Beyond Colorectal Cancer Screening: Dr. Zou Hongzhi on Conligmed's Post-Approval Innovations and Multi-Cancer Detection Pipeline

VCBeat (WeChat ID: vcbeat) has learned that on November 20, 2018, the human SDC2 gene methylation detection kit (fluorescent PCR method), a Class III in vitro diagnostic reagent independently developed and manufactured by Creative Biosciences (Guangzhou) Co., Ltd. under the brand name “Chang’an Xin,” passed the review of the National Medical Products Administration (NMPA) and officially obtained the Class III medical device registration certificate.

As previously reported by VCBeat in the article “Developing a Powerful Colorectal Cancer Screening Tool Using Stool DNA: This Company Secured Hundreds of Millions in Investment Over Three Years,” Creative Biosciences was founded in 2015 by Dr. Zou Hongzhi, who returned to China from the United States. It is a biomedical technology company focused on developing molecular diagnostic products in the field of tumor screening and diagnosis.

Unlike foreign products, Creative Biosciences’ core product, “Colosafe,” is primarily based on independently developed PCR patent technology with high detection performance, used for the qualitative in vitro detection of SDC2 gene methylation in human stool samples. This product is China’s first approved test kit for the auxiliary diagnosis of colorectal cancer, utilizing a fecal DNA methylation biomarker identified specifically within the Chinese population.

Professor Wang Jianping, Honorary Chairman of the Colorectal Surgery Group of the Chinese Medical Association and Head of the “Chang’an Xin” Project Team, stated: “The incidence of colorectal cancer in China has been rising year by year with the improvement of people’s living standards. In developed regions of China, it is now the second most common malignant tumor and a major disease threatening the health of the Chinese population. However, colorectal cancer progresses relatively slowly, allowing for curative treatment or even prevention through early detection.”

Compared with other colorectal cancer screening methods, stool-based genetic testing is non-invasive and easy to perform. The stool-based genetic testing product led by Dr. Zou Hongzhi during his tenure in the United States has received FDA approval and has been incorporated into major U.S. colorectal cancer screening guidelines, becoming one of the primary methods for colorectal cancer screening in the United States.

Although foreign products have gained widespread recognition, Dr. Zou did not simply replicate them in China. Instead, he reselected biomarkers and streamlined and optimized the product to align with the physiological characteristics of the Chinese population. (Colorectal cancer in Chinese patients is more commonly located in the left colon, whereas it is evenly distributed between the left and right colon in Americans. Even if clinical manifestations show only subtle differences, there may be underlying genetic distinctions.)

“Chang’an Xin” initiated a multicenter clinical trial in July 2017, using colonoscopy and/or pathological examination as the gold standard for comparison. Clinical validation conducted across three trial centers—the Sixth Affiliated Hospital of Sun Yat-sen University, Nanfang Hospital of Southern Medical University, and Shandong Cancer Hospital—on 1,213 valid cases demonstrated that the test kit could consistently detect 84.22% of colorectal cancer cases at a specificity of 97.85%. The detection rate for clinically curable Stage I/II colorectal cancer reached 86.35%, with a kappa value of 0.85.

Zou Hongzhi told reporters that Chang’an Xin has fully reached medical-grade standards and will next be promoted as an auxiliary diagnostic product in major hospitals.

“Chang’an Xin” secured approximately RMB 100 million in financing across three rounds prior to obtaining regulatory approval. Zou Hongzhi revealed to VCBeat that Creative Biosciences will undertake large-scale fundraising to further deepen its research and vigorously promote its products.

In terms of product promotion, Creative Biosciences adopts a hybrid model combining direct sales and agency partnerships, with a primary focus on direct sales. This approach enables its sales team to engage deeply with relevant hospital departments, such as gastroenterology, proctology, general surgery, and gastrointestinal medicine. Additionally, the company collaborates with health examination centers to further expand product reach.

Zou Hongzhi told reporters that Creative Biosciences has currently divided China into four regions—East, South, West, and North—with sales directors based in Beijing, Shanghai, Guangzhou, and Chengdu, respectively, to lead teams in promoting its products. It is reported that Creative Biosciences currently has only around 30 sales personnel, a number expected to expand to 100–200 by the end of next year, with the sales force projected to exceed 300 within three years.

Zou Hongzhi stated that even before the product received regulatory approval, more than 100 hospitals had expressed interest in purchasing it, and it is expected to enter over 100 hospitals within the next few months. Sales of the Chang’an Xin product are projected to exceed 200,000 units next year.

In terms of product R&D, Zou Hongzhi stated that Creative Biosciences would continue to optimize the R&D of “ColoClear,” with “ColoClear 2.0” expected to be launched next year. Additionally, Creative Biosciences is currently developing detection methods for bladder cancer and lung cancer. VCBeat has learned that the company is attempting to extract DNA from urine and sputum samples, and its lung cancer product is expected to enter the clinical stage next year.

Regarding future plans, Zou Hongzhi stated that Creative Biosciences aims to list on the STAR Market within three years and on the ChiNext Board within five years. Furthermore, over the next three years, the company will remain focused on the development and commercialization of kit-based products for cancer screening and diagnosis. Subsequently, while maintaining its core business unchanged, Creative Biosciences will further expand its operations across the upstream and downstream segments of the industry.

It is reported that Creative Biosciences (Guangzhou) Co., Ltd. is currently recruiting extensively. In addition to its sales team, the company is also hiring for its executive leadership team. Interested parties may contact the reporter via WeChat (ID: Shirley_CaiAx) for complimentary matchmaking services.