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Economic Observer Network Reporter Qu Yixian On November 25, at the press conference for China’s first cancer early detection certificate, Zhu Yeqing, co-founder and CEO of Nuohui Health, detailed that Chang Weiqing, developed by his company, the first cancer early detection product from China won the national award. Process approved by the Supervision Bureau. The product research and development lasted 7 years, the clinical trial enrolled 5,881 subjects, which lasted 16 months, the investment in research and development was 100 million US dollars, and the current price is 1996 yuan.
Chang Weiqing was approved by the State Food and Drug Administration on November 9, and the intended use made it clear that the product is suitable for “screening of people at high risk of colorectal cancer between 40 and 74 years old.” This is also the only cancer early detection product in China.
This product was developed in 2013. In the first two years a large number of clinical samples were used to verify the product model. In 2017, this product had 2,325 registered clinical numbers.
In 2018, Nuohui Health reported to the National Food and Drug Administration for a registered clinical trial. Zhu Yeqing said that the two sides argued for a long time. One of the issues discussed was whether Nuohui Health has the capacity to carry out large-scale, forward-looking and multicenter activities. Clinical trials, and in strict Food and Drug Administration procedures, present the same results as preclinical ones.
“Even after the CFDA gave us the green channel for innovation in April 2018, we continue to discuss the clinical plan with the experts appointed by the CFDA. The clinical plan was discussed for 6 months and was not officially confirmed until September 2018 ., The first sample was registered on September 25 of that year and the last sample was registered on October 15, 2020. ”Zhu Yeqing said that in January of this year, all the materials were sent to the Drug Administration and formally approved in November.
Bowel cancer detected 605Example
In preliminary communication with the drug regulatory authority, Nuohui Health asked the State Drug Administration the same question several times: Can China issue a certificate for early detection of cancer? Relevant leaders of the State Food and Drug Administration stated that as long as Nuohui Health is willing to conduct forward looking multicenter clinical trials and the results can meet expectations, this certificate can be approved.
Chang Weiqing’s clinical trial is called the “Clear-C” Registered Clinical Trial. The second affiliated hospital of Zhejiang University Medical School is the main research unit. Ding Kefeng, the vice president of the hospital, acts as the principal investigator (PI) and unites the population of Jiangsu province. The hospital, Fudan University Affiliated Tumor Hospital, Sichuan University West China Hospital, Zhengzhou University First Affiliated Hospital and eight other large-scale tertiary hospitals were jointly developed.
Ding Kefeng said that “Clear-C” is China’s first large-scale prospective multicenter clinical study for early detection of colorectal tumors. In discussing the clinical trial plan, he also borrowed from the similar American product Cologuard’s clinical design plan. “Clear-C” conducted a direct comparison study between Chang Weiqing and the traditional FIT (fecal occult blood test) colorectal cancer screening method. Subjects were between 40 and 74 years of age, and invalid samples were excluded and included in the statistics. The data analyzed were 4758 cases and 605 cases of bowel cancer were detected.
Results from clinical trials show that Chang Weiqing has a sensitivity of 95.5% for bowel cancer. Combined with the questionnaire and preliminary detection of fecal occult blood, it can significantly increase the colonoscopy detection rate. “Compared to Cologuard, although it is not a head-to-head study, our results are not inferior to the results of Cologuard’s research,” said Ding Kefeng.
Furthermore, in the “Clear-C” trial, the negative predictive value of Chang Weiqing for colorectal cancer was 99.6%. Negative predictive value (NPV) refers to the proportion of people tested who are considered healthy based on the diagnostic methods to be assessed, and it is also one of the widely recognized internationally authoritative indicators for measuring early detection products. In simple terms, for every 100 people who tested negative on Chang Weiqing, 0.4 were actually positive, avoiding “missing tests” to the greatest extent. Ding Kefeng said that all previous inspection methods, including colonoscopy, have not achieved such a high negative predictive value.
Prices 1996yuan
Chang Weiqing’s current price is 1996 yuan and it is mainly sold by hospitals and medical examination institutions.
Regarding future sales, Zhu Yeqing said that he hopes that the product can be purchased in any channel and that professional doctors can help understand the value of this product. “We will gradually promote channel C and hope that everyone can buy the product more conveniently.”
Zhu Yeqing also said that all the designs for this product are based on homemade samples. “SF Express, JD.com and EMS can send samples to our central lab for analysis.” Once the samples are sent, the user can verify them on the mobile phone within five days. You can view the test report.
In order to open up sales channels, Zhu Yeqing said that he will cooperate with more partners in the future, such as Internet medical services and insurance companies. Nuohui Health currently has a sales team of 500 people. In the future, it will adopt the sales strategy of the self-built sales team and partners to promote together. .
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