Shanghai Kehua Bio-engineering Co Ltd - Company Profile
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Business Description
Shanghai Kehua Bio-engineering Co Ltd (KHB) develops, manufactures and markets in vitro diagnostic (IVD) devices and related diagnostic reagents and kits. It divides its products into five categories: Signature product, Clinical Chemistry, CLIA (Chemiluminescence Immunoassay), ELISA (Enzyme-Linked Immunosorbent Assay), Colloid Gold (POCT), Molecular Diagnostics, and Veterinary Diagnostics. The company's signature products categories offer the Polaris LAS, an HIV(1+2) Colloidal Gold V2 kit, an ELISA HBV kit, and a renal management solution. The Clinical Chemistry provides the ZY-260, ZY-400, ZY-1200, and Polaris c1000 automatic analyzers. The CLIA line includes the Polaris V150 and i2400 analyzers alongside a dedicated reagents test menu. The ELISA hardware consists of the ST-360 and ST-960 microplate readers, plus the ST-36W and ST-96W washers. Colloidal Gold (POCT) offerings cover HIV V2, an HIV self-test, and HBsAg and HCV antibody kits. Molecular Diagnostics comprises Tianlong integrated solutions, a multi-target HBV/HCV/HIV PCR kit, and a dedicated HIV-1 PCR kit. Finally, their Veterinary Diagnostics sector features the Pegasus MF200 multifunctional analyzer.
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R&D Overview
KHB is engaged in several R&D initiatives aimed at enhancing its product offerings and competitiveness in the in vitro diagnostics (IVD) industry. The company is focusing on the development of a cerebrospinal fluid/urine total protein measurement reagent kit, a zinc assay kit, and leucine aminopeptidase detection kits for kidney and liver function diagnostics. These projects are expected to be listed between the first and third quarters of 2025, with the goal of obtaining product certification listings. The anticipated impact includes improved product packages for kidney and liver functions, enhanced competitiveness, and the provision of systematic solutions for clients. The R&D units of Shanghai Kehua Bio-engineering Co., Ltd. include 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. These units are responsible for managing the company's R&D activities, focusing on independent research, innovation, and the development of new diagnostic solutions. The company operates R&D and manufacturing bases in multiple locations, including Xian, Suzhou, the Greater Bay Area, Italy, and South Korea. It has built a robust product portfolio with over 100 self-developed diagnostic instruments and more than 700 diagnostic reagents. KHB's products have obtained over 300 Chinese medical device registrations and filings, as well as more than 600 international certifications. The company has established strategic partnerships with leading international IVD enterprises to foster collaborative innovation and technology co-development. In FY2025, the company spent CNY189.6 million in its R&D activities, which is 11.5% of the company's total revenue, and declined 4.6% YoY.
Product Categories
Performance
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Geographical Segments
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Performance
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