- CEO
- Shu Jiang Wu
- Full Time Employees
- 613
- Sector
- Health technology
- Industry
- Medical specialties
- Address
- 27 Tuyi Road Hangzhou Zhejiang Province China 311100
- IPO Date
- Sep 8, 2021
- Business
- Hangzhou Biotest Biotech Co., Ltd. (688767.SS) engages in the research, development, production, and sale of in vitro diagnostic (IVD) reagents and point-of-care testing (POCT) products. Founded in 2008 and headquartered at No. 17 Futai Road, Zhongtai Street, Yuhang District, Hangzhou, China, the company offers a comprehensive portfolio spanning five core categories: infectious disease testing for over 32 pathogens including SARS-CoV-2, HIV, HBV, HCV, syphilis, malaria, dengue, and influenza A+B in strip and cassette formats using specimens such as whole blood, serum, plasma, feces, and nasal aspirate; drug abuse testing covering 51 products like acetaminophen, adulteration, alcohol, amphetamine, barbiturates, benzodiazepines, buprenorphine, cocaine, and cotinine, including hair screening and multi-drug cassettes for urine, hair, and saliva; fertility and women's health testing including FSH, hCG, LH, Chlamydia/Gonorrhea, Rubella, Toxo, HSV, CMV, ToRCH, Vaginosis pH, Strep B, and IGFBP-1; tumor marker testing such as AFP, CEA, FOB, Hb/NOB/TF, PSA, CA15-3, lactoferrin, and ferritin; and cardiac marker testing encompassing NT-proBNP, CRP, D-Dimer, CK-MB, Myoglobin/CK-MB/Troponin I, MYO, cTnI, and H-FABP. These POCT rapid diagnostic reagents leverage colloidal gold/latex/fluorescent particle technologies, immunochromatography, and monoclonal antibodies for high specificity, sensitivity, speed, and cost-effectiveness without requiring specialized equipment, serving hospitals, clinics, judicial systems, CDC centers, blood stations, third-party labs, and private practices. The company also provides veterinary test kits, fluorescence immunoassay rapid test kits, instruments, and is expanding into molecular diagnostics and animal disease platforms.
Geographic operations span over 100 countries across Asia, North America, Europe, South America, Africa, and other regions, with products holding NMPA registrations in China, EU CE-IVDR certifications covering 603 items, and US FDA 510(k) clearances for 21 tests. In recent developments, Hangzhou Biotest Biotech listed on the Shanghai Stock Exchange STAR Market in 2021; achieved EU IVDR certification for its first 69 products, primarily in drug abuse testing with extensions to infectious diseases, women's health, and tumor markers, in 2023; earned recognition as a Zhejiang Province Enterprise Technology Center, specialized and innovative enterprise, and manufacturing "cloud enterprise" in 2023; broke ground on new R&D and marketing centers in 2023; secured German PEI No. 1 sensitivity for COVID-19 antigen tests, EU self-testing CE for saliva kits, and US FDA EUA for at-home COVID-19 antigen tests during 2020-2022; and completed the 2015 acquisition of US-based Advin Biotechnology Co., Ltd. to bolster global R&D capabilities in Silicon Valley. The firm maintains 230+ patents (including 16 invention patents), invests 13.4% of staff in technical roles across 85,000 square meters of facilities with 900+ square meters of clean workshops, and continues strategic expansions in automation, biologics, and international certifications.