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Leifeng.com News, on November 25, Nuohui Health announced that the State Food and Drug Administration approved the innovative three-class medical device registration application of the Chang Weiqing colorectal cancer early detection product, and clearly defined the application by Chang Weiqing on the intended use Yu “Screening for people at high risk of colorectal cancer between 40 and 74 years.”
This is China’s first and only registration certificate for cancer early detection products approved by the National Administration of Medical Products.
According to Leifeng.com, Chang Weiqing will maintain the 1996 yuan price and expand out-of-hospital channels for private medical examinations, insurance, and Internet medical services, in addition to hospital customers.
Founded in 2015, Nuohui Health is the first company to enter the colorectal cancer early detection market in China. It has medical testing laboratories in Beijing, Hangzhou, and Guangzhou, Nuohui Health’s product portfolio currently covers the fields of colorectal cancer, cervical cancer, stomach cancer, lung cancer, liver cancer, etc. , and its two colorectal cancer screening products (Chang Weiqing®And puff tube®) Has been approved by the State Drug Administration and marketed.
Already 6 years ago, a “Cologuard” genetic testing early detection product was approved for marketing abroad. In fact, from a national perspective, the cancer early detection market started late, and Nuohui Health’s Chang Weiqing products have the meaning of filling in the “blank”.
According to Lei Feng(Public account: Leifeng.com)Please understand that in August 2014, the US FDA approved “Cologuard”, an in vitro fecal inspection instrument (ExactSciences Corporation) for the detection of colorectal cancer (CCR). The purpose of Cologuard is to quantitatively detect DNA markers associated with colorectal tumors and occult hemoglobin present in human feces.
Subsequently, the FDA included Cologuard in the coverage of CMS (Center for Medicaid and Health Insurance Services of the United States) and underwritten by Medicare. American Cancer Society guidelines also included Cologuard on the list of recommended colorectal cancer screening options.
It is also the success of Cologuard that led Nuohui Health to seek to make the “Cologuard of China.”
Zhu Yeqing, Co-Founder and CEO of Nuohui Health, presented that after 7 years of research and development, Chang Weiqing invested more than 100 million US dollars and completed the first prospective, large-scale, multicenter early registration cancer clinical trial China “Clear-C” And finally won the first cancer early detection certificate in China.
Zhu Yeqing, Co-Founder and CEO of Nuohui Health
Recalling the approval process, Zhu Yeqing said that when we started to design the clinical trial, we repeatedly asked the State Food and Drug Administration: Can China approve a certificate for early cancer detection? The head of the State Food and Drug Administration said: “We have never said that we cannot have this certificate, but the question is whether you are willing to make such a risky attempt. As long as we can meet our expectations, we dare to approve it.” .
In September 2018, under the direction and supervision of the National Medical Products Administration, “Clear-C” was officially launched. It lasted 16 months and a total of 5,881 cases were registered. It was carried out jointly by 8 large tertiary hospitals throughout the country to carry out the screening. The verification provides the highest level of scientific evidence, which has also become an important node for early cancer detection research in China.
“Clear-C” Clinical Research Project Leader, Vice Dean of the Second Affiliated Hospital of Zhejiang University School of Medicine, Chair-designate of the Colorectal Cancer Committee of the China Cancer Association, and a colorectal cancer cohort study in the 13th National Five-Year Plan Chief scientist Professor Ding Kefeng said that this trial has three characteristics: first, China had never before had a prospective clinical trial registered for early detection of bowel cancer, second, the size of sample is large and third, the test results are excellent.
“Everyone in the group must be in Chang Weiqing®At the same time, the colonoscopy was completed and the gold standard verification of colonoscopy and pathology was compared. Chang weiqing®Screening results. The large-scale prospective trial design “Clear C” approaches the real application scenarios of screening, supports early detection, has clear clinical significance, and can greatly enhance the effect of early treatment and prevent the occurrence of bowel cancer. It is of great value for the detection of malignant tumors in China. “
Zhu Yeqing said at the press conference that significant early detection of cancer must meet three points:Clear clinical guidance, simple diagnostic methods, and viable clinical interventions.Changweiqing® can clearly guide asymptomatic high-risk groups to determine whether to go to the hospital for a more detailed examination, in order to carry out convenient and non-invasive home sampling for ordinary people.
At the same time, the importance of early cancer detection is not only to reduce cancer mortality, but, more importantly, to reduce the incidence of cancer.
China has the highest incidence of colorectal cancer in the world. The number of new cases has increased from 388,000 in 2015 to 440,000 in 2019, with a compound annual growth rate of 3.2%. Due to the long-term development of colorectal cancer, sufficient time has been set aside for intervention and treatment of precancerous lesions and early colorectal cancer.
“Despite the dire cancer situation in China, the incidence of colorectal cancer has been somewhat controlled.” Professor Zhao Ping, Chairman of the China Cancer Foundation, said the focus of the prevention and treatment of colorectal cancer is early diagnosis and treatment, and early diagnosis of colorectal cancer. The rate can exceed 90%. This is a very mature technology that can meet the basic needs of clinical and proven populations.
From the product side, Negative Predictive Value (NPV) is an authoritative international indicator for measuring cancer early detection products, and it is also a decisive factor for the approval of Changweiqing products.
The negative predictive value (NPV) represents the proportion of subjects who are negative and who are not really sick. As an internationally recognized authoritative indicator for measuring the performance of early detection products, the NPV is used to assess the “missing detection” ability of cancer early detection products.
Professor Gu Yanhong, deputy director of the Oncology Department of Jiangsu Provincial People’s Hospital, once 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 health and financial value. The cost of treating colorectal precancerous lesions is 20,000 yuan, while the cost of treating the advanced stage (fourth stage) is over 250,000 yuan.
Zhu Yeqing, CEO of Nuohui Health, said the main value of screening is to exclude negatives. To achieve screening, it is necessary to ensure that “people who are considered negative should be well and you can be sure that a colonoscopy is not necessary”; Those that are positive may have problems, “requiring an additional clinical diagnosis.
According to the results of the Clear-C clinical trial, Chang Weiqing®The detection sensitivity of colorectal cancer is 95.5%; the detection sensitivity of advanced adenoma is 63.5%, which is more than double that of traditional occult blood detection; the negative predictive value of colorectal cancer is as high as 99.6%.
Zhang Ligang, Founder, Chairman and CEO of iKang Group, said: “In recent years, 75,000 people in iKang used Chang Weiqing for early detection, and the positive rate was 9%. Chang Weiqing®It is very effective for early cancer detection, not only can it improve colonoscopy compliance, but it can also effectively detect precancerous bowel cancer lesions. “
According to Leifeng.com, the three founders of Nuohui Health graduated from the Faculty of Life Sciences at Peking University. President and Chief Scientific Officer Dr. Chen Yiyou has more than 20 years of R&D experience in the field of oncology. He is the inventor of six US patents and more than 20 global patent applications, and has published many articles in professional scientific research medical journals.
Zhu Yeqing has served as a senior executive for Samsung, Reuters Finance, GE Finance, and other Fortune 500 companies. Lu Ning is a Ph.D. in microbiology from Duke University and a postdoctoral fellow at Stanford University. He has worked for Roche Diagnostics, Quest Lab, and many other well-known molecular diagnostic companies. He has more than ten years of experience in developing IVD. He has led or participated directly in the development process of eight products. Five are listed in Europe and America.
Leifeng.com learned that Nuohui Health has received six rounds of more than US $ 160 million in financing so far, and just completed US $ 30 million in Series E financing in July this year, led by Rock Springs Capital, OrbiMed, Eli Lilly Asia Fund (LAV), Cormorant Asset Management, China Resources Chia Tai Life Science Fund, Octagon Capital and former shareholder Qiming Venture Capital followed suit.
On November 10, Nuohui Health submitted a prospectus to the Hong Kong Stock Exchange.
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