IVD China last week: Orient Gene, Wondfo Biotech, Shanghai Biomed & Kanghua Bio, Wuhan Union Hospital, ByteDance

Orient Gene's Respiratory Multiplex Tests Get Approved in New Zealand and Brazil

Recently, some partner clients of Orient Gene have obtained registration approval from New Zealand’s Medsafe (Medicines and Medical Devices Safety Authority) for two respiratory virus multiplex self-test kits, allowing them to enter the market.

In addition to New Zealand, Healgen Scientific LLC, a U.S. subsidiary of Orient Gene, has also secured approval from Brazil’s ANVISA (National Health Surveillance Agency) for its COVID-19/Influenza A&B Triple Test, enabling its commercialization in Brazil.

Wondfo Biotech’s Dengue Fever Rapid Diagnostic Solution

As the first Chinese company to obtain full regulatory approval for its dengue fever rapid test series, Wondfo Biotech pioneered the innovative "Antigen + Antibody" combo detection technology. This breakthrough solution enables simultaneous detection of NS1 antigen, IgM and IgG with results in just 15 minutes - requiring only a single sample collection to distinguish between primary and secondary dengue infections.

Shanghai Biomed Acquisition Fund Plans to Acquire 21.9% Stake in Kanghua Bio for RMB 1.85 Billion

On the evening of July 20, Kanghua Biotechnology Products issued an "Announcement on Progress of Planned Change of Control and Trading Resumption", stating that trading of its shares would resume on Monday, July 21, 2025.

Wankexin Biotech intends to acquire a total of 28,466,638 shares (representing 21.91% of total outstanding shares) through negotiated transfer using self-owned and raised funds.

World's First Ultra-High Sensitivity Test Kit Developed by Wuhan Union Hospital

When a septuagenarian presented with fever, fatigue, and muscle pain, the initial diagnosis suspected Severe Fever with Thrombocytopenia Syndrome (SFTS) caused by a tick bite. However, confirmation required viral nucleic acid testing. Due to limited resources at the primary care facility, the test results were delayed, and the patient's condition progressively worsened, developing symptoms like slurred speech and limb tremors.

The breakthrough came with Wuhan Union Hospital's independently developed viral nucleic acid test kit, which delivered results in just 45 minutes, confirming SFTS diagnosis. Subsequent lab reports fully validated this finding. After days of targeted treatment, the patient's condition has significantly improved.

ByteDance Invests 6 Billion Yuan to Build Smart Hospital

A groundbreaking ceremony marked the launch of Airui International Medical Complex, RMB 6-billion healthcare megaproject spanning 11.37 hectares in Zhongguancun Digital Health Industrial Park, Chaoyang District.

This flagship development represents the first hospital project under ByteDance's healthcare subsidiary MeiZhongYiHe since acquisition, and a Beijing 2025 Key Infrastructure Project featuring 800 beds across 224,000 sqm, slated for 2029 completion.