Shanghai Kehua Bio-engineering Co., Ltd. (KHB) was established in 1981 and is headquartered in Shanghai, China. In 2004, the company was listed on the Shenzhen Stock Exchange (stock code: 002022.SZ), becoming the first publicly listed company in China's in vitro diagnostics (IVD) industry. Through strategic investments and overseas acquisitions, the group now operates nearly 40 subsidiaries and employs around 2,000 staff. It has established R&D and manufacturing bases in Xi'an, Suzhou, the Greater Bay Area, Italy, South Korea, and other locations.

KHB focuses on five key areas: immunodiagnostics, clinical chemistry, molecular diagnostics, mass spectrometry, and point-of-care testing (POCT), providing comprehensive IVD solutions that integrate reagents, instruments, and services. The company was a pioneer in launching the first ELISA reagents for hepatitis B and hepatitis C and dual-liquid clinical chemistry reagents in China. It also received the first drug license in China for the blood nucleic acid screening products. Driven by innovation, the group has built a robust product portfolio with more than 100 self-developed diagnostic instruments and over 700 diagnostic reagents. To date, its products have obtained over 300 Chinese medical device registrations and filings, as well as more than 600 international certifications, including CE marking from the European Union and FDA clearance from the United States.

With over four decades of deep industry experience, KHB remains committed to independent R&D and innovation. It has received numerous honors, including the National Science and Technology Progress Award (Second Class), the Shanghai Science and Technology Award, and recognition as a National Intellectual Property Demonstration Enterprise. The company also serves as the National Postdoctoral Research Workstation, the Shanghai Municipal Enterprise Technology Center, the Shanghai Engineering Research Center for Immunodiagnostic Reagents, and the Shanghai Innovation Center for In Vitro Diagnostic Reagent Technology.

Through partnerships with renowned research institutions and leading hospitals—such as the Chinese Academy of Sciences, Tsinghua University, Shanghai Jiao Tong University, Fudan University, Peking Union Medical College Hospital, and Xijing Hospital—KHB has led or participated in hundreds of major national, provincial, and municipal scientific research projects. These include the National Key R&D Program, Major National Scientific Instrument Development Projects, Major Projects for the Prevention and Control of Infectious Diseases, and the National 863 Program. Many of the resulting innovations have been successfully translated into products.

Rooted in China with a global outlook, KHB serves over 10,000 healthcare institutions, blood centers, Centers for Disease Control and Prevention, and research organizations worldwide. Its solutions are widely used in clinical diagnostics, blood screening, public health, food safety, and scientific research. While consolidating its position in the Chinese market, the company is also accelerating its global expansion. KHB's products are now exported to over 100 countries and regions. Notably, its self-developed HIV diagnostic reagents have been prequalified by the World Health Organization (WHO PQ) and included in procurement lists by organizations such as UNICEF and USAID. The company has also established strategic partnerships with leading international IVD enterprises to foster collaborative innovation, resource sharing, and technology co-development—further driving product innovation and iteration.

Looking ahead, KHB will remain true to its mission of  "Care for Life, Dedicate to Excellence", with a vision to become a cornerstone in the global IVD industry. Guided by its core values—customer focus, innovation, collaboration, responsibility and pragmatism—the company will continue advancing precision medicine and contribute to the global pursuit of better health.