The | is elegant
Editor| Peng Xiaoqiu
36Kr learned that Shenzhen Silicon-based Bionic Technology Co., Ltd. (hereinafter referred to as "Silicon-based Bionics") has recently completed a round of financing of more than 500 million yuan, jointly led by CPE Yuanfeng and China Life Science and Technology Innovation Fund under China Life Investment Company, followed by Qianhai Fund, Jiangu Capital, C&D Emerging Investment, Jingming Capital and old shareholder Luxin Venture Capital, etc. This round of financing will be used for the technological upgrading, marketing promotion and new product line development of CGM products.
In the past year, "Silicon-based Bionics" has completed three consecutive rounds of C series financing totaling more than 800 million yuan, and the investors include source code capital, Sunshine Ronghui, Luxin Venture Capital, Dachen Caizhi, Hubai Capital and other well-known institutions.
From the perspective of product layout, "silicon-based bionics" focuses on the research and development and industrialization of medical active implantation and medical artificial intelligence. Its businesses include continuous glucose monitoring systems (CGM), diabetic retinopathy assisted diagnostic software, artificial retinas and capsule gastroscope robots.
Specifically, CGM instrument is one of the key businesses of "silicon-based bionics", which indirectly reflects blood glucose levels by monitoring the glucose concentration of the subcutaneous interstitial fluid through glucose sensors, so as to provide continuous and comprehensive blood glucose data, easy to understand the trend of blood glucose fluctuations, and find that high blood sugar and hypoglycemia are not easily detected by traditional monitoring methods, which have been widely used in clinical practice, and many domestic and foreign guidelines recommend clinical use.
36Kr learned that the current key business of "Silicon-based Bionic", GS1 Silicon-based Dynamic Continuous Glucose Monitoring System (CGM), has been approved by the State Drug Administration on November 4, 2021, becoming the first domestic continuous glucose monitoring system with finger-free blood calibration.
According to JP Morgan, diabetes is one of the largest, fastest growing and most exciting markets in MedTech. This judgment comes from two aspects, one is the continuous growth of the diabetic population, and the other is that medical instruments have created incremental space for the diabetes market.
According to IDF data, the number of diabetes in China in 2021 is 140 million, which is the largest number of diabetes in the world, with an increase of 56% from 2011 to 2021, and this number is expected to maintain rapid growth. The market penetration rate of CGM is very low, and the penetration rate of CGM for diabetic patients in the global market in 2020 is about 5.3%, about 45.8% in the United States, and only 0.6% in the mainland, which is almost a blank market that has yet to be filled.
In the current global CGM market, Abbott and Dekang occupy an absolute dominant position. In 2020, Dekang achieved operating income of $1.927 billion (CAGR of 62.41% from 2006 to 2020) and the company's market capitalization was $43.3 billion as of January 18. Abbott's sales revenue of CGM products in 2020 was $2.635 billion, with a compound growth rate of 53.8% in three years.
However, "china's diabetes digital management is still in its infancy," said Chen Jinhao, managing director of CPE Yuanfeng, to 36Kr, "Whether it is type 1 and severe insulin-dependent type 2 patients, or ordinary type 2 patients, there are many unmet needs in the monitoring, management and treatment of diseases." ”
So, what iterations can forge better CGM products? This is reflected in three aspects.
1. Product research and development. The first is the sensor, whose research and development core involves the structural design and synthesis of the reaction medium (enzyme complex), which requires repeated experiments to complete the product stereotyping, which has the characteristics of high work difficulty, strong uncertainty and long research and development cycle. The second is the algorithm, the establishment and optimization of the algorithm calibration system not only needs to establish an algorithm model based on the sensor, but also needs to accumulate a large amount of clinical data to optimize the algorithm in depth to make the product more accurate.
2. Mass production. Batch-to-batch and in-batch differences are key indicators that affect the accuracy of data, so they put forward higher requirements for manufacturers' single-batch manufacturing processes. The scale effect of mass production has also brought strong cost advantages to enterprises.
3. Sales Channels. The choice of CGM by patients depends largely on the education of doctors, and the recognition of products by doctors requires long-term clinical observation, from product research and development to market science, from market promotion to perfect digital services, all need excellent product protection and rapid iteration capabilities, in order to obtain long-term recognition of doctors and experts. In addition, the reputation of retail users will also directly affect product sales, of which service capabilities are an important part.
Based on this understanding, the "silicon-based bionic" CGM sensor started the layout in May 2016, aiming at the second-generation sensor route, and spent two years to achieve a breakthrough in the core technology of the sensor. In 2018, "Silicon-based Bionics" began to invest in the design of CGM's whole machine, and was approved for listing in November 2021. In the same month, the production line with an annual production capacity of more than 1 million yuan was approved for production, marking the first finger-free blood calibration CGM product in mainland China to enter the stage of large-scale mass production.
In the process of CGM listing, sensor electrodes, film layers, sensing layers, algorithms, mass production, etc. are the key factors that determine performance, and the innovation of "silicon-based bionic" product "silicon-based dynamic CGM" can be reflected in four aspects.
First of all, measurement accuracy is an important evaluation index of CGM products. According to the clinical trial results led by Shandong Provincial Hospital, Sun Yat-sen University Sun Yat-sen Memorial Hospital and Shenzhen University General Hospital, the average absolute relative error value (MARD) of silicon-based dynamic CGM is 8.83%, which is one of the most important indicators concerned by CGM manufacturers, and only a few manufacturers can achieve a level below 10%; at the same time, the Consensus error raster analysis A+B area is 99.9%, and the product accuracy rate reaches the international frontier level.
The second is to upgrade the usage experience. Silicon-based dynamic CGM has functions such as fingerless blood calibration, direct mobile phone connection, 14-day real-time monitoring, high and low blood glucose reminders, and remote data sharing.
Again, multi-scenario application. The waterproof level of silicon-based dynamic CGM reaches IPX8, which supports daily activities such as exercise, bathing, swimming, etc., and is equipped with a miniature temperature sensor that can sense the ambient temperature change in real time to adjust the algorithm accordingly, so as to make the blood glucose monitoring value more accurate and suitable for the whole scene.
Scenario usage
For the hospital scene, the hospital-wide blood glucose management program of "silicon-based bionics" realizes the unified management of multi-disciplinary patients, opens up the whole process of blood glucose data display, storage and transmission, and provides good conditions for endocrine remote consultation. Helping doctors more fully understand the changes in patients' conditions, assessing the degree of metabolic disorders in patients, and formulating reasonable hypoglycemic programs are conducive to improving the work efficiency of medical staff, improving the blood glucose compliance rate of hospitalized patients, reducing the incidence of blood glucose, and helping to improve patient prognosis.
In the home scene, users can view blood glucose levels, trends, receive high and low blood glucose reminder information in real time on the silicon-based dynamic mobile phone APP, get suggestions on diet, exercise, sleep, etc., and can also realize remote data sharing and disease co-management between family members through the SiJoy Mini Program. The user's personal software also supports the generation of clinically compliant blood glucose reports for further consultation with medical professionals.
At the same time, through its silicon-based Internet hospital, combined with a professional service team composed of endocrinologists and doctor assistants, "Silicon-based Bionics" provides more digital medical services for users, users' families and medical staff in multiple blood glucose management scenarios inside and outside the hospital.
At present, 37 invention patents have been declared for related core technologies, of which 12 have been authorized for invention patents.
"Silicon-based bionic" factory diagram
Talking about future planning, Han Mingsong, executive vice president of "Silicon-based Bionics", told 36Kr that the essential purpose of CGM technology development is to improve the accuracy and reliability of products while effectively improving the blood glucose control rate of diabetic patients and reducing the living burden of diabetic patients. Silicon-based will further do a good job in the iterative upgrading of silicon-based dynamic CGM hardware products, with the help of silicon-based AI underlying technical capabilities, combined with the professional medical service team of silicon-based Internet hospitals, to provide comprehensive solutions for digital blood glucose management for diabetic patients.
Han Mingsong also said that the relevant sensor technology accumulated in the development process of CGM can not only be applied to blood glucose monitoring, but also can create a medical wearable technology platform for multi-index monitoring, so that silicon has the opportunity to serve a wider range of healthy people.
Team, "silicon-based bionics" was established in 2015, headquartered in Shenzhen, the company's core team by Caltech, University of Washington, Princeton, Tsinghua, Peking University and other famous universities at home and abroad science and engineering scientists led, the company's current scale of more than 400 people, of which R & D personnel accounted for more than 50%, the company obtained more than 100 patents authorized, the current "silicon bionics" has built a product-enabled integrated circuit design (chip design), medical active implant product development process, Artificial intelligence and medical big data three basic technology platforms.
Chen Jinhao, managing director of CPE Yuanfeng, told 36Kr that "silicon-based bionics", as the first domestic calibration-free CGM product on the market in China, and adopts second-generation sensor technology, is very promising to bring breakthroughs and changes to the current domestic diabetes digital management industry through high-quality product quality, acceptable product prices and multi-dimensional product services, and become a changemaker in the industry.
Huang Xiongtao, project leader of the National Life Science and Technology Innovation Fund, also told 36Kr: "Medical health, as an important field of scientific and technological innovation application, is ushering in great changes in China, and the National Life Science and Technology Innovation Fund is firmly optimistic for a long time. There are 140 million diabetics in mainland China, and various chronic complications caused by inadequate monitoring and management of blood glucose seriously affect the life and quality of life of the people, and place a heavy burden on individual patients, families and society. Through independent research and development, "Silicon-based Bionic" has successfully launched the first domestic CGM product using new second-generation sensor technology and preparation process, 14 days without calibration, which is at the international leading level, which can inject strong momentum into the digitization and precision of diabetes management in mainland China, and help medical, insurance and other institutions improve the effectiveness, inclusiveness and accessibility of diabetic chronic disease patient group services, which we highly recognize. ”