According to the investment community, recently, kuanran biomedical technology (Shanghai) Co., Ltd. (hereinafter referred to as”kuanran gene”) announced that it had completed the pre-A round of financing of tens of millions of yuan. This round of financing is led by Guosheng Furui, and Jinxi Shanghui serves as the Financing Consultant. The funds will be used to further promote the layout of the company’s next-generation pathology technology (NGP) and IVD product application and registration reserves, and accelerate product listing.
Kuanran gene is a leading enterprise in-depth layout of the next generation of pathological diagnosis, central nervous system tumor and hepatobiliary tumor in vitro diagnosis products. At present, the company has a total of 48 kinds of testing products, has carried out the application and registration reserve of 6 IVD products, and operates 2 independent medical testing laboratories certified by cap nationwide, which can realize the accurate detection of tumor early screening, auxiliary diagnosis, intraoperative prediction and monitoring, and postoperative recurrence risk assessment, It has cooperated with more than 500 medical institutions.
01. Unique layout:ldt+ivd, ngp+ngs
The founding team of kuanran gene has more than 10 years of experience in the medical field and has inherent advantages in sales network layout, process management and cost control. In terms of business layout, kuanran gene has formed a unique model of”ldt+ivd, ngp+ngs”.
In the business layout of”ldt+ivd”, kuanran gene fully communicated with clinical experts, and deployed dozens of testing products through LDT mode, which not only formed a stable business income, but also laid a channel for IVD products. On the basis of LDT products, the company chose some products with broad market and great industrialization prospects to register and declare. At present, it has the declared registration reserves of six IVD products, including hcc7s”seven kinds of microRNA liver cancer auxiliary diagnosis and detection kit”, hcc5r”liver cancer postoperative metastasis and recurrence risk assessment kit”, which has formed a technical barrier on IVD products of brain tumors and hepatobiliary tumors.
In addition, kuanran gene pioneered the new clinical application of ngp+ngs and laid out the next generation of pathological technology. Kuanran gene is an enterprise that entered the ngs market earlier and is applied to solid tumors such as brain tumors. The market competition of NGS is increasingly fierce. At the same time, with the focus of tumor diagnosis and pathology shifting from targeted therapy to tumor immune microenvironment research, NGS has gradually exposed its shortcomings.
Therefore, kuanran gene began to deploy the next-generation pathological Technology (NGP), represented by multiple fluorescent immunohistochemical technology, to solve the problem of tumor immune microenvironment research, and formed a strategy of ngp+ngs parallel development. Combined with NGP technology, NGS can evaluate the tumor immune microenvironment more accurately, comprehensively and efficiently, which can be used to guide clinical diagnosis and treatment, immunotherapy efficacy and prognosis evaluation.
LDT and IVD, NGP and ngs complement each other, and can make kuanran gene form a differentiated layout in the increasingly competitive market. At present, kuanran gene has formed cooperation with more than 500 medical institutions, such as cancer hospital affiliated to Fudan University, Huashan Hospital Affiliated to Fudan University, Shanghai Oriental Hepatobiliary Hospital, Beijing Temple of Heaven hospital, Beijing Xuanwu Hospital, etc.
02. Take the lead in promoting the next generation, and commercialize pathological diagnosis technology
Based on multiple fluorescent immunohistochemistry technology, kuanran gene is focusing on the pathological diagnosis market.
According to the report of the 2020 World Congress of Pathology, it is estimated that by 2024, the size of the global pathology market will reach 255billion yuan from 191.3 billion yuan in 2019, with a compound annual growth rate of 6.1%from 2019 to 2024. According to the prediction of Western securities, the potential market of China’s pathology industry exceeds 40billion yuan.
However, the data shows that there are less than 20000 licensed pathologists in China at present. According to the allocation requirements of the National Health Commission for one to two pathologists per 100 beds, the gap of pathologists is more than 90000. The uneven distribution of pathological resources, long diagnosis time, low efficiency and overloaded work are the main pain points faced by the pathological diagnosis industry.
Pain points mean opportunities. From HE staining to fish to immunohistochemistry, pathological diagnosis technology has not achieved a disruptive breakthrough. Bu Lingbin said,”pathological diagnosis will expand from qPCR and ngs to the next generation of pathological technology represented by multiple fluorescent immunohistochemistry.”
It is worth noting that qPCR has been applied in the Department of pathology to a certain extent. The reagent kit of NGS is not fully covered for the time being. The startup of the machine entering the hospital requires a large panel. There is no standard charging mode in the hospital, and it is still in the early stage of application. Multiple fluorescent immunohistochemistry meets the new needs of tumor immune microenvironment research, and there are kits with registration certificates and ready-made charging models, which solve many pain points of NGS admission, and is expected to be quickly implemented in the pathology department.
Multiple fluorescence immunohistochemistry is a technology specially developed for the study of tumor immune microenvironment. The existing research results show that the multiple fluorescence immunohistochemistry technology can significantly improve the detection sensitivity, detect low abundance samples, and achieve a comprehensive and objective analysis of tumor immune typing of patients. The tumor microenvironment detection based on the multiple fluorescence immunohistochemistry technology can have a deeper understanding of the mechanism of tumor occurrence, more likely to predict the response of tumor to immunotherapy, and accurately screen the population benefiting from immunotherapy.
At this stage, multiple fluorescent immunohistochemistry technology is generally in the scientific research stage, and kuanran gene is expected to become the first enterprise in China to realize the commercialization of multiple fluorescent immunohistochemistry technology. It has opened up the upstream and downstream of the industry, and has laid out a complete set of multiple fluorescent immunohistochemistry technology platforms, including opal multi label staining technology, phenoimager HT (formerly Vectra Polaris) multispectral imaging system and inform image analysis system, Seven testing products have been developed.
Next, kuanran gene will carry out the registration and certification of phenoimager HT (formerly Vectra Polaris) multispectral imaging system, further optimize the inform image analysis system, and speed up the landing of multiple fluorescent immunohistochemistry technology in the pathology department for different disease output solutions.
03. Investment perspective
Bulingbin, the founder of kuoran gene, said,”kuoran gene has carried out research and development projects and marketing according to clinical needs, achieved controllable costs, received the support of many senior clinical experts, and has a deep layout in the subdivided fields of brain tumors and hepatobiliary tumors. It has strong technical barriers and forward-looking vision, and proposed NGP (next generation pathological Technology) +ngs (next generation sequencing) Technological innovation has great potential for future development. More importantly, kuanran gene has laid out a variety of technical platforms such as multiple fluorescent immunohistochemistry (mihc), ngs, mass spectrometry, etc., forming a good scalability and brand effect.”
Zhangshouzhong, general manager of Guosheng Furui, said,”Koran gene focuses on the research and application of precision medicine transformation, and is committed to providing one-stop molecular diagnosis solutions for multiple application scenarios. First, with diversified platform innovation technology as the cornerstone of operation, it establishes an innovative laboratory self construction project (LDT) that meets clinical and scientific research needs.” Provide more application fields for clinical inspection and scientific research, and lay a sales channel for IVD products; Secondly, we will cooperate deeply with universities, enterprises, scientific research institutions and Grade-A hospitals to realize the transformation and implementation of various achievements, provide high gross profit products and profits with in vitro diagnostic reagents (IVD), and further support research and development; At the same time, the next generation of pathological diagnosis based on the platform of multiple fluorescent immunohistochemistry technology is deeply deployed to realize the commercialization. This is completely in line with the entrepreneur’s business philosophy and methodology of”potential, market and things”, that is, optimistic about the trend and determine the strategic direction; Look at the market and determine the segmentation areas; Do good deeds to the utmost and implement various plans.”