Shanghai Reigncom Biotech Co., Ltd. (the “Company”) is a high-tech enterprise specializing in the research and development, production, sales, and related technical services of medical diagnostic equipment and clinical in vitro diagnostic reagents. Reigncom was founded in September 2011 and is located in Pujiang Hi-Tech Park, Caohejing Development Zone, Shanghai.
We operate first-class, standardized, large-scale manufacturing plants and R&D laboratories, with several subsidiaries located in Shanghai, Tianjin, and Silicon Valley. We have established a high-standard quality assurance system and passed the TÜV SÜD ISO13485 certification. The R&D, production, and management teams are all led by Chinese and international experts with PhDs.
We established a comprehensive biochemical reagent development platform with independent research and development at its core, particularly leading in the domestic latex-enhanced immunoturbidimetry platform. We obtained nearly 100 registration certificates for Class II biochemical reagent medical devices. We have built a globally leading clinical mass spectrometry development platform, owning self-branded Class II medical device registrations for instruments including the ultra-high performance liquid chromatography tandem mass spectrometry system RZ-500 and the fully automated sample processing system AUTOMAN ELITE. More than 30 Class I and II clinical mass spectrometry reagents have been registered or filed, positioning us at the forefront of Chinese clinical mass spectrometry development. Additionally, we have established an international-standard third-party quality control product development platform, offering a wide range of stable and high-quality QC products.
We have undertaken numerous scientific and technological innovation projects funded by Shanghai municipal and district science and technology commissions and Zhangjiang Special Development Funds. Several R&D achievements have been recognized as Shanghai High-Tech Achievement Transformation Projects. Dozens of technologies and products have been awarded national invention patents. We have been consecutively recognized as a "High-Tech Enterprise" for many years, and have received honors including "Specialized and New Enterprise" of Shanghai, "Innovative SME" of Shanghai, "Shanghai Patent Work Pilot Enterprise," "30-Year Star Innovation Enterprise of Shanghai Science and Technology Business Incubator," "Minhang District Patent Work (Intellectual Property Education) Demonstration Unit," and "Minhang District Science and Technology Little Giant Enterprise," among others.
We collaborate extensively with overseas research institutions, renowned enterprises, and leading domestic clinical institutions and scholars to establish a clinical mass spectrometry R&D and application exploration alliance. We are committed to addressing clinical application challenges of mass spectrometry technology and providing a comprehensive clinical mass spectrometry IVD product solution covering the entire workflow of sample pre-processing, instruments, reagents, software, and services. Furthermore, we strive to achieve compliance, standardization, and automation in clinical mass spectrometry, and aim to become a leader in this field.
To uphold our vision of “Science Elevates Lives," we are establishing a long-term, efficient and mutually beneficial business cooperation platform nationwide. We are open and look forward to partnering with like-minded collaborators for mutual growth, leveraging leading technology services to contribute to China’s healthcare industry.
Science Elevates Lives
Integrity、Pragmatism、Pursuing Excellence
We respect science, embrace innovation, and provide clinical diagnostic products that drive medical advancement with a reverence for life.
Empowering China’s health industry through leading-edge technology and professional services.
Founder and Chairman of Shanghai Reigncom Biotechnology Co., Ltd., Mr. Li has over 30 years of experience in the in vitro diagnostics (IVD) industry. Since the company's inception, he has invested in and established multiple subsidiaries in China and Silicon Valley focused on IVD reagent and instrument R&D and manufacturing. He was among the first to develop a mass spectrometry-based diagnostic platform in the IVD field, promoting precision diagnostics and steering industry advancement with a global perspective.
Prior to founding Reigncom, Mr. Li held key positions at Shanghai Kehua Bio-engineering Co., Ltd., including Supervisor, Director, and General Manager of Marketing. He led national marketing efforts, built an extensive sales network across China, and drove continuous innovation that enabled breakthrough business growth—laying a solid foundation for Kehua to become the first listed IVD company in China.
As one of the first successful entrepreneurs in China's IVD industry, Dr. Li is widely respected for his deep professional insight, hands-on expertise, long-term strategic vision, and unwavering commitment to scientific advancement.
Chief Scientific Officer (CSO) of Shanghai Reigncom Biotech and CEO of Shanghai Ridge Technology. He is also a part-time professor at Shanghai Jiao Tong University School of Medicine and a recognized overseas high-level talent in Shanghai.
Dr. Xie has over 20 years of experience in mass spectrometry research, application development, and market expansion. He previously led the global clinical mass spectrometry application team at Thermo Fisher Scientific in the U.S., where he developed more than 100 clinical mass spectrometry methods. He holds a Ph.D. in Biochemistry and Molecular Biology from Peking University, completed postdoctoral research at the University of Michigan, and attended executive education at Stanford University Graduate School of Business.
He has authored over 20 peer-reviewed publications in the field of mass spectrometry, holds six invention patents, co-edited Clinical Applications of Liquid Chromatography–Mass Spectrometry, and served as lead author for the Expert Consensus on Mass Spectrometry-Based Detection of Androgens in Polycystic Ovary Syndrome.
Dr. Xie currently serves on several professional committees, including the Mass Spectrometry Group of the Medical Laboratory Quality Management Committee under the China Pharmaceutical Quality Management Association, the Therapeutic Drug Monitoring Committee of the Shanghai Pharmacological Society, and the CACLP Mass Spectrometry Subcommittee.
Tel
021-60838199
Customer Service Line
400-839-8199
Fax
021-60705089
Address
Floor 3&4, 1st Building of Building 1,
NO.3279 Sanlu Road, Minhang District,
Shanghai, China（201112）