Sansure Biotech Inc. (圣湘生物科技股份有限公司) - Global Leader in Molecular Diagnostics & Gene Technology

Company Profile (Updated April 2026)

Sansure Biotech Inc. (圣湘生物科技股份有限公司) is a global leader in molecular diagnostics and gene technology, headquartered in Changsha, Hunan Province, china. Founded in 2008 by Dr. Dai Lizhong, the company has grown into one of the world's foremost integrated solution providers in in vitro diagnostics (IVD), with independent innovation capabilities spanning diagnostic reagents, nucleic acid diagnostic instruments, complete laboratory solutions, third-party medical testing services, and biopharmaceuticals.

Development History:

- 2008: Established in Changsha, China, focusing on gene technology and molecular diagnostics

- 2009: Developed globally leADINg high-precision "Magnetic Beads" nucleic acid extraction technology

- 2010: Launched automated instrument product lines; began construction of Changsha headquarters Science park

- 2012: Initiated blood screening product line; undertook China's national "863 Program" and "12th Five-Year" Major Science and Technology Special Projects

- 2014: Launched genetic sequencing product lines and bioinformatics platform construction

- 2015: Won the National Science and Technology Progress Award (Second Class) and China Patent Silver Award

- 2016: Approved as National Gene Testing Technology Application Demonstration Center; launched globally leading universal automated nucleic acid extraction system

- 2017: Approved to establish National Local Joint Engineering Research Center for Infectious Disease and Tumor Gene Diagnosis Technology

- 2018: Approved to establish National Post-Doctoral Research Workstation

- 2019: HPV detection reagent won China IVD Excellent Innovation Product Gold Award; launched RNA one-step method and metagenomic sequencing platforms

- 2020: Successfully listed on Shanghai Stock Exchange STAR Market (688289); broke foreign monopoly in molecular diagnostics during COVID-19 pandemic

- 2021: Launched six respiratory pathogen nucleic acid detection kits and iPonatic four-channel nucleic acid detection analyzer

- 2022: Launched HPV 13+2, pertussis, and six respiratory pathogen bacteria products; obtained EU CE List A certification for hepatitis B, hepatitis C, HIV, and blood screening products

- 2023: Respiratory product revenue exceeded RMB 400 million, up 680% YoY; marked the beginning of "Second Entrepreneurship" era

- 2024: R&D investment reached RMB 361 million (24.79% of revenue), up 53.36% YoY; obtained 200+ domestic and international registrations; total registrations approached 1,800

- 2025: Annual revenue RMB 1.648 billion, up 13.04% YoY; wholly acquired Zhongshan Haiji (RMB 808 million) to enter health consumer market; launched SUREXEVO AI-integrated molecular POCT and SansureSeq1000 high-throughput sequencer; newly added nearly 200 domestic and international product registrations throughout the year

- Jan 2026: Acquired controlling stake in inno-train Diagnostik GmbH (Germany); Nipah virus nucleic acid detection kit prepared for market launch

Core Mission: To provide affordAble and accessible gene technology, products, and services for people worldwide, promoting the "five modernizations" of gene technology: high-precision, simplified, automated, mobile, and systematic.

National Honors & Qualifications

Sansure has been recognized with multiple top-tier national designations in China:

- National Technology Innovation Demonstration Enterprise (国家技术创新示范企业): Recognized by the Ministry of Industry and Information Technology for sustained innovation leadership

- National Enterprise Technology Center (国家企业技术中心): Approved by the National Development and Reform Commission, representing the highest level of enterprise R&D institution in China

- National Intellectual Property Demonstration Enterprise (国家知识产权示范企业): Recognized by the China National Intellectual Property Administration for outstanding IP creation, management, and protection

- National Gene Testing Technology Application Demonstration Center (国家基因检测技术应用示范中心): Approved by the National Development and Reform Commission in 2016

- National Local Joint Engineering Research Center (国家地方联合工程研究中心): For infectious disease and tumor gene diagnosis technology

- National Post-Doctoral Research Workstation (国家级博士后科研工作站): Approved in 2018 for high-level talent cultivation

Core Technologies & Platforms

Proprietary Technology Platforms

Sansure has independently developed a series of globally leading core technologies that have broken import monopolies and advanced domestic molecular diagnostics to international levels:

- Advanced Magnetic Beads Technology: High-precision nucleic acid extraction system with superior purity and yield

- One-Tube Fast Release Technology (One-Step Method): One of the simplest and fastest DNA/RNA lysis systems globally, enabling Rapid sample processing

- Automated Universal Sample Processing: Standardized, automated nucleic acid extraction compatible with diverse sample types

- POCT Mobile Molecular Diagnosis: Portable, rapid molecular testing platforms for point-of-care and field applications

- Real-Time PCR Technology: Quantitative fluorescence PCR systems with high sensitivity and specificity

- Gene Sequencing Platforms: tNGS (targeted next-generation sequencing), mNGS (metagenomic NGS), and WGS (whole genome sequencing) technologies

- AI-Integrated Diagnostics: DeepSeek-R1 model integration for intelligent diagnostic systems and data analysis

Core Products & Solutions

Respiratory Disease Detection

Sansure has established a comprehensive respiratory pathogen detection matrix with 60+ products, offering singleplex, multiplex, and panel testing solutions:

- "6/3+X" Respiratory Rapid Nucleic Acid Detection Solution: Covers common respiratory viruses, bacteria, fungi, atypical pathogens, and drug-resistance genes

- Respiratory Six-Plex Panel: Simultaneous detection of six major respiratory pathogens

- Respiratory Triple-Plex and Dual-Plex Panels: Flexible combination for different clinical scenarios

- Pertussis (Whooping Cough) Detection: Singleplex rapid test for Bordetella pertussis

- Disease X Solution: Comprehensive solution for future emerging respiratory disease threats

- Internet + Medical Home Testing: Home-based respiratory pathogen nucleic acid testing services launched in Fujian, Sichuan, Shanghai, Beijing, Shandong, and other provinces

Maternal and Child Health

- HPV 13+2 Nucleic Acid Detection Kit: Covers all 14 high-risk HPV types recommended by WHO plus type 53 prevalent in China; obtained national cervical cancer screening qualification

- HPV Rapid Detection Method: Complete workflow in 40 minutes, enabling "detection-assessment-vaccination" one-hour closed loop with domestic 9-valent HPV vaccine

- Coxsackievirus A6/A10 Detection: For hand, foot, and mouth disease diagnosis

- Immunoassay Products: Progesterone (Prog), HCG, and AMH detection kits via chemiluminescence platform

Blood Source Infectious Diseases & Screening

- Hepatitis B, Hepatitis C, HIV, and Blood Screening Kits: First in China to obtain EU CE List A certification for blood screening nucleic acid testing products, reaching international leading performance

- HBV RNA Detection Reagent: Fills the gap in existing chronic hepatitis B clinical diagnosis indicators, potentially transforming CHB treatment paradigms

- Natch CS3 Plus Automated Blood Screening System: Fully automated blood screening workstation with high integration and intelligent anti-contamination design for single and pooled testing

Genetic Sequencing

- SansureSeq1000 High-Throughput Sequencer: Obtained Class III medical device registration in January 2025, enabling clinical and research applications with tNGS, mNGS, and WGS technologies for pathogen identification in tuberculosis, respiratory, bloodstream, and central nervous system infections

- Intelligent Sequencing System: Integrated with DeepSeek AI for automated pathogen sequencing analysis

Pharmacogenomics

- 8-Series Product Matrix: Covering Alzheimer's disease, cardiovascular disease, hypertension, and other common conditions for precision medication guidance

POCT & Molecular Diagnostic Instruments

- iPonatic III Pro: Flagship molecular POCT platform integrating fully automated nucleic acid extraction and amplification in a closed, portable system for community health, mobile clinics, and remote medical scenarios

- SUREXEVO Series: World's first AI-integrated molecular POCT product, achieving rapid detection, data interconnection, and intelligent diagnosis closed loop; shortlisted for national AI medical device innovation project

- SureXler 48: Real-time PCR instrument with 30-minute amplification, ±0.1°C temperature uniformity, and 8 detection channels

- Natch 16S / Natch 96: Automated nucleic acid extraction systems for high-throughput laboratories

Emerging Infectious Diseases

- Nipah Virus Nucleic Acid Detection Kit (Fluorescence PCR Method): Prepared for market launch in January 2026, designed to prevent false-negative results

- COVID-19 Full Solution: During the pandemic, provided nucleic acid diagnostic kits, antigen tests, POCT rapid tests, triple COVID/Flu A/Flu B tests, and mutant strain identification tests, becoming a major global COVID-19 detection solution provider

Health Consumer Products

- Human Growth Hormone Injection (Haizhiyuan®): Acquired through Zhongshan Haiji; clinical trial approval obtained in April 2026 for Idiopathic Short Stature (ISS) indication expansion

- Sansure Health (圣湘健康) Brand: Launched Internet + Medical home testing services, enabling consumers to complete respiratory pathogen nucleic acid testing at home with online appointment, home sampling, and mobile report delivery

Financial Performance

2025 Annual Results (Preliminary)

Full Year 2025:

- Total Revenue: RMB 1,648.24 million (~USD 231 million), up 13.04% YoY

- Net Profit Attributable to Parent: RMB 198.15 million, down 28.10% YoY (impacted by VAT rate increase from 3% to 13% for self-produced diagnostic reagents, national centralized procurement price pressure, goodwill impairment, and Zhongshan Haiji consolidation integration costs)

- Non-Recurring Net Profit: RMB 164.54 million, down 18.64% YoY

- Basic EPS: RMB 0.34

- R&D Investment: Approximately RMB 310 million, accounting for nearly 20% of revenue

- Total Assets: RMB 9,543.72 million, up 10.92% YoY

- New Class III Medical Device Registrations: Nearly 20 items in 2025

- New Domestic and International Registrations (Full Year): Nearly 200 items

- Cumulative Domestic and International Registrations: Exceeded 1,800

2025 First Half Results

- Revenue: RMB 868.62 million, up 21.15% YoY

- Net Profit Attributable to Parent: RMB 162.72 million, up 3.84% YoY

- Non-Recurring Net Profit: RMB 135.89 million, up 12.19% YoY

- R&D Investment: RMB 153.82 million, accounting for 17.71% of revenue

- Zhongshan Haiji Contribution: Revenue RMB 240 million, net profit RMB 97 million, up 120% YoY (consolidated from January 31, 2025)

Historical Performance

- 2024: Revenue RMB 1,458.06 million; R&D investment RMB 361 million (24.79% of revenue)

- 2023: Revenue RMB 1,423.51 million; respiratory product revenue exceeded RMB 400 million (680% growth)

- 2022: Revenue RMB 957.80 million; net profit RMB 287.59 million

- 2020: Peak COVID-19 revenue period with significant global pandemic response contributions

Strategic M&A and Diagnosis-Treatment Integration

Major Strategic Moves (2024-2026)

Sansure actively advances its "Diagnosis-Treatment Integration" strategy through mergers, acquisitions, equity investments, and ecosystem partnerships:

- Wholly Acquired Zhongshan Haiji (RMB 808 million): Entered the health consumer market with human growth hormone products; consolidated from January 31, 2025

- Controlled Hong'an Jiyuan: Strengthened grassroots medical testing capabilities and expanded market reach

- Increased Investment in GeneMind Biosciences (真迈生物): Reinforced upstream gene technology capabilities in sequencing instruments and core components

- Increased Investment in Saintwin Kunteng (圣维鲲腾): Accelerated layout in multiplex molecular POCT and clinical frontier testing scenarios

- Equity Investment in Saintwin Sirui (圣维斯睿): Layout in innovative diagnostic reagents and instruments

- Established Hunan Jin Furong Sansure Bio-Industry Fund: Further investment in AI medical devices and innovative pharmaceuticals/medical devices

- Strategic Partnerships: Collaborated with BeiGene, Alibaba Health, and Meinian Health to build full-lifecycle services from screening and diagnosis to treatment and health management

- AI + Molecular Enzyme Research: Joint research with Fapon Biotech on underlying AI + molecular enzyme technology, exploring the path from "AI computing" to "biological manufacturing"

- Acquired inno-train Diagnostik GmbH (Germany) - Jan 2026: Enhanced competitiveness in transfusion safety, organ transplantation, and other high-threshold domestic segments

Subsidiary Platform Layout

Sansure is building a comprehensive IVD platform enterprise through strategic subsidiary investments:

- Sansure Anse (圣湘安赛): Immunodiagnostics platform, expanding into chemiluminescence and immunoassay fields

- Sansure Yuanjing (圣湘元景): Biochemical diagnostics platform, covering clinical chemistry and biochemical analysis

- Sansure Kunteng (圣湘鲲腾): Multiplex molecular POCT and clinical frontier testing solutions

- Sansure Sirui (圣湘思睿): Innovative diagnostic reagents and instruments R&D

Global Market Presence

International Expansion

Sansure solutions have been widely used in nearly 160 countries worldwide, including France, UK, Germany, Russia, Philippines, Brazil, Indonesia, and others. The company holds product registrations and certifications in over 65 countries:

- China NMPA: 1,800+ domestic and international registrations

- US FDA EUA: Emergency use authorization for COVID-19 detection products

- EU CE Certification: Including CE List A for blood screening products (hepatitis B, hepatitis C, HIV)

- Brazil ANVISA, Australia TGA, and others

Overseas Subsidiaries: Established in Indonesia, France, UK, Philippines, USA, and other countries, implementing "One Country, One Strategy" localized operations

Global Employees: Over 2,300 staff, with more than 40% dedicated to R&D and technical services

AI + Medical Innovation

Artificial Intelligence Integration

Sansure is at the forefront of integrating AI technology into molecular diagnostics:

- SUREXEVO Series: World's first AI-integrated molecular POCT product, shortlisted for China's national "AI Medical Device Innovation Task" project, enabling intelligent diagnostic closed loops from rapid detection to data interconnection

- Infectious Disease Digital Intelligence System: Successfully passed national digital transformation project review; integrated with DeepSeek-R1 model for significantly improved management efficiency

- Digital Intelligence Sequencing System: Integrated with DeepSeek for automated pathogen sequencing analysis and interpretation

- AI + Molecular Enzyme: Joint research with Fapon Biotech on AI-driven molecular enzyme design and optimization

- Three-End Integrated Medical Service Model: "Hospital as support, community as platform, home as Foundation" innovative service system, bridging serious medical care and consumer healthcare through internet + medical home testing

Company Information & Leadership

Corporate Overview

Company Full Name: Sansure Biotech Inc. (圣湘生物科技股份有限公司)

Founded: 2008

Headquarters: Changsha, Hunan Province, China

Stock Exchange: Shanghai Stock Exchange STAR Market (科创板)

Ticker Symbol: 688289

Company Type: Public listed company

Industry: Medical Devices - In Vitro Diagnostics (IVD) / Molecular Diagnostics / Gene Technology

Employees: Over 2,300 worldwide

Global Patents: Over 1,400 patents under application or currently valid

Leadership Team

Founder & Chairman: Dr. Dai Lizhong (戴立忠)

- Pioneer in China's molecular diagnostics industry, leading Sansure from startup to STAR Market listing

- National People's Congress deputy, actively advocating for life science industry upgrading through technological innovation

- Vision: "Within 5-6 years, build Sansure into a world-class enterprise and pioneer in precision diagnosis-treatment integration"

Board Member: Wei Zhe (卫哲) - Appointed January 2025; founder of JiaYu Capital, driving strategic cooperation in full-scenario application, internationalization, universalization, and AI-driven innovation

Chief Financial Officer: Peng Zhu (彭铸)

Accounting Officer: He Xinyu (贺新宇)

2026 Outlook & Strategic Focus

Future Development Priorities

- AI-First Strategy: Implement "AI一票出彩、一票否决" (AI as key differentiator and veto power) dual-track system, deeply integrating AI into R&D, production, testing, and service

- Platformization: Transform from molecular diagnostics leader to comprehensive IVD platform enterprise, covering sequencing, immunoassay, chemiluminescence, and POCT

- Diagnosis-Treatment Integration: Build full-lifecycle solutions from screening, diagnosis, treatment to health management through ecosystem partnerships

- Internationalization: Accelerate global layout with "One Country, One Strategy" approach, deepen presence in Europe, Southeast Asia, and emerging markets

- Grassroots Medical Empowerment: Expand "Three-End Integrated" service model (hospital-community-home) to enhance healthcare accessibility

- Ecosystem Multiplication: Drive portfolio companies from "technically feasible" to "commercially viable" transformation

- Pipeline and Automation: Capture industry second-growth dividend through laboratory automation and total lab solutions

Contact Information

China Headquarters

Address: Sansure Biotech Science Park, Changsha, Hunan Province, China
   Official Website: www.sansure.com.cn (Chinese)
   Global Website: www.sansureglobal.com (English)

Investor Relations

Stock Exchange: Shanghai Stock Exchange STAR Market
   Ticker: 688289
   IR Contact: ir@sansure.com.cn

Global Business

Email: info@sansureglobal.com
   Overseas Subsidiaries: Indonesia, France, UK, Philippines, USA, Germany (inno-train)

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