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    Home > Active Ingredient News > Antitumor Therapy > Nohui health by the domestic "cancer early screening first certificate", the industry into an accelerated period?

    Nohui health by the domestic "cancer early screening first certificate", the industry into an accelerated period?

    • Last Update: 2020-12-14
    • Source: Internet
    • Author: User
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    From abroad to at home, the cancer screening circuit is heating up.
    , Illumina's acquisition of Its subsidiaries, Grail and Exact Science, of Trive has undoubtedly increased the heat on the track.
    recent years, the domestic cancer early screening track wind mouth gradually began to grow.
    , however, compared with the FDA's approval of Cologuard for colorectal cancer screening by Act Sciences in 2014, similar products approved in China are approved for "assisted diagnosis."
    Recently, Novo Health obtained the country's first registration certificate with the significance of cancer early screening products - its registration certificate clearly stated the intended use of "screening", for such registration certificates approved to open a breaking point.
    Its approved product is Chang Weiqing, china's first use of multi-target fecal FIT-DNA technology, to detect a variety of DNA and protein molecular indicators (including gene mutations, gene methylation mutations and hemoglobin) in stool samples closely related to the occurrence of colorectal cancer, is a non-invasive home-based colorectal cancer early screening detection products.
    is currently priced at 1996 yuan.
    According to Nohui Health co-founder and CEO Zhu Yeqing, Chang Weiqing after 7 years of research and development, invested more than 100 million U.S. dollars, and completed China's first forward-looking, large-scale, multi-center cancer early screening registered clinical trial "Clear-C", and finally won the first certificate of china's cancer early screening.
    the good news, the star-studded Nohui Health embarked on the path of an IPO.
    the day after Chang Weiqing obtained the registration certificate for the innovative three types of medical devices, OnoHui Health submitted its listing application to the Hong Kong Stock Exchange on the evening of November 10.
    according to its prospectos, Nohui Health currently has two commercial products in its hands, Chang Weiqing and thyroid (another colorectal cancer early screening test product).
    2018, 2019 and the first half of 2020, Chang Weiqing and Wei Guan generated revenues of 18.8 million yuan, 54 million yuan and 9.8 million yuan, respectively, accounting for total revenue 99.9% (18.816 million yuan), 92.7% (58.275 million yuan), 93.1% (10.526 million yuan).
    it is not difficult to see that in the short term to Chang Weiqing as the representative of the early screening products of bowel cancer is nohui health's main source of revenue.
    after obtaining a registration certificate with the significance of early screening products, what kind of answer will the commercial exploration of the enterprise hand over? Before answering this question, we must first clarify the meaning of the "early screening" of the "first evidence of early screening of cancer in China".
    the first time in the expected use of "screening" this Changweiqing registration certificate "early screening" significance is mainly reflected in the following two aspects: the first clear use of "screening", its applicable population for the 40-74 year old colorectal cancer with poor compliance with the colonoscopy high-risk population (judged to refer to the "China colorectal cancer early diagnosis and treatment expert consensus"), which includes people with a high risk of bowel cancer but no clinical symptoms.
    previously, approved similar products were intended to be used for complementary diagnostic purposes, and the applicable population was patients "recommended by clinicians for colonoscopy" to provide supporting evidence for clinicians' diagnosis.
    It is worth noting that Zhu Yeqing also stressed that Chang Weiqing's intended use is screening is not a diagnosis, its intended use is clear, this product can not replace enteroscopy, can not be used for cancer screening in the general population, clinical diagnosis process should not be based on the product test results as the only basis for clinical diagnosis.
    ", even as a "gold standard" of bowel glasses, is only a screening function, and only a pathology report can determine the final diagnosis.
    , according to the World Health Organization's Guidelines for Early Diagnosis of Cancer, early diagnosis of cancer is the early identification of cancer patients with cancer symptoms.
    , early cancer screening, by contrast, identifies latent-stage cancer and precanceroctic lesions in target populations that are physically healthy and have not yet developed abnormal symptoms, most of whom are negative.
    in the application scenario, after the certification of Chang Weiqing will first enter the hospital.
    such as doctors in the course of diagnosis and treatment, can be for high-risk groups to make recommendations for the use of Chang Weiqing, so as to make a preliminary screening.
    "Why did we choose a hospital in the first step?" Because we want to have a professional endorsement first, but in the future Chang Weiqing's main application scenario must be outside the hospital.
    to solve the life-and-death problem, he has no incentive to use early screening technology.
    ," Mr Zhu said.
    Zhu Yeqing explained that when facing consumers at the C end, Chang Weiqing also applies to the general population.
    "It's screening for high-risk people, and it doesn't advertise what it sells to people with average risk, but I can't limit them to buying it," he said.
    said of the frequency with which different groups of people use Chang Weiqing, adding that the general risk group can be tested every three years, while the high-risk group is more valuable every three months.
    Forward-looking large-scale multi-center clinical trials are key: the early screening approved reference standard This registration certificate approved "key first service" from a registered clinical trial ("Clear-C"), this study is known as the first cancer early screening population forward-looking large-scale multi-center registered clinical trials.
    to do this experiment because of the close communication with the Drug Administration in the early stages of Nohui's health.
    May 2018, Chang Weiqing entered the Green Channel for National Innovation Medical Device Review.
    , Zhu recalls, when designing clinical trials, they repeatedly asked the Drug Administration a question about whether China could approve a registration certificate for early screening for cancer.
    : "We never said we couldn't have this certificate, but the question is whether you're willing to do a large-scale, forward-looking multi-center clinical trial."
    " and the most difficult part of such experiments is "multi-center", where a regional or national large PI (chairman) initiates a clinical trial that needs to take into account the overall organization and implementation.
    organization of all research centers is much more complex than the regulatory, registration, compliance, operational, and other challenges faced by a single-center clinical study.
    "As long as your results meet (our) expectations, we dare to approve."
    ", after six months of repeated talk, Nohui Health finalized clear-C clinical trials.
    The trial lasted 16 months, according to the Chinese Association of Anti-Cancer Colorectal Cancer Professional Committee issued the "China Colorectal Cancer Early Diagnosis and Screening Strategy Expert Consensus" defined by the population selected 5881 samples into the group, such as over 40 years of age, have cancer-promoting habits or family history and other conditions.
    these samples belong to people at high risk of colorectal cancer, who come from eight hospitals in China, including the second hospital affiliated with Zhejiang University Medical College, Fudan University Affiliated Oncology Hospital, Sichuan University Huaxi Hospital, etc.
    Clear-C will be Chang Weiqing? In a "head-to-head" matching study with the traditional clinical screening method fit for colorectal cancer," At the CSCO academic annual meeting in September, Nohui Health published a series of results from Clear-C: Chang Weiqing's detection sensitivity to colorectal cancer was 95.5%, FIT's detection sensitivity was 69.8%, and Chang Weiqing's progressing adenoma was 69.8%. The detection sensitivity was 63.5%, fit detection sensitivity was 30.9%, and Cologuard's detection sensitivity of progressive adenoma was 42.4%, Chang Weiqing's detection specificity of new organisms during progression was 87.1%, and Chang Weiqing's negative prediction (NPV) for colorectal cancer reached 99.6%.
    in Zhu Yeqing's view, Chang Weiqing 99.6% of the NPV is the most moving data of the State Drug Administration, which means that it is less likely to miss the test.
    negative predictor (NPV) refers to the proportion of people who are judged to be healthy by the diagnostic method to be evaluated, and is also one of the authoritative indicators widely recognized internationally to measure early screening products.
    In addition, to further validate Chang Weiqing's clinical performance against colorectal cancer, this clinical trial also retrospectively included 419 cases of different stages of colorectal cancer, and 94 cases of other patients with digestive tract diseases and other cancer patients.
    doing so, on the one hand, magnifying the number of positive and negative samples, on the other hand, these interfering cases will make the distribution of samples more uniform, more comprehensive reflection of the overall characteristics, resulting in more stable performance parameters.
    it is understood that Nohui Health will also carry out a later follow-up and continue to dig up data from the Clear C trial.
    , after analyzing the age subgroup, There were differences in the performance of Chang Weiqing in different age groups.
    " is more sensitive and specific to people aged 40-50 than people aged 60-70.
    " based on colorectal cancer, expand the cancer sales in addition to Chang Weiqing this product, Nohui Health another commercial product is the tube, it is a proprietary non-invasive fecal FIT colorectal cancer screening product, used to test for colorectal cancer-related hemoglobin biomarkers.
    is known to be the first self-test FIT screening product approved by the State Drug Administration for colorectal cancer screening in China.
    two core products of the company's adaptation is colorectal cancer, colorectal cancer is a common result of the colon or rectum of a malignant tumor.
    present, including Nohui Health, a number of enterprises to force colorectal cancer early screening field, to a large extent depends on the outstanding effect of early screening of the cancer species and economic health value.
    colorectal cancer is a cancer of great value for screening and screening.
    if detected early before developing a tumor, colorectal cancer can generally be prevented by surgical removal of progressant adenoma, and the patient's five-year survival rate can reach 100%.
    according to the China Rural Cancer Early Diagnosis and Treatment Project (2006-2017), colorectal cancer has the highest detection rate of 5.29% among the seven common cancers.
    "Only 40% of cancers in the world can be treated early, and the rate of early diagnosis of colorectal cancer can exceed 90%, " said Professor Zhao Ping, president of the China Cancer Foundation.
    , it often takes about a decade to develop from an early adenoma to colorectal cancer, and more than 90 percent of early stage patients can be cured with effective treatment.
    " colorectal cancer has a long developmental period in which we can intervene at any stage to reduce the incidence of cancer.
    , early screening is not just about reducing mortality, it's about reducing morbidity.
    ," Zhu said.
    at the patient level, due to the invasiveness of colonoscopy and the difficulty of making appointments, resulting in poor compliance.
    addition, early screening of colorectal cancer has significant health economic value.
    treatment of pre-cancer lesions of the colorectal cancer was about $20,000, while the cost of treatment in late stages (stage 4) was more than $250,000.
    According to Professor Ding Kefeng, vice president of the Second Hospital affiliated with Zhejiang University School of Medicine, the medical cost of colorectal cancer ranks first among malignant tumors, and most of the patients have entered the middle and late stages of diagnosis, which places a heavy burden on China's health care system.
    , the detection efficiency of colonoscopies in high-risk groups needs to be improved to maximize the use of medical resources.
    in Zhejiang large-scale CRC sequence population screening, the data show that at least 70% of the colonoscopy test results are negative.
    "We let patients who would otherwise need to do a colonoscopy for molecular testing (Chang Weiqing), test positive for no need to do colonoscopy."
    Shu, director of the Academic Committee of Zhejiang University's Institute of Oncology, said.
    addition to the above two products for early screening for colorectal cancer, Nohui Health has also developed a late-stage cancer screening candidate for stomach and cervical cancer.
    Among them, the claustrophobia trial for stomach cancer has been completed in 2020 and is expected to be submitted to the State Drug Administration by the end of 2020, and the cervical cancer cervical cancer is also expected to start a registration trial in 2021, the trial into the population of about 3-5 million people, is expected to take 3-5 years.
    The reason for the layout of stomach cancer and cervical cancer, Zhu Yeqing told Edo big health, gastric cancer is the second largest cancer species in the country, Helicobacter helicobacteria infection rate is very high, it is also the main cause of stomach cancer in China.
    especially important for the protection of minors, who may be at high risk of future stomach cancer.
    for minors, regular testing for Helicobacterrobacteria may be just in need.
    in the field of cervical cancer screening, Nohui Health wants to be able to take home samples that take into account privacy.
    why the liver cancer field is not laid out, Zhu said companies need to pursue input-output ratio.
    incidence of liver cancer is particularly rapid, from early to late 6 months or so, for early screening, the development cycle of the disease does not have enough window period.
    the first step of the certification process, and the pace of Nohui's health commercialization is about to accelerate.
    At present, Nohui Health has established a number of direct marketing channels throughout the country, including hospitals, medical examination centers, insurance companies, pharmacies and online channels, in cooperation with 35 insurance companies, and in cooperation with Penguin Almond and Ping An Good Doctor to promote early screening products.
    addition, it will further expand its partners and its own sales team, which will reach a thousand people in the future.
    on the question of whether to work with pharmaceutical companies, Zhu stressed that Nohui Health will focus on the field of early screening for cancer, the drug is not currently specialized, but will consider working with them in the future.
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