全球發售 杭州德適生物科技股份有限公司 Hangzhou Diagens Biotechnology Co., Ltd. （於中華人民共和國註冊成立的股份有限公司） 股份代號 : 02526 獨家保薦人、保薦人兼整體協調人、整體協調人、 聯席全球協調人、聯席賬簿管理人及聯席牽頭經辦人 整體協調人、聯席全球協調人、 聯席賬簿管理人及聯席牽頭經辦人 重要提示 重要提示：閣下如對本招股章程的任何內容有任何疑問，應徵詢專業獨立意見。 Hangzhou Diagens Biotechnology Co., Ltd. 杭州德適生物科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 全球發售 股份代號 : 2526 獨家保薦人、保薦人兼整體協調人、整體協調人、 聯席全球協調人、聯席賬簿管理人及聯席牽頭經辦人 | HILATAL INTEDNATIONAL | | --- | 整體協調人、聯席全球協調人、 聯席賬簿管理人及聯席牽頭經辦人 聯席賬簿管理人及聯席牽頭經辦人 香港交易及結算所有限公司、香港聯合交易所有限公司及香港中央結算有限公司對本招股章程的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明 確表示概 ...

香港聯合交易所有限公司及證券及期貨事務監察委員會對本聆訊後資料集的內容概不負責，對其準確性或 完整性亦不發表任何聲明，並表明概不就因本聆訊後資料集全部或任何部分內容而產生或依賴該等內容而 引致的任何損失承擔任何責任。 Hangzhou Diagens Biotechnology Co., Ltd. 杭州德適生物科技股份有限公司 （「本公司」） （於中華人民共和國註冊成立的股份有限公司） 聆訊後資料集 警告 本聆訊後資料集乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會的要求而刊 發，僅用作向香港公眾人士提供資料。 本聆訊後資料集為草擬本，其所載資料並不完整，亦可能會作出重大變動。 閣下閱覽本文件，即表 示 閣下知悉、接納並向本公司、其各自保薦人、整體協調人、顧問及包銷團成員表示同意： 倘在適當時候向香港公眾人士提出要約或邀請，有意投資者務請僅依據於香港公司註冊處處長註冊的本公 司招股章程作出投資決定。該文件的文本將於發售期內向公眾人士派發。 (a) 本文件僅為向香港公眾人士提供有關本公司的資料，概無任何其他目的。投資者不應根據本文件所 載資料作出投資決定； (b) 在聯交所網站登載本文件或 ...

Core Insights - Chromosome karyotype analysis is the gold standard core technology in genetic disease diagnosis, prenatal screening and diagnosis, infertility cause investigation, blood system malignancy classification, and genetic testing of solid tumors, demonstrating irreplaceable clinical value [1][7] - The demand for prenatal diagnosis is steadily increasing due to the widespread adoption of the concept of optimal childbirth, the continuous expansion of the advanced maternal age population, and the ongoing standardization of marriage and pregnancy check-up processes [1][7] - The market size for chromosome karyotype analysis systems in China is projected to reach 196.7 million yuan by 2025, with a year-on-year growth of 18.6% [1][7] Overview - Chromosome karyotype analysis involves pairing, numbering, and grouping chromosomes based on specific morphological characteristics, and the karyotype analysis system integrates optical microscopy, computer image processing, AI algorithms, and digital storage for chromosome identification and analysis [2][3] - The system automates and standardizes chromosome analysis, replacing traditional manual methods, and is primarily applied in genetic disease diagnosis, prenatal diagnosis, tumor genetics research, and species identification [2][3] Market Policies - The chromosome karyotype analysis system is classified as a Class III medical device, and the medical device industry is a strategic emerging industry with strong growth potential, playing a crucial role in implementing the "Healthy China" strategy [4][5] Industry Chain - The upstream of the chromosome karyotype analysis system industry includes suppliers of high-magnification optical microscopes, fluorescence microscopes, and other hardware, while the downstream encompasses applications in reproductive health, blood malignancies, and research [6] - Reproductive health is the core demand market for chromosome karyotype analysis systems in China, projected to account for over 80% by 2025, with key applications in prenatal diagnosis centers and reproductive centers [6] Competitive Landscape - The market is characterized by international giants dominating the high-end market, while domestic leading enterprises are accelerating their replacement of imported products, with companies like Leica and Thermo Fisher leading in high-end systems [8] - Domestic companies such as Hangzhou Deshi Biotechnology Co., Ltd. are gaining market recognition through continuous AI algorithm iteration and localization, establishing a competitive advantage in both mid-range and high-end markets [8][9] Development Trends - Future advancements will see the integration of AI and deep learning technologies into chromosome karyotype analysis systems, automating the entire process and enhancing the ability to identify complex karyotype abnormalities [12] - The application fields will expand beyond traditional areas to include reproductive health, solid tumor auxiliary diagnosis, and occupational disease prevention, with a focus on enhancing capabilities in grassroots medical institutions [13] - Domestic enterprises will increase investment in core technology R&D, aiming to break the market monopoly of imported brands, while the industry may experience consolidation, leading to a higher concentration of leading enterprises [14]

Group 1 - The China Securities Regulatory Commission has issued a notice regarding the overseas issuance and domestic unlisted shares "full circulation" registration for Hangzhou Deshi Biotechnology Co., Ltd. [1] - Deshi Biotechnology plans to issue no more than 31.04 million overseas listed ordinary shares and will list on the Hong Kong Stock Exchange [1] - A total of 27 shareholders of the company intend to convert their combined 80.88 million domestic unlisted shares into overseas listed shares for circulation on the Hong Kong Stock Exchange [1] Group 2 - Deshi Biotechnology is a leading enterprise in the field of medical imaging AI and medical imaging equipment, with a global market presence [2] - The company has developed a diversified matrix of intelligent equipment and supporting products based on its self-developed general medical imaging base model iMedImage™, including systems for chromosome karyotype analysis and automatic cell imaging [2] - In 2024, Deshi Biotechnology achieved a market share of 30.6% in the chromosome karyotype analysis field in China, ranking first and breaking the long-standing monopoly of imported brands [2] - The company has established a customer base covering over 400 medical care centers and institutions nationwide, gaining widespread market recognition [2] - In 2025, Deshi Biotechnology was selected for the 11th batch of the "Excellent Domestic Medical Equipment Product Catalog" due to its technological innovation and clinical value [2] - The company aims to continue providing standardized intelligent imaging equipment, model-as-a-service (MaaS) cloud platforms, and localized self-training solutions to enhance the efficiency, accuracy, and accessibility of medical imaging diagnosis [2]

Core Viewpoint - The company, Deshi Biotechnology, has submitted a second listing application to the Hong Kong Stock Exchange, marking a significant step in its journey towards going public after receiving regulatory approval [1][10]. Group 1: Company Overview - Deshi Biotechnology is recognized as a "national specialized and innovative small giant" in the field of chromosome karyotype analysis, achieving the highest market share in China [1][7]. - The company has developed a fully automated cell laboratory workflow that significantly enhances the accuracy of chromosome karyotype analysis to over 99%, addressing long-standing clinical challenges in the industry [3][6]. Group 2: Industry Context - Chromosome karyotype analysis is crucial for diagnosing various genetic disorders, including Down syndrome and certain blood cancers, but has historically faced issues with accuracy and lengthy reporting times [2]. - The market for chromosome karyotype analysis has been dominated by international giants like Carl Zeiss and Leica, which hold over 95% of the market share [3]. Group 3: Financial Performance - In 2024, Deshi Biotechnology achieved a market share of 30.6% in the chromosome karyotype analysis sector, surpassing international competitors [7]. - The company's revenue for the first three quarters of 2025 reached 112 million RMB, a 470% increase compared to 19.59 million RMB in the same period of 2024, with a gross margin of 75.9% [7][8]. - As of September 30, 2025, the company had cash and cash equivalents totaling 250 million RMB, indicating strong market recognition and the ability to convert technological advantages into commercial success [7].

Company Overview - 德适生物科技股份有限公司 (德适生物) has submitted an IPO application to the Hong Kong Stock Exchange, with Huatai International as the sole sponsor [1] - Established in 2016 and headquartered in Hangzhou, Zhejiang, the company focuses on AI-driven medical imaging solutions, particularly its core product, iMedImage™ [1][2] - The company has completed multiple rounds of financing, achieving a post-investment valuation of 2.56 billion yuan after the latest round in June 2025 [1] Product and Technology - 德适生物's core product, iMedImage™, is a leading medical imaging base model that supports 19 imaging modalities and covers over 90% of clinical scenarios [4][11] - The company has developed a complete automated chromosome analysis pipeline, including AI AutoVision® and MetaSight® systems, which have received regulatory approvals [4][5] - The AI AutoVision® is expected to be the world's first AI-driven chromosome karyotype analysis system upon approval from the National Medical Products Administration [4] Market Position and Financial Performance - 德适生物 has established a distribution network of over 75 distributors, covering more than 400 healthcare centers across 31 provinces in China [6] - The company reported revenues of 52.84 million yuan and 70.35 million yuan for 2023 and 2024, respectively, with a year-on-year growth of 33.1% [5] - In 2024, the company achieved a gross profit margin of 65.5%, positioning it among the top in the medical device industry [5] Industry Context - The medical imaging AI industry faces challenges such as low standardization of multimodal data and a shortage of skilled professionals, creating a demand for efficient AI tools [2] - The chromosome karyotype analysis market is highly concentrated, with international giants holding 95% of the market share; 德适生物 has captured 30.6% of the market following the launch of its innovative products [10][7] - The reproductive health medical device market in China is projected to grow significantly, with an expected market size of 71 billion yuan by 2024 and over 173 billion yuan by 2035 [7][10]

Core Viewpoint - The article discusses the upcoming IPO of Hangzhou Deshi Biotechnology Co., Ltd., which focuses on AI in medical imaging and has developed the world's largest general-purpose medical imaging foundation model, iMedImageTM [2][3]. Group 1: Company Overview - Hangzhou Deshi Biotechnology was established in 2016 and specializes in the medical imaging AI industry [2]. - The proprietary iMedImageTM model supports 19 types of medical imaging modalities and covers over 90% of clinical medical imaging scenarios, including reproductive health and hematological malignancies [2]. Group 2: Product Offerings - Based on the iMedImageTM model, the company provides a comprehensive end-to-end AI medical imaging solution that includes "foundation model - smart medical devices - reagents and consumables - large model services" [3]. - The core product, AI AutoVision®, is expected to be the world's first AI-driven chromosome karyotype analysis auxiliary diagnostic system [4]. - The company has developed a complete automated chromosome analysis pipeline, including systems for sample preparation and reporting [4]. Group 3: Market Position - As of June 21, 2025, Deshi Biotechnology's product portfolio includes three types of reagents and six types of consumables registered as Class II medical devices, along with 18 types of Class I medical device filings [5]. - According to Frost & Sullivan, the company holds the number one position in China's chromosome karyotype analysis market with a market share of 30.6% based on projected sales revenue for 2024 [6]. Group 4: Financial Performance - The company's revenue for 2023 and 2024 is projected to be 52.84 million yuan and 70.35 million yuan, respectively, with gross margins of 71.0% and 65.5% [7]. - As of the last round of equity transfer before the IPO, the company's valuation stands at 2.56 billion yuan [8]. Group 5: IPO Fund Utilization - The net proceeds from the IPO will primarily be used for the R&D and commercialization of AI AutoVision® and other iMedImageTM AI analysis system candidates, enhancing the foundation model and AI technology, and expanding global market presence [8].