Diagens Biotechnology has passed a listing hearing with the Hong Kong Stock Exchange and disclosed its post-hearing prospectus on March 15, with Huatai International serving as the sole sponsor. The move puts the Hangzhou-based firm on track to become the world’s first publicly listed company offering artificial intelligence-driven tools and solutions built on a medical imaging foundation model.
Founded in 2016, Diagens develops medical imaging products and services. Its portfolio includes six medical imaging software products, three commercialized medical devices, four key reagents and consumables, and two technology licensing products.
At the center of its lineup is AI Autovision, a chromosome karyotyping-assisted diagnostic software designed for chromosome analysis. The product targets applications including birth defect prevention, premarital and preconception screening, and assisted reproductive technology.
Clinical trials of AI Autovision have been completed, and an application was submitted in May 2025 to the National Medical Products Administration for registration as a Class 3 medical device. In the same month, the regulator designated it an innovative Class 3 medical device, allowing the product to enter an accelerated approval process.
In a multicenter clinical trial involving 1,518 real-world samples, AI Autovision achieved a sensitivity and specificity of 100% in detecting numerical chromosomal abnormalities. For structural abnormalities, the system recorded a sensitivity of 94.05% and a specificity of 100%.
The company said the average analysis time per case is more than three times faster than conventional manual systems, highlighting the potential clinical value of AI-assisted analysis in complex medical imaging tasks. The claim is attributed to the company and is not independently verified.
Beyond its flagship product, Diagens has developed a full workflow solution for chromosome karyotype analysis that spans sample preparation through result interpretation. Its lineup includes the Autovision chromosome analysis software, Kayoflow automatic cell harvester, Kayoflow slide preparation and staining system, and Metasight automated cell microscopic imaging scanner.
According to Frost & Sullivan, Diagens ranked first in China’s chromosome karyotype analysis market by revenue in 2024, with a 30.6% market share.
Chromosome karyotype analysis remains the gold standard in cytogenetic diagnostics. It is widely used in preconception screening, assisted reproductive technology, inherited metabolic disease diagnosis, and hematologic cancer research.
The mainland China market for chromosome analysis is projected to expand to RMB 2.038 billion (USD 294.9 million) by 2030 and RMB 6 billion (USD 868.3 million) by 2035, according to Frost & Sullivan. Diagens said its current market position could allow it to capture growth as demand increases.
The company attributes the performance of AI Autovision largely to iMedImage, its proprietary model.
iMedImage is a general-purpose foundation model designed for reasoning-oriented learning and training in medical imaging. Built on this architecture, Diagens is developing customized AI models and tools for targeted disease diagnosis and treatment applications.
As of March 10, iMedImage reportedly supports 19 medical imaging modalities and covers more than 90% of clinical medical imaging scenarios, including reproductive health, hematologic malignancies, and other clinical applications. According to the company, its cross-domain generalization capabilities have been validated across multiple environments and imaging formats, including microscopic imaging, obstetric ultrasound, CT imaging, and microscopic video.
Diagens plans to further develop the iMedImage foundation model to improve its generalization capability and reasoning efficiency. It also intends to expand computing capacity to process large-scale medical imaging datasets more efficiently, while extending cloud services to support deployment across clinical environments.
The firm also plans to extend the model to additional medical imaging modalities and clinical specialties to broaden its applications.
To accelerate the healthcare sector’s transition toward smart systems, Diagens intends to license the iMedImage model for localized deployment. The company said this approach could help address a challenge in remote areas where medical equipment is available but specialized expertise is limited. It also plans to allow hospitals and medical experts to train disease-specific models tailored to their own clinical needs.
Policy support may further reinforce the company’s strategy. Last October, the National Health Commission, together with four other government agencies, issued guidelines promoting and regulating healthcare applications that use AI. The policy calls for AI-assisted medical imaging diagnostic services to become widely available in hospitals classified as secondary level and above nationwide by 2030.
Financially, Diagens reported revenue of RMB 112 million (USD 16.2 million) in the first three quarters of 2025, up from RMB 20 million (USD 2.9 million) in the same period of 2024. Gross margin during the period reached 75.9%.
Since its founding, the company has attracted investment from institutions including Goldport Capital, Meihong Investment, Grand Flight Investment, Liyuan Investment, Jiayuan Venture Capital, Guozhong Capital, Winning Venture Capital, Tenghua Investment, Yuhang Economic Development Zone, Sinowisdom, Yingboli Investment, Huabao Venture Capital, Blue Shell Capital, and Huadan Investment.
According to the prospectus, proceeds from the planned IPO will primarily be used for the R&D and commercialization of AI Autovision, development of other medical imaging software candidates and medical devices, advancement of the iMedImage foundation model and related AI technologies, expansion of the company’s technology licensing business, strengthening commercialization capabilities and market penetration in China, expanding global operations, pursuing strategic partnerships and investments across the healthcare value chain, and general corporate purposes.
This article was adapted based on a feature originally written by Stone Jin and published on IPO Zaozhidao. KrASIA is authorized to translate, adapt, and publish its contents.
Note: RMB figures are converted to USD at rates of RMB 6.91 = USD 1 based on estimates as of March 16, 2026, unless otherwise stated. USD conversions are presented for ease of reference and may not fully match prevailing exchange rates.