-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Recently, Shenzhen Jinbaihui Biotechnology Co.
, Ltd.
announced the completion of China's first real-world general population colorectal cancer screening 10,000 prospective clinical trials: "Ruichangtai" miR-92a detection kit (fluorescent RT-PCR method) for colorectal cancer, advanced adenoma combined with polyps (collectively referred to as intestinal tumors).
The positive predictive value of screening is as high as 80.
45%, and the screening sensitivity for colorectal cancer and advanced adenoma is as high as 94.
74% and 68.
33%, respectively, showing its excellent potential
as an early screening product for colorectal cancer.
Jinbaihui Biologics has submitted an application
to the National Medical Device Technical Evaluation Center for the change of applicable population and intended use of the product.
"Ruichangtai" miR-92a detection kit (fluorescent RT-PCR method) is expected to be upgraded to the industry's first, after pre-marketing retrospective controlled clinical trials and post-marketing prospective screening clinical trials evaluation, it can grade precancerous lesions, accurately capture, and is suitable for the general population of bowel cancer early screening products
.
Prevention and control have achieved results, and the status quo cannot be relaxed
Globally, the incidence of colorectal cancer continues to rise overall, with East Asia as the main region [1].The incidence of colorectal cancer in men and women in China has been rising for 20 years
.
According to the "China Cancer Statistical Annual Report" released by the National Cancer Center in the Journal of the National Cancer Center in 2022, the incidence of colorectal cancer continues to rise, and it has become the second most common malignant tumor in China, second only to lung cancer; And because its early symptoms are not obvious and specific, most of the colorectal cancer patients in China are in the middle and advanced stages when they are found, the prognosis is poor, and the mortality rate is also rising
.
A small number of countries, such as the United States, Germany, and Canada, have achieved prevention and control results in high-risk groups over 50 years old, but the incidence of colorectal cancer among young people under 50 years old is still increasing, showing an overall trend of younger age [3].
The effective prevention and control of high-risk groups benefits from the continuous, extensive and effective screening of risk groups, which is also a feasible reference
for future prevention and control of areas and populations where the risk of morbidity is still rising.
Global and Chinese colorectal cancer incidence trends[1,2]The incidence of colorectal cancer is getting younger[3]
Fortunately, the development process of colorectal cancer is clear, and normal intestinal epithelial cells go through the polyp stage, such as inflammatory polyps, and then through the advanced adenoma stage.
Such as tubular villous adenoma, serrated adenoma, or tumor with high-grade intraepithelial neoplasia and infiltration to distant metastasis
.
Precancerous progression can range from three years to several years, making it an important window
for early screening and clinical intervention.
Therefore, an early screening tool that can achieve high sensitivity in screening precancerous advanced lesions, such as advanced adenomas, and high positive predictive value in precancerous early lesions, such as polyps, is of great
significance for clinical and preventive medicine to achieve early prevention and early treatment of colorectal cancer.
The "Rui Changtai" fecal miR-92a test was first approved for marketing
MicroRNA (miR) is a small molecule non-coding RNA in the cell, generally composed of 21-23 bases, involved in the regulationof post-transcriptional translation expression of genes 。 MiR-92a is composed of 22 bases and belongs to the human chromosome 13 miR-17-92 gene cluster, which mainly regulates: 1) PTEN, p21 and p53 genes participate in the PI3K-AKT signaling pathway and 2) KLF4, GSK3 and DKK3 genes participate in the Wnt/β-catenin signaling pathway, thereby showing the characteristics that its own expression amount is positively correlated with the tumor development process [4]
。
The tumor risk early warning value of MiR-92a and its feasibility in human fecal sample detection have been proved by a number of studies in Hong Kong Chinese University to have preliminary colorectal cancer screening application value, and later through Jinbaihui Biologics clinical trial and industrial transformation into China's first approved fecal sample bowel cancer detection innovative Class III medical device product: miR-92a detection kit (Fluorescence RT-PCR method) (National Equipment Injection 20183400108) [5, 6].
The product technology won the second prize of the National Natural Science Award
in 2016.
The products have obtained a number of invention patents in China, Hong Kong and the United States, and obtained the EU CE certification
.
The application for overseas multi-country marketing authorization is now in progress
.
Second Prize of National Natural Science Award - Molecular Mechanism, Early Warning, Prevention and Control of Colorectal Cancer Research
National Machinery Accurate 20183400108
In the real world, 10,000 people look forward to promising results[8].
.
This trial included 15,586 subjects aged 30-75 years, of which 73.
91% were included in the high incidence of colorectal cancer aged 41-70, 77.
71% of the total population was 71-75 years old, and 22.
29%
were 30-40 years old.
While fully including people at high risk of colorectal cancer, the trial effectively covered groups
aged 40 years and below with a sustained and rapidly increasing incidence.
The overall initial screening positive rate of fecal miR-92a detection was 10.
11%, and the compliance rate of colonoscopy in the initially screened positive population was 56.
83%, that is, high-risk individuals were enriched from the overall colorectal cancer risk group with about 10 times the efficacy, and colonoscopy was completed with more than half of the compliance ratio
.
The 1,000 incidence rate of colorectal cancer and the percentage incidence of advanced adenoma in the test population were at the same level as the incidence rate of clinical trials and products of Exact Sciences Corporation in the United States, that is, the average risk level of colorectal cancer [7].
The positive predictive value of fecal miR-92a detection for colorectal cancer and advanced adenoma with polyps (collectively referred to as intestinal tumors) was 80.
45%, and the sensitivity of screening for colorectal cancer and advanced adenoma was 94.
74% and 68.
33%,
respectively 。 The test results show that fecal miR-92a detection is suitable for the average risk of colorectal cancer, that is, the general population for screening including colorectal cancer, advanced adenoma and polyps, effectively screening out precancerous early lesions and referring colonoscopy and intervention
.
In addition to the screening application of precancerous early lesions, fecal miR-92a detection is for colorectal cancer and colorectal cancer combined with early cancer (according to the 2020 edition of the "China Guidelines for Colorectal Cancer Screening, Early Diagnosis and Early Treatment" and the "National Health Commission China Colorectal Cancer Diagnosis and Treatment Standards", patients with high-grade intraepithelial neoplasia are classified as "early cancer" by histopathological examination) The screening sensitivity was 94.
74% and 85.
00%, and the negative predictive values were 99.
96% and 99.
77%,
respectively.
Fecal miR-92a detection can fully detect colorectal cancer and eliminate missed detection while efficient enrichment, accurate referral, and early detection
of precancerous lesions.
Form a pattern and improve efficiency
People aged 30-75 are naturally at the average risk level of colorectal cancer, and annual screening should be carried out as needed: that is, fecal miR-92a detection is the main initial screening method, the subject collects stool samples on site or remotely for testing, screens positive and refers colonoscopy, timely confirms and intervenes in advanced adenomas and polyps found under microscopy.
Taking the screening of 100,000 people every year and the continuous follow-up screening of 100,000 people in the previous year in the following year, for 3 years, it is estimated that a total of 39,246
polyps, 7,537 advanced adenomas, and 683 colorectal cancer will be found in 3 years 。 Based on the screening found that all precancerous lesions have progressed to colorectal cancer in the future and the per capita treatment cost is 200,000 yuan, the gross overall income of screening is 9,356.
8 million yuan
.
683 colorectal cancer patients were not included in the gross pooled benefit
of screening.
Schematic diagram of screening work pattern and performance prediction of 100,000 people
Capital helps to benefit the public
At the same time, Jinbaihui Biotech announced the completion of the B+ round of strategic financing of US$15 million led by BOC Guangdong Finance Fund, and will mainly use the funds for multi-line business development and product pipeline under research.
Jinbaihui Biologics business will continue to strengthen its main products in government screening, medical institutions, commercial physical examination, To B/To C and other types of market development, so far has served hundreds of thousands of people.
Jinbaihui Biologics' IVD reagent pipeline includes three types of medical device products for early screening and early diagnosis, such as gastric cancer, pancreatic cancer, nasopharyngeal cancer and breast cancer, which will be successively launched from 2023
.
In addition, Jinbaihui Biologics will launch a pre-IPO round of financing
at the end of this year.
Dr.
Yu Haoyang, founder/CEO of Jinbaihui Biologics, said: Since its establishment 9 years ago, Jinbaihui Biologics has always adhered to the original intention and vision of "developing affordable tumor early screening products for Chinese people", and has completed the approval of 1 innovative Class III medical device, several Class I and II medical devices and dozens of
domestic and foreign invention patents 。 Jinbaihui Biotech is not only committed to the development of serious medical products, but also innovates and develops in consumer medical care and services, and the successful financing of this financing is based on the core technology of Jinbaihui Biologics with independent intellectual property rights and the affirmation of the team of Jinbaihui Biologics by multiple capital institutions, which also contributes to our long-term development strategy
.
Liu Xiang, General Manager of the Medical and Health Investment Department of BOC Guangdong Finance Fund, said: "Jinbaihui Biologics has built a multi-technology platform in the field of early cancer screening, covering miRNA, DNA methylation, ctDNA and other markers, and has achieved landmark innovations and changes in related aspects, and we look forward to working with Jinbaihui Biologics to jointly promote the commercialization of
the domestic early cancer screening industry.
" 。 The investment was led by its Guangdong Finance Biomedical Fund, which will continue to pay attention to outstanding entrepreneurial teams in the field of big health and promote the industrialization and commercialization
of innovative products in the biomedical health industry.
References: [1]GBD 2019 Colorectal Cancer Collaborators.
Global,regional,and national burden of colorectal cancer and its risk factors, 1990-2019:a systematic analysis for the Global Burden of Disease Study 2019.
Lancet Gastroenterol Hepatol.
2022 Jul; 7(7):627-647.
[2]Zheng RS,Zhang SW,Zeng HM,Wang SM,Sun KX,Chen R,Li L,Wei WQ,He J.
Cancer incidence and mortality in China,2016.
Journal of the National Cancer Center,2022 Feb; 2(1):1-9.
[3]Siegel RL,Torre LA,Soerjomataram I,Hayes RB,Bray F,Weber TK,Jemal A.
Global patterns and trends in colorectal cancer incidence in young adults.
Gut.
2019 Dec; 68(12):2179-2185.
[4]Jung G,Hernández-Illán E,Moreira L,Balaguer F,Goel A.
Epigenetics of colorectal cancer:biomarker and therapeutic potential.
Nat Rev Gastroenterol Hepatol.
2020 Feb; 17(2):111-130.
[5]Ng EK,Chong WW,Jin H,Lam EK,Shin VY,Yu J,Poon TC,Ng SS,Sung JJ.
Differential expression of microRNAs in plasma of patients with colorectal cancer:a potential marker for colorectal cancer screening.
Gut.
2009 Oct; 58(10):1375-81.
[6]Wu CW,Ng SS,Dong YJ,Ng SC,Leung WW,Lee CW,Wong YN,Chan FK,Yu J,Sung JJ.
Detection of miR-92a and miR-21 in stool samples as potential screening biomarkers for colorectal cancer and polyps.
Gut.
2012 May; 61(5):739-45.
[7]Imperiale TF,Ransohoff DF,Itzkowitz SH,Levin TR,Lavin P,Lidgard GP,Ahlquist DA,Berger BM.
Multitarget stool DNA testing for colorectal-cancer screening.
N Engl J Med.
2014 Apr 3; 370(14):1287-97.
[8]Stool-based miR-92a test for colorectal cancer risk population screening.
Manuscript in preparation.
Source: Medical Proofreader: Zang Hengjia Editor: Tian Dongliang
* The medical profession strives to be accurate and reliable in its published content at the time of approval, but does not make any commitment and guarantee for the timeliness of the published content, the accuracy and completeness of the cited information (if any), etc.
, and does not assume any responsibility
arising from the fact that the content is out of date and the cited information may be inaccurate or incomplete.
Relevant parties are requested to check
separately when adopting or using this as the basis for decision-making.
Click "Read Original" for more information
