NewTimeSpace Stars | Diagens Biotechnology Re-submits to HKEX, Aiming to Become the First Stock of AI Chromosome Diagnosis

According to a document disclosed by the Hong Kong Stock Exchange (HKEX) on January 6, 2026,Diagens Biotechnology has completed its re-submission of listing application, with China Renaissance International continuing to act as the sole sponsor. This re-submission comes only less than 8 days after the expiration of the company's initial prospectus submitted in June 2025 (the validity period of HKEX's Form A1 prospectus is 6 months, and the initial prospectus expired in late December 2025), demonstrating its eagerness to rush into the capital market and its attempt to seize the scarce position of "the first stock of AI chromosome diagnosis".

As stated in the prospectus,Diagens Biotechnology is a medical device enterprise focusing on the development of medical imaging products and services. Its core business covers genetic and reproductive health, hematological tumor diagnosis, radiation health and other fields. It reconstructs the chromosome karyotype analysis process through AI technology, breaking the industry limitation of traditional reliance on manual work.

As a national high-tech enterprise,Diagens Biotechnology has built a complete industrial chain of "algorithm model - intelligent equipment - supporting reagents - platform services" since its establishment in 2016. The funds to be raised from this submission will mainly be used for the commercial expansion of core products, the R&D of iMedImage™ general medical imaging foundation model, global market layout and working capital supplement. The prospectus shows that the company's products have entered more than 400 hospitals nationwide, among which the admission rate to the top 10 hospitals in China reaches 40%, laying a solid foundation for commercialization.

Technical Barrier: AI Reconstructs Chromosome Diagnosis Process

As the gold standard for cytogenetic diagnosis, chromosome karyotype analysis has long been monopolized by overseas enterprises such as Leica and Zeiss. It relies on manual scanning and interpretation, with pain points such as long report cycle and uneven accuracy.Diagens Biotechnology has achieved a breakthrough with AI technology. Its core product, AI AutoVision® Chromosome Karyotype Assisted Diagnosis System, obtained the "Class III Innovative Medical Device" certification from the National Medical Products Administration (NMPA) in May 2025, making it the first AI chromosome diagnosis system in China to receive this certification. Currently, the product is in the listing registration approval stage, and is expected to complete registration in the first quarter of 2026.

The prospectus discloses that the system has shown excellent clinical performance: the sensitivity of chromosome abnormality detection reaches 95.86%, and the specificity reaches 100.00%, among which the sensitivity and specificity of numerical abnormality detection both achieve full marks. In terms of efficiency, compared with the shortcomings of traditional manual analysis which takes 30 minutes per image and 2-3 weeks for report cycle, AI AutoVision® only takes 2.5 minutes per image analysis, shortens the report cycle to 4-7 days, reduces the human-machine interaction per case by more than 99.5%, and significantly improves the work efficiency of laboratory.

The technical advantage stems from the full-chain layout and continuous R&D. The company has built a complete solution covering "sample pre-processing - image acquisition - intelligent analysis", supporting KayoFlow® automatic cell processing equipment, MetaSight® intelligent scanning system and a series of reagents and consumables, forming a closed-loop ecosystem. As of the disclosure date of the prospectus, the company has owned more than 80 core independent intellectual property rights in China, the United States, Europe and other regions. More than 50% of the R&D team holds a master's degree or above, and has presided over and participated in a number of national key R&D program projects.

Financial Picture: Coexistence of High Growth and Sustained Losses

In terms of performance,Diagens Biotechnology shows a phased characteristic of "high revenue growth and narrowing losses". Financial data shows that the company's revenue in 2023, 2024 and the nine months ended September 30, 2025 was RMB 52.844 million, RMB 70.352 million and RMB 111.616 million respectively. The revenue in the first nine months of 2025 increased by 469.8% compared with the same period of the previous year (about RMB 19.58 million). The high growth is mainly driven by the low base and the explosion of technology licensing business. Among them, the revenue from technology licensing business increased from RMB 19.539 million in 2024 to RMB 57.367 million in the first nine months of 2025, accounting for 27.8% to 51.4% of the total revenue, becoming the largest source of income.

The gross profit performance has improved simultaneously. The gross profit in the same period was RMB 37.495 million, RMB 46.061 million and RMB 84.669 million respectively, maintaining a high gross profit margin. However, affected by high R&D investment, the company has not yet achieved profitability. The net losses in the same period were RMB 56.116 million, RMB 43.375 million and RMB 36.649 million respectively, with a cumulative loss of more than RMB 136 million. The R&D expenditure in the first nine months of 2025 reached RMB 68.672 million, accounting for 61.5% of the revenue. Among them, the R&D cost ratio of the core product AI AutoVision® has increased significantly, reflecting the company's focused investment in core technologies.

In addition, the company also faces multiple operational challenges. As of September 30, 2025, the revenue from the top five customers accounted for 56.0% of the total revenue, and the excessively high customer concentration may increase operational risks; although the inventory turnover days decreased from 614 days in 2023 to 232 days in the first nine months of 2025, it is still much higher than the industry average, occupying a large amount of working capital; the operating cash flow has been negative for a long time, with a net outflow of RMB 21.533 million in the first nine months of 2025, showing significant capital pressure.

Industry Opportunities: Driven by Policies and Technology

Diagens Biotechnology's growth track is closely bound to industry dividends. With the implementation of national fertility support policies, the assisted reproductive field has ushered in a period of rapid growth. In January 2025, 31 provinces (autonomous regions and municipalities directly under the Central Government) and the Xinjiang Production and Construction Corps have fully included assisted reproductive technologies in medical insurance reimbursement, with a cumulative total of more than 1 million person-times enjoying relevant benefits. As a necessary pre-operative testing link for assisted reproduction, chromosome karyotype analysis has continuously released market demand. It is estimated that 1 million assisted reproductive cycles alone can drive a direct market size of about RMB 2 billion, and the industrial value will be further expanded with the addition of equipment and reagent supporting.

The increasing penetration rate of AI medical imaging has injected more momentum into the industry. According to a report by Frost & Sullivan, the market size of China's AI-driven medical imaging reached RMB 240 million in 2024, and is expected to achieve a high compound annual growth rate of 60.2% by 2030 (this data is a forecast and subject to uncertainty), with the market size expected to reach RMB 7.81 billion in 2035. In the segmented field of chromosome karyotype analysis,Diagens Biotechnology has established a leading position, ranking first in China with a 30.6% market share (by sales revenue) in 2024, successfully realizing partial domestic substitution for Leica and Zeiss.

To open up the growth ceiling, the company is extending its technical capabilities to a wider range of scenarios. The independently developed iMedImage™ cross-modal medical imaging foundation model is pre-trained based on 80 million medical imaging data, supporting the processing of 19 imaging modalities such as CT, MRI and ultrasound, covering more than 90% of clinical scenarios. The prospectus states that the model can build a specialist model with only hundreds of imaging data and a training cycle of several days, significantly reducing R&D costs, and is expected to become the core engine for the intelligent upgrading of global medical imaging equipment.

Game Between Scarcity and Uncertainty

As a pioneer in the field of AI chromosome diagnosis,Diagens Biotechnology's listing process has attracted much attention from the market. The technical barrier of its core products, its leading position in the segmented market, and the high growth potential of the track it is in constitute the core investment value. However, risks such as sustained losses, high R&D investment and high customer concentration have also added variables to its capital market journey.

The prospectus clearly states that the company will focus on three major directions in the future: deepening the layout of intelligent detection in the entire assisted reproduction chain, promoting the globalization of the iMedImage™ platform, and empowering the intelligence of edge devices. If it can successfully convert technical advantages into profitability, coupled with policy dividends and the trend of domestic substitution, the company is expected to occupy an important position in the AI medical imaging track. Whether this re-submission can successfully open the door to the HKEX remains to be tested by regulatory review and the market.

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