The R&D Center of Shanghai Reigncom Biotech is led by Ph.D. experts with overseas experience and upholds the spirit of “continuous innovation and striving for excellence.” The center has established a full-spectrum biochemical reagent development platform, a globally leading clinical mass spectrometry technology platform, and a third-party quality control development platform. Its core product lines rank among the top in the domestic clinical diagnostics market. The center actively collaborates with leading enterprises and academic institutions at home and abroad to jointly develop innovative and economically valuable diagnostic reagent kits tailored for clinical use. Strategic partnerships include Thermo Fisher Scientific (a Fortune Global 500 company), industry-academia collaborations with Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, and co-founding of the Clinical Mass Spectrometry Joint Laboratory with Xuhui District Central Hospital. The center has undertaken numerous scientific research projects funded by municipal, district-level, and Zhangjiang innovation programs, with multiple R&D achievements recognized as High-Tech Transformation Projects in Shanghai.
To date, the company has obtained 42 intellectual property rights, including 23 authorized invention patents, 16 utility model patents, and 3 design patents.
Looking ahead, Shanghai Reigncom Biotech will continue to deepen its focus on precision medicine, enhance its independent innovation capabilities, and develop advanced diagnostic products that align with market needs in precision healthcare.
Reigncom has developed over 100 biochemical reagent kits and obtained Class II medical device registration certificates. These products cover a broad range of diagnostic categories, including glucose metabolism, blood lipids, liver and kidney function, cardiac enzyme panels, pancreatic function, rheumatology, and blood gas and electrolytes. A leading latex-enhanced immunoturbidimetry R&D platform has been established, resulting in several invention patents in “high-sensitivity latex-enhanced turbidimetry.” These innovations have significantly improved detection precision at the nanogram level, offering superior reagent stability, higher sensitivity, broader linear ranges, and stronger anti-interference capabilities. Diagnostic kits have been developed for clinical application, particularly in tumor markers and reproductive health.
Recognized High-Tech Achievement Transformation Projects in Shanghai include:
Shanghai Ridge Technology has developed over 30 diagnostic products on its liquid chromatography–tandem mass spectrometry (LC-MS/MS) platform, covering a wide range of clinical needs such as fat- and water-soluble vitamins, steroid hormones, catecholamines and their metabolites, amino acid profiles, bile acids, and therapeutic drug monitoring (TDM). Compared to conventional immunochemical methods, LC-MS/MS offers high accuracy, high sensitivity, and the ability to detect multiple targets in a single injection, and is recognized as the reference method in the industry.
Ridge holds proprietary Class II medical device registration certificates for its clinical mass spectrometry instrument—the RZ-500 Ultra-High Performance Liquid Chromatography Tandem Mass Spectrometry System—and the AUTOMAN ELITE fully automated sample processing system. Among the developed products, 10 have received Class II registration certificates and the rest are registered Class I products. All are in commercial production and are widely used in hospitals and third-party laboratories with excellent customer feedback.
Rebio works in close collaboration with leading experts and laboratories globally to develop and support quality control and traceability solutions in the in-vitro diagnostics (IVD) field. It offers advanced technical services and leading clinical laboratory quality management solutions, including ISO 15189 compliance consulting. The product range currently covers key IVD segments including immunodiagnostics, biochemical diagnostics, and molecular diagnostics.