Reliable reagents,
connecting laboratories and clinics
HEMANOVA is a company dedicated to the R&D, manufacturing and technical service of in vitro diagnostic reagents. We believe that consistent products and prompt professional service are the foundation of trustworthy results.
Company profile
Founded in 2012, HEMANOVA Biotech (Shanghai) Co., Ltd. is headquartered in Zhangjiang Hi-Tech Park, Shanghai, with an R&D and manufacturing base in Suzhou. The company focuses on the development, production and technical service of in vitro diagnostic reagents, covering clinical chemistry, immunoassay, molecular, coagulation and QC calibration.
We operate an ISO 13485 medical device quality management system, with ISO Class 8 cleanrooms, automated formulation and filling lines, and quality management processes covering raw materials, production, finished goods and post-market surveillance. Our products serve healthcare institutions, regional testing centers and third-party laboratories across China, and we are expanding into overseas markets.
Guided by our mission "making reliable testing accessible", we continue to invest in the independent development of key raw materials, reagent formulations and detection systems, working with partners to advance high-quality laboratory medicine.
Employees
R&D staff share
Registered products & pipeline
Service network coverage
We take the long view
Medical diagnosis leaves no room for error. We treat every product detail with scientific rigor, and every customer and partner with a commitment to long-term collaboration.
Mission
Make reliable testing accessible. Through stable, traceable reagents and professional service, help laboratories earn results they can trust.
Vision
To be the IVD partner laboratories trust, contributing to global laboratory medicine through continuous innovation and consistent quality.
Values
Rigor, collaboration, long-termism. Let data and records speak; be accountable for our products, our customers and every patient result.
Our journey
From a single clinical chemistry line to five technology platforms, we have moved forward steadily around the real needs of laboratories.
"Making every batch stable matters more than telling a great story." — Founder of HEMANOVA
Founded in Zhangjiang, Shanghai
Starting with clinical chemistry reagents, we built our R&D and application teams and began exploring in vitro diagnostics.
Suzhou manufacturing base commissioned
ISO Class 8 cleanrooms and automated filling lines completed, creating end-to-end manufacturing capability from formulation to finished product.
Chemiluminescence platform launched
Magnetic particle chemiluminescence reagents and matching detection systems released, extending the portfolio into infection and cardiac markers.
Molecular and coagulation lines established
Fluorescent PCR and coagulation platforms completed, forming a multi-technology product landscape.
Quality system upgrade
End-to-end lot traceability and post-market surveillance improved; the service network reached 28 provincial-level regions.
New-generation platform released
New fully automated chemiluminescence platform launched for mid- to large-sized laboratories, with an overseas expansion plan underway.
Five platforms powering continuous innovation
From key raw materials to reagent formulations, from assay design to system integration, platform-level capabilities shorten development cycles and improve batch-to-batch consistency.
Clinical chemistry platform
Enzymatic, immunoturbidimetric and latex-enhanced technologies for routine and specialty assays on mainstream analyzers.
Chemiluminescence platform
Magnetic particle coating, acridinium ester labeling and automated reaction systems focused on infection, cardiac and metabolic markers.
Molecular diagnostics platform
Fluorescent PCR, multiplex amplification and nucleic acid extraction technologies covering pathogen detection, viral load and genotyping.
Coagulation platform
Clotting, immunoturbidimetric and chromogenic reagents with matching calibration and QC systems for routine coagulation laboratories.
Key raw material research
Screening, evaluation and in-house preparation of antibodies, enzymes, antigens and other key materials.
Formulation & process development
Formulation optimization and scale-up for stability, interference resistance and reaction efficiency.
Method validation
Systematic validation of precision, accuracy, linearity, reference intervals and interference.
Registration & transfer
Coordinating regulatory, clinical and production teams to drive compliant market launch and continuous improvement.
Quality system & compliance
Quality is not inspected in at the end — it is designed, produced and managed. Risk management and process control run through the entire product life cycle.
Material control
Supplier audits, batch acceptance and retained samples for key materials, with dual sourcing and safety stock.
Process control
Real-time cleanroom monitoring; formulation, filling and packaging parameters recorded and traceable.
Product release
Performance testing against registration standards; every batch retained with ongoing stability studies.
Post-market surveillance
Complaint and adverse event intake, trend analysis, corrective and preventive actions and recall management.
"Our ultimate measure of quality is not the number on a test report, but whether laboratories can issue trustworthy results reliably, every single day."Head of Quality, HEMANOVA