Sibionics, China's First Company to Gain Approval and Mass-produce Finger-prick-free CGM, Submits IPO Prospectus Following Over RMB 800 Million Series C Financing

VCBeat has learned thatShenzhen Sibionics Co., Ltd. (hereinafter referred to as “Sibionics”) has recently closed its Series C++ financing round, raising over RMB 500 million. The round was co-led by CPE Yuanfeng and China Life Science & Technology Innovation Fund, a subsidiary of China Life Investment Holdings. Existing shareholder Luxin Venture Capital, along with Qianhai Fund of Funds, Jianggu Capital, C&D Emerging Investment, and Jingming Capital, participated as follow-on investors.Combined with the over RMB 100 million Series C round led by Source Code Capital, with Sunshine Ronghui and Luxin Venture Capital participating, and the over RMB 100 million Series C+ round led by Fortune Capital, with Yunbai Capital and Source Code Capital participating, Shenzhen Sibionics Co., Ltd. has completed three rounds of Series C financing totaling over RMB 800 million in the past year.This round of financing will be used for the technological upgrade of CGM products, market promotion, and the development of new product lines.

From the perspective of product layout, Sibionics has always focused on the R&D and industrialization of medical active implants and medical artificial intelligence, with its business includingContinuous Glucose Monitoring (CGM) System、Diabetic Retinopathy Computer-Aided Diagnosis Software、Artificial RetinaandCapsule Gastroscopy RobotOn November 4, 2021, the GS1 Sibionics Dynamic Continuous Glucose Monitoring System, developed by Shenzhen Sibionics Co., Ltd., received approval from the National Medical Products Administration (NMPA). It became the first domestically produced continuous glucose monitoring system to eliminate the need for fingerstick blood calibration and currently represents a core business focus for Shenzhen Sibionics.

Working Principle of CGM: By monitoring glucose concentrations in subcutaneous interstitial fluid via a glucose sensor, CGM indirectly reflects blood glucose levels, thereby providing continuous and comprehensive glucose data. This facilitates the understanding of glucose fluctuation trends and the detection of hyperglycemia and hypoglycemia that are often missed by traditional monitoring methods. Currently, CGM is widely used in clinical practice and is recommended for clinical use by numerous domestic and international guidelines. With the rising global incidence of diabetes, CGM will become a crucial tool for glucose management, delivering digital glucose management services to hundreds of millions of patients with diabetes and a broader population.

The global CGM market is large and growing rapidly. In terms of sales volume, Abbott and Dexcom hold an absolute dominant position. In 2020, Dexcom reported operating revenue of USD 1.927 billion (with a compound annual growth rate of 62.41% from 2006 to 2020). As of January 18, the company’s market capitalization stood at USD 43.3 billion. Meanwhile, Abbott’s CGM product sales revenue reached USD 2.635 billion in 2020, with a three-year compound annual growth rate of 53.8%.

Whether viewed from the market capitalization of comparable companies, the sales performance of flagship products, or the market growth rate, this is a “dream sector” for investors. But what is the underlying logic behind this new trillion-yuan market? We can attempt to analyze it from the perspectives of product R&D, mass production, and sales.

1. Product R&D.First, regarding the sensor, its R&D core involves the structural design and synthesis of the reaction medium (enzyme complex). Finalizing the product requires multiple rounds of experimentation, characterized by high technical difficulty, significant uncertainty, and a prolonged development cycle. Second, concerning the algorithm, establishing and optimizing the calibration system not only requires building algorithmic models based on the sensor but also accumulating extensive clinical data to deeply optimize the algorithms, thereby enhancing product accuracy.

2. Mass production of the product.Inter-batch and intra-batch variability are key metrics affecting data accuracy, thereby imposing stringent requirements on manufacturers’ single-batch production processes. The economies of scale associated with mass production also provide companies with significant cost advantages.

3. Sales Channels.Patients’ choice of continuous glucose monitoring (CGM) systems largely depends on physician education, while physicians’ endorsement of a product requires long-term clinical observation. From product development to market education, and from market promotion to comprehensive digital services, robust product assurance and rapid iteration capabilities are essential to earn long-term recognition from medical experts. In addition, user reviews in the retail sector directly impact product sales, with service capability being a critical component.

The future market potential for CGM in China is substantial, a judgment driven by rapidly growing market demand.

According to IDF data, in 2021, China had 140 million people with diabetes, making it the country with the largest number of diabetes patients globally. The prevalence increased by 56% from 2011 to 2021, and this figure is expected to continue growing at a high rate. In terms of market penetration, the global CGM penetration rate among diabetes patients was approximately 5.3% in 2020, with about 45.8% in the United States, while in China it was only 0.6%.

Judging from international cases, the “winner-takes-all” dynamic is a common rule, with selecting the market leader being the core strategy. Although industry barriers are high and the competitive landscape appears crowded, the number of truly competitive players is limited. Domestic CGM companies are generally in the early stages of commercialization. It will take time to determine which company will emerge as the next billion-dollar market leader. However, enterprises possessing core advantages such as first-mover advantage, robust product quality, and successful mass production are scarce and highly valuable targets within the industry.

In fact, the layout for silicon-based bionic CGM sensors was initiated in May 2016, targeting the second-generation sensor pathway, and it took two years to achieve breakthroughs in core sensor technologies. In 2018, work on the complete device design for CGM commenced, culminating in regulatory approval for market launch in November 2021. In the same month, the production line with an annual capacity exceeding 1 million units obtained its production license, marking the entry of China’s first fingerstick blood calibration-free CGM product into large-scale mass production. Reportedly, this is currently the largest manufacturing base for fingerstick blood calibration-free CGM products in China.

During the commercialization of CGM, key factors determining performance include sensor electrodes, membrane layers, sensing layers, algorithms, and mass production capabilities. Previously, foreign companies with first-mover advantages nearly monopolized the core technologies in this field. Domestic brands require strong independent innovation capabilities. Shenzhen Sibionics Co., Ltd. achieved this breakthrough over six years, reflecting the results of its forward-looking strategic layout.

Source: Sibionics

Sibionics’ “Silicon-Based Dynamic CGM” product overcomes the limitations of existing CGM devices—such as rigid needles, short monitoring duration, the need for fingerstick blood calibration, and mandatory scanning—through multiple technological innovations, significantly enhancing accuracy, safety, comfort, and ease of use during blood glucose monitoring. The company has filed 37 invention patents for its core technologies, 12 of which have already been granted.

Measurement Accuracy Is a Key Evaluation Metric for CGM Products。According to clinical trial results led by Shandong Provincial Hospital and participated in by Sun Yat-sen Memorial Hospital of Sun Yat-sen University and Shenzhen University General Hospital, the Mean Absolute Relative Difference (MARD) of Sibionics CGM was 8.83%. This is one of the most critical metrics for CGM manufacturers, with only a few currently achieving levels below 10%. Meanwhile, the Consensus Error Grid analysis showed that 99.9% of data points fell within Zones A and B, indicating that the product’s accuracy has reached an internationally advanced level.

Second, the user experience has been upgraded.Sibionics CGM features fingerstick-free calibration, direct smartphone connectivity, 14-day real-time monitoring, hypo- and hyperglycemia alerts, and remote data sharing.

Third, it is applicable to multiple scenarios.Sibionics CGM features an IPX8 waterproof rating, supporting daily activities such as exercise, showering, and swimming. Equipped with a micro temperature sensor, it detects real-time ambient temperature changes and adjusts its algorithms accordingly, ensuring more accurate blood glucose readings and enabling suitability for all scenarios.

Source: Sibionics

For In-Hospital Scenarios, Sibionics’ hospital-wide blood glucose management solution enables unified management of patients across multiple departments, integrating the entire workflow of blood glucose data display, storage, and transmission, thereby creating favorable conditions for remote endocrinology consultations. It helps physicians gain a more comprehensive understanding of changes in patients’ clinical status, assess the severity of metabolic disturbances, and formulate rational glucose-lowering regimens. This contributes to improved healthcare worker efficiency, higher rates of inpatient glycemic target attainment, reduced incidence of hypoglycemia, and ultimately better patient outcomes.

In home settingsUsers can view their blood glucose levels and trends in real time, receive alerts for hyperglycemia and hypoglycemia, and obtain recommendations on diet, exercise, and sleep through the Sibionics mobile app. Additionally, via the SiJoy mini-program, they can enable remote data sharing and collaborative disease management among family members. The personal software also supports the generation of blood glucose reports compliant with clinical guidelines, facilitating further consultation with healthcare professionals.

Meanwhile, Sibionics, through its subsidiary Silicon-based Internet Hospital and in collaboration with a professional service team comprising endocrinologists and physician assistants, delivers enhanced digital healthcare services to patients, their families, and medical personnel across multiple blood glucose management scenarios both within and outside hospital settings.

Sibionics, founded in 2015 and headquartered in Shenzhen, is led by a core team of scientists with backgrounds in science and engineering from prestigious domestic and international institutions such as Caltech, the University of Washington, Princeton University, Tsinghua University, and Peking University. The company currently has over 400 employees, with more than 50% engaged in R&D. It has been granted over 100 patents and, within five years, has established three foundational technology platforms to empower its products: integrated circuit design (chip design), manufacturing processes for active implantable medical devices, and artificial intelligence combined with healthcare big data.

Regarding future plans, Han Mingsong, Executive Vice President of Shenzhen Sibionics Co., Ltd., statedThe fundamental purpose of advancing CGM technology is to enhance product accuracy and reliability while effectively improving glycemic control rates among patients with diabetes and alleviating their daily life burden. Sibionics will continue to iterate and upgrade its Sibionics Dynamic CGM hardware products, leveraging its underlying AI technologies and integrating with the professional medical service team of its internet hospital to provide comprehensive digital glycemic management solutions for patients with diabetes.

Han Mingsong also stated that the sensor technologies accumulated during the development of CGM are not only applicable to blood glucose monitoring but can also establish a multi-parameter medical wearable technology platform, enabling Sibionics to serve a broader health-conscious population.

Introduction by Chen Jinhao, Managing Director of CPE YuanfengIn China, digital diabetes management is still in its early stages. There are significant unmet needs in disease monitoring, management, and treatment, whether for patients with type 1 diabetes or severe insulin-dependent type 2 diabetes, or for those with common type 2 diabetes. As the first domestically produced, factory-calibrated continuous glucose monitoring (CGM) product to be marketed in China, Sibionics employs second-generation sensor technology. With high-quality products, affordable pricing, and multi-dimensional product services, it holds great promise to bring breakthroughs and changes to China’s current digital diabetes management industry, becoming a game-changer in the sector. CPE Source Peak is committed to establishing long-term partnerships with its portfolio companies to support their sustainable development. Chen Jinhao stated, “CPE Source Peak will help Sibionics further refine its comprehensive product, technology, and market layout, positioning it as a leading enterprise in the field of digital diabetes management.”

Huang Xiongtao, Project Leader of the China Life Science and Technology Innovation Fund, stated:“As a key sector for the application of technological innovation, healthcare is undergoing significant transformation in China, and China Life Science & Technology Innovation Fund remains firmly optimistic about its long-term prospects. With 140 million diabetes patients in China, various chronic complications caused by inadequate blood glucose monitoring and management severely impact citizens’ health and quality of life, imposing a heavy burden on patients, their families, and society. Through independent research and development, Shenzhen Sibionics Co., Ltd. has successfully launched the first domestically produced continuous glucose monitoring (CGM) product featuring novel second-generation sensor technology and manufacturing processes, requiring no calibration for 14 days. This product ranks among the most advanced globally and provides strong momentum for the digitalization and precision of diabetes management in China. It helps medical institutions, insurers, and other stakeholders enhance the effectiveness, inclusiveness, and accessibility of services for patients with chronic diabetes—a development we highly endorse. Looking ahead, we look forward to collaborative empowerment, supporting the company’s growth into a leader in diabetes health management, thereby creating unique value for society and our times.”

CPE Yuanfeng is an asset management firm with a global perspective and extensive experience in China. It aims to leverage a long-term vision and value investment strategies to provide innovative investment solutions for leading enterprises in four key sectors: healthcare and wellness, consumer and internet, technology and industry, and software and enterprise services. Currently, CPE’s funds under management have earned the trust and support of more than 200 institutional investors both domestically and internationally, with cumulative assets under management exceeding RMB 100 billion. Over the past decade, the company’s core team has invested in more than 200 companies, accumulating profound industry insights and an extensive resource network. Through a robust investment research framework and professional post-investment management capabilities, CPE is committed to building long-term partnerships with its portfolio companies. It strives to support their sustainable development, deliver substantial returns to investors, promote the overall advancement of the industries in which these companies operate, and create positive social impact.

China Life Science and Technology Innovation Fund is the first private equity fund initiated and established by China Life Insurance (Group) Company, focusing exclusively on investments in technological innovation. With a fund size of approximately RMB 5 billion, it operates under a market-oriented model and primarily targets investment areas such as algorithmic technology, the Internet of Things (IoT), advanced manufacturing, new healthcare, and new consumption. Managed by China Life Capital Investment Co., Ltd., a wholly-owned professional fund investment management platform of China Life Investment Company, the fund has launched a series of strategy-focused funds prioritizing new infrastructure, new energy, and emerging industries. It is committed to becoming a “leader in new economy private equity funds” characterized by sound governance, professional excellence, and an outstanding brand. Currently, it manages 19 funds with a signed scale exceeding RMB 160 billion. Leveraging its comprehensive strengths, the fund won six prestigious industry awards in 2021 from authoritative institutions such as CVSource, China Index Academy, and Securities Times. Over the past four years, it has accumulated 24 major awards, earning high recognition from both the industry and the market.