InnoPen®: China's First Domestically Developed Smart Insulin Pen Receives NMPA Approval

This October, the intelligent electronic insulin injection pen—InnoPen®—developed by Kailian Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Kailian Medical”) successfully obtained the Class III medical device registration certificate issued by the NMPA.

InnoPen® is the first intelligent electric insulin pen independently developed by a domestic enterprise and approved for market launch by the NMPA in China.The approval of InnoPen® not only signifies the National Medical Products Administration’s recognition of the product’s safety, efficacy, and innovativeness, but also marks a breakthrough in China’s diabetes management market. Through independent innovation, domestic manufacturers have truly achieved digital and intelligent management of chronic diseases by integrating smart hardware with cloud-based data, ushering in a new chapter for diabetes care in the era of digitalization.

For patients with type 1 diabetes, insulin is indispensable. However, during diabetes management, long-standing pain points persist, including poor adherence to blood glucose monitoring and unclear glycemic control targets. Insulin dosing relies primarily on empirical judgment; patients using traditional syringes struggle to accurately regulate their daily insulin requirements, leading to a heightened risk of hypoglycemia due to overdosing. Furthermore, the cumbersome process of recording blood glucose data and insulin administration is prone to omissions and errors, thereby hindering physicians’ ability to make informed decisions and implement effective chronic disease management plans.

Smart electric insulin pens can precisely maintain patients' blood glucose balance and address the aforementioned challenges by acquiring and analyzing their blood glucose data.This year, the American Diabetes Association (ADA) formulated"Standards of Medical Care in Diabetes"Digital coaching and digital self-management are thus employed as effective educational and supportive strategies to address the aforementioned pain points.It affirms the role of digital technologies in diabetes management and adds extensive content on smart insulin pens, along with evidence of their effectiveness.

Kailian Medical’s newly approved InnoPen® is an intelligent insulin pen that features continuous innovation and iteration in product design, empowered by digital technologies. It is understood that, apart from Kailian Medical, the only intelligent insulin pen with connectivity and data transmission capabilities currently available in the Chinese market is NovoPen® 6.

The breakthrough of InnoPen® lies inIt not only features Bluetooth connectivity, allowing it to pair with patients’ mobile devices to transmit real-time data generated during disease treatment and management. This enables patients to view, record, share, track, and receive reminders for each insulin injection. Furthermore, its design moves away from the traditional mechanical delivery mechanism of conventional insulin pens, employing a micro-motor-driven system to achieve smoother and more precise insulin administration (with dose increments as fine as 0.1 units, meeting the injection needs of diabetic patients across all age groups, including children).

From a functional perspective, InnoPen® features a large screen that automatically displays injection history, automatic countdown after injection, and an automatic air-bleeding function. These features effectively ensure infusion safety for users and prevent issues such as duplicate or missed injections.

Distinct from traditional insulin syringes, Kailian Medical has also established a professional cloud-based backend for diabetes management., enabling the product to synchronize and manage data from blood glucose meters and CGMs, effectively helping users monitor blood glucose levels and learn to estimate completed doses of active insulin, thereby reducing the occurrence of hypoglycemia and other issues.Meanwhile, the product’s algorithmic analysis capability for large volumes of data enables the provision of more precise treatment plans for patients., enabling the attending physician to promptly make clear treatment adjustment decisions through data sharing.

It is evident that Kailian Medical has departed from its previous mechanical infusion model, adopting a micro-motor design to enhance the precision of insulin injection. By establishing a digital diabetes ecosystem, it has truly achieved visualization and digitization of injection behaviors, as well as closed-loop diabetes management. Through an integrated approach combining hardware and software, Kailian Medical has created a “smart” insulin pen and built a comprehensive, multi-faceted digital ecosystem for diabetes support.

Building a digital diabetes ecosystem that integrates offline medical devices, pharmaceuticals, and healthcare institution resources to provide comprehensive support for online diabetes management has become a top priority in addressing the blood glucose control needs of the diabetic population. The intelligent digital management of insulin therapy represents a significant development trend that offers substantial benefits to both hospitals and patients. Recent initiatives by Novo Nordisk and Medtronic in this area further underscore this point.

InnoPen® clearly caters to this development trend. Moreover, its functionality has evolved beyond early smart insulin pens that could only record single-dose administrations, thereby truly innovating and transforming diabetes management models.

However, Huang Xiaomin, the founder of Kailian Medical, had already identified this direction as early as 2014 and firmly believed thatThe “Internet+” model based on medical hardware devices presents ongoing opportunities for development, with the construction of a digital-intelligent ecosystem for diabetes being particularly crucial.

That year, Huang Xiaomin founded Kailian Medical, focusing on the research, development, and production of precision infusion devices for micro-dose medications, while also making early strategic investments in product intelligence and cloud-based data exchange. Unlike similar infusion devices for chronic disease management, Kailian Medical incorporated Bluetooth technology into its first-generation product—the Kailian LePump® Insulin Pump—and collaborated with partners to jointly develop APP platforms and cloud data interaction platforms for diabetes and rare diseases. This approach enabled long-term services for patients with chronic and rare conditions, established communication channels between doctors and patients, created a care network, and ensured that patients’ treatment received continuous medical attention.

In just a few short years, Kailian Medical has achieved a series of breakthroughs in the fields of diabetes, chronic diseases, and rare diseases. Through the deep integration of “digital technology + products,”Independently developed solutions including pituitary hormone pumps, insulin pumps, and intelligent medication management systems. This year, the approval of InnoPen® reflects Kailian Medical’s years of exploration and accumulation in the field of diabetes, as well as the correctness of its strategic direction.

Huang Xiaomin told VCBeat.“Although many companies have made valuable explorations in the field of diabetes, the level of intelligence in the insulin pen segment within the digital and intelligent diabetes ecosystem has long been insufficient. Since its inception, Kailian Medical has keenly anticipated the trend toward digital and intelligent diabetes management, strategically positioning itself through smart hardware integrated with cloud-based data management technologies. Years of exploration have enabled Kailian Medical to launch new smart insulin pen products simultaneously with, or even ahead of, their European and American counterparts, thereby providing a robust supplement to the digital and intelligent diabetes ecosystem. Through InnoPen® and the Kailian LePump® insulin pump, Kailian aims to offer patients undergoing insulin therapy a more comprehensive chronic disease management solution.”

From laying the groundwork with Bluetooth technology to now offering a supporting cloud-based management service platform, Kailian Medical has successfully established its competitive moat in the field of chronic disease management. This achievement stems from its accurate understanding and R&D application of the deep integration of “digital technology + products,” enabling rapid product iteration by leveraging the company’s years of accumulated expertise.

According to data from the International Diabetes Federation (IDF) Diabetes Atlas, the number of people with diabetes in China increased from 90 million in 2011 to 140 million in 2021 over the past decade, representing a 56% increase. China has become one of the largest diabetes markets globally. This trend has inevitably driven the expansion of related sectors, including the smart blood glucose meter market, personalized services market, oral hypoglycemic agents market, and insulin market.

However, what kind of solution can better help patients achieve diabetes management remains to be answered. From the market development situation since the outbreak of the "Hundred Sugar War" in China in 2016, digital and intelligent chronic disease management clearly has high clinical value and good market prospects. Relevant diabetes application guidelines are also promoting the use of digital technology in the field of diabetes management, especially in blood glucose monitoring and insulin treatment, and propose that the application of digital technology will be more conducive to achieving corresponding management goals.

Nowadays, driven by favorable policies, China’s digital chronic disease management industry has moved from the initial stage of traffic competition to a phase of industrial expansion, with the overall market becoming more mature. The digital management of diabetes has evolved from the 1.0 stage, which emphasized “information collection” and focused on establishing chronic disease monitoring systems and information management platforms for single diseases, to the 2.0 stage, which emphasizes “information sharing” and centers on building regional healthcare information platforms that enable interconnectivity and data exchange among tertiary and secondary hospitals, primary healthcare institutions, and across multiple disease types.

In the future, digital-intelligent diabetes management will shift its focus toward “information utilization,” marking the advent of Stage 3.0 development, in which technologies such as big data and artificial intelligence are leveraged to monitor and utilize chronic disease data, thereby enhancing patient management outcomes. This overarching trend of upgrading digital-intelligent management will create greater opportunities for enterprises equipped with capabilities in digital-intelligent diabetes care.

At that time, the user data accumulated by enterprises, along with user health profiles generated through digital technologies such as the Internet of Things (IoT), artificial intelligence (AI), and big data, will help companies explore more business models and development paths. These efforts aim to meet the diverse needs of patients with chronic diseases, including strengthening disease management and reducing risks for patients in the early stages. For a vibrant company with a promising future, continuous innovation is the most critical attribute.

Addressing urgent clinical challenges such as missed insulin injections and the digitalization of insulin administration records, Kailian Medical has not only achieved breakthroughs in the design of its hardware product for micro-dose drug infusion—the insulin pen—but also integrated communication and internet healthcare technologies to establish the Kailian Cloud Management Platform, thereby expanding possibilities for chronic disease management models.

Furthermore, given the lengthy cycle for bringing medical products to market, Kailian Medical has already prepared next-generation, smarter, and more innovative products in both its pump and smart pen product lines, which have entered the regulatory approval process. In contrast, the products currently on the market are based on a technology platform from five years ago. Moving forward, Kailian Medical will continue to focus on intelligent drug infusion and digital-intelligent management of chronic diseases, and will work to enhance the digital-intelligent ecosystem for diabetes through collaborations with various manufacturers.