In February 2026, Shanghai SAGA Biotechnology signed a formal agreement with Gaoyou Economic Development Zone in jiangsu Province for an in vitro diagnostic reagent and equipment manufacturing project with a total investment of 100 million yuan (RMB). Upon reACHing full production capacity, the project is expected to produce 5 million test chips and 500 diagnostic instruments annually, generating approximately 100 million yuan in annual sales revenue. As of early 2026, the company has cumulatively obtained 4 Class II medical device registration certificates in China and has 2 Class III medical device registrations under application. On January 7, 2026, the company completed investor (equity) changes, articles of association amendments, and capital contribution method changes per official industrial and commercial records.
Company Profile (Updated April 2026)
Shanghai Saga Biotechnology Co., Ltd.（上海萨迦生物科技有限公司） is an innovative biotech company focused on the research, development, production, and commercialization of novel biological detection platforms and related products. Founded on April 1, 2017 and headquartered in the Shanghai Pilot Free Trade Zone (Zhangjiang area), the company was established by a team with over 15 years of combined experience in biotechnology, novel biomaterials, and advanced instrumentation. Saga Biotechnology is recognized as one of the first batch of registrant pilot enterprises in Zhangjiang, operating under a light-asset model with all instrument and reagent products manufactured through contracted OEM partners while concentrating capital on R＆D and clinical collaboration.
Development History:
- 2017: Company founded on April 1 in Zhangjiang Medicine Valley Incubator, Shanghai Pilot Free Trade Zone; registered address at No. 250 Bibo Road, Building 2, 4th Floor, Room 405
- 2019: Completed Angel Round financing with investment from Hualing Capital
- 2021: Completed Pre-A Round financing with investment from Qingning Venture Capital Fund and Yuanfu Investment
- 2023: In January, completed Series A financing of tens of millions of RMB, led by Zhangke Herun (a professional biomedical fund under Zhangjiang Hi-Tech Investment) with follow-on investment from Qingdao Zhenze Fund and others; in July, obtained two Class II medical device registration certificates from Shanghai Municipal Medical Products Administration for its pepsinogen and multi-tumor marker test kits; in August, obtained NMPA approval for its biochip scanner; one instrument product received U.S. FDA registration; one instrument and three reagent products obtained EU CE certification
- 2024: Selected for the Zhangjiang Science City Special Development Fund Exhibition Project Support List; in April, co-hosted the "Institute of Traditional Chinese Medicine—SAGABIO·Rixin Academic Salon" with Shanghai University of Traditional Chinese Medicine; in October, granted an invention patent by the china National Intellectual Property Administration (Publication No.: CN109470666 B)
- 2025: Recognized as a Technology-Based Small and Medium-Sized Enterprise (科技型中小企业)
- 2026: On January 7, completed industrial and commercial changes including investor (equity) changes, articles of association amendments, and capital contribution method changes; in February, signed a 100-million-yuan manufacturing project with Gaoyou Economic Development Zone, Jiangsu Province, for annual production of 5 million test chips and 500 diagnostic instruments
Core Mission: To make life better through biotechnology by becoming an innovator and leader in solid-phase protein chip technology within the biotech field, providing customers with high-quality products and services through high-throughput, multi-index combined detection platforms.
Technology Platform ＆ Core Innovation
Solid-Phase Protein Chip Detection Platform
Saga Biotechnology has developed a proprietary solid-phase protein chip detection platform through independent innovation, combining three key technologies:
- Functional Silicone Membrane: Used as the chip substrate instead of traditional nitrocellulose (NC) membrane. The silicone membrane offers chemical inertness, low surface energy, excellent physical/chemical/mechanical stability, and good biocompatibility. Its surface is modified with anti-protein adsorption materials to reduce non-specific adsorption, simplify washing procedures, and enAble automation
- Near-Infrared (NIR) Fluorescence Labeling: NIR fluorescent signals are emitted only under excitation light illumination and can be rescanned repeatedly (≥3 times), providing high sensitivity, wide linear range, and excellent accuracy
- Laser Confocal Scanning: Advanced optical detection system combining laser confocal technology with NIR fluorescence detection, overcoming limitations of traditional protein chip detection in sensitivity, accuracy, stability, and linear range
Platform Advantages:
- High Throughput: One chip can test 40–88 samples simultaneously
- Multi-Index Combined Detection: One sample can be tested for multiple indicators simultaneously (e.g., 2 pepsinogen indicators or 4 tumor markers)
- Small Sample Volume: ≤20 microliters per sample
- Fast Detection: First batch of 40 samples completed in 45 minutes; subsequent batches every 15 minutes
- Short Wash Time: Only 5 minutes required (vs. ~30 minutes for traditional NC membrane chips)
- Full Automation Ready: Compatible with robotic arm automation after preprocessing
Product Portfolio
Instrument Products
Biochip Scanner (Clinical):
- Registration: NMPA-approved (沪械注准); FDA-registered; CE-marked
- Technology: Laser confocal + near-infrared fluorescence detection
- Scan Range: 130mm × 110mm (max)
- Dynamic Range: ＞4 logs
- Laser Source: 785nm solid-state laser (customizable within 350nm–1000nm range)
- Resolution: 5–120μm (8 levels)
- Z-Axis Adjustment: 0–17mm adjustable working distance
- Applications: Solid-phase protein chips, gene chips, liquid fluorescence substances, membranes, gels, microplates, tissue sections
- Patent: Invention patent granted by China National Intellectual Property Administration (Publication No.: CN109470666 B)
Biochip Scanner (Research Use):
- Scientific research version with same core laser confocal + NIR fluorescence technology
- Suitable for fluorescence intensity detection and quantitative analysis in multiple research applications
Reagent Products
Pepsinogen I / Pepsinogen II Detection Kit (Protein Chip Fluorescence Luminescence Method):
- Registration No.: 沪械注准20232400176
- Intended Use: Quantitative detection of PGI and PGII concentrations in human serum for evaluating gastric acid-secreting cell function and gastric mucosal lesions
- Clinical Significance: Important diagnostic indicators for Helicobacter pylori infection, atrophic gastritis, and gastric cancer risk; serum PG levels serve as key clinical indicators for early gastric cancer diagnosis, screening, treatment, and prevention. Also serves as the best screening test for peptic ulcers, with diagnostic significance for early asymptomatic ulcer patients.
- Packaging: 48 tests/box
- Detection Range: PGI [2.5–200] ng/mL; PGII [1.4–100] ng/mL
Multi-Tumor Marker (Four-Item) Detection Kit (Protein Chip Fluorescence Luminescence Method):
- Registration No.: 沪械注准20232400180
- Markers: CA15-3, CA19-9, CA125, and HE4
- Intended Use: In vitro quantitative determination of carbohydrate antigen 15-3 (CA15-3), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 125 (CA125), and human epididymis protein 4 (HE4) in human serum using microarray-NIR fluorescence immunoassay. CA15-3 for breast cancer treatment efficacy and prognosis monitoring; CA19-9 for pancreatic and digestive tract malignancy monitoring; CA125 and HE4 for ovarian cancer treatment monitoring. Not intended for early diagnosis, confirmation, or general population screening of malignancies.
- Packaging: 48 tests/box, 96 tests/box
- Detection Range: CA15-3: [7–200] U/mL; CA19-9: [5–1000] U/mL; CA125: [3–1000] U/mL; HE4: [15–1000] pmol/L
- Storage: 2℃–8℃, 12-month shelf life
Consumables ＆ Accessories
- Anti-Protein Adsorption Silicone Substrate Microarray Plates: 48-well and 96-well formats
- Chamber Slides / Anti-Protein Adsorption Microarray Glass Slides: For research and custom chip applications
Regulatory Status ＆ Certifications
China (NMPA)
- Class II Medical Device Registration Certificates: 4 certificates cumulatively obtained as of February 2026, including:
- Pepsinogen I/II Detection Kit (沪械注准20232400176)
- Multi-Tumor Marker (Four-Item) Detection Kit (沪械注准20232400180)
- Biochip Scanner (clinical)
- Additional instrument/reagent approvals
- Class III Medical Device Registrations: 2 items currently under application
- Registrant Pilot Enterprise: One of the first batch of registrant pilot enterprises in Zhangjiang, operating under the medical device registrant system (委托生产模式)
International Certifications
- U.S. FDA: Biochip scanner registered with FDA
- EU CE Mark: One instrument product and three reagent products certified
Enterprise Qualifications
- Technology-Based Small and Medium-Sized Enterprise (科技型中小企业) — recognized in 2024 and 2025
- Invention Patent: Granted by China National Intellectual Property Administration in October 2023 (Publication No.: CN109470666 B)
Financial Performance ＆ Funding History
Funding Rounds
- Angel Round (October 2019): Undisclosed amount — Hualing Capital
- Pre-A Round (July 2021): Undisclosed amount — Qingning Venture Capital Fund, Yuanfu Investment
- Series A (January 2023): Tens of millions of RMB — led by Zhangke Herun (Zhangjiang Hi-Tech Investment professional biomedical fund), with follow-on from Qingdao Zhenze Fund and other investors
- Total Raised: Approximately 20+ million RMB across disclosed rounds
Business Model
Saga Biotechnology operates a "Instrument + Reagent" bundled sales model. The company deploys instruments to physical examination institutions and small-to-medium hospitals at low cost or free of charge to drive sales of supporting reagents. This strategy leverages the platform's technological advantages to penetrate the grassroots medical market and体检 (health checkup) sector.
Company Overview
Corporate Information
Company Name: Shanghai Saga Biotechnology Co., Ltd.（上海萨迦生物科技有限公司）
Founded: April 1, 2017
Registered Address: Room 405, 4th Floor, Building 2, No. 250 Bibo Road, China (Shanghai) Pilot Free Trade Zone, Pudong New Area, Shanghai
Operational Address: Room 904, No. 781 Cailun Road, China (Shanghai) Pilot Free Trade Zone, Pudong New Area, Shanghai
Production Address: Rooms 3101–3105, 3107, 3109, No. 3 Incubation Building, Comprehensive Building, No. 568 Jinyang East Road, Jiashan County, Jiaxing City, Zhejiang Province, China
Legal Representative ＆ General Manager: Xu Yingyuan（许颖原）
Chairman: Xu Yingyuan（许颖原）(also serving as General Manager)
Registered Capital: 7.680518 million RMB
Company Type: Private Limited Liability Company (Joint Venture of Foreign-Invested and Domestic Enterprises)
Industry: Biotechnology / In Vitro Diagnostics (IVD) / Medical Devices
Employees (Social Insurance Contributors): 37 people (2023 annual report)
R＆D Personnel Ratio: Over 70%
Phone: +86-21-5899-3829
Email: info@sagabio.cn
Website: www.sagabio.cn
Shareholder Structure (as of January 2026)
- Xu Yingyuan（许颖原）: Major shareholder, suspected actual controller and beneficial owner
- Shen Yi（沈懿）: Shareholder
- Shanghai Yiyun Enterprise Management Consulting Co., Ltd.（上海益赟企业管理咨询有限公司）: Shareholder
- Hubei Qingning Venture Capital Investment Fund Co., Ltd.（湖北青柠创业投资基金有限公司）: State-owned enterprise shareholder
- Xu Peng（徐鹏）: Shareholder
- Shanghai Zhangke Herun Biomedical Venture Capital Partnership（上海张科禾润生物医药创业投资合伙企业）: State-owned enterprise shareholder (Zhangjiang Hi-Tech Investment)
Key Personnel
- Xu Yingyuan（许颖原）: General Manager, Chairman
- Gu Jiefeng（顾杰锋）: Director
- Wang Bin（王斌）: Director
- Liu Tao（刘涛）: Director
- Yan Youliang（严幼良）: Director
- Tao Yinghua（陶颖华）: Supervisor
- She Renji（佘仁吉）: Financial Officer
Strategic Partnerships ＆ Collaborations
Academic ＆ Research Collaborations
- Shanghai University of Traditional Chinese Medicine (TCM) Institute of Translational Medicine: Co-hosted the "Institute of Translational Medicine—SAGABIO·Rixin Academic Salon" in April 2024 to strengthen exchanges and cooperation between universities/research institutes and enterprises, promoting deep integration of industry, academia, and research
- Zhangjiang Public Service Platform: Resident incubation enterprise of Zhangjiang Medicine Valley Public Service Platform
Manufacturing ＆ Supply Chain
- OEM Manufacturing Partners: All instrument and reagent products are manufactured through contracted OEM partners under the medical device registrant system; production addresses include Zhejiang Jiaxing (Jiashan County)
- Gaoyou Manufacturing Base (2026): New 100-million-yuan manufacturing project signed in February 2026 with Gaoyou Economic Development Zone, Jiangsu Province, for in vitro diagnostic reagent and equipment production
Global Market ＆ Competitive Landscape
Target Markets
China: Core market focusing on physical examination institutions, grassroots hospitals, and secondary/tertiary hospital clinical laboratories; products distributed through direct sales and distributor networks
International: FDA-registered and CE-marked products enable export to the U.S., European, and other international markets; global layout with synchronized registration in China, the U.S., and Europe
Primary Competitors
- Raybiotech (USA): Protein microarray and antibody array solutions
- Quanterix (USA): Ultra-sensitive digital immunoassay platform (Simoa)
- Meso Scale Discovery (USA): ElectRochemiluminescence multi-array platform
- Luminex (USA/DiaSorin): xMAP multi-analyte profiling technology
- Chinese Domestic IVD Chip Companies: Multiple domestic competitors in protein chip and chemiluminescence immunoassay markets
Competitive Advantages
- Proprietary Silicone Membrane Substrate: Unique functional silicone membrane replaces traditional NC membrane, offering superior biocompatibility, chemical stability, and anti-non-specific adsorption performance
- NIR Fluorescence + Laser Confocal Integration: First domestic productized combination of these technologies for protein chip detection, achieving major breakthroughs in sensitivity, accuracy, stability, and linear range
- High-Throughput Multi-Index Combined Detection: Platform enables simultaneous detection of multiple indicators with small sample volumes, fast turnaround, and high cost-performance ratio
- Light-Asset Registrant Model: Typical light-asset company concentrating capital on R＆D and clinical collaboration; over 70% R＆D personnel; all production outsourced to qualified OEM partners
- Full Regulatory Foundation: NMPA Class II approvals, FDA registration, and CE certification provide strong market access credentials domestically and internationally
- Instrument + Reagent Bundled Strategy: Low-cost/free instrument deployment drives reagent consumption, effectively penetrating体检 and grassroots hospital markets
2026 Outlook ＆ Strategic Priorities
Near-Term Objectives
- Gaoyou Manufacturing Base Construction: Execute the 100-million-yuan manufacturing project in Gaoyou Economic Development Zone to achieve annual capacity of 5 million test chips and 500 diagnostic instruments
- Class III NMPA Registration: Advance 2 Class III medical device registration applications currently under review
- Product Line Expansion: Continue developing "General IVD Reagents, Clinical Special Test Reagents, and Scientific Research Detection Reagents" to enrich the product portfolio
- Market Penetration: Expand presence in physical examination institutions and grassroots hospitals through the instrument + reagent bundled sales model
- International Expansion: Leverage FDA and CE certifications to expand into Southeast Asian, Middle Eastern, and other emerging markets
Contact Information
Corporate Headquarters
Registered Address: Room 405, 4th Floor, Building 2, No. 250 Bibo Road, China (Shanghai) Pilot Free Trade Zone, Pudong New Area, Shanghai, China
Phone: +86-21-5899-3829
Email: info@sagabio.cn
Operational ＆ Manufacturing Addresses
Shanghai Office: Room 904, No. 781 Cailun Road, China (Shanghai) Pilot Free Trade Zone, Pudong New Area, Shanghai
Production Address: Rooms 3101–3105, 3107, 3109, No. 3 Incubation Building, Comprehensive Building, No. 568 Jinyang East Road, Jiashan County, Jiaxing City, Zhejiang Province, China
Gaoyou Project: Gaoyou Economic Development Zone, Jiangsu Province, China (signed February 2026)
Online Presence
Website: www.sagabio.cn
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