Company Profile
Shanghai Rendu Biotechnology Co., Ltd. is a China-based manufacturer of RNA molecular diagnostic reagents and automated detection systems, headquartered in Shanghai, China. Founded on June 13, 2007 by Dr. Jingliang Ju (居金良), the company operates as a publicly listed entity on the Shanghai Stock Exchange STAR Market (688193) with approximately 239 employees, serving global molecular diagnostics markets across reproductive, respiratory, digestive, and blood-borne disease testing.
Core Products ＆ Technologies
Automated SAT Detection Systems
• AutoSAT: Fully automated sample-to-result nucleic acid detection and analysis system delivering first results in 90 minutes and 200 tests in 8 hours; integrates extraction, amplification, and detection for high-throughput molecular diagnostics
• SuperSAT: Fully automated isothermal nucleic acid amplification analysis system; NMPA approved (March 2025, No. 国械注准20253220599) for streamlined RNA pathogen detection
• NAPure96: Automated nucleic acid extraction system for high-purity sample preparation upstream of SAT assays
RNA Molecular Diagnostic Reagents
• Reproductive Health: SAT-based RNA detection kits for Chlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, and Mycoplasma genitalium from urine or swab samples
• Respiratory Infections: Mycobacterium tuberculosis, Mycoplasma pneumoniae, and Influenza A virus RNA detection kits; TB SAT kit is a leading RNA-based tuberculosis diagnostic
• Blood-Borne Diseases: HBV RNA, HCV RNA, and HIV-1 RNA quantitative detection kits utilizing SAT technology; HBV RNA kit features 50 copies/mL sensitivity without DNase treatment or DNA interference
• Enterovirus: Coxsackievirus A16 and Enterovirus 71 RNA detection kits for hand, foot, and mouth disease surveillance
Emerging Oncology ＆ Digital Platforms
• ddSAT Digital RNA Quantification: Digital SAT technology for ultra-sensitive absolute quantification of RNA targets; applied to prostate cancer and bladder cancer urine-based screening
• MiniSAT: Compact isothermal amplification device for small-to-mid-size laboratories and point-of-care settings
Market Position ＆ Certifications
Rendu Biotechnology holds a pioneering domestic position in China's RNA molecular diagnostics market as one of the earliest developers of RNA isothermal amplification technology, competing with Roche Diagnostics (cobas) and Abbott Molecular in molecular IVD. Key strengths include:
• 19 years of Chinese RNA diagnostics innovation heritage since founding
• Proprietary SAT platform: RNA real-time fluorescent isothermal amplification technology with 43 invention patents; detects viable pathogens by targeting RNA with higher sensitivity than DNA-based PCR
• Regulatory compliance: 17 NMPA Class III registrations and 20 Class I filings; 37 total domestic medical device registrations; 6 CE-IVD certifications under Directive 98/79/EC; ISO 13485:2016 quality management
• Hospital adoption: Products deployed in 500+ medical institutions across China, 70% of which are Tier 3 Grade A hospitals
• National recognition: Designated as a National Specialized and Innovative "Little Giant" Enterprise (2021, re-certified 2024); Shanghai Municipal Technology R＆D Center; listed in the National Innovative Medical Device Catalogue
Corporate Timeline
2007 — Founded in Shanghai Zhangjiang Hi-Tech Park, China
2012 — Launched first SAT-based RNA diagnostic reagents for reproductive and respiratory pathogens
2018 — AutoSAT fully automated system listed in the National Innovative Medical Device Catalogue
2020 — Reorganized as a joint-stock company
2022 — Completed IPO on the Shanghai Stock Exchange STAR Market (688193), raising RMB 726.5 million
2023 — Recognized as a National Specialized and Innovative "Little Giant" Enterprise; designated as Shanghai Municipal Technology R＆D Center
2024 — Debuted prostate and bladder cancer ddSAT screening products at AACC Chicago; expanded international market presence
2025 — SuperSAT received NMPA registration approval (March); full-year revenue RMB 161.9 million; reported net profit of RMB 10.1 million (turnaround from 2024 loss); HBV RNA and HCV RNA solutions showcased at APASL Beijing
2026 — Announced controlling shareholder planning control change, trading halted (May 8); released Q1 2026 results showing revenue and net profit YoY growth
Target Markets ＆ Applications
• Reproductive Health: Non-invasive urine-based RNA screening for sexually transmitted infections (CT, NG, UU, MG) in obstetrics, gynecology, and urology clinics
• Tuberculosis Control: AutoSAT and TB SAT reagents for rapid, high-throughput Mycobacterium tuberculosis detection in pulmonary and extrapulmonary samples
• Hepatitis Management: HBV RNA quantitative monitoring for antiviral therapy efficacy assessment and functional cure prediction in chronic hepatitis B
• Pediatric Infectious Disease: Enterovirus RNA detection for hand, foot, and mouth disease outbreak surveillance
• Oncology Screening (Emerging): ddSAT urine-based tests for prostate cancer (PSA gray zone) and bladder cancer post-surgery recurrence monitoring
Contact Information
Global Headquarters
Address: Building 15 Yi, No. 528 Ruiqing Road, East Zone, Zhangjiang Hi-Tech Park, Shanghai 201201, China
Telephone: +86 21 5072 0200
Fax: +86 21 5072 0069
Email: ir@rdbio.com
Corporate Status
Entity Type: Publicly Listed Company (No Parent Company)
Stock: Shanghai Stock Exchange STAR Market: 688193
Website: rdbio.com
Investor Relations: ir@rdbio.com
