Shanghai Upper Bio-Tech Pharma Co., Ltd. (Upper Bio-Tech) is a high-tech company specializing in the R&D, production and sale of Point-of-Care Testing (POCT) reagents and devices, as well as healthcare big data services.
In 2001, the Upper Bio-Tech founder team led by Xu Jianxin started business in Shanghai Zhangjiang Torch Entrepreneurship Park. For more than a decade, Upper Bio-Tech has transformed itself from an agent to an R&D-minded business and finally to an independent innovator, contributing nearly 100 million RMB worth of tax revenue. Currently, it has over 280 employees, more than 60 percent of whom are college graduates and over fifty of whom hold a master’s or doctoral degree, making Upper Bio-Tech a pioneer in China’s POCT industry.
Upper Bio-Tech has developed six series of nearly 40 products under two categories, which are mainly used for fast clinical quantitative detection of coronary artery diseases (CAD) and inflammation and infectious diseases. To some extent, it has broken the monopoly of the international giants by providing effective substitutes, with some of its products representing the highest level of innovation. Its products are supplied to more than 10,000 hospitals nationwide and exported to more than 40 countries in the EU and Southeast Asia, serving over 50 million patients each year. They have been recognized as “National New Products”, “Shanghai New Products”, “Shanghai SME Brand Products” and “Excellent Domestic Medical Devices”.
Upper Bio-Tech has been certified as having Good Manufacturing Practice (GMP) by the State Food and Drug Administration (SFDA) and granted ISO9001 and ISO13485 certifications by TÜV Rheinland. All products have obtained CE marking. It has an 1800 square meter purification workshop and P3 biological laboratories, as well as an advanced working environment, cutting-edge instruments and high-performance test equipment for product development. With an advantageous R&D environment and rich experience in POCT product development, Upper Bio-Tech has been recognized as a “Shanghai Specialized, Sophisticated, Special and Novel SME” and “Shanghai Patent Affairs Pilot/Demonstration Unit”. The company has published two academic works, which redefined the POCT industry and advanced the issuance of national standard GB/T 29790-2013: Point of Care Testing (POCT) -- Requirements for Quality and Competence. It has established a core technology platform with independent intellectual property rights, applied for nearly 200 patents and trademarks, and won four S&T Progress Awards.
In 2018, Upper Bio-Tech was approved as a Pudong New Area Corporate Postdoctoral Research Substation. Its CRP+SAA joint detection drew high attention at the 10th National Conference of Clinical Laboratory Management. In November, Upper Bio-Tech joined the Editorial Board of POCT Progress and Practice, was invited to the TV program Observation, and won a “Pudong New Area Innovation Award”.
Looking ahead, leveraging the open policies and institutional innovation of the China (Shanghai) Pilot Free Trade Zone and the synergy of the biomedical industry cluster in Zhangjiang, Upper Bio-Tech will further enhance independent innovations and speed up the integrated development of capital, technology and markets, so as to realize “corner overtaking” in the medical devices industry and make a larger contribution to the implementation of national and municipal strategies.