About Jingzhun Bio

Master distribution and sales authorization

As the master distributor within the Kangsheng Yanxuan system, Jingzhun Bio has been granted sales authorization for 165 products (devices for which no Notified Body certificate was required in the IVDD era, listed in the TÜV Rheinland NB 0197 confirmation letter). The EU regulatory status of these products is "listed in a Notified Body confirmation letter" (TÜV Rheinland, NB 0197), with Kangsheng Information Technology (Hangzhou) Co., Ltd. (SRN: CN-MF-000053775) as the legal entity; see the regulatory note on the product portfolio page.

Focus and direction

Our portfolio addresses respiratory and gastrointestinal infections, sexually transmitted diseases, tropical infectious diseases (dengue, malaria, cholera and more), fertility and women's health, inflammation and cardiac markers, coagulation, and drugs-of-abuse testing — 15 testing application categories in total, with 165 products listed in the Notified Body confirmation letter (TÜV Rheinland, NB 0197).

Technology platform 1: isothermal amplification + CRISPR (RAA + CRISPR)

We have established a molecular POCT platform based on RAA (recombinase-aided amplification, an isothermal method) and CRISPR: RAA rapidly amplifies target nucleic acids at a constant temperature without complex thermal-cycling equipment, while the CRISPR-Cas system specifically recognizes the target base sequence and, upon binding, is activated to produce a detectable signal — effectively avoiding cross-reactions. We have completed prototype development and preliminary methodological evaluation of molecular diagnostic reagents for all four dengue virus serotypes (DENV-1/2/3/4) (nucleic acid test strips and fluorescent reagents; in development — not on the market, registration not yet initiated), with the methodological evaluation performed on clinical samples (not a registration clinical trial).

Dengue reagent performance (in development, not yet on the market; methodological evaluation data)

• Sensitivity 95.8%, specificity 100%
• Time to result: reduced from 2–3 hours (qPCR) to 20–30 minutes
• LoD (limit of detection): 500 copies/mL for fluorescent reagents; 1,000 copies/mL for nucleic acid test strips (20 plasma samples per DENV 1–4 serotype)

Platform highlights

• Sensitivity: detects low concentrations of pathogen nucleic acids, with a measured LoD of 500 copies/mL (fluorescent reagents), supporting early diagnosis.
• Specificity: based on CRISPR-specific recognition of the target base sequence, reducing the risk of cross-reactions.
• Fast and convenient: isothermal amplification with an integrated kit design typically delivers results in 20–30 minutes.
• Highly extensible: switching primers and crRNA extends the platform to nucleic acid detection of different pathogens.
• Wide application scenarios: suitable for laboratories and on-site testing.

R&D pipeline

Multiple early-stage products are under development: public-health/CDC directions (influenza virus, respiratory syncytial virus, adenovirus, Mycoplasma pneumoniae and more), animal and pet testing (canine/feline parvovirus, Toxoplasma, Mycoplasma, herpesvirus and more) and border quarantine (plague, Ebola virus, etc.).

Based on our proprietary platform and authorized product portfolio, we engage in product sales, collaborative R&D, co-development and custom development, among other forms of cooperation.

Manufacturing and quality

We work with GMP-compliant production facilities equipped with ISO Class 8 cleanroom laboratories, supporting an annual capacity of up to 10 million tests. Our quality management system operates in line with ISO 13485 and ISO 9001 standards, with process control from raw materials to finished goods. The production site and facilities are owned by our contracted manufacturing partner; the photographs on this page are provided by that partner.

Production and R&D facilities at a glance

• GMP-compliant reagent manufacturing environment
• ISO Class 8 cleanroom laboratory areas
• Annual capacity of up to 10 million tests
• Quality management under ISO 13485 and ISO 9001 systems
• In-process and finished-product quality control before release

Photographs on this page are provided by our contracted manufacturing partner and are real photos of that partner's site; they are not Jingzhun Bio's own premises. Documentary evidence (certificates, capacity statements, audit reports and facility references) is available to qualified partners on request — please contact us via the quality and regulatory route on the contact page.

Global reach

Our products and services serve distribution and laboratory partners across Greater China, Europe, the Middle East, Africa, Southeast Asia and Latin America, including product supply, technical training and after-sales collaboration. To discuss cooperation, please visit our contact page.