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Original title: China’s first cancer screening product approved to target 120 million people at high risk of colorectal cancer in China
“Chang Weiqing lasted 7 years and invested more than US $ 100 million in research and development. The clinical trial enrolled 5,881 subjects and took 16 months to complete the registered clinical trial.” On November 25, the first certificate of early cancer detection in China was published. At the meeting, Zhu Yeqing, co-founder and CEO of Nuohui Health, introduced reporters from the 21st Century Business Herald.
Chang Weiqing is currently the only cancer early detection product approved by the National Medical Products Administration. It uses a combined FIT-DNA multi-target detection technology and is a non-invasive home-use colorectal cancer early detection test. , Designed for the genetic locus of the Chinese population, and obtained a series of nationally authorized clinical consensus recommendations, targeting 120 million populations at high risk of colorectal cancer in China.
The project leader of Clear-C, China’s first early cancer registration clinical trial, and lead investigator Professor Ding Kefeng, Vice Dean of the Second Affiliated Hospital of Zhejiang University School of Medicine and chief scientist of the 13th Five-Year National Plan for Specialized Cohort Research in Colorectal Cancer It is noted that “early detection and treatment are an important starting point for solving the burden of colorectal cancer diagnosis and treatment. The design of large-scale prospective trials of Clear C, close to the real application scenarios of detection, is conducive to early detection, has clear clinical importance and can greatly improve The effect of early treatment prevents the occurrence of bowel cancer. It is of great value for the detection of malignant tumors in China “.
It is worth noting that the 21st Century Business Herald reporter found that Zhu Yeqing mentioned “compliance” 10 times in a media interview. Zhu Yeqing believes that “compliance” is one of Nuohui Health’s strengths. Regarding the promotion of follow-up products, its business model will not change much before and after obtaining the certificate, and it will cooperate with more hospitals in better compliance. Promote the market in compliance with regulations. Zhu Yeqing also particularly emphasized that compliance is very important and that the product should be used for the type of people it is intended for.
7 year certificate
On November 9, the National Medical Products Administration (NMPA) approved the application for registration for Changweiqing®’s innovative Category 3 medical device, a colorectal cancer early detection product from Nuohui Health, and made it clear that Changweiqing® is suitable for its intended use “Screening for people aged 40 to 74 years at high risk of colorectal cancer.” Since research and development in 2013, Chang Weiqing has been certified after 7 years. The current price is 1996 yuan.
Chang Weiqing’s clinical trial is called the “Clear-C” registered clinical trial, with the Zhejiang University Medical College Second Affiliated Hospital as the main research unit, combined with the Jiangsu Provincial People’s Hospital, Hospital University of Fudan Tumor, Sichuan University West China Hospital and Zhengzhou The first affiliated hospital of the university and 8 other large-scale tertiary hospitals are jointly developed.
“Clear-C” was launched in September 2018 and lasted 16 months, with a total of 5,881 registered cases, and was carried out jointly by 8 large tertiary hospitals across the country, providing scientific evidence to verify the performance of the screening. Based on the results of the Clear-C clinical trial, the sensitivity of Changweiqing® for colorectal cancer is 95.5%; the sensitivity for advanced adenoma is 63.5% and the negative predictive value for colorectal cancer is as high as 99.6%.
According to Ding Kefeng, the clinical design for Cologuard, a similar product in the United States, was also used as a reference when discussing the clinical trial program.
Cologuard is a colorectal cancer screening product in the United States. It can be tested by three gene loci, one mutation, two methylation, and fecal occult blood detection. High-risk groups that originally need a colonoscopy can perform this test first. Ruled out, if the test is negative, then a colonoscopy is not necessary, which can significantly reduce the pressure on the accessibility of the colonoscopy.
“Compared to Cologuard, although it is not against each other, our results are not inferior to Cologuard’s research results. At the same time, among our secondary research objectives, its sensitivity to advanced adenoma and colorectal cancer is compared to fecal occult blood Very good improvement. ”Ding Kefeng said Chang Weiqing is based on Chinese methylation site, mutation site, etc. detection products.
Zhu Yeqing pointed out that in terms of application scenarios, Chang Weiqing will enter the hospital first after obtaining the certificate. For example, in the process of diagnosis and treatment, doctors may suggest the use of Chang Weiqing for high-risk groups for preliminary evaluation. However, Zhu Yeqing emphasized that in the future, detection technology hospitals will definitely not be the main stage, and more health problems will be carried out in the out-of-hospital setting. “Why choose a hospital in the first step? Because we want to have professional support first.”
“Chang Weiqing is a selection for high-risk groups. To comply with regulations, it cannot be promoted to sell to average risk groups, but it cannot restrict buying from them,” Zhu Yeqing added.
The “Expert Consensus on Early Diagnosis and Treatment of Colorectal Cancer in China” recommends that the general population between 40 and 74 years of age undergo colonoscopy every 5-10 years, and for high-risk groups, starting at 40 years or before the earliest diagnosis of colorectal cancer in the family. Starting 10 years before, the colonoscopy should be done every 5 years. If the compliance of tested subjects is poor, multi-target fecal DNA testing can be used for those who are initially positive or rejected.
Sayaji Saya
In the opinion of the industry, the application and promotion of early detection technology will better prevent cancer to some extent.
Professor Zhao Ping, president of the China Cancer Foundation, told the 21st Century Business Herald that the country has been advocating for early diagnosis and treatment of cancer, but in fact only 40% can. However, the rate of early diagnosis of colorectal cancer can reach more than 90%, which is the best compared to other cancers. Early diagnosis of colorectal cancer is a very mature technology that can meet the basic needs of clinical and proven populations. , It is an important advance in reducing the overall burden of cancer.
According to the country’s first and only large sample of the “China Middle Advanced Colorectal Patients Diagnosis and Treatment Status Survey”, published interim results show that there are many advanced intermediate patients in China with more metastases, and 83% of colorectal cancer patients are already in the middle and late stages, 44% of patients have metastases to the liver and lungs, putting enormous pressure on treatment and prognosis.
Professor Gu Yanhong, deputy director of the Oncology Department of Jiangsu Provincial People’s Hospital, also said that the core of early cancer detection is early diagnosis and treatment. Early detection of colorectal cancer (and precancerous lesions) can effectively reduce personal medical expenses and has significant economic health value. The cost of treating colorectal precancerous lesions is 20,000 yuan, while the cost of treating the late stage (fourth stage) is more than 250,000 yuan.
However, Zhu Yeqing also emphasized that early detection products must undergo a large-scale prospective multicenter clinical verification before they can meet detection requirements. “The choice of a direction for the early detection of cancer must meet multiple conditions: including high morbidity and more suitable populations; high mortality, which can fully awaken public vigilance; cancer has a long development cycle and can meet the detection window period. Demand, in addition to feasible diagnosis and treatment. “
In fact, before Nuohui Health was approved, there were already similar products on the market, and the relevant approved documents showed that their intended use was primarily an auxiliary diagnosis. The applicable population were patients who “clinicians recommended for colonoscopy” and physicians The diagnosis provides supporting evidence.
Zhu Yeqing explained that complementary diagnosis means that it cannot be diagnosed independently, but must be combined with existing standards to help improve the accuracy of existing diagnostic methods. “The cancer early detection industry is a new industry. We hope to develop in a healthy way. Compliance is very important. It can be used by anyone who is expected to use it. Chang Weiqing’s clinical enrollment population is the same as our certificate of registration. The intended use population is exactly the same and 120 million people at high risk for colorectal cancer will be screened. “
Zhu Yeqing emphasized that Chang Weiqing’s intended use is detection, not diagnosis, and its intended use is clear. This product cannot replace colonoscopy and cannot be used for tumor detection in the general population. It is suitable for the “early diagnosis and treatment of Chinese colorectal cancer” The “Expert Consensus” recommends the detection of “40-74 years of age at high risk of colorectal cancer”, and the test results of this product should not used as the sole basis for clinical diagnosis during the clinical diagnosis process.
The “Expert Consensus on Early Diagnosis and Treatment of Colorectal Cancer in China” recommends that the general population between 40 and 74 years of age undergo colonoscopy every 5-10 years, and for high-risk groups, starting at 40 years or before the earliest diagnosis of colorectal cancer in the family. Starting 10 years before, the colonoscopy should be done every 5 years. If the compliance of tested subjects is poor, multi-target fecal DNA testing can be used for those who are initially positive or rejected.
(Author: Zhu Ping Editor: Xu Xu)
