Zybio Inc. (中元汇吉生物技术股份有限公司) - Leading Chinese Full-Line IVD Solutions Provider

Company Profile (Updated April 2026)

Zybio Inc. (中元汇吉生物技术股份有限公司) is one of China's leading in vitro diagnostic (IVD) companies, providing comprehensive "product + service" integrated solutions for medical laboratories. Founded in 2008 in Chongqing, china, and restructured as a joint-stock company on August 30, 2021, the company is headquartered in DadUKou District, Chongqing.

The company specializes in the research, development, production, and sale of clinical diagnostic products and instruments, with core business segments covering biochemistry, immunoassay, molecular diagnostics, POCT, clinical laboratory, microbiology, pathology, coagulation, hematology, urinalysis, intelligent laboratory management systems, and TLA (Total Laboratory Automation) pipelines. The company has ACHieved full industrial chain layout from raw materials to reagents, from core components to instruments.

Core Mission: "Every drop of sincerity, only for precision" (点滴真情，只为精准). The company is committed to meeting customers' multi-dimensional needs, deepening cooperation with global medical institutions, and creating greater value for customers.

Financial Performance

Revenue History (Estimated, Non-Listed Company)

2022 Estimated Revenue: RMB 8.5 billion (85亿元), as reported by industry media in January 2023

2021 Estimated Revenue: RMB 4.0+ billion (40+亿元), with tax contribution exceeding RMB 400 million

Growth Trajectory: From several million RMB in 2016 to tens of billions in 2022, with sales compound annual growth rate exceeding 100% during key growth periods

Note: The company is a non-listed private enterprise. Revenue figures above are based on industry reports and local government disclosures, not audited financial statements.

Core Products and Technology Platforms

Mass Spectrometry (Market Leader)

- MALDI-TOF Microorganism Mass Spectrometer (EXS1600 / EXS2600 / EXS3000): Ranked #1 in China for three consecutive years by sales volume, capturing 34.10% of the national market in 2024

- Triple Quadrupole Tandem Mass Spectrometer: For clinical and research applications

- Nucleic Acid Mass Spectrometer: For genetic analysis

- Teaching Mass Spectrometer: For academic and education applications

Chemiluminescence Immunoassay

- EXI2400 / EXI8000 Automated Chemiluminescence Immunoassay Analyzers: The EXI8000 was selected for the National High-End Medical Equipment Promotion and Application Project (2024), recognized as one of the fastest detection-speed devices on the market

- Full coverage of cardiac, tumor, thyroid, infectious disease, and other marker panels

Hematology and Coagulation

- EXZ6000Pro Automated Hematology Analyzer: Five-classification blood cell analysis with CRP/SAA integration

- EXT9800 Automated Coagulation Analyzer: Integrating optical, magnetic, and microparticle methodologies — a domestic first

- Desktop Small Pipeline: "Hematology + Immunofluorescence" integrated system — a domestic first

Molecular Diagnostics

- EXM3000 / EXM6000 Nucleic Acid Extraction Systems: Automated nucleic acid extraction platforms

- Real-Time Fluorescence Quantitative PCR Analyzer: Approved October 2025 (National Medical Device Registration No. 20253222179)

- Respiratory Pathogen Detection Kits: Including influenza A/B, RSV, parainfluenza, metapneumovirus, adenovirus, and rhinovirus (multiple approvals in 2025)

Biochemistry

- EXC2000 / EXC800 Automated Biochemistry Analyzers

POCT and Rapid Testing

- Q20 / Q8 Pro Automated Fluorescence Immunoassay Analyzers

- Colloidal Gold Rapid Test Readers

- MxA Viral Infection POCT Detection Product: Launched August 2025 — a domestic exclusive viral-specific biomarker developed in collaboration with China-Japan Friendship Hospital

Other Product Lines

- Urinalysis Systems

- Microbiology and Pathology Diagnostics

- Intelligent Laboratory Management Systems

- TLA (Total Laboratory Automation) Pipelines

2025-2026 Latest Developments

National High-End Medical Equipment Project — Two Consecutive Years

- 2024: The EXI8000 automated chemiluminescence immunoassay analyzer was selected for the National High-End Medical Equipment Promotion and Application Project (2024), with Beijing Hospital as the lead medical institution

- January 2026: The "Automated Clinical Laboratory Promotion and Application Project" was selected for the National High-End Medical Equipment Promotion and Application Project (2025), with Renmin Hospital of Wuhan University as the lead institution and over ten participating units. This marks the company's second consecutive year of being selected for this national-level project

New NMPA Registrations (2025)

- March 6, 2025: Influenza A/B and Respiratory Syncytial Virus (RSV) Triple Nucleic Acid Detection Kit (Fluorescence PCR Method) approved (National Medical Device Registration No. 20253400501)

- April 30, 2025: Soluble Growth Stimulation Expression Gene 2 Protein (ST2) Detection Kit (Magnetic Particle Chemiluminescence Method) approved (Chongqing Medical Device Registration No. 20252400184)

- May 2025: Rivaroxaban Assay Kit (Chromogenic Substrate Method) approved

- August 2025: MxA Viral Infection POCT Detection Product launched

- September 5, 2025: Influenza A/B Antigen Detection Kit (Colloidal Gold Method) approved (National Medical Device Registration No. 20253401792)

- September 17, 2025: Chitinase-3-like Protein 1 (CHI3L1) new product launch

- October 30, 2025: Real-Time Fluorescence Quantitative PCR Analyzer approved (National Medical Device Registration No. 20253222179)

- December 23, 2025: Adenovirus, Parainfluenza Virus, and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR Method) approved (National Medical Device Registration No. 20253402672)

- December 31, 2025: COVID-19 Nucleic Acid Detection Kit (Fluorescence PCR Method) registration cancelled (National Medical Device Registration No. 20213400228)

Strategic Partnerships (2025)

- November 2025: Beckman Coulter and Zybio reached a strategic partnership to promote the integration of medical diagnostic technologies, establishing a "foreign giant + domestic leader" cooperation model

- January 2025: Huapu Kepu (华谱科仪) and Zybio initiated cooperation in the chromatography and mass spectrometry fields

- May 2025: Chongqing Center for Disease Control and Prevention (重庆疾控) and Zybio established an industry-university-research cooperation to jointly promote public health technology innovation

Industry Leadership and Recognition (2024-2025)

- 2024 Mass Spectrometer Sales: Ranked #1 nationwide with 34.10% market share, leading for three consecutive years

- June 2025: Featured in national media coverage as the chain-master enterprise of Chongqing's IVD industry chain

- July 2025: Awarded Technology Innovation Navigation Unit at the 19th China Hospital Director Annual Conference

- 2023: Led a Chongqing Municipal Science and Technology Bureau multi-million RMB major research project

- 2023: The Chongqing Clinical Immunology Detection Technology Innovation Center, led by the company, was officially approved

- 2023: Groundbreaking ceremony for the Zybio Technology Park (estimated annual capacity: 30 billion test reagents upon completion)

Technology and R&D Strength

Global R&D Network: Eight R&D centers in Chongqing, Beijing, Shanghai, Guangzhou, Shenzhen, Nanjing, Xiamen, and Changchun

Core Technologies:

- Genetic engineering antigens/antibodies

- Diagnostic nanomaterials

- High-precision diagnostic instruments and core component development

- Multiple labeling signal amplification

- Rapid nucleic acid extraction and detection

Intellectual Property:

- Invention Patents: 100+ (per official website) / 43+ (per recruitment materials)

- Product Registrations: 4,800+ (per 2026 recruitment) / 500+ (per official website) / 397 (earlier data)

- International Market Access: 2,500+ registrations in target countries

- China Patent Excellence Award: 23Rd China Patent Excellence Award (2022)

Reference Laboratory: Established standardized reference measurement laboratory in 2018; partial projects passed IFCC-RELA (International Federation of Clinical Chemistry and Laboratory Medicine Reference Laboratory External Quality Assessment); obtained CNAS Medical Calibration Laboratory Accreditation

R&D Investment: Annual R&D investment ratio ≥15% of revenue; R&D personnel account for >30% of total staff, with nearly 50% holding master's degrees or above

Production Capacity:

- Current: Reagents 30 billion tests/year, Instruments 35,000 units/year

- Production facility: 100,000+ sqm with 19 production lines

- Technology Park (under construction): 83 mu land, ~150,000 sqm, total investment >RMB 600 million; estimated capacity upon completion: reagents 40 million boxes/year, instruments 60,000 units/year

Certifications and Honors

- National High-Tech Enterprise

- National Enterprise Technology Center

- National Post-Doctoral Research Workstation

- National Intellectual Property Advantage Enterprise

- Chongqing IVD Industry Chain Chain-Master Enterprise (designated by Chongqing Municipal Economic and Information Commission)

- Chongqing Science and Technology Award — Enterprise Technology Innovation Award (2022)

- 23rd China Patent Excellence Award (2022)

- Chongqing Clinical Immunology Detection Technology Innovation Center (approved 2023)

- National May 1st Labor Certificate

- National Science and Technology System Advanced Collective in Fighting COVID-19

- 2023 Chongqing Private Enterprise Technology Innovation Index Top 100: Ranked 18th

- 2023 Chongqing Private Enterprise Top 100

- 2023 Chongqing Manufacturing Private Enterprise Top 100

- Chongqing Smart Medical Equipment Innovative Product Catalogue (First Batch)

- ISO 9001 and ISO 13485 Certifications

Market Presence

Domestic Market

- Coverage: All 31 provinces, municipalities, and autonomous regions in China

- Service Teams: 29 domestic teams / 79 service teams

- Hospitals Served: 13,000+ hospitals / 30,000+ terminal clients / 20,000+ medical institutions (varying data sources)

- Tertiary Hospitals: Nearly 1,400 Class III (tertiary) hospitals

- Service Capability: "1-hour response, 12-hour arrival" service promise; 300+ service engineers globally

International Market

- Countries/Regions: 110+ countries across Asia, South America, North America, Europe, and Africa

- Overseas Subsidiaries: 15 in Indonesia, Thailand, Philippines, Brazil, Mexico, Pakistan, Russia, Netherlands, and other countries

- Overseas Offices: Multiple countries

- International Market Access: 2,500+ product registrations in target countries

Company Basic Information

Corporate Overview

Company Full Name: Zybio Inc. (中元汇吉生物技术股份有限公司)

Founded: 2008 (initial establishment); January 27, 2015 (limited liability company registration); August 30, 2021 (joint-stock restructuring)

Registered Address: No. 45 Shilin Avenue, Tiao Deng Town, Dadukou District, Chongqing, China (new address); formerly No. 30 Building, Taikang Road 6, Jianqiao Industrial Park C District, Dadukou District, Chongqing

Legal Representative (Business Registration): Guo Yongli (郭永利)

Founder / Chairman / Actual Controller: Ji Quan (吉权)

Board Member / Domestic Marketing General Manager: Sun Wenhao (孙文浩)

Chief Scientist / Raw Material Development: Yi Weijing (易维京)

Company Type: Joint-Stock Limited Company (Non-Listed, Natural Person Investment or Holding)

Industry: Medical Devices / In Vitro Diagnostics (IVD)

Registered Capital: RMB 377,402,600 (377.40 million)

Unified Social Credit Code: 915001043278176610

Employees: 2,000+ globally (per 2026 recruitment data); 400+ incentive plan participants

Official Website: www.zybio.com

Email: wangjiao@zy-ivd.com (HR); zybio@zybio.com

Shareholder Structure (2021 Restructuring)

- Ji Quan (吉权)

- Chongqing Bohao Enterprise Management Co., Ltd. (重庆博昊企业管理有限公司)

- Chongqing Yuanqian Industrial Group Co., Ltd. (重庆元乾实业集团有限公司)

- Chongqing Hejia Diyuan Health Management Partnership (LP) (重庆和嘉谛元健康管理合伙企业)

- Chongqing Rensheng Diyuan Health Consultation Partnership (LP) (重庆仁昇谛元健康咨询合伙企业)

- Guangzhou Defu Zhongyuan Partnership (LP) (广州德福中元合伙企业)

- Guangfa Xinde (Suzhou) Health Industry Venture Capital Partnership (LP) (广发信德（苏州）健康产业创业投资合伙企业)

- Chongqing Dihe Diyuan Health Management Partnership (LP) (重庆地和谛元健康管理合伙企业)

2026 Outlook and Strategic Priorities

Strategic Focus Areas

- Technology Innovation: Continue strengthening eight R&D centers and maintaining R&D investment ≥15% of revenue; advance core technologies in mass spectrometry, chemiluminescence, and molecular diagnostics

- Product Expansion: Launch more exclusive products with significant clinical testing value, particularly in respiratory pathogen detection, coagulation, and neuro-autoimmunity

- Market Leadership: Maintain #1 position in mass spectrometry and expand market share in chemiluminescence, hematology, and coagulation

- International Growth: Leverage 15 overseas subsidiaries and 2,500+ international registrations to expand global presence, particularly in Southeast Asia, Latin America, and Europe

- Smart Laboratory Solutions: Promote intelligent laboratory management systems and TLA pipelines to drive laboratory automation and digital transformation

- Technology Park Completion: Complete the Zybio Technology Park to significantly expand production capacity

- Strategic Partnerships: Deepen cooperation with Beckman Coulter, Huapu Kepu, and other partners to advance technology integration and market expansion

Competitive Advantages

- Full Product Line: One of the few domestic companies with 9+ product lines covering nearly all IVD domains

- Industrial Chain Integration: Full industrial chain layout from raw materials to reagents, from core components to instruments

- Market Leadership: #1 in China mass spectrometer sales for three consecutive years

- Technology Innovation: Multiple domestic firsts and exclusives (optical-magnetic-microparticle coagulation analyzer, MxA viral biomarker, etc.)

- Strong R&D: 100+ invention patents, 4,800+ product registrations, national enterprise technology center, and post-doctoral workstation

- Quality Certification: IFCC-RELA participation, CNAS accreditation, ISO 9001/13485

- National Recognition: Two consecutive years selected for the National High-End Medical Equipment Promotion and Application Project (2024-2026)

Risk Factors

- Policy Pressure: IVD centralized procurement, DRG/DIP payment reforms, and testing fee adjustments may impact pricing

- Post-Pandemic Transition: COVID-19-related product demand normalization requires continued diversification into routine diagnostics

- Competition: Intense domestic competition from Mindray, Autobio, SNIBE, and international giants

- Data Transparency: As a non-listed company, financial data transparency is limited compared to public peers

Contact Information

Headquarters

Address: No. 45 Shilin Avenue, Tiao Deng Town, Dadukou District, Chongqing, China
   Former Address: No. 30 Building, Taikang Road 6, Jianqiao Industrial Park C District, Dadukou District, Chongqing
   Website: www.zybio.com

R&D and Office Locations

Chongqing, Beijing, Shanghai, Guangzhou, Shenzhen, Nanjing, Xiamen, Changchun

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