FAPON

What FAPON does

Fapon Biotech (菲鹏生物股份有限公司) is a Chinese in vitro diagnostics (IVD) upstream platform company founded in 2001 and headquartered in Dongguan, Guangdong, with listings on China's NEEQ (838391). The company operates across three integrated layers of the IVD value chain: (1) raw materials (1,400+ antigens, antibodies, and diagnostic enzymes), (2) reagent solutions across chemiluminescence, molecular diagnostics, immunofluorescence, biochemical, and flow cytometry platforms, and (3) open instrument platforms including the Shine series chemiluminescence analyzers (Shine i8000/9000 at 900 tests/hour single-unit up to 3,600 tests/hour in 4-unit connection, plus i6000, i3000, i2000, i1000), Shine mT8000 biochemical-immunoassay assembly line, molecular POCT systems (Ideal 30, Nous 30V veterinary), and fluorescence immunoassay analyzers. Underlying technology spans an antibody discovery platform (phage display P-DisExpress, single B-cell FastHTP), protein expression technology, high-density cell fermentation, and an AI-driven biomarker discovery platform. Fapon reports 1,200+ patent applications and 450+ patents granted (80%+ invention), with 8,000+ instruments deployed and 5,000+ global chemiluminescence shipments within three years of launch.

The company runs a B2B business model selling upstream inputs to IVD manufacturers globally through direct technical sales, regional subsidiaries (Indonesia, Boston R&D, San Francisco R&D), and an ecosystem of 300+ partners serving 2,500+ customers across 68+ countries. Revenue streams include IVD core raw materials (one-time/license), open instrument hardware sales, reagent solutions, and licensing/co-development (e.g., exclusive PSP sepsis biomarker license from Abionic). Customer segments are primarily IVD manufacturers, with secondary segments in research institutions, biopharmaceutical companies (via Fapon Biopharma subsidiary for T-cell engagers and in-vivo CAR-T with MOTE Therapeutics), medical laboratories, and veterinary diagnostics (PawNovo). The organization maintains subsidiaries including Fapon Biopharma (biopharmaceuticals), Fapon Shuhui (AI-driven digital diagnostics), PawNovo (veterinary molecular POCT), and Fapon Indonesia, supported by a management team with founder/Chairman Cui Peng (崔鹏) and President He Zhiqiang (何志强) leading globalization strategy.

Geographic expansion is a defining feature, with strategic partnerships and MoUs in Indonesia (Bio Farma, Kalbe Farma, Halodoc, 2023), Middle East (Dubai Chamber of Commerce, 2023; Chinese Embassy Saudi Arabia), Korea (KIVDA, 2025), and North America (Stanford University HIL, 2023; Boston and San Francisco R&D centers, 2023-2024). The company participates extensively in international exhibitions (MEDICA, CACLP, AACC/ADLM, Medlab Middle East, BIO) and joined the Pandemic Fund's External Advisory Council in 2025. Distribution relies on direct sales teams, channel/reseller partnerships (notably Huarun Medical Devices), and an open-ecosystem network designed to enable partner reagent development without instrument lock-in.

Name

FAPON

Legal name

菲鹏生物股份有限公司

Website

https://faponbiotech.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Fapon Biotech (菲鹏生物股份有限公司) is a Chinese IVD upstream platform company offering core raw materials, reagent solutions, and open instrument platforms (chemiluminescence, molecular POCT, flow cytometry) to 2,500+ IVD manufacturers across 68+ countries, with biotechnology (T-cell engagers, in-vivo CAR-T) and veterinary diagnostics subsidiaries.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics Manufacturing

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Microscopy, Imaging & Flow Cytometry Instruments (HLAGAIAE)

Keywords

• In vitro diagnostics
• IVD raw materials
• Chemiluminescence immunoassay
• Molecular diagnostics reagents
• Open platform instruments

Headquarters

HQ city

Dongguang

HQ country

China

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Infrastructure, Operations

Revenue model

1. IVD Core Raw Materials: B2B sales of antigens, antibodies, and diagnostic enzymes to IVD manufacturers. The company offers 1,400+ core raw material varieties covering immunity, molecular, and biochemical detection platforms.
2. Open Instrument Platform: Sales and deployment of automated chemiluminescence analyzers (Shine i series), molecular POCT systems (Ideal, Nous series), immunofluorescence analyzers (WS series), and flow cytometry platforms. Over 8,000 instruments deployed globally.
3. Reagent Solutions: Complete reagent solutions for various disease detection including tumor markers, cardiac markers, infectious diseases, respiratory diseases, tropical diseases, thyroid function, hormones, and metabolism.
4. Licensing and Co-development: Technology licensing for biomarkers (e.g., PSP for sepsis), co-development partnerships with pharmaceutical companies and strategic technology transfer arrangements.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

FAPON manufactures and supplies IVD core raw materials (antigens, antibodies, diagnostic enzymes) covering 1,400+ varieties, open instrument platforms (Shine series chemiluminescence, molecular POCT, immunofluorescence, flow cytometry), and complete reagent solutions for disease detection across immunoassay, molecular, and biochemical platforms. The company offers AI-driven biomarker discovery and serves 2,500+ IVD manufacturer partners across 68+ countries as an upstream platform enterprise.

Product overview

FAPON (菲鹏生物) is a leading global in vitro diagnostic (IVD) upstream platform company offering a comprehensive three-dimensional solution comprising core reagent raw materials (antigens, antibodies, diagnostic enzymes), reagent solutions (chemiluminescence, clinical biochemistry, molecular diagnostics, immunofluorescence), and open instrument platforms. The product portfolio includes the Shine series chemiluminescence immunoassay systems (i8000/9000, i6000, i3000, i2000, i1000) covering speeds from 120-900 tests/hour, Shine fL3000 flow cytometry platform, molecular POCT systems (Ideal 30, Nous 30V), fluorescence immunoassay analyzers (WS-Mi6000, WS-Si1500, WS-Si1000), and the Shine mT8000 fully automated biochemical immunoassay assembly line. The company serves 2,500+ global partners across 68+ countries, with instrument installations exceeding 8,000 units globally.

Differentiator

Problem solved

Functional benefit

Brands

• PawNovo (鹏佑): Pet healthcare molecular POCT brand under Fapon, providing molecular diagnostic solutions for veterinary clinics and pet hospitals.

Products and services

• IVD Core Raw Materials (Antigens, Antibodies, Diagnostic Enzymes) Foundational IVD raw materials including antigens, antibodies, and diagnostic enzymes serving as core components for immunoassay, molecular diagnostics, and biochemical testing reagent development. Target customers are IVD reagent manufacturers seeking high-quality upstream inputs.
• Shine i8000/9000 Fully Automated Chemiluminescence Immunoassay System Ultra-high-speed chemiluminescence immunoassay analyzer with single-unit speed of 900 tests/hour and 3,600 tests/hour when 4 units connected. Designed for high-volume clinical laboratories and IVD manufacturers.
• Shine i6000 Fully Automated Chemiluminescence Immunoassay System High-throughput chemiluminescence platform with 600 tests/hour throughput, compact footprint of 0.86 sqm. For mid-to-large clinical laboratories and IVD reagent developers.
• Shine i3000 Fully Automated Chemiluminescence Immunoassay System Mid-speed chemiluminescence system with 300 tests/hour speed and compact design. For mid-volume clinical and IVD development settings.
• Ideal 30 Fully Automated Nucleic Acid Detection Analysis System Molecular POCT system using magnetic bead nucleic acid extraction and rapid fluorescent quantitative PCR detection. Results in as fast as 30 minutes. For clinical molecular diagnostics and IVD manufacturers.
• Shine fL3000 Flow Fluorescence Chemiluminescence Detection System Flow cytometry platform combining chemiluminescence and flow fluorescence technologies, achieving 150 tests/hour with multiplexing capability up to n*150 tests/hour for multi-item detection. For clinical laboratories and life science research.
• Shine mT8000 Fully Automated Biochemical Immunoassay Assembly Line First fully open high-speed biochemical-immunoassay assembly line integrating Biochemistry 2800 T/h and Immunoassay 900 T/h dual-engine performance within a 5 sqm footprint for one-tube full-process rapid detection. For clinical diagnostics labs.
• Nous 30V Veterinary Fully Automated Nucleic Acid Detection Analysis System Veterinary molecular POCT system for pet hospitals using rotating magnetic bead extraction and qPCR detection, with 50 test menu items for cats and dogs. Sold under PawNovo sub-brand.
• WS-Mi6000 Multi-channel Fluorescence Immunoassay Analyzer Multi-channel fluorescence immunoassay analyzer with 160 tests/hour speed and first result in 2-8 minutes. For clinical and medical laboratory use.
• Reagent Solutions Complete reagent solutions covering chemiluminescence, clinical biochemistry, molecular diagnostics, and immunofluorescence platforms for disease detection including tumor markers, cardiac markers, infectious diseases, respiratory diseases, tropical diseases, thyroid function, hormones, and metabolism. For IVD manufacturers and clinical labs.
• Ideal 36 and Ideal 66 Fully Automated Nucleic Acid Detection Analysis Systems New generation fully automated nucleic acid detection analysis systems expanding the Ideal molecular POCT series, launched alongside Shine mT8000 at CACLP 2025.
• hs-cTnI Chemiluminescence Reagent Solution High-sensitivity cardiac troponin I chemiluminescence reagent solution with LOQ <2pg/mL and fg/mL-level detection sensitivity for early cardiac event diagnosis. For clinical laboratories and IVD manufacturers.
• PSP Sepsis Early Detection Solution (China Version) Pancreatic Stone Protein (PSP) sepsis early detection reagent solution for the Chinese market, enabled by exclusive licensing agreement with Abionic SA/Lascco SA. Predicts sepsis up to 72 hours before onset. For clinical diagnostics and sepsis management.
• Mpox Antigen Detection Product Mpox antigen detection diagnostic product with detection limit at 1pg/mL, capable of detecting most clinical positive specimens. For clinical diagnostics and public health surveillance.
• AI Biomarker Discovery Platform First knowledge-driven AI biomarker discovery platform in China featuring AI-driven design, zero-threshold interactive interface, and ultra-low cost R&D capabilities. Uses multi-omics AI algorithms to discover and validate novel biomarkers. For internal R&D and partner diagnostic product development.

Quantifiable outcome

• Shine i8000/9000 achieves 900 tests/hour single unit, 3,600 tests/hour with 4 units connected
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability9 records

Feature7 records

Partnerships

15 partnerships are on record, tiered core, major and minor.

• MOTE TherapeuticscoreStrategic or Co-development Partner · 19 June 2026Both Fapon Biopharma and MOTE Therapeutics are members of Fapon Group, presenting dual-platform B-cell immunotherapy franchise including FPE024 (tri-specific T-cell engager, IND filing Q1 2027) and MTX001 (in-vivo CAR-T, first-in-human Q4 2026). Pursuing flexible partnership models including co-development and licensing.
• The Pandemic Fund (大流行病基金)coreOthers · 9 July 2025Fapon officially joined the Pandemic Fund's newly established External Advisory Council (EAC) in 2025. The EAC consists of 19 non-sovereign entities including private sector, philanthropy, academia, and think tanks. The Pandemic Fund, established by World Bank as trustee, focuses on strengthening pandemic prevention, preparedness, and response capabilities in low- and middle-income countries.
• Korean IVD Association (KIVDA)majorStrategic or Co-development Partner · 23 May 2025Strategic cooperation covering technology innovation, market scale, and policy coordination. Explores joint technology transfer and IP collaboration, promotes standard mutual recognition between China and Korea, and explores joint market entry models in emerging markets.
• Tencent HealthmajorStrategic or Co-development Partner · 23 March 2025Strategic cooperation covering brand building, technology collaboration, and industry solution development. Collaboration leverages Fapon's IVD industry resources and Tencent's cloud computing, AI, and big data capabilities. Joint activities include overseas expansion programs for medical healthcare companies.
• Sansure Biotech (圣湘生物)majorStrategic or Co-development Partner · 22 March 2025Strategic cooperation focused on AI molecular enzyme innovation R&D and next-generation diagnostic solutions. Fapon's AI molecular enzyme development technology combined with Sansure's clinical diagnostics experience and industrialization capabilities to create more accurate and reliable diagnostic solutions.
• Stanford UniversitycoreStrategic or Co-development Partner · 26 September 2024Co-hosted 'Proteomics: From Gene to Function' symposium with Stanford Health Innovation Lab, gathering top scientists from Stanford, Harvard, and Northwestern to discuss latest proteomics advances and applications in precision medicine.
• Huarun Medical Devices (华润医药商业集团医疗器械有限公司)majorChannel Partner/ Reseller/ Distributor · 16 March 2024Strategic cooperation in open instrument platform, reagent solutions, and innovation project introduction. Partnership leverages Huarun's commercial advantages to build full ecological chain integrating Fapon's industry and technology platform resources.
• Bio FarmacoreStrategic or Co-development Partner · 1 February 2024Strategic cooperation with Indonesia's largest state-owned pharmaceutical company covering biopharma, medical devices, and IVD solutions. Full-spectrum strategic cooperation leveraging Bio Farma's strong local channels and Fapon's diagnostic and biopharma technology platforms.
• Indonesian IVD Companies (multiple)majorChannel Partner/ Reseller/ Distributor · 1 January 2024Partnership with multiple top Indonesian medical device customers providing technical support for diagnostic product lines, recognized by local government and IVD enterprises.
• Chinese Embassy in Saudi Arabia (Economic and Commercial Office)minorOthers · 7 November 2023Visit and exchange with Saudi Embassy commercial office regarding local economic policies, pharmaceutical regulations, and biopharmaceutical field cooperation. Fapon expressed interest in leveraging technology advantages to build local healthcare ecosystem.
• Dubai Chamber of Commerce China Innovation CentermajorStrategic or Co-development Partner · 2 November 2023MoU signing for strategic partnership in IVD, pharmaceuticals, treatment, biomarker screening, and medical/healthcare industry investment. Collaboration to empower local medical diagnostic enterprises, promote localization development, and provide quality medical services in the Middle East market.
• LASCCO SA / Abionic SAcoreOEM/ Whitelabel/ Licensing Partner · 23 October 2023Exclusive licensing agreement for pancreatic stone protein (PSP) biomarker application in sepsis diagnosis in China. Fapon received exclusive authorization to develop, produce, and commercialize PSP detection raw materials and chemiluminescence reagent solutions. PSP has received EU IVDR CE, Australia certification, and FDA 510(k) approval expected in 2024.
• HalodoccoreStrategic or Co-development Partner · 12 October 2023Strategic cooperation with Indonesia's largest online healthcare platform. Joint venture establishment for IVD product localization R&D and production in Indonesia. Fapon provides core raw materials, reagent solutions, and open instrument platforms; Halodoc provides local internet channels and service advantages.
• Guangdong Smart Medical International Research Institute (π-HuB Plan)coreStrategic or Co-development Partner · 22 September 2023Strategic cooperation signing for the Human Proteome Navigation International Big Science Program (π-HuB). Fapon supports π-HuB plan implementation in Guangdong-Hong Kong-Macao Greater Bay Area, sharing proteomics experimental platforms and research resources.
• Stanford University Health Innovation Laboratory (HIL)coreStrategic or Co-development Partner · 4 September 2023Strategic cooperation with Stanford University HIL as an industry member of its affiliated program. Collaboration on medical health academic research and scientific cooperation, including participation in the Mental Health Innovation Summit. Partnership leverages Stanford's top research capabilities and expert resources combined with Fapon's diagnostic underlying technology platform to advance precision diagnosis and treatment innovation.

Scale indicators10 records

Recent moves9 records

Expansion highlights10 records

Direct peers

• HyTest (Anogen Yes Biotech): Finland-based IVD raw material specialist producing monoclonal antibodies, antigens, and diagnostic reagents. Acquired by Anogen Yes Biotech, it is the most direct upstream peer to FAPON's core raw materials business, serving global IVD manufacturers with comparable antibody/antigen portfolios.
• Medix Biochemica: Finland-headquartered IVD raw materials manufacturer specializing in monoclonal antibodies and antigens for diagnostics. Closely comparable to FAPON's core raw materials business, serving global IVD kit manufacturers across immunoassay and molecular platforms.
• Surmodics: US-based company whose IVD division (acquired by Sartorius in 2024) supplied antigens, antibodies, and reagents to IVD manufacturers. Direct peer in the IVD raw materials value chain with comparable B2B customer model and global IVD manufacturer relationships.
• Aalto Bio Reagents: Ireland-based specialist in IVD raw materials including native and recombinant antigens, antibodies, and viral proteins. Comparable niche-focused peer serving global IVD manufacturers, particularly in infectious disease and serology testing.
• Snibe (Shenzhen New Industries Biomedical): Chinese chemiluminescence immunoassay specialist competing directly with FAPON's Shine series in hospital and clinical lab placements. Comparable product category (CLIA instruments and reagents), target customers (mid-tier hospitals), and pricing band.

Broad incumbents

• Roche Diagnostics: Global IVD leader offering fully integrated closed systems spanning immunoassays, molecular diagnostics, clinical chemistry, and tissue diagnostics. Operates a much broader portfolio than FAPON but competes for both upstream raw materials customers and downstream instrument placements.
• Siemens Healthineers: Major global IVD player with the Atellica and ADVIA Centaur immunoassay platforms, plus upstream reagent manufacturing capability. Comparable as a broad IVD incumbent that both competes with FAPON's open platform and overlaps in upstream raw materials.
• Abbott Diagnostics: Global IVD giant with the Architect and Alinity immunoassay platforms alongside a broad raw materials/reagent portfolio. Comparable as a broad incumbent that competes with FAPON's open-platform approach and operates across the same IVD end markets.

Emerging players

• Mindray: China's largest domestic IVD and medical device manufacturer with comprehensive chemiluminescence, hematology, and ultrasound platforms. Increasingly comparable to FAPON as it expands vertically into upstream raw materials while competing head-to-head in instruments.
• Sansure Biotech: Chinese molecular diagnostics and IVD company that signed a strategic partnership with FAPON in March 2025 for AI molecular enzyme innovation. Competes with FAPON in molecular diagnostics raw materials and reagent solutions while also acting as a customer/partner.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/fapon-biotech-inc-

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries4 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about FAPON