Shukun Technology Files IPO Prospectus Amid National AI Policy Tailwinds: Addressing the Dual Challenges of Sustained Innovation and Strategic Direction in Medical AI

For modern medicine, innovation is inevitably the key to the upgrading and transformation of the medical industry. In the past year or two, a large number of policies promoting the translation of innovations have been introduced, accelerating the pace of innovation in the healthcare sector.

On May 20 this year, the “14th Five-Year Plan for National Health” issued by the General Office of the State Council once again set the tone for the healthcare sector and its core drivers. While highlighting “digitalization” and “high-quality development” as strategic directions, the plan repeatedly emphasized the importance of promoting the application of innovative technologies such as artificial intelligence (AI). This includes launching high-quality medical equipment integrated with AI and other new technologies, facilitating the entry of eligible AI products into clinical trials, and further advancing intelligent healthcare services, real-time personal health monitoring and assessment, disease early warning, and chronic disease screening.

It is evident that innovative technologies such as artificial intelligence have become “fundamental core areas critical to national security and overall development,” while the fields of artificial intelligence and digital health are ushering in new incremental markets. However, to gain a competitive edge in these sectors, it is imperative to drive sustained innovation.“How can such innovation be sustained, and how can competitiveness be maintained throughout the innovation process?” These are the two critical questions that AI companies must address today.

As a highly innovative industry in China, medical artificial intelligence has received substantial policy support and significant attention from the business community.

The Outline of the 14th Five-Year Plan proposes to drive the industry to gradually break through frontier basic theories and algorithms, develop specialized chips, and build open-source algorithm platforms such as deep learning frameworks through a batch of major national science and technology projects, so as to further address the deficiencies and shortcomings in China’s core artificial intelligence technologies. The third batch of Beijing’s “Specialized, Refined, Differential, and Innovative” SMEs for 2022 and the list of Beijing’s Technology-Based SMEs for 2022 were successively announced, aiming to select a group of enterprises with strong innovation and R&D capabilities and promote the implementation of frontier technologies.

However, securing special government support is no easy feat. Enterprises must undergo comprehensive evaluations covering economic performance, specialization level, innovation capability, and operational management proficiency. They must also meet specific criteria, such as maintaining a long-term focus on a particular segment of the industrial chain or a specific product, and holding a significant market share in their respective domestic niche markets for their flagship products.

In the artificial intelligence sector,SHUKUN was included in Beijing’s list of “Specialized, Refined, Distinctive, and Innovative” SMEs; listed among technology-based SMEs; designated as a pilot unit for intellectual property in Beijing; and admitted to the “Science and Technology Innovation China” innovation base, being the sole medical AI enterprise.. In addition, SHUKUN was successfully selected in the joint evaluation conducted by the Ministry of Industry and Information Technology and the National Medical Products Administration"Shortlisted Entities for the AI Medical Device Innovation Challenge", becoming the only company on the list to have two projects selected in the field of intelligent assisted diagnosis. This reflects, to some extent, the recognition by the government and the industry of SHUKUN’s independent innovation capabilities and its level of technological research and development.

In terms of regulatory approval and certification, SHUKUN has also made significant progress this year, securing two Class III medical device registrations for its AI solutions for pulmonary nodules and head-and-neck imaging within a single month. To date, SHUKUN has obtained four NMPA Class III certifications, 11 NMPA Class II certifications, and four EU MDR CE certifications, making it the only medical AI company globally to hold both NMPA Class III certifications and CE certifications across the three key therapeutic areas of cardiology, neurology, and thoracic imaging.

Meanwhile, SHUKUN has established the “Digital Human” proprietary technology platform.and has built a portfolio of AI-assisted diagnostic and therapeutic products for major common diseases across various body parts, branded as “Digital Doctor,” based on the “Digital Human” platform. The company continues to innovate and iterate on its products, which have been deployed in over 2,000 hospitals. This demonstrates that the enterprise has achieved notable progress in R&D innovation, regulatory review and approval, and product implementation.

VCBeat conducted an in-depth interview with Zheng Chao, CTO of SHUKUN Technology. Using SHUKUN as a case study, the discussion aimed to address two key questions: how companies can sustain innovation amid the increasingly clear trend toward digitalization, and how they can choose the right direction during the innovation process.

Effective and sustained innovation requires two essential conditions:

First, an independently developed and proprietary technological core;

Second, practical products and models aligned with actual clinical needs.

Take SHUKUN as an example. Built upon its proprietary, independently developed core technologies, SHUKUN has established a dedicated “Digital Human” technology platform that deeply integrates medical knowledge with artificial intelligence capabilities to address healthcare scenarios characterized by complex contexts, high specialization, and stringent precision requirements. Positioning the “Digital Human” as the intelligent brain and engine for healthcare “smart manufacturing,” the company has secured over one hundred invention patents.

However, the key to technological advancement lies in whether it meets clinical needs. The development of medical AI is valuable and meaningful only when it is demand-driven, problem-oriented, and expands business innovation by referencing actual clinical requirements. It is precisely for this reason thatPrior to this, companies must address how to genuinely eliminate the barriers between cutting-edge technologies and clinical needs, achieving true integration—a challenge that has long perplexed most industry practitioners.

Zheng Chao believesThroughout the process of product innovation and iteration, integration with clinical practice has always been a critical component in the development of medical AI. For enterprises, innovation should be guided by the goal of genuinely meeting China’s public health needs, leveraging clinical integration to build a platform-based product ecosystem that delivers closed-loop value in specific scenarios. By enhancing R&D capabilities, continuously refining products, and fostering collaborations, companies can achieve their innovation objectives, ensuring that innovative technologies truly address clinical needs and are seamlessly embedded into the entire workflow of physician-led screening, diagnosis, and treatment.

Guided by this logic, SHUKUN has developed a portfolio of AI-powered medical imaging products that cover disease screening, diagnosis, treatment selection, and planning. By integrating its suite of “Digital Heart,” “Digital Brain,” “Digital Chest,” “Digital Abdomen,” and “Digital Musculoskeletal” digital doctors, the company realizes its vision of a platform-based AI imaging ecosystem. Centered on patients’ physiological functions and adopting a holistic perspective, this approach delivers more precise and convenient smart healthcare services to patients while enabling hospitals to deploy AI solutions across multiple departments, thereby breaking through the limitations of single-department, single-modality applications.

“A single product serves as the breakthrough point, but the product portfolio must be broadened to break the “single-product” constraint. As future products become increasingly tailored to specific scenarios, the key focus for AI enterprises lies in delivering “closed-loop value” to users within those specific contexts.”Zheng Chao added.

SHUKUN has now taken a further step forward,Pioneered a new clinical model for the ‘Digital Heart’ spanning the entire lifecycle of ‘screening–diagnosis–treatment,’ establishing high-barrier solutions for cardiovascular and cerebrovascular diseases.to cover the entire process from disease screening (calcium scoring) and diagnosis (intelligent diagnosis of coronary CT and MR images) to treatment selection and planning (FFR intelligent assessment based on CT images and DSA, plaque analysis, and pericoronary fat analysis).

Unlike previous approaches that required patients to undergo multiple imaging examinations,AI-Based “Digital Heart” Model: Maximizing the Utilization of Medical Imaging DataFor cardiac assessment, a single computed tomography angiography (CTA) scan can generate four evaluation reports, covering coronary artery stenosis, fat attenuation index (FAI), fractional flow reserve derived from CT (FFR-CT), and vascular plaque characterization. This was previously difficult to achieve in clinical practice, representing one of the most significant values brought by the integration of artificial intelligence into the clinical domain.

Today, SHUKUN continues to leverage its hospital-level intelligent imaging platform as a foundation, maintaining its strategic position at the entry point for diagnosing major acute and chronic diseases. Meanwhile, through its platform-based products, it creates “closed-loop value” in health management, further enhancing clinical diagnostic efficiency and truly realizing personalized and precise diagnosis.

Furthermore, in the realms of clinical validation and scientific research, research platforms built upon digital human technology have effectively enhanced medical research capabilities.

Zheng Chao commented on this:“The overall volume of in-hospital medical imaging data, including structured tables, semi-structured text, and unstructured images, is massive, accounting for 80% of the total hospital data. Based on the panoramic digital human view, it is possible to”Achieve rapid structured data analysis and automated modeling through our research platform, empowering the digitalization of scientific research.”

It is reported that Xuanwu Hospital, Beijing Friendship Hospital, Wuhan Central Hospital, and Sun Yat-sen University Cancer Center have all engaged in scientific research collaborations with SHUKUN, publishing their findings in Nature subsidiary journals, the European Respiratory Journal, and ISMRM, a top-tier journal in magnetic resonance imaging.

An analysis of SHUKUN’s strategic approach reveals that leading enterprises must prioritize product innovation and R&D aimed at addressing China’s public health needs, while gaining a deep understanding of clinical requirements. By maintaining the competitiveness of individual products and leveraging a platform-based product ecosystem, these companies can deliver “closed-loop value” to users and unlock the next blue-ocean market.

On August 15, the Ministry of Science and Technology issued the "Notice on Supporting the Development of Demonstration Application Scenarios for New-Generation Artificial Intelligence," stating that it will support the initial development of ten demonstration application scenarios to foster an AI industry application ecosystem covering the entire chain and full process. Among these, the intelligent diagnosis and treatment scenario will address the diagnostic and therapeutic needs for common diseases, chronic diseases, and frequently occurring conditions. Leveraging intelligent medical infrastructure—such as the large-scale construction of medical databases and knowledge bases, and the training of large-scale medical AI models—it will employ key AI technologies for evidence-based diagnostic and therapeutic decision-making to establish a new model of AI-empowered medical services. This initiative will primarily target county-level hospitals to enhance the quality of primary healthcare services.

This information conveys two key points.On one hand, AI has become an infrastructure deployed across various sectors, potentially unlocking new incremental markets in the artificial intelligence landscape. On the other hand, addressing the diagnosis and treatment needs for common, chronic, and frequently occurring diseases, as well as enhancing primary healthcare services, are key innovation priorities for AI enterprises.

The policy outlines the direction for China’s healthcare needs and the development of medical AI. Artificial intelligence-based medical devices originating from tertiary hospitals must expand into the primary care market, while enterprises need to explore this path through practical implementation.

Since the beginning of this year, SHUKUN has not only been deployed at Yunyang County People’s Hospital, empowering the hospital to achieve an upgrade under the “Thousand Counties Project”; it has also been applied at the Third Affiliated Hospital of Beijing University of Chinese Medicine, facilitating the precision of traditional Chinese medicine diagnosis and treatment; supported Guidong People’s Hospital in Guangxi Zhuang Autonomous Region in establishing a cooperative base for early lung cancer screening, thereby creating a regional center for early lung cancer screening; and further engaged in strategic collaborations with enterprises and universities such as Chongqing Medical University and China Unicom, integrating upstream and downstream industry resources to build an intelligent healthcare ecosystem.

Currently, SHUKUN’s AI-powered “Digital Doctor” products are in use at more than 2,000 public hospitals and nearly 1,000 health examination institutions across China, while the company explores their value across diverse scenarios, regions, and specific application contexts. By delivering cost-effective, high-impact solutions, these products help elevate healthcare standards in resource-scarce areas, enhance diagnostic efficiency at the primary care level, and thereby strengthen the capability and credibility of grassroots medical services, ultimately promoting the development of a tiered diagnosis and treatment system.

In an era where the trajectory of “digitalization” is increasingly clear, AI companies must address two critical questions: how to sustain innovation and how to choose the right strategic direction during the innovation process. After all, the most significant pain point in the AI healthcare sector is severe product homogenization. Moreover, as the “winner-takes-all” effect becomes more pronounced, primary application scenarios for AI imaging diagnostic products—such as Grade A tertiary hospitals—are likely to reach saturation rapidly in the near future. At that point, AI healthcare enterprises will face even more formidable challenges.

Therefore, startups should prioritize product innovation and R&D aimed at meeting China’s public health needs, avoid saturated “red ocean” markets, rapidly develop flagship products to gain market entry, and simultaneously expand into imaging diagnostic products with low market penetration but high clinical value.

For leading enterprises, it is essential to build a comprehensive ecosystem and establish a “value loop.” By offering platform-based products, they can secure key entry points for the diagnosis of major acute and chronic diseases, thereby delivering incremental value in hospital settings. This approach also enables companies to revitalize their existing customer base and rapidly expand their clientele through innovative products, generating recurring revenue. Furthermore, guided by policy directives, enterprises should explore the value of AI in additional scenarios, such as primary care and traditional Chinese medicine.