Prostate cancer, bladder cancer, kidney cancer is the three malignant tumors of the urinary system, also known as "urinary three cancers", currently has a high incidence in the Chinese group, of which prostate cancer has become the second most common cancer in men worldwide, the incidence is second only to lung cancer. And with the acceleration of the aging process of the population, the number of urinary tumors will further increase.
According to the Guidelines for Screening and Early Diagnosis and Early Treatment of Prostate Cancer in China (2022 Edition), the survival time of prostate cancer patients is closely related to the staging of malignant tumors at the time of clinical diagnosis. Most of the initial diagnosed cases of prostate cancer in mainland China are in the middle and advanced stages of clinical practice, and the clinically localized cases are only 30%, resulting in a poor overall prognosis of prostate cancer patients in mainland China. From 2003 to 2015, the age-standardized 5-year survival rate of prostate cancer in mainland China increased from 53.8% to 66.4%, but there is still a large gap compared with the overall 5-year survival rate of male prostate cancer in developed countries. Data from the U.S. Surveillance, Epidemiology, and Final Outcomes Database from 2010 to 2016 show that the 5-year survival rate of clinically limited prostate cancer patients after receiving standardized therapy is close to 100%, while the 5-year survival rate of patients with metastatic prostate cancer is only 30%. Therefore, early diagnosis of prostate cancer is essential to reduce its mortality.
At present, prostate puncture biopsy is recognized as the gold standard for diagnosing prostate cancer, but puncture biopsy is an invasive examination, when the puncture point is increased, bleeding and urinary retention, infection and other complications increase significantly, and the patient experience and compliance are poor. Therefore, the use of effective clinical screening to improve the early diagnosis rate of prostate cancer and avoid unnecessary puncture biopsy is the direction of the development of the industry. At present, the most extensive prostate cancer screening in the world is still a prostate-specific antigen (PSA) test, but PSA is disturbed by many factors, such as hyperplasia, inflammation, urinary retention, etc., which can easily lead to misdiagnosis, missed diagnosis and overdiagnosis.
In this regard, experts call for moving the early screening threshold of urinary tumors forward and seeking precise treatment strategies by strengthening research on genomics and other aspects. This will also further advance new tumor screening biotechnologies, such as liquid biopsy technology. 36Kr's recent exposure to "Yuding Bio" is exploring the use of liquid biopsy technology to achieve early screening of urinary tract tumors.
Founded at the end of 2017, located in Xiaoshan Economic and Technological Development Zone, Hangzhou, Zhejiang Province, Yuding Biology is an innovative in vitro diagnostic reagent R&D and production enterprise, focusing on the field of urinary tumor diagnosis, focusing on tumor liquid biopsy: exosome detection and gene editing (CRISPR/Cas) two cutting-edge technology routes, through the integration of a variety of leading molecular detection platforms, according to clinical needs, urinary tumor diagnostic marker tracking and translational medicine research, Develop a series of independent innovation of tumor full-course detection products, and commercialize technical achievements.
According to Zhu Xiaoxia, CEO of Yuding Biology, the current technical path of its prostate cancer early screening and early diagnosis products is to extract a very small amount of mRNA from urine samples, target enrichment in multiplex fluorescent PCR platform, and quantitatively detect mRNA expression in real time; through precision calculation, the risk of prostate cancer is judged, and its performance is several times that of traditional PSA detection.
She introduced that there are many cutting-edge research in the field of urinary system tumors, taking prostate cancer as an example, from the diagnostic level, there are biomarkers such as ctDNA, exosomes, and CTC to study tumors. She believes that with the promotion of "DRGs by disease type", hospitals need to use the most economical principles to guide the screening and diagnosis of diseases, along this line of thinking, Yuding Bio wants to use the simplest and most labor-saving and affordable way to productize and commercialize.
She added that the company's current commercialization idea is very clear, that is, by declaring three types of device certificates, promoting it to the clinic on a large scale in the mode of IVD products instead of LDT, obtaining the recognition of doctors through its "accurate and effective", fully opening up hospital channels, and then achieving large-scale application, the first thing the company has to do is to make the doctor group familiar with and recognize the application of this indicator.
According to Zhu Xiaoxia, Professor Huang Jiaoti, the founder of Yuding Biologics' technology, is a world-renowned pathologist, a tenured professor and head of the Department of Pathology at Duke University, a review expert of the NIH and the National Foundation of China in the United States, and has trained more than 70 professors and associate professors for the Chinese urinary system, and has extensive clinical resources at home and abroad, which can help the company quickly complete product polishing and promote clinical trials.
It is reported that at present, the company has established in-depth cooperation with The West China Hospital of Sichuan University, the First Affiliated Hospital of Zhejiang University School of Medicine, the Second Affiliated Hospital of Zhejiang University School of Medicine, the Drum Tower Hospital Affiliated to Nanjing University School of Medicine and other hospitals to capture clinical needs and verify product effects in a timely manner.
Image source: IC Photo
However, the positioning of Yuding Bio is not only early screening, at present, the company has carried out a comprehensive strategic layout around "focusing on urinary tumors and realizing the diagnosis of the whole course of tumors", and carried out the research and development and marketization of corresponding innovative diagnostic products. From a commercial point of view, enterprises can realize the diagnosis of the whole course of the patient and the whole life cycle management by screening the customer base in the early stage, and then collect the subsequent accompanying diagnostic products, so as to form a stronger, deeper and more stable binding method, and the application scenarios are more abundant, and it is easy to achieve rapid market volume and stable development.
Zhu Xiaoxia told 36Kr that the diagnosis of the whole course of the disease mainly includes three parts: early screening and early diagnosis, real-time monitoring, and accompanying diagnosis. Among them, real-time monitoring is mainly for cases with related symptoms but punctures can not be diagnosed; concomitant diagnosis is for the tumor patient group available with targeted drugs, and testing services will also be just needed for this group.
These three parts of the demand correspond to the corresponding market prospects, Zhu Xiaoxia analysis, in the field of early diagnosis, for the current lack of PSA projects, there have been hundreds of millions of people used every year; in terms of real-time monitoring, limited by detection technology, less than 50% of cancer patients diagnosed early, the remaining 50% of patients need real-time monitoring; as for the accompanying diagnosis, it is for the confirmed population, the magnitude has reached tens of millions. On the whole, this is a business for hundreds of millions of people, and the market size is at least one million.
Zhu Xiaoxia said that at present, around these three areas, the company has a product layout, of which early diagnosis products have entered clinical trials. Up to now, the company has completed two rounds of financing, and just completed a $10 million A round of financing last month, and the investor is Qinzhi Capital. She revealed that as clinical trials continue to advance, the company will also raise further funds as needed.
Combined with the market supply side, the fastest developed cancer early screening products in domestic clinical development mainly focus on the two major cancer species of bowel cancer and liver cancer - mainly based on the total population incidence and technical feasibility, for example, Nuohui Health, Kang Liming in the layout of bowel cancer products, and Rui Gene and Panshengzi have a layout in liver cancer products.
Relatively speaking, there are relatively few companies focusing on subdividing into the field of urinary tumors, which is still a relatively blue ocean market. Zhu Xiaoxia said that Yuding Biology currently has a first-mover advantage in the layout of research and development pipelines, the progress of clinical trials, and the commercialization method, and there are high barriers.
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