Kangji Medical Recognized as National 'Specialized, Sophisticated, Distinctive, and Innovative' Little Giant Enterprise; Files IPO Prospectus

Recently, the Ministry of Industry and Information Technology announced the list of the fourth batch of specialized, refined, distinctive, and innovative “Little Giant” enterprises. Kangji Medical was successfully included as a “specialized, refined, distinctive, and innovative” enterprise, thanks to its outstanding innovation capabilities and core competitiveness.

Kangji, founded in 2004, has deeply cultivated the field of minimally invasive surgery, providing comprehensive, high-quality, reliable, and accessible total solutions for minimally invasive surgical procedures to doctors and patients in China and around the world. It has now become China’s largest platform for minimally invasive surgical instruments and related consumables, currently serving nearly 50 countries worldwide and more than 3,500 hospitals across China, including over 1,000 Grade A tertiary hospitals.

As a leading enterprise in the field of minimally invasive surgery, Kangji has achieved rapid performance growth in recent years, with a compound annual growth rate (CAGR) of over 40% from 2010 to 2019. Despite the impact of the pandemic, its revenue still increased by 35.0% year-on-year in fiscal year 2021. Meanwhile, Kangji has actively expanded its global business, with overseas revenue rising by 35.8% year-on-year in fiscal year 2021.

Over two decades of trials and tribulations, Kangji has garnered numerous accolades: it was recognized as a National Key Supported High-Tech Enterprise in 2008, named a Zhejiang Province “Hidden Champion” enterprise in 2016, and awarded the Hangzhou Municipal People’s Government Quality Award in 2021.

As early as 20 years ago, the founder of Kangji Medical keenly recognized the vast growth potential in the field of minimally invasive surgery, and thus firmly chose this emerging sector, focusing on the research, development, manufacturing, and provision of minimally invasive surgical instruments for departments such as obstetrics and gynecology, urology, general surgery, and thoracic surgery.

In an era when the medical device market was monopolized by foreign companies and domestic enterprises had yet to emerge, Kangji Medical dared to be a pioneer. By conducting in-depth clinical insights and keeping pace with the latest minimally invasive technologies, it independently developed a range of surgical instruments that closely met clinical needs and aligned with the usage habits of Chinese physicians.

Kangji Medical became the first Chinese enterprise to receive marketing approval from the National Medical Products Administration (NMPA) for polymer ligation clips in 2013, and the first company to obtain NMPA Class III marketing approval for disposable electrosurgical coagulation forceps in 2015. By pioneering breakthroughs against import monopolies in the field of minimally invasive surgical instruments and consumables, Kangji has provided high-quality, reliable, and accessible minimally invasive surgical devices for Chinese physicians and patients.

As a leading provider of comprehensive minimally invasive surgical solutions in China, Kangji continues to develop a complete, innovative, and reliable portfolio of minimally invasive surgical products. From disposable and reusable minimally invasive surgical instruments, ultrasonic scalpel systems, and surgical imaging equipment to surgical robots, Kangji has established a presence across the entire field of minimally invasive surgery, committed to delivering comprehensive solutions for surgeons and patients worldwide.

Currently, Kangji is the largest manufacturer of disposable trocars in China and the second largest globally. Its disposable polymer ligation clips, disposable electrocoagulation forceps, and reusable trocars and forceps have long held the number one market share in China. Its flagship product, "endoscopic surgical instruments," is widely used as standard clinical equipment by renowned hospitals such as Peking Union Medical College Hospital.

Continuous business expansion is inseparable from large-scale manufacturing capabilities. For many years, Kangji has been committed to enhancing automation in processing and manufacturing as well as digitalization of information. In recent years, the company has extensively imported advanced precision equipment from abroad and, in alignment with production needs, independently developed multiple automated production systems specifically for Kangji. It operates a 100,000-class cleanroom workshop spanning nearly 5,000 square meters, equipped with extensive production facilities.

To accelerate digital transformation and maximize production efficiency, Kangji has implemented an ERP system for end-to-end data management spanning from R&D to market services. Meanwhile, the introduction of a MES system enables centralized control over all digital workshops, significantly boosting equipment utilization through automation and digitalization.

Kangji has implemented the Excellence Performance Management Model and the 6S Lean Management Model, strengthening quality management throughout the entire process in accordance with Good Manufacturing Practice (GMP) requirements for medical devices. “Treating every patient as our own family member and meticulously refining every product” is a code of conduct ingrained in Kangji’s corporate DNA and a shared consensus among all employees. This commitment ensures that every product safely, stably, and effectively assists physicians in performing surgeries more efficiently, thereby alleviating patients’ suffering.

Meanwhile, Kangji has established a comprehensive supply chain assurance system, exercising end-to-end control over product design and development, clinical trials, manufacturing, sales and distribution, and adverse event reporting through full lifecycle management of medical devices. Currently, Kangji is certified under the EN ISO 13485 and ISO 9001 quality management systems, the ISO 14001 environmental management system, and the ISO 45001 occupational health and safety management system, with its flagship products having obtained CE certification.

As the “first stock in minimally invasive surgery,” Kangji has consistently upheld and practiced a clinically oriented mindset of “derived from clinical practice, applied to clinical practice,” along with a product R&D philosophy of “joint creation and development through industry-academia-research collaboration.” By continuously addressing clinical needs, integrating medicine and engineering, and precisely resolving clinical pain points, Kangji has established long-term industry-academia-research-application partnerships with the top 20 tier-3A hospitals in China, thereby achieving mutual empowerment among R&D, clinical practice, and the market, as well as collaborative development and effective translation of innovations.

Kangji Medical, in collaboration with Academician Lang Jinghe, an academician of the Chinese Academy of Engineering and President of the Obstetrics and Gynecology Branch of the Chinese Medical Doctor Association, established the only provincial-level academician and expert workstation in the field of obstetrics and gynecology within a corporate setting in China. To date, it has successfully hosted six annual academic conferences, attracting over 450 industry experts.

Meanwhile, Kangji Medical has partnered with institutions such as the State Key Laboratory of Robotics and Systems, Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences, and West China Second University Hospital of Sichuan University. By inviting numerous clinical experts to engage directly with its manufacturing and R&D teams, Kangji Medical collaborates to develop innovative medical devices that align with clinical needs, while also providing customized medical device services to more precisely meet the individualized requirements of physicians.

Kangji drives market growth through academic initiatives by establishing the Kangji Academic Platform and Weekend Surgery Live Streaming Room. In collaboration with top academic experts across China, Kangji conducts academic promotion and training programs. In 2021, nearly 100 academic training sessions were held, with participation from over 100 leading experts, accumulating more than one million online views. These efforts provide a platform for communication and learning for minimally invasive surgeons in China, supporting their professional development and shared growth.

2022 Symposium on Hot Topics in Minimally Invasive Urology

Leveraging its Provincial Key Enterprise Research Institute and Provincial Enterprise Academician and Expert Workstation as platforms, Kangji actively constructs a dual-engine strategy for innovative development, adhering to the principle of “starting with clinical insights, achieving results through R&D innovation, and aiming for clinical application.”

Kangji’s outstanding R&D advantages are underpinned by two decades of accumulated expertise and craftsmanship. The company’s R&D center has been successively recognized as a Hangzhou Municipal High-Tech Enterprise R&D Center, a Zhejiang Provincial High-Tech Enterprise R&D Center, a Zhejiang Provincial Enterprise Research Institute, and a Zhejiang Provincial Key Enterprise Research Institute, currently holding 230 valid patents.

Kangji actively participates in the research and development of innovative medical devices. In 2022, Kangji’s laparoscopic surgical instruments for robotic-arm-assisted surgery passed through the “Green Channel” for innovative medical devices launched by the Zhejiang Medical Products Administration and have obtained an innovation approval certificate, marking a new breakthrough in our R&D and innovation capabilities.

During clinical application, the R&D team identified limitations in traditional laparoscopic instruments, such as rigid operation and an inability to perform complex, delicate maneuvers with precision. Through iterative research and breakthroughs, the team developed multi-dimensional laparoscopic instruments. These devices leverage the multi-articulated wrists of robotic arms to execute a wide range of surgical tasks—including grasping, dissecting, cutting, resecting, electrocoagulation, and suturing—from multiple angles. This innovation results in lighter instrument handling and enhanced operational precision, enabling surgeons to perform procedures more easily and efficiently.

In recent years, China’s medical device technology has advanced steadily, and its supporting industrial chain has become increasingly mature. Meanwhile, the state encourages independent innovation to achieve import substitution. Kangji has consistently aligned with policy directives, vigorously enhanced its independent innovation capabilities, and accelerated the development of digital smart factories. By leveraging R&D strength to drive growth and brand power to promote business operations, Kangji is ultimately committed to continuously advancing minimally invasive surgical technologies in China and facilitating the widespread adoption of minimally invasive surgical procedures.

Kangji Medical will leverage its status as a “Specialized, Refined, Differential, and Innovative” Little Giant as a key driver for continued progress. The company is committed to actively exploring frontier technologies in minimally invasive surgery, expanding and optimizing its product portfolio, strengthening independent innovation capabilities, breaking import monopolies, and achieving self-sufficiency in domestically produced medical devices. Kangji aims to provide physicians with comprehensive, reliable, one-stop total solutions for minimally invasive surgery that are closely aligned with clinical needs, while offering patients advanced, safe, effective, and affordable minimally invasive surgical products and services.