Glunovo Medical Secures China's First NMPA Approval for 14-Day Real-Time Continuous Glucose Monitoring System

On November 3, 2021, Infinovo Medical Co., Ltd., a leading enterprise in the continuous glucose monitoring (CGM) industry, announced that its “Gudekang” GN-I Continuous Glucose Monitoring System (CGMS) had received approval from the National Medical Products Administration (NMPA) for market launch.

“Goodcare” GN-I has become the first 14-day real-time continuous glucose monitoring system (CGMS) approved in China, with key performance metrics comparable to those of leading global products, marking a significant breakthrough in product technology within this field. This device enables up to 14 days of continuous glucose monitoring with stable performance and high accuracy (MARD=9.38%), representing a professional-grade CGMS product launched by Infinovo for the Chinese market. Through internal product integration and synergy, it achieves a calibration-free function. Meanwhile, its user-friendly operation meets home-use requirements, making blood glucose management smarter, more precise, and more convenient for a broad population of patients with diabetes. It provides a new medical option for improving glycemic control among diabetic patients in China.

It is reported that Infinovo Medical obtained the EU CE certification in June 2019, initiating its overseas sales. Currently, Infinovo Medical’s CGMS products are being sold simultaneously in 15 overseas countries, with their superior performance widely recognized by global users.

According to estimates by the International Diabetes Federation (IDF), there were approximately 487 million people with diabetes worldwide in 2019, making it an increasingly serious global chronic disease that threatens human health. With socioeconomic development and changes in lifestyle, the incidence of diabetes in China has risen rapidly; China has become the country with the largest number of diabetes patients globally, reaching 119 million. Influenced by factors such as population aging, unhealthy diets, accelerated urbanization, and physical inactivity, the IDF predicts that the number of people with diabetes will continue to increase both globally and in China. Effectively controlling blood glucose levels and improving patients' quality of life have become significant challenges for contemporary clinical medicine.

Blood glucose monitoring is a critical component of diabetes management. Its results help assess the severity of glucose metabolism disorders in diabetic patients, formulate reasonable glucose-lowering regimens, reflect the efficacy of glucose-lowering therapy, and guide adjustments to treatment plans. Continuous Glucose Monitoring Systems (CGMS) monitor changes in glucose concentration in subcutaneous interstitial fluid via glucose sensors, providing more comprehensive and continuous blood glucose information (typically updating glucose levels every 1–5 minutes, offering either retrospective or real-time data). Compared with traditional fingerstick blood glucose meters, CGMS eliminates the need for finger pricking, thereby reducing patient discomfort. Furthermore, by providing continuous "trend line" data, CGMS offers advantages such as blind-spot-free monitoring, dynamic real-time data analysis, and real-time alerts, making it a revolutionary product in the field of blood glucose monitoring.

With advancements in CGMS technology and the expansion of application scenarios, the CGMS industry has experienced rapid development over the past five years, emerging as a remarkable high-growth blue-ocean sector. Data from the Hong Kong Stock Exchange shows that its market size grew from just USD 1.7 billion in 2015 to USD 5.7 billion in 2020, representing a compound annual growth rate (CAGR) of 28.2%, and is projected to reach USD 36.5 billion by 2030, with a CAGR of 20.3%. Among regional markets, China has been the fastest-growing. Over the past five years, the Chinese CGMS market expanded from only USD 8.78 million in 2015 to USD 100 million in 2020, achieving a CAGR as high as 73.2%. The market size for CGMS products in China is expected to grow to USD 2.6 billion by 2030, at a CAGR of 34%.

Dexcom, Abbott, and Medtronic, three American giants, account for nearly 100% of the global market share. In China’s CGM market, Abbott and Medtronic together hold over 90% of the market share. However, due to the relatively high prices of imported products, the adoption rate of domestic CGMS among patients is less than one-tenth of that in developed countries. The “Gudekang” CGMS launched by Infinovo Medical is poised to break the long-standing monopoly of European and American companies in this field, significantly reducing medical expenses and improving people’s quality of life.

Infinovo Medical, established in 2016, is a global innovative enterprise dedicated to continuous glucose monitoring (CGM) technology. Its manufacturing base is located in Nantong, Jiangsu Province, with R&D centers in Suzhou and London, and an overseas sales center in Amsterdam, the Netherlands. Over the past five years, Infinovo Medical has achieved rapid, leapfrog growth by focusing on breakthrough research in semi-permeable membrane materials, dehydrogenase technology, blood glucose prediction algorithms, data mining and interaction, soft cannula delivery systems, wireless transmission systems, and ecosystem development. The company’s CGM products have reached industry-leading standards across all key parameters.

Jiunuo Medical’s outstanding performance has attracted strong interest from leading healthcare venture capital firms. Over the past five years since its establishment, Jiunuo has completed multiple rounds of financing, including a Series C round in June this year amounting to hundreds of millions of yuan. The company’s current institutional shareholders include LVC, Prosperico Ventures, Vertex Venture Capital, RAYS, TF Capital, GL Ventures, HM CAPITAL, Zhongyuan Qianhai Fund, YF Capital, Ming Bioventures, and Life Capital.

The company is accelerating the construction of its global production bases and expects to complete the world’s first fully automated production line based on dehydrogenase technology and printing processes in 2023, with a designed annual capacity of 12 million units. At that time, Infinovo Medical is poised to become the first company globally to achieve commercial mass production of CGM devices based on dehydrogenase technology, establishing itself as a leading enterprise in China’s CGMS industry.

Mr. Cheng Rongen, Founder of Infinovo Medical, stated, “We are delighted that the ‘Gudekang’ GN-I Continuous Glucose Monitoring (CGM) System has received approval from the National Medical Products Administration (NMPA) for market launch. This will provide more options for the vast population of diabetes patients in China and marks a significant milestone in the development of Infinovo Medical. We believe that, leveraging our excellent marketing team and extensive experience in the local market, we can bring this product to more diabetes patients, helping them achieve more effective diabetes management, thereby improving their health outcomes and quality of life. Through continuous independent research and development innovation, Infinovo Medical is committed to promoting the application of CGM technology across broader fields, empowering the entire industry chain related to diabetes management and care.”

Loyal Valley Capital has always adhered to the investment values of “long-termism, focus, and altruism,” striving to build China’s premier investment research and post-investment management teams. Covering three major sectors—new consumption, healthcare, and advanced manufacturing—the firm leverages in-depth industry research and proactive post-investment value creation to partner with outstanding entrepreneurs. Together, they aim to build great enterprises that represent the future growth direction of China’s economy and create value for society. Since its establishment in 2015, Loyal Valley Capital has invested in more than 70 leading companies that exemplify the future trajectory of China’s economic development, including Bilibili, ByteDance, POP MART, Perfect Diary, NetEase Cloud Music, Jiangxiaobai, Junshi Biosciences, InnoCare Pharma, Abbisko Therapeutics, CARsgen Therapeutics, Genetron Health, Henlius, Supcon Technology, Bayi Space, Avary Holding, O-Net Technologies, and Unisoc.

Prosperico Ventures is an investment institution focused on the healthcare sector, dedicated to value investing that identifies high-quality enterprises across the healthcare industry chain and facilitates their rapid growth. Since its inception, Prosperico Ventures has continuously refined its investment layout in sub-sectors such as innovative medical devices, pharmaceutical R&D, precision medicine, and chain medical services. Its portfolio includes companies such as Leno Medical, PhenoGen Biopharma, Infinovo Medical, Genetron Health, and Fourier Intelligence.

Vertex Ventures, established in 1988, is one of Asia’s earliest venture capital firms and a member company of Temasek Holdings. Headquartered in Singapore, Vertex Ventures maintains branch offices in entrepreneurial hubs such as China, the United States, Israel, and India. Vertex Ventures China launched its early-stage venture capital operations in China in 2008 and currently operates offices in Beijing, Shanghai, and Shenzhen. It manages multiple USD and RMB-denominated funds, with assets under management exceeding RMB 10 billion. Vertex Ventures China has made extensive investments in the healthcare sector, including portfolio companies such as Chipscreen Biosciences, Harbour Biomed, Phoenix Healthcare Group, Recombinant Bio, Edge Medical, Akeso Biopharma, Rigor Pharmaceuticals, Infinovo Medical, and Haici Medical.

RAYS was established in Beijing in September 2014, focusing on incubating and supporting innovative startups in the healthcare sector. The medical funds initiated and managed by RAYS are positioned as specialized early-stage venture capital vehicles dedicated to the healthcare industry, investing in high-potential enterprises in medical devices, biotechnology, innovative drug development, and healthcare services.

RAYS strives to become China’s most competitive healthcare venture capital fund management firm. It has been recognized as one of the Top 10 Emerging Investment Institutions in China’s Healthcare Sector by 36Kr and ranked among the Top 50 Early-Stage Investment Institutions Most Preferred by LPs in China.

TF Capital focuses on venture capital investment in the life sciences sector, primarily investing in promising early-stage and growth-stage companies. Through diversified and strategic positioning and by selecting high-quality partners, it aims to seize opportunities amid the rapid development of China’s life sciences industry. The investment team brings years of experience and extensive industry resources in these fields, with the goal of achieving rapid growth alongside its portfolio companies.

GL Ventures is Hillhouse’s venture capital platform dedicated to early-stage innovative companies, with a focus on key sectors including hard tech, software, biotechnology, new materials, emerging brands, and consumer technology. GL Ventures seeks out all entrepreneurs who are passionate about technology and believe in innovation. We aim to be the first call for founders seeking financing, and we look forward to accompanying them throughout their entrepreneurial journey.

HM Capital is a specialized fund dedicated to healthcare investment. Leveraging the ecosystem advantages of Huimei Medical Group, it invests in the healthcare ecosystem through a multi-dimensional and holistic approach. Committed to building a professional investment platform with global vision and local execution capabilities, HM Capital helps early-stage and growth-stage healthcare companies achieve rapid development.

We work closely with fast-growing, innovative healthcare companies to provide comprehensive strategic value-added services and systematic empowerment from a global perspective, sharing HM CAPITAL’s worldwide business network and resource ecosystem with outstanding entrepreneurs.

Zhongyuan Qianhai Fund was established in 2019 with a scale of RMB 5 billion. The fund adopts a unique "fund of funds + direct investment" business model, with investment directions covering information technology, intelligent manufacturing, internet, consumer goods/modern services, biotechnology/healthcare, new materials, and new energy/energy conservation and environmental protection. The fund has cumulatively invested in over 60 direct investment projects and 7 funds.

YF Capital, established in 2010, is dedicated to fostering forward-looking enterprises, partnering with them to create long-term value and build a better future. The firm focuses on sectors including deep tech, enterprise services, green energy, modern agriculture, biotechnology, and consumer industries, working alongside startups to drive technological innovation and sustainable development, thereby facilitating industrial transformation and upgrading.

Ming Bioventures, established in 2018, is dedicated to partnering with outstanding enterprises in the fields of innovative drugs, biotechnology, and medical devices (including diagnostics), accompanying entrepreneurs in their growth and addressing substantial unmet clinical needs. Currently, Ming Bioventures manages five funds with a total scale of approximately RMB 2 billion. Since its inception, Ming Bioventures has been ranked first on Zhiyin Capital’s “Invest in Suzhou” Top Institutions List, named the Best Early-Stage Healthcare Investment Firm of the Year at the 5th Excellent Healthcare Investment Awards in 2021, and repeatedly recognized as an Outstanding Cooperative Fund by the Suzhou Industrial Park Guidance Fund. To date, Ming Bioventures has invested in nearly 40 companies across sectors such as novel drug development, biotechnology, medical devices, and diagnostic reagents, with multiple portfolio companies planning to go public within the next 18 months.

Life Capital is a leading financial services institution in China, specializing in the broader healthcare sector. Its portfolio encompasses investment banking and venture capital operations, dedicated to cultivating future industry leaders in the healthcare field.

Our team members hail from renowned investment banks, academic institutions, and healthcare enterprises, bringing decades of accumulated expertise in the healthcare and investment and financing sectors.

Over the past four years, the team has completed dozens of financing and M&A transactions in the healthcare industry, with a cumulative value amounting to tens of billions of RMB. These transactions span various sub-sectors, including new drug R&D, medical devices, diagnostics, consumer healthcare, smart healthcare, and health insurance. In 2021, the company was named Healthcare Financial Advisor of the Year by VCBeat. In 2020, Life Capital was ranked among the Top 3 financial advisory firms in China’s healthcare sector in the China Financial Advisory Firm Rankings organized by Qiming Technology, a renowned financial big data institution.