Company Profile
Jiangsu Weihe Biotechnology Co., Ltd. is a China-based manufacturer of molecular in vitro diagnostic (IVD) reagents, headquartered in Taizhou, Jiangsu, China. Founded on April 3, 2014 by molecular immunology experts with Wang Hao as legal representative, the company operates as an independent private entity (limited liability company with Hong Kong, Macao and Taiwan investment), serving global transplant and transfusion medicine markets as a pioneer in China's molecular diagnostics industry for transplantation and immunohematology.
Core Products ＆ Technologies
HLA Genotyping ＆ Transplant Diagnostics
• HLA Genotyping Kit (Fluorescence PCR Method): NMPA Class III innovative medical device (approved April 27, 2026) for qualitative detection of HLA-A, B, C, DRB1, and DQB1 loci from whole blood, supporting solid organ transplant donor-recipient matching; registration certificate No. 国械注准20263400857
• HLA-B*5801 / B*27 Nucleic Acid Detection Kits: NMPA Class III kits (approved April 2023) for pharmacogenomic screening of allopurinol hypersensitivity and ankylosing spondylitis risk assessment
• HLA SBT ＆ NGS Typing Kits: High-resolution HLA class I and II gene sequencing-based typing reagents for hematopoietic stem cell transplantation
• HLA ＆ HPA ＆ RBC Blood Group NGS Panel: Next-generation sequencing reagents for comprehensive transplant and transfusion immunogenetics
Transfusion ＆ Immunohematology
• HPA Genotyping Detection Kit: Quadruple fluorescent PCR assay for human platelet antigen (HPA-1 to HPA-21) typing to manage platelet transfusion refractoriness
• ABO / H Blood Group Genotyping Kit: PCR-sequencing assay for ABO, FUT1, and FUT2 genotyping in transfusion medicine
• KIR Genotyping Kit (Fluorescence Probe qPCR): Killer-cell immunoglobulin-like receptor typing for natural killer cell compatibility in transplantation
NGS ＆ Intelligent Platforms
• WH-SEQ-G99 NGS Platform: High-throughput sequencing system for HLA and blood group genotyping developed in partnership with MGI Tech
• DNBSEQ-AIO Integrated Sequencer: All-in-one library-preparation and sequencing platform for transplant and transfusion diagnostics
Market Position ＆ Certifications
Jiangsu Weihe holds a pioneering domestic position in China's transplant and transfusion molecular diagnostics market, competing with Immucor (Werfen) and One Lambda (Thermo Fisher Scientific) in HLA typing. Key strengths include:
• 12 years of Chinese molecular diagnostics heritage in transplantation and immunohematology
• Innovative device recognition: HLA genotyping kit approved via NMPA Innovation Medical Device Special Review Program (green channel) on April 27, 2026; registration certificate No. 国械注准20263400857
• Regulatory compliance: Complete IVD registration system spanning Class II and Class III NMPA certificates; EU CE marking for select products
• National reference standards: Commissioned by the National Institutes for Food and Drug Control (NIFDC) to develop national reference materials for HLA-B27 and HLA-B5801/5701/1502 nucleic acid detection
• Manufacturing capacity: Approximately 1,000㎡ standard laboratories; approximately 1,000㎡ Class 10,000 and Class 100,000 cleanrooms with Class III nucleic acid and Class II protein IVD production lines
Corporate Timeline
2014 — Founded in Taizhou, China Medical City, focusing on molecular diagnostics for transplantation and transfusion
2017 — Completed Series A financing led by Caijin Capital
2021 — Completed equity financing from Jiuzhao Kangqian
2023 — Obtained NMPA Class III certificates for HLA-B*5801 and B*27 kits; established strategic partnership with MGI Tech
2024 — Completed tens of millions RMB financing; HLA genotyping kit entered NMPA Innovation Special Review Program
2025 — Launched WH-SEQ-G99 and DNBSEQ-AIO NGS platforms with MGI Tech; recognized as Jiangsu Province Specialised and Innovative SME
2026 — HLA genotyping kit (fluorescence PCR) approved as NMPA Class III innovative medical device (April 27)
Target Markets ＆ Applications
• Solid Organ Transplantation: HLA-A/B/C/DRB1/DQB1 typing for kidney, liver, and other organ transplant donor-recipient compatibility assessment
• Hematopoietic Stem Cell Transplantation: High-resolution HLA class I and II typing for bone marrow and cord blood transplant matching
• Precision Transfusion: HPA and HLA genotyping for platelet transfusion refractoriness management and compatible donor selection
• Pharmacogenomics: HLA-B*5801 screening for allopurinol hypersensitivity and HLA-B*27 detection for ankylosing spondylitis diagnosis
Contact Information
Global Headquarters
Address: 2F East, G57 Building, No. 75, China Medical City, Taizhou, Jiangsu, China
Telephone: 0523-86201335
Email: wanghao@wehelpinc.com
Website: wehelpinc.com
Corporate Status
Entity Type: Independent Private Company (No Parent Company)
Stock: Not Publicly Traded
Registered Capital: RMB 7.252418 million
Unified Social Credit Code: 91321291094046674U
