"In the death cases of acute myocardial infarction, about 50%~70% of the people are delayed because they did not receive timely and correct rescue before arriving at the hospital. Recently, at the kick-off meeting of a project called "R&D of High-performance Immune On-site Rapid Detection System", Hu Yanhui, chairman of Yahuilong, said in an exclusive interview with a reporter from the Securities Times that the rapid detection system and supporting reagents will provide patients with rapid and accurate on-site immunodetection methods.
"The system is fully capable of condensing the whole process of complex manual operation from sampling to results in the traditional laboratory to less than 15 minutes in the ambulance, realizing efficient diagnosis, preparing for rescue and admission in advance, and truly saving lives." Hu Yanhui said.
According to reports, the project is a national key research and development plan, led by Yahuilong, and Professor Zhou Zhou of Fuwai Hospital of the Chinese Academy of Medical Sciences is the project leader. The project will fill the gap of on-site rapid detection of cardiovascular and cerebrovascular critical diseases in China, and the self-developed complete system will reduce the cost of medical treatment for patients and promote the industrialization and marketization of high-end medical technology products while completing import substitution, which is of great significance for comprehensively improving the diagnosis and treatment capacity of cardiovascular and cerebrovascular diseases.
Conquer a number of key technologies
Behind the introduction of the project of "R&D of High-performance Immunoassay On-site Rapid Detection System" is a national key R&D plan. According to the announcement released by Yahuilong on December 14, Yahuilong recently signed the "National Key R&D Program Project Task Book" with the Ministry of Science and Technology of the People's Republic of China, and took the lead in undertaking the research and development of high-performance immune on-site rapid detection system for the key special project of "diagnosis and treatment equipment and biomedical materials" of the "14th Five-Year Plan" National Key R&D Plan.
On December 16, at the project kick-off meeting, Hu Yanhui said that the project was led by Yahuilong, and Professor Zhou Zhou served as the project leader. According to the clinical needs of accurate and quantitative on-site rapid immunoassays, through key technical research, high-performance immunofield rapid detection systems, and completed the research and development of a variety of cardiovascular and cerebrovascular marker detection reagents, we are committed to solving the problems of on-site whole blood detection interference, low sensitivity of micro-detection, and time-consuming detection points, and improving the overall medical service capacity of existing critical and severe disease in specific scenarios.
Hu Yanhui introduced that one of the key technologies in the research and development project of high-performance immunofield rapid detection system is the development of a cardiovascular and cerebrovascular disease detection system based on microfluidic chemiluminescence technology, covering three parts: instruments, reagents and chips, which is also the research direction of Yahuilong's current key layout.
"In the field of cardiovascular, after years of preparation, this year we have launched and carried out the "multi-center research on the diagnostic value of high-sensitivity troponin" with many well-known hospitals such as Fuwai Hospital , to establish the normal reference interval of high-sensitivity troponin and the triage cut-off value of high-sensitivity troponin in patients with suspected acute coronary syndrome in emergency departments in apparently healthy people of different ages and genders in China, to achieve full coverage and linkage detection of central laboratory and emergency POCT, and to explore the establishment of detection standards and industry norms for cardiovascular markers truly applicable to the Chinese population. Internationally, we have cooperated with Japan's MBL in research, striving to formulate an international standard for high-sensitivity troponin in whole blood, and promote China's scientific and technological innovation to the world. Hu Yanhui said.
But Yahuilong's technical breakthroughs don't stop there. Hu said that Yahuilong will also overcome cascade sensitization rapid luminescence technology, full-component lyophilization and online reconstitution technology, develop high-sensitivity chemiluminescence detection reagents that can be stored at room temperature, develop microfluidic immunopolydetection chips for magnetic particle chemiluminescence, and develop intelligent identification and monitoring modules based on depth Xi and opto-mechanical electromagnetic temperature modules. The whole set of microfluidic immunoassay system can solve the clinical pain points of complex reaction system of whole blood sample on-site detection, many interference factors, poor accuracy and low sensitivity of whole blood immunoassay results, and long detection time caused by multiple steps and indicators.
At the same time, Hu Yanhui said that Yahuilong will also make efforts to real-time detection at home, and use the innovative technology of microfluidics to gain valuable time for the rescue of patients with sudden cardiovascular and cerebrovascular diseases.
According to reports, the implementation period of the above project is from November 2023 to October 2027, Yahuilong has formulated a detailed and clear task plan, and it is expected that a number of related innovative products will be released during the project implementation period, and the localization of microfluidic chips and optical detection devices will be fully realized.
Why Ahuilong?
It is understood that in 2014, the State Council issued the "Plan on Deepening the Management Reform of the Central Financial Science and Technology Plan (Special Projects, Funds, etc.) (Guo Fa [2014] No. 64), and established a new national key research and development plan, focusing on funding the core competitiveness of the industry, major common key technologies and product research and development, as well as major international scientific and technological cooperation. At the same time, the key special project is the carrier for the organization and implementation of the national key R&D plan, focusing on major national strategic tasks, goal-oriented, and carrying out the whole chain of innovative design and integrated organization and implementation from basic frontiers, major common key technologies to application demonstrations.
From the above information, it is not difficult to find that the strategic significance of the national key R&D plan is huge, why did the national key R&D project of "R&D of high-performance immune on-site rapid detection system" choose to be led by Yahuilong?
In this regard, Hu Yanhui said: "On the one hand, we are optimistic about the company's many years of R&D experience and technology accumulation in related fields, and secondly, we are also optimistic about Yahuilong's huge advantages in technology transformation as a listed company. He further said that the approval of this project is the country's recognition of Yahuilong's R&D and application capabilities in the field of biomedical testing, which reflects the company's advantages in technological innovation strength, organizational management capabilities and talent accumulation, which is conducive to the company to further strengthen the research and development of microfluidic cutting-edge biological detection technology, and is of great significance for comprehensively improving the diagnosis and treatment capabilities of acute and critical cardiovascular diseases. The company will also take the implementation of this project as an opportunity to actively respond to the major strategic needs of the country, continue to increase R&D investment, and launch in vitro diagnostic products that are more in line with the needs of clinical use.
According to reports, since its establishment, Yahuilong has always adhered to the responsibility and responsibility of a national enterprise, with the mission of "focusing on life and health and striving to make science and technology benefit mankind", and is committed to providing high-quality and high-performance in vitro diagnostic products and services for the global medical and health industry.
"Over the years, we have never stopped R&D and innovation in the field of IVD, and now we have six in vitro diagnostic technology platforms such as chemiluminescence, biochemical detection, indirect immunofluorescence, western blotting, fluorescence immunochromatography, colloidal gold immunochromatography, etc., and our products cover autoimmunity, reproduction, infection, diabetes, liver disease, In six characteristic fields such as cardiovascular, and on this basis, we continue to explore excellent industry-university-research cooperation models and academic exchanges at home and abroad, continue to make efforts to improve the technical level and innovation ability, and have achieved a series of achievements to promote the progress of the industry. At the same time, we have also established an industrial chain layout from raw material development to product research and development to production and sales. In recent years, Yahuilong has invested more in R&D and innovation, successively set up R&D centers in Tokyo, Wuhan and Changsha in Japan, and set up production bases in Xiangtan, Hunan, constantly forging ahead and assuming the responsibility of promoting a more prosperous IVD industry in China. Hu Yanhui said.
At the same time, Yahuilong is committed to continuously solving unmet clinical needs through new technologies, and gradually forming multiple growth points. In the development of a new generation of technology, the company is laying out microfluidic and sequencing business. In addition to consolidating the advantages of autoimmune diagnosis, the company has also successively laid out multi-platform businesses such as biochemical diagnosis and sequencing.
According to Yole statistics, the total size of the global microfluidic chip industry in 2022 will be $18.1 billion, and the global microfluidic chip market share is expected to reach $20.6 billion by 2028. The top 3 microfluidic market share segments are point-of-care diagnostics, clinical testing, and pharmaceutical and life science research. It is believed that the company's layout of the microfluidic technology track will bring new performance growth points to the company in the near future.
Go overseas and PK with giants
It is understood that at present, mainland IVD enterprises are facing multiple challenges, the main raw materials required are highly dependent on foreign imports, many core raw materials, key components and advanced testing technologies are "stuck" by Western countries, and there is still a large gap between domestic products and foreign countries in terms of performance and quality stability. At the same time, most of the low-end technology fields of the mainland IVD industry have been localized, such as enzyme-linked immunoassay technology and clinical biochemical diagnosis technology, while in the middle and high-end technology fields, such as chemiluminescence detection and high-end POCT, international products have entered the market early, and the market recognition and coverage are high. Only a few domestic enterprises in China occupy a high market share, and domestic products must find a breakthrough in product performance and clinical recognition if they want to enter the market.
However, it should be noted that in recent years, with the gradual rise of domestic IVD companies such as Yahuilong, the above-mentioned industry challenges are being dismantled. Hu Yanhui introduced that Yahuilong has been building a matrix of external products in a targeted manner, and the overseas installed capacity has risen rapidly. The company has created a product matrix for overseas and in line with the characteristics of overseas markets according to customer needs, such as the company's weak medical foundation in the vast developing country market, and continues to export its own advantages of enzyme-linked immunoassay products. At the same time, in view of the characteristics of overseas population density and small demand for single detection, the company has launched iFlash-1800 and iFlash-1200 chemiluminescence instruments, which can better meet the needs of overseas customers in terms of detection volume and cost, and also drive the rapid increase in the cumulative installed capacity of chemiluminescence instruments.
At the same time, on the one hand, Yahuilong has built its own localized service team and sales team in strategically important markets, such as establishing a local sales team in Athens, Greece, and establishing a local regional service center in Egypt in North Africa and Saudi Arabia in the Middle East to create a Mediterranean service system; India is the main player, and Latin America is dominated by Brazil and Chile.
Looking forward to the future, with the improvement of the economic development level of the mainland, the improvement of residents' health awareness and the improvement of payment ability, the development space of the in vitro diagnostic industry is huge. The growth rate of China's IVD industry is about 18%, much higher than the global growth rate of less than 5%, and the competition between domestic enterprises in the middle and the head and international IVD giants will become particularly fierce.
Hu said frankly that with the promotion of demand-side factors such as aging, urbanization, hierarchical diagnosis and treatment, and health awareness, as well as the progress and upgrading of domestic cutting-edge detection technology, the clinical development of new projects and new indicators, and the improvement of supply-side capabilities such as self-sufficiency upgrading of raw materials, I believe that in the next 5 to 10 years, domestic IVD companies will still be able to maintain the momentum of rapid development and compete with internationally renowned in vitro diagnostic brands.
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