Allez Health Enters China's Booming CGM Market with iCGM Ambitions and Submits IPO Prospectus

In 2024, CGM continued to experience robust growth.

According to Gongyan Industrial Consulting, the market size of China’s CGM sector increased by 55.4% year-on-year in 2023, and is projected to grow by 49% year-on-year in 2024.

From Abbott’s previously released Q1 2024 financial report, we can also glimpse the robust “vitality” of the CGM market. In Q1 2024, Abbott achieved revenues of $9.964 billion, with its FreeStyle Libre CGM series generating $1.5 billion in revenue, a year-on-year increase of 22.4%. This indicates that there is still substantial room for market growth for CGMs globally.

Specifically, in the Chinese market, according to Guolian Securities, the penetration rates of continuous glucose monitoring (CGM) systems for type 1 diabetes, type 2 diabetes, and gestational diabetes are only 6.9%, 1.1%, and 0.3%, respectively, due to factors such as high out-of-pocket costs and product immaturity. There remains substantial growth potential for CGM in China.

Such a vast market space has naturally attracted numerous domestic enterprises to join. Recently, VCBeat identified a new entrant—Allez Health Inc. (formerly Zense-Life Inc.)

Allez Health is a company headquartered in San Diego, California, dedicated to providing affordable metabolic health data management solutions for diabetic patients worldwide through advanced biosensor technology. In May 2024, it secured $60 million in Series A+ financing, led by South Korea’s Osang Healthcare Co., Ltd.

In 2020, Allez Health entered the Chinese market and established Zansi (Shanghai) Health Technology Co., Ltd. (hereinafter referred to as “Zansi”) to conduct research and development, manufacturing, and sales of CGM and even iCGM products within China. To date, Allez Health has built a 15,000-square-foot high-efficiency production facility in the United States and operates a 900-square-meter GMP-compliant production site in China.

During the interview, VCBeat posed the following question: “Currently, in addition to multinational giants such as Abbott and Dexcom competing in the Chinese market, a number of equally competitive domestic companies have emerged, which, to some extent, enjoy first-mover advantages. As a ‘latecomer,’ how does Zansi compete with them?”

In response, Dr. Zhang Huashi, General Manager of Zansi, stated, “This is also a question frequently asked by investment institutions. Our answer is quite simple—we have accumulated extensive experience in the CGM field.”

Taking the core founding team as an example, first, this team shares a common characteristic: all members have worked at Dexcom for many years. CEO Leif Bowman drove the market launch of Dexcom CGMs; CTO Robert Boock participated in the R&D of the Dexcom G4 CGM; and CSO Huashi Zhang also contributed to the development of the sensor membrane for the Dexcom G4 CGM.

Secondly, the three founding members have each accumulated extensive industry experience and resources in the CGM niche. For instance, CEO Leif Bowma, who specializes in marketing, has facilitated the market entry of over 100 medical products, including the aforementioned Dexcom CGMs. CTO Robert Boock has dedicated many years to sensor R&D, amassing substantial expertise in this area. As for Dr. Zhang Huashi, he focuses on the R&D of sensor membranes and participated in the drafting of the NMPA’s Technical Review Guidelines for the Registration of Continuous Glucose Monitoring Systems.

In addition to the three founding team members, Allez Health has also assembled a robust R&D team, with each member boasting over a decade of R&D experience in the CGM field.

So, what innovative momentum can such an experienced team bring to the CGM field?

In terms of products, leveraging years of industry insights, Allez Health has not only chosen to enter the CGM market but has also been striving toward iCGM development.

iCGM refers to systems that can automatically and continuously or frequently measure glucose levels in the extracellular fluid over a specified period, and reliably and securely transmit blood glucose measurement data to Automated Insulin Delivery (AID) systems, enabling more precise or intelligent management of diseases or conditions related to glycemic control.

In recent years, with the further development of CGM technology and the growing demand for intelligent diabetes management, iCGM has emerged as a prominent player in the CGM field.

The FDA has established a new category for iCGM devices—Class II Special Controls—and provided essential guidance for premarket submission, thereby streamlining the review process and accelerating the approval timeline for iCGMs. This move reflects, to some extent, the U.S. market’s strong impetus to bring iCGM products to market, as well as the significant growth potential of iCGM technology in the future.

However, to date, only three foreign companies, represented by Abbott and Dexcom, have had their iCGM products approved. Given the market’s maturity and growth potential, many companies still have the opportunity to carve out a niche in the iCGM market.

In response, Allez Health has seized the momentum to initiate the research and development of its iCGM. According to Zhang Huashi, although Allez Health’s iCGM is currently in the technical optimization phase, relevant experiments suggest that its iCGM product is poised to become the first iCGM approved in the Chinese market.

According to Zhang Huashi, the core performance indicator for iCGM products—regardless of whether they are used in conjunction with an insulin delivery system—is their ability to accurately measure low blood glucose levels. Based on the current clinical trial results of Allez Health’s CGM product, its performance has approached iCGM requirements through algorithm adjustments, thereby basically achieving iCGM functionality.

Furthermore, it is important to note that while securing iCGM approval is Allez Health’s ultimate goal, the company will also develop a pipeline of conventional CGM products prior to the official launch of its iCGM product, in consideration of corporate development strategies.

It is reported that Allez Health’s CGM product utilizes first-generation CGM sensor technology. However, it should be emphasized that, as previously mentioned, Allez Health has assembled a robust R&D team. As a result, the company has secured more than 40 invention patents to date, thereby mitigating the risk of patent infringement.

Meanwhile, it is precisely based on these more than 40 invention patents that Allez Health has achieved multiple breakthroughs in the performance of its CGM products. According to data from Phase I clinical trials and usage by over 1,500 patients for the first-generation CGM product developed by Allez Health in the United States, the device can be used continuously for 15 days. This indicates that Allez Health’s CGM product not only offers superior detection accuracy but also provides a longer duration of use.

Furthermore, in the interview, Dr. Zhang Huashi also introduced to VCBeat that, in terms of product design, Allez Health’s CGM is more compact, thereby offering greater convenience for users. In terms of cost, supported by the aforementioned 40+ invention patents and empowered by automated production lines, Allez Health’s CGM products demonstrate a significant advantage in cost-effectiveness.

Specifically, Allez Health has achieved full automation of its production lines. Its wholly-owned subsidiary, Zansi, boasts a production capacity of 500,000 units in Shanghai, ensuring product stability and production efficiency while reducing labor costs. Moreover, “when production capacity reaches 3 million units, the price of Allez Health’s CGM will be only $15.”

And now, Allez Health has also launched its second-generation CGM product. This product features continuous improvements in size and accuracy, and incorporates AI technology into its algorithms and software, thereby enhancing the intelligence of the industry to provide patients with more personalized and intelligent glucose management solutions.

According to Dr. Zhang Huashi, Allez Health’s first-generation CGM product is currently in the NMPA approval stage and is expected to be approved in 2025. Meanwhile, Allez Health will initiate FDA-registered clinical trials for its second-generation product in the United States this year, with FDA clearance anticipated in 2026 to accelerate its expansion into the North American market.

Allez Health has also devised its market promotion strategy.

On one hand, its wholly-owned subsidiary, Zansi, is seeking industry partners—such as investment firms, distributors, chronic disease management companies, and even health insurance providers—to accelerate the market launch and sales of Allez Health products in China.

On the other hand, Allez Health has recognized the strong demand among Chinese medical device companies to expand overseas in recent years. With its well-established and professional sales resources and network in European and American markets, Allez Health can also assist these companies in entering and developing their presence in Europe and the United States.

From the perspective of Zhang Huashi and Allez Health as a whole, the development potential of the CGM market in China and globally is immense. However, after years of growth, some new changes have indeed emerged in the market recently.

For example, this June, the FDA approved two over-the-counter (OTC) continuous glucose monitoring (CGM) products from Abbott, officially kicking off the OTC CGM market. In other words, a trend has already emerged in foreign markets, shifting from the more strictly regulated medical device sector to an OTC market with more pronounced consumer-oriented characteristics.

However, in the interview, Dr. Zhang Huashi emphasized that the rise of CGM in the OTC market does not imply a lowering of performance requirements for products; on the contrary, products with superior performance will undoubtedly possess strong competitiveness in the OTC market. “This is precisely why we are committed to achieving iCGM standards.”

Meanwhile, Dr. Zhang Huashi also noted that in the OTC market, cost-effectiveness is another competitiveness indicator that cannot be overlooked. Clearly, Allez Health’s CGM product already possesses a cost-effectiveness advantage.

At the end of the interview, Dr. Zhang Huashi also shared with VCBeat, “In fact, the application of CGM has far from reached its ceiling. In the future, as health awareness rises, blood glucose management may become a standard component of overall health management, and fitness enthusiasts could well emerge as a target demographic for CGM. What Allez Health aims to do in the future is to continuously expand the boundaries of biosensor applications, explore more potential uses for CGM, and provide smarter, more convenient, more precise, and superior blood glucose management solutions to a broader population.”