

Since its inception, cispoly has been dedicated to the early screening and diagnosis of gynecological tumors and is currently conducting a multicenter prospective study on cervical cancer across China. On July 3, 2021, cispoly shared its findings at the 6th Xiangya Forum on Hot Topics in Gynecology.Research Progress in Cervical Cancer Screening Based on Methylation Detection (Trade Name: Hegongkang) (Abbreviated as METHY3, Clinical Trial Registration Number: NCT04646954), and the unblinding of clinical data from nearly 10,000 cases across multiple centers.

It is reported that this study was led by Peking Union Medical College Hospital, co-organized by cispoly, and participated in by 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 Inner Mongolia Autonomous Region People’s Hospital, among others. This isChina's First Multicenter Prospective Study on Gene Methylation in Gynecological Tumors, and 30,000 participants have been enrolled in the cervical cancer screening program to date.

Through a multicenter prospective cohort study, cispoly unveiled the clinical performance data of Hegongkang, including sensitivity, specificity, and positive/negative predictive values:Building on a negative predictive value (NPV) of 0.996 (compared to 1 for HPV testing and 0.997 for TCT), the Hegongkang assay demonstrated a significantly superior positive predictive value (PPV) compared to current methodologies—three times higher than that of HPV testing and twice as high as that of TCT. In data analyses involving the triage of outpatient patients to colposcopy or surgery, with comparable NPVs (Hegongkang: 0.901; TCT: 0.890; HPV: 0.917), the PPV of Hegongkang (0.635) was significantly superior to those of HPV testing (0.203) and TCT (0.256).。

It can be seen that cispoly's independently developedHegongkang demonstrates sensitivity comparable to HPV testing for cervical squamous cell carcinoma, superior detection rates for cervical adenocarcinoma, and exceptionally high specificity. It can replace HPV testing or serve as a critical, objective adjunctive test or triage method.。

It is reported that there are currently no mature DNA methylation products for cervical lesion screening, and large-scale clinical studies comparing them with existing screening strategies are lacking. The multicenter, large-cohort prospective study on cervical lesion screening based on HeGongKang, initiated by cispoly, has validated the advantages of DNA methylation as a screening approach, providing stronger evidence to support its market launch as a method for cervical cancer screening.

It is worth mentioning that cispoly has also carried outEndometrial Cancer Early Screening Productmulticenter cohort study and regulatory submission work.

Regarding the investment in cispoly,Dr. Zhou Yi, General Manager of Shenzhen Capital Group’s Healthcare Industry Fund“Endorsing this view, we remain bullish on the ‘golden track’ of early cancer screening. High-quality early cancer screening products possess significant clinical value and social importance, representing a niche area poised for future policy support. Cispoly has established a clear strategic focus on gynecologic oncology, making in-depth arrangements for the early screening and diagnosis of cervical, endometrial, and ovarian cancers, thereby filling gaps in the industry. Dr. Liu Pei’s team has completed retrospective and prospective studies on their early screening products within a short timeframe, while prospective multi-center cohort studies are progressing in an orderly and rapid manner. We firmly believe that, leveraging its profound technological expertise and strong execution capabilities, Cispoly will drive further product innovation and lead the development of the early screening industry for gynecologic cancers.”

Shenzhen Capital Group Co., Ltd. is committed to its mission of discovering and empowering great enterprises, striving to be a discoverer and cultivator of innovative value. Since its establishment in 1999, SCGC has managed total assets exceeding RMB 400 billion, invested in more than 1,000 innovative high-tech enterprises, among which 192 have achieved public listings. Its portfolio spans industries such as information technology, internet, biotechnology/health, new energy/energy conservation and environmental protection, new materials, intelligent manufacturing, and consumer goods/modern services, covering the full life cycle of enterprises.

Established in 2018, the SCGC Hongtu Medical and Health Industry Fund is the first medical and health industry fund launched by Shenzhen Capital Group (SCGC) as part of its “specialization” strategy. The fund focuses on identifying high-quality investment targets with strong innovation capabilities and significant growth potential, thereby driving industrial development. Within less than three years, the fund has invested in outstanding enterprises such as Akeso, YHLO, Medcaptain, Union Medical, Ant Medical, Yuanhua Intelligence, Kangsheng Medical, Shanghai Zhimeng, GenFleet Therapeutics, and Leadcom.

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 detection products for cervical cancer, ovarian cancer, and endometrial cancer, leveraging its proprietary technologies and patented biomarkers, thereby filling a gap in this field.

cispoly, established in 2020, is located in the Daxing Biomedical Base and boasts a 900-square-meter GMP-certified production facility and an 800-square-meter R&D laboratory. 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.