Prima (Nanjing) Biotechnology Co., Ltd. (普睿玛（南京）生物科技有限公司) - Innovative Pathology Diagnostics High-Te

Company Profile (Updated April 2026)

Prima (Nanjing) Biotechnology Co., Ltd. (普睿玛（南京）生物科技有限公司) is a technology enterprise dedicated to revolutionizing pathology diagnostics through innovation. Founded on December 23, 2019 in Nanjing, jiangsu Province, china, the company is headquartered in the Nanjing Economic and Technological Development Zone.

The company focuses on the research, development, production, and sales of immunohistochemistry (IHC) diagnostic reagents, companion diagnostic kits, microbial detection products, and automated pathology equipment. Leveraging its proprietary ExactBiofusion antibody technology, Prima aims to reconstruct IHC detection standards and provide efficient, reliAble solutions for clinical pathology diagnosis, tumor precision medicine, and new drug development.

Core Mission: "Making precision diagnostics accessible" (让精准诊断触手可及). The company is committed to advancing pathology diagnostics from "precision" to "intelligence" through continuous innovation.

Core Technology

ExactBiofusion Antibody Technology

Prima has developed proprietary ExactBiofusion antibody technology, which forms the Foundation of its immunohistochemistry detection standard system. This technology enables:

- High-Specificity Antibody Development: Proprietary antibody engineering for precise tumor marker detection

- Biofusion Enzyme Antibody Signal Amplification: Enhanced staining sensitivity and specificity for reliable diagnostic results

- Standardized IHC Protocols: Reconstructed IHC detection standards ensuring reproducibility across laboratories

AI-Assisted Pathology Diagnosis

The company has extended its R&D into pathology AI-assisted diagnostic systems, collaborating with multiple universities and research institutions to build an intelligent pathology ecosystem combining reagents, equipment, and data analytics.

Product Portfolio

Pathology Diagnostics

- Tumor Marker Detection: Comprehensive panel covering routine tumor markers for lung cancer, breast cancer, gastric cancer, lymphohematopoietic system diseases, and other high-incidence malignancies

- Infectious Disease Pathology Screening: Reagents for pathogen detection in tissue samples

Companion Diagnostics

- PD-L1 Detection Kits: For immune checkpoint inhibitor therapy selection

- HER2 Detection Kits: For targeted therapy in breast and gastric cancers

- Other Companion Diagnostic Reagents: Supporting precision medicine and new drug development

Microbial Detection

- Fungal Fluorescence Staining Solution (Immunofluorescence Method): Approved March 2023

- Fungal Microscopy Processing Solution: Approved April 2023

Automated Equipment

- PM2000B Plus Fully Automated Immunohistochemistry Stainer: Debuted June 2025 (Registration No. 苏宁械备20250293). Features optimized dual-liquid circuit system for enhanced staining speed while preventing cross-contamination. Compatible with both high-throughput automated staining and manual precision operation workflows

Immunohistochemistry Reagent Series (Registered Products)

Selected Class I medical device registrations:

- CD3 Antibody Reagent (Immunohistochemistry): Registration No. 苏宁械备20250177, approved April 30, 2025

- p16 Antibody Reagent (Immunohistochemistry): Registration No. 苏宁械备20230228, approved June 26, 2023

- TPO Antibody Reagent (Immunohistochemistry): Registration No. 苏宁械备20230210, approved June 7, 2023

- Vimentin Antibody Reagent (Immunohistochemistry): Registration No. 苏宁械备20250236

- p120 Antibody Reagent (Immunohistochemistry): Registration No. 苏宁械备20250224

- β-catenin Antibody Reagent (Immunohistochemistry): Registration No. 苏宁械备20250433

2025 Latest Developments

PM2000B Plus Debut (June 2025)

At the 4th Annual Academic Conference of the Pathology Professional Committee of China Medical Device Industry Association and the 2025 Shanxi Medical Association Pathology Academic Annual Conference held in Taiyuan, Prima debuted its PM2000B Plus fully automated immunohistochemistry stainer (Registration No. 苏宁械备20250293).

Key Features:

- Optimized dual-liquid circuit system for precise detail control

- Enhanced staining speed with cross-contamination prevention

- 40-minute complete staining protocol from post-repair incubation

- Live demonstration of "biofusion enzyme antibody" staining received recognition from pathology experts including Professor Dang Yiwu from the First Affiliated Hospital of Guangxi Medical University

New Product Registrations (2025)

- April 30, 2025: CD3 antibody reagent (immunohistochemistry) approved (苏宁械备20250177)

- 2025: Multiple IHC antibody reagents registered including Vimentin, p120, and β-catenin

Industry Participation

- June 2025: Participated in CACLP (China Association of Clinical Laboratory Practice Expo) and national pathology conferences

- 2023: Participated in the 20th CACLP and the 3Rd China International IVD Raw Materials and Manufacturing Circulation Supply Chain Expo

Strategic Partnerships and Collaborations

The company has established industry-university-research collaborative transformation bases with multiple higher education institutions, including:

- Zhejiang University

- Chinese Academy of Medical Sciences

- Nanjing Medical University

Company Basic Information

Corporate Overview

Company Full Name: Prima (Nanjing) Biotechnology Co., Ltd. (普睿玛（南京）生物科技有限公司)

Former Name: Nanjing Runtang Biotechnology Co., Ltd. (南京润塘生物科技有限公司)

Founded: December 23, 2019

Legal Representative / Executive Director: Jia Fengqin (贾凤芹)

Supervisor: Jia ShUKe (贾淑柯)

Parent Company / Shareholder: Nanjing Fuxiao Biotechnology Co., Ltd. (南京拂晓生物科技有限公司) — 100% ownership, RMB 8 million capital contribution

Registered Address: Room 502, Building C5, Hongfeng Science and Technology Park, No. 1 Zhixin Road, Nanjing Economic and Technological Development Zone, Nanjing, Jiangsu, China

Production Address: West Side, 4th Floor, Building C5, Hongfeng Science and Technology Park, No. 1 Zhixin Road, Nanjing Economic and Technological Development Zone, Nanjing, Jiangsu, China

Unified Social Credit Code: 91320104MA20NHAQ91

Business Registration No.: 320104000545694

Registered Capital: RMB 8 million

Company Type: Limited Liability Company (Wholly Owned by Legal Person Invested or Controlled by Natural Person)

Industry: Medical Devices / Biotechnology / Pathology Diagnostics

Social Insurance Employees: 10 (per 2024 annual report)

Official Website: www.primadiagnostic.com

Email: order@primadiagnostic.com

Telephone: +86-025-83112152

WeChat Public Account: Available (search "普睿玛生物")

Business Scope

Licensed projects: Health food production; special medical purpose formula food production; medical services; Class III medical device production; internet hospital services based on physical hospitals; food sales; Class II medical device production; Class III medical device operation; Class III medical device leasing; inspection and testing services.

General projects: Goods import and export; health food (pre-packaged) sales; technology import and export; import and export agency; cell technology research and application; medical research and experimental development; bio-based material sales; technical services, technology development, technology consultation, technology exchange, technology transfer, technology promotion; Class I medical device production; information technology consulting services; Class I medical device sales; new material technology research and development; software development; experimental analysis instrument sales; Class II medical device sales; cosmetics retail; sanitary products and disposable medical supplies sales; intelligent instrument and meter sales; health consultation services (excluding diagnosis and treatment services); environmental protection monitoring; network technical services; computer software and hardware and auxiliary equipment wholesale; computer software and hardware and auxiliary equipment retail; information system integration services; information consulting services (excluding licensed information consulting services); drug testing instrument manufacturing; drug testing instrument sales; experimental analysis instrument manufacturing; Class II medical device leasing; Class I medical device leasing; metal structure sales; technology promotion and application services.

2026 Outlook and Strategic Priorities

Strategic Focus Areas

- Integrated Ecosystem: Build the "reagent + equipment + data" integrated ecosystem, driving pathology diagnostics from precision to intelligence

- Product Pipeline: Continue expanding the IHC antibody reagent portfolio and automated equipment lineup

- AI Development: Advance pathology AI-assisted diagnostic systems through university collaborations

- Companion Diagnostics: Strengthen PD-L1, HER2, and emerging biomarker detection capabilities for precision medicine

- Market Expansion: Extend coverage from domestic hospitals to broader clinical and research markets

Competitive Advantages

- Proprietary Technology: Proprietary ExactBiofusion antibody technology providing differentiated IHC solutions

- Full Product Matrix: Comprehensive coverage from tumor markers to infectious disease screening to companion diagnostics

- Equipment + Reagent Integration: PM2000B Plus stainer optimized for Prima's proprietary reagents, ensuring workflow efficiency

- Research Collaborations: Strong ties with top-tier medical universities and research institutions

- Technology Enterprise: Innovation-focused company advancing pathology diagnostics standards

Risk Factors

- Market Competition: Intense competition from established IHC reagent manufacturers (e.g., Fuzhou Maixin, Beijing Jiujiang)

- Scale Constraints: Relatively small team size (10 insured employees) may limit Rapid scaling

- Regulatory Compliance: Continuous need to maintain and renew medical device registrations

- Technology Validation: Need for extensive clinical validation to gain market trust as a newer market entrant

Contact Information

Headquarters

Address: Room 502, Building C5, Hongfeng Science and Technology Park, No. 1 Zhixin Road, Nanjing Economic and Technological Development Zone, Nanjing, Jiangsu, China
   Postal Code: 210046
   Tel: +86-025-83112152
   Email: order@primadiagnostic.com
   Website: www.primadiagnostic.com

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