Kailian Medical's Next-Generation Insulin Pump Receives NMPA Approval

On December 13, 2019, Kailian Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Kailian”) obtained the registration certificate issued by the National Medical Products Administration for its independently developed next-generation insulin pump.

In recent years, with the continuous improvement of living standards and changes in habits and lifestyles, the incidence of type 1 and type 2 diabetes has been rising year by year. As a common and frequently occurring disease, diabetes has become the third largest non-communicable disease worldwide, posing a serious threat to human health. Currently, one of the most ideal methods for insulin therapy in diabetic patients is the insulin pump. This device, about the size of a name card, is connected to the patient’s subcutaneous tissue via a very thin tube. It continuously infuses insulin into the subcutaneous tissue at doses tailored to the body’s physiological needs, thereby maintaining stable blood glucose levels throughout the day and achieving effective diabetes control. The insulin pump is also known as an artificial pancreas.

Kailian Medical’s independently developed next-generation insulin pump is designed around patient needs, adhering to the principles of safety, simplicity, style, and cost-effectiveness, thereby infusing medical products with greater human-centricity and aesthetic appeal. For instance, the OLED color screen and capacitive touch keys not only enhance user comfort but also improve the device’s water resistance and durability. The optimized UI design simplifies operation and settings, making information clear at a glance. Bluetooth connectivity enhances data management capabilities. Features such as automatic basal rate allocation, automatic bolus calculation, seamless switching between two basal rate profiles, and on-demand switching between square wave and dual-wave bolus patterns—along with personalized adjustments—ensure safer and more effective insulin delivery. This makes insulin pump therapy no longer an expensive and complex treatment option.

As the National Medical Products Administration (NMPA) has further tightened regulations on market access for medical products, Kailian Medical’s insulin pump has undergone a multi-year process encompassing research and development, quality control, clinical validation under Good Clinical Practice (GCP) regulations, and product registration. The clinical trials for this product were led by the Chinese People's Liberation Army (PLA) General Hospital as the primary investigational site, under the direction of Professor Mu Yiming, Director of the Department of Endocrinology. At a protocol discussion meeting for this clinical project, Professor Mu stated to the principal investigators from five clinical centers in Beijing: “This marks the first time the Department of Endocrinology at the PLA General Hospital has conducted clinical trials for a domestic medical device. Our aim is to demonstrate our support for innovation in China-made medical equipment, as we believe that domestically produced medical devices with advanced technological content will see significant growth over the next decade.” After two years of clinical validation across multiple clinical centers, it was confirmed that the insulin pump developed by Kailian Medical is equivalent to imported insulin pumps in terms of safety and efficacy, making it a viable substitute for imported products.

Kailian Medical, established in 2014, boasts a management team with over two decades of industry experience and specializes in precise micro-dose drug infusion technology. Its marketed products include pituitary hormone pumps, insulin pumps, and related pump consumables. Since its inception, Kailian has strategically positioned itself in product intelligence and cloud-based data exchange. In collaboration with partners, the company has developed APP platforms and cloud data interaction platforms for diabetes and rare diseases, aiming to provide long-term services to patients with chronic and rare conditions. By establishing communication channels between doctors and patients and creating a care network, Kailian ensures that patients’ treatments receive continuous medical attention. Looking ahead, Kailian will integrate with all drug infusion devices to offer more comprehensive integrated solutions for diabetes and rare disease medication management, providing greater choices for both patients and physicians, and jointly creating a brighter future for patients.